Drugs Off-Patent Reports

P HARMACEUTICAL
DRUG DEVELOPMENT

DRUGS
oFF-Patents

REPORTS
2000 ISSN 0793 694X

L O C U M P U B L I S H I N G H O U S E

Drugs Off-Patent Reports 2 Over USD $100 million

 Drugs Off-Patent Reports

Drugs Off-Patent Reports

First International Edition - 01.

First published and distributed in UK, US, EU, RSA, Israel and Japan in November 1996: by
Locum International Publishing House (Houston, Israel, South Africa). Second International
Edition - 02 (First to Fourth Print). Third International Edition - 04 (First to Fourth Print).
Fourth printing published and distributed in UK, US, EU, Israel, Asia, and Japan in January
2001 by Locum International Publishing House (Houston, Israel, South Africa) in Hard
Cover; Soft and Spiral Cover; Electronic Diskette; and e-mail attachment versions. All print
and electronic versions identical in content and format.
Copyright © 1995 - 2001, Handbook of Pharmaceutical Generic Development.
Text Copyright © 1995 - 2000, Handbook of Pharmaceutical Generic Development.
Illustration copyright © 1995 - 2000, Handbook of Pharmaceutical Generic Development.
Locum International Publishing House PO Box 874, 50 Gilad Street Kochav Yair 44864
Israel. - All right reserved.
ISSN 0793 8632
ISSN 0793 8640 - Electronic Version (Diskette, CD ROM and e-mail attachment version)
Handbook Development 24 volume series
General Generic Development ISSN Series number 0793 7407
General Generic Development ISSN Series number 0793 7792 - Electronic Issue (Diskette
and e-mail attachment version are identical in size and content to the printed hard or soft
cover version.)
Duplication: No part of this publication may be reproduced, stored in a retrieval
system or transmitted in any form or by any means, electronic, mechanical,
photocopying, microfilming, recording or otherwise, without the prior written
permission of the copyright owner or subject to the following conditions:
Authorization to photocopy items for internal or personal use or internal or personal
use of specific company personnel, is granted by Locum International Publishing
House, provided that the base fee of $1 per page is paid directly to the Copyright
Clearance Center (CCC) 222 Rosewood Drive, Danvers, MA 01923 USA. For
organizations that have been granted a photocopy license by CCC, a separate
system of payment has been arranged.
For additional information, contact the Publications Department Locum International
Publishing House; PO Box 874, 50 Gilad Street, Kochav Yair, 44864 Israel.

UK Fax: +(44) 207-900 2096

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Fax: +972-97-494 532
E-mail: info@locum. co. il
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handbooks@l o c u m u s a . com
Current Printing (last digit): 10 9 8 7 6 5 4 3.
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Ö PRINTED IN USA
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WARNING: THIS ISSUE A IS MULTIPLE PAGE UV ENCODED EDITION.
PRINTED IN IRELAND
PRINTED IN REPUBLIC OF SOUTH AFRICA

Drugs Off-Patent Reports 3 Over USD $100 million

 Drugs Off-Patent Reports

A IAGIM Drug
Development
Publication

Locum International
ISSN 0793 694X

DRUGS
over
$100m
Copyright ©1995-2001 by Locum
Publishing House Inc. All Rights
Reserved.

Neither this drug development letter nor

any part may be reproduced or
transmitted in any form or by any means,
electronic or mechanical, including
photocopying, microfilming and
recording, or by any information storage
and retrieval system, without the
permission of the publishers.

Locum International Publishers A L o c u m H o u s e P u b l i c a t i o n

Drugs Off-Patent Reports 4 Over USD $100 million

 Drugs Off-Patent Reports

PHARMACEUTICAL
DRUG DEVELOPMENT

DRUGS
OFF-Patents
Reports

2000 ISSN 0793 694X

[This report consists of 24 pages]

Drugs Off-Patent Reports 5 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
HOW THE CODES WORK
Generic Drug Products generally have two codes namely a PATENT USE Code and
an EXCLUSIVITY code. These two patent protection codes usually expire at quite
different times.

Generally when the New Chemical Entity (NCE) expires the Generic equivalent of
the Brand Leader may be manufactured after appropriate ANDA approval. However
several exclusivity's may be in force (i.e. the 'N' or 'D' codes) such as 'New Dosage',
'New Salt' or 'New Strength' etc. The 'D codes' apply to New Dosing Schedules and
are much less common.

Naturally the package insert of an on-market generic drug will not show a new
indication still protected by an I-code exclusivity. Thus I-code exclusivity's may run for
several years while the generic is being marketed. The same applies for the 'N' and
'D' codes as well.
Drug OFF Generic Patent Patent Exclusivity Patent Earliest 1999
or ON Name Holder Expiry Expiry & Generic 20001
Patent Marketer + Exclusivity
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)

More than U-Codes All other DD/MM/YY In

one name apply here codes Millions
may exist apply here of US
Dollars

The following codes This Date is the

U-Codes apply to this earliest generic
exclusivity date:- marketing date and
Apply to this All may apply to either
Patent # and I-codes the patent expiry or
this Patent D-codes a Exclusivity Expiry.
date. NCE NOTE
Several NDF In many cases an
Patents may NE OFF-Patent Generic
exist for each NC may have an
Generic NS ON-Patent
NP I Code; U Code or N
ODE code

The Codes:-
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength
NCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug Product
1
NDF = New Dosage Form NC = New Combination 2000 USA + EU Sales
U = Code for 'Therapeutic Use' still I = Code for New Specific D = New Dosing Schedule
under Patent Protection. Indication under Exclusivity
Protection.

Drugs Off-Patent Reports 6 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Electronic < Reports on Disk

Reports on Web :
e-- Reports
Ï20v01Ò

Drugs Over $100 million US Dollars

Year of Expiration - 1997
Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Bactroban Mupirocin SKB 1/31/95 1/31/97 - Expired 180
204
06/08/92 1/31/97 -
Lodine Etodolac AHP/Wye 2/28/95 2/28/97 NCE Expired 372
Ayerst 411
6/1/91 2/28/97
Timoptic Timolol Merck & 3/25/97 - Expired 245
maleate Co
9/26/95 3/25/97 270
Trental Pentoxi- Hoechst- 6/5/90 4/3/97 Expired 314
346
fylline Roussel 8/30/85 4/3/97
Zovirax Acyclovir BW 4/22/97 - 1.71 Expired 354
394
8/27/95 4/22/97
Glucotrol Glipizide Pfizer/ 4/26/97 NDF Expired 153
170
XL Pratt N/A 4/26/97
Zantac Ranitidine Glaxo 12/5/95 - D-21, Expired 2688
2934
Wellcome 7/25/97 7/25/97 I-116
Taxol Paclitaxel B-M-S 12/29/97 - I - 77, Expired 513
572
N/A 12/29/97 NP,NCE
Toradol Ketorolac Roche/ 5/16/95 5/16/97 NR Expired 295
331.
trometh- Syntex 7/14/96 5/16/97
amine

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug Product
1
NDF = New Dosage Form NC = New Combination 2000 USA + EU Sales
U = Code for 'Therapeutic Use' still I = Code for specific Indication D = New Dosing Schedule
under Patent Protection under Exclusivity Protection
1
Includes Generics

Drugs Off-Patent Reports 7 Over USD$ 100 million

 Drugs Off-Patent Reports

Drugs Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 1998

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
mm/dd/YY (Mil)

RETIN A Tretinoin Ortho/J&J 1/02/98 1/27/98 - Expired 101

Gel 4-247-547 121

Paraplatin Carboplatin B-M-S 2-20-96 8/28/98 - Expired 255

285
6/8/92 8/28/98

Lescol Fluvastatin Sandoz 12/31/98 - D-31 Expired 349

Novartis 386
NA 12/31/98 NCE

Diltazem Tiazac Forest 6/25/13 9/11/98 NS Expired 120

HCl /Biovail 5-529-791 166

Oxycodone Oxycontin Perdue 2/05/08 12/12/985- NDF Expired 300

HCl Frederick 266-331 343

Fluvastitin Lescol Norvaris 10/11/11 12/31/98 NCE Expired 247

Sodium 5-354-772 276.
Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug Product
NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales
U = Code for Therapeutic Use still I = Code for specific Indication D = New Dosing Schedule
under Patent Protection under Exclusivity Protection

Drugs Off-Patent Reports 8 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 1999

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Primaxin Imipenen Merck & 2/18/99 M/D/YY - Expired 139
cilastatin Na Co 4-194-047 154
Diclofenac Voltarin XR Novartis P 3/8/99 - Expired 132
Na NDF 158
Etodolac Londine XL AHP 10/30/07 10\25\99 Expired 150
CR Wyeth 4-966-768 181
NIZEROL Ketaconazole JNJ I - 88 Expired 155
Janson 6/15/99 186
Zoladex Goserelin Zeneca 4/22/99 I - 88 Expired 138
acetate 162
Daypro Oxaprozin Searle P NCE Expired 252
Monsanto 10/29/99 360.
Norcuron Vecuronium Organon 8/20/99 - - Expired 150
bromide 8/20/99 152
Vancenase Beclo Schering- P - Expired 285
AQ methasone Plough 6/26/99 NP 315
dipropionate
Vancenase Beclo Schering- 12/21/99 M/D/YY Expired 65
Plain methasone Plough 4-364-923 - 82
dipropionate
Vanceril Beclo Schering- 12/21/99 M/D/YY Expired 190
methasone Plough 4-364-923 - 211
dipropionate Key
Unasyn Ampicillin Sod/ Pfizer 11/18/97 M/D/YY - Expired 184
sulbactam 4-234-579 199
Sod.
Versed Inj. Midazolam Roche/ 11/18/99 12/20/99 - Expired 310
Syntex 12/20/99 353
Nicoderm Nicotine SKB - NP Expired 160
CQ 8/2/99 177
Azmacort Triamcinalone RPR - - D-7 Expired 255
acetonide 18,117 10/30/99 273
Luvox Fluvoxamine U.S. P NCE Expired 179
maleate Phillips 12/05/99 201
Omnipaque 12/26/99 M/D/YY - Expired 265
Iohexal Sanofi 292
4-250-133
Lamisil Terbinafine Novartis 12/30/06 U-73 Expired 415
cream HCl 4-755-534 12/30/99 NCE 452.
Beconase Beclo 12/21/99 M/D/YY - Expired 130
+ methasone Glaxo- 4-364-923 45
Beclovent dipropionate Wellcome 12/21/99 62
4-364-924 89

Drugs Off-Patent Reports 9 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2000

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Vasotec Enalaprilat Merck & 2/22/00 2/22/00 Expired 725
Co. 4-374-829 -- 02/22/00 860
Hismanal Astemizole JNJ- 4/3/00 M/D/YY Expired 28
Janssen 4-219-559 -- 04/03/00 33
Buspar Buspirone B-M-S 5/22/00 5/22/00 U-13 Expired 540
HCl 4-182-763 05/22/00 611
Lotrisone Betamethaz Schering 10/06/00 M/D/YY Expired 201
one Diprop 4-298-604 -- 10/06/00 233
Pepcid Famotidine Merck 10/15/00 M/D/YY Expired 1350
& Co. 4-283-408 -- 10/15/00 1487
Pepcid Famotidine Merck 10/15/00 NS Expired 125
AC & Co. 4-283-408 04/28/98 10/15/00 138
Glucotril Glipizide Pfizer 11/25/00 NDF Expired 179
XL Pratt -- 11/25/00 199
Intal Cormolyn Rhone- 9/20/00 M/D/YY Expired 89
sodium Poulenc- 4-405-598 -- 09/20/00 98
Rorer
Gluco Metformin BM 3/03/00 M/D/YY NCE Expired 1110
phage HCl Squibb - 3/03/00 1302.
Ultram Tramadol J/J - Mc M/D/YY NCE Expired 453
Hcl Neil P 501.
03/03/00
ZIAC Bisoprolol AHP 3/24/00 U-63 03/24/00 173
fumerate Lederle 4-258-062 7/31/97 NCE 198
CEFTIN Cefuroxime GW 5/12/00 M/D/YY Expired 425
acetil 4-267-320 -- 05/12/00 485.
Atrovent Ipratropium B 5/24/00 NDF Expired 306
Br Ingelheim 4-385-048 10/20/98 U-119 05/24/00 346
Cardura Doxazosin Pfizer 10/18/00 NCE Expired 330
mesylate 4-188-390 2/6/98 1-96 10/18/00 401
ZOLADEX Goserelin Zeneca 4/22/99 6/27/00 -- Expired 219
Acetate 4-100-274 I-191 06/27/00 244
Sevo- ULTANE Abbott 12/26/04 6/7/00 Expired 114
flurane 4-250-334 NCE 06/07/00 134
Terazosin Hytrin Abbott 2/17/00 M/D/YY -- Expired 425
4-251-532 02/17/00 598.
Neurontin Gabapentin WLA 01/16/00 12/30/98 U-106 Expired 500
P Davis (Epilepsy) 01/16/00 590
5-084-479

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug Product
NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales
U = Code for Therapeutic Use still I = Code for specific Indication D = New Dosing Schedule

Drugs Off-Patent Reports 10 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2001

Drug OFF Generic Patent Patent Exclusivit Patent & Earliest 1999
Patent Name Holder Expiry y Exclusivity Generic 20001
Marketer Expiry
Trade Generic NAME Patent # DATE CODES DATE USD$
MM/DD/YY (Mil)
Calcitriol Calcijex Abbott 1/28/01 1/28/01 - 01/28/01 190
inj 4-308-264 210
Prilosec Ompera Astra 4/5/01 3/22/99 U-108 10/01/01 3495
zole Zeneca 4-255-431 I-23 3540
Mertaza REMERON Organon P 6/14/01 NCE 06/14/01 132
pine 134
Mevacor Lovastin Merck & Co 6/15/01 2/8/98 - 06/15/01 595
4-231-938 I-117 300.
Accutane Isotretinoin Roche 8/7/01 M/D/YY -- 08/07/01 395
[Syntex] 4-464-394 462.
Brimonidine Alphagan Allergan P 9/06/01 - 09/06/01 98
NCE 101
PLENDIL Felodipine Merck 6/19/01 M/D/YY U-3 06/19/01 150
& Co. 4-264-611 178
Xalatan Latano Pharmacia P 6/05/01 NCE 06/05/01 507
prost 510
Levo- levaquin RWJ -- 12/17/01 I-246 12/17/01 288
floxacin 310
Lovenox Enox- RPR 12/04/01 05/06/00 U-122 12/04/01 299
aparin Na 4-692-435 NCE 320
I-192
Milrinone Primacor Sanofi 2/2/01 M/D/YY - 02/02/01 101
4-313-951 110
Tercon- TERAZOL J+J 11/09/01 M/D/YY - 11/09/01 103
azole 4-358-449 114
Lisinopril Zestril Astra- 12/30/01 11/24/98 - 12/30/01 600
Zeneca 4-374-829 I-141 646
Lisinopril Prinivil Merck 12/30/01 11/24/98 I-141 12/30/01 350
& Co. 4-374-829 365

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity
NDF = New Dosage Form
U = Code for Therapeutic Use still
under Patent Protection
NE = New Active Salt or Ester NP= New Drug Product
1
NC = New Combination 2000 USA + EU Sales
I = Code for specific Indication D = New Dosing Schedule
under Exclusivity Protection

Drugs Off-Patent Reports 12 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2002

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivit Generic 20001
Marketer y
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Axid Nizatidine Lilly 4/12/02 4/12/02 -- 04/12/02 340
255
4-375-547
Suprax Cefixime AHP/ 10/11/02 M/D/YY -- 10/11/02 105
Lederle 4-409-214 121
Effexor Venlafa- AHP/ 12/13/02 12/28/98 - 12/13/02 205
xine
Wyeth 4-535-186 NCE
Ayerst
Cordarone Amio AHP/ 08/03/02 - 08/03/02 250
Wyeth
darone P ODE
Ayerst
Optiray Ioversol Mallinc 12/30/02 M/D/YY -- 12/30/02 168
320 4-396-598
Optiray Ioversol Mallinc 12/30/02 M/D/YY -- 12/30/02 69
350 4-396-598
Monopril / Fosinopril BMS 12/4/02 05/02/98 - 12/04/02 202
Vasopril Na
4-337-201 I-92
(10.20mg)
Relafen Nambutone Smith 12/13/02 M/D/YY -- 12/13/02 450
380
Kline 4-420-639
Beecham
Trovaflox- TROVAN Pfizer -- 12/18/02 - 12/18/02 160
acin 155
mesylate NCE
Carvedilol Coreg SKB 3/5/02 9/14/00 U-3 03/05/02 100
4-503-067 NCE 101

Midazolam VERSED Roche 6/20/00 4/15/02 PED 04/15/02 324

inj 4-280-957 380

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug Product
NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales
U = Code for Therapeutic Use still I = Code for specific Indication D = New Dosing Schedule
under Patent Protection under Exclusivity Protection

Drugs Off-Patent Reports 13 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2003

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Fluoxitine Prozac Lilly 12/2/03 M/D/YY - 12/02/03 2281
4-626-549 3200
Cipro Cipro- Beyer 12/9/03 6/03/00 - 12/09/03 908
floxacin /Miles 4-670-444 I-188 997
Ketoconaz NIZORAL JJ- 2/11/03 5/30/00 - 02/11/03 158
ole 4-942-162 I-186 180
Floxin Ofloxacin JNJ- 09/02/03 12/16/00 - 09/02/03 190
McNeil 4-382-892 I-174 211
Flutica Glaxo 11/14/03 10/07/00 - 11/14/03 294
Flovent sone Wellcome 4-335-121 NDF 301
propionate
Flutica- Glaxo 11/14/03 10/19/97 - 11/14/03 440
Flonase sone Wellcome 4-335-121 NDF 488
propionate
Serzone Nefaz BMS 03/16/03 12/22/99 - 03/16/03 239
odone HCl 4-338-317 NCE 255
Biaxin Clarithro ABBOTT 5/25/03 M/D/YY 05/25/03 689
mycin 4-331-803 749
Lotensin Benazepril Novartis 08/11/03 M/D/YY 08/11/03 295
4-410-520 320
Ortho Ethinyl Ortho 9/26/03 12/31/99 - 12/26/03 205
NOV 777 estradiol JJ 4-628-051 - 235
-28
Ortho- Ethinyl Ortho 9/26/03 12/31/99 U-66 12/26/03 254
TRI estradiol JJ 4-628-051 I-177 261
Cyclin

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug Product
NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales
U = Code for Therapeutic Use still I = Code for specific Indication D = New Dosing Schedule
under Patent Protection under Exclusivity Protection

Drugs Off-Patent Reports 14 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2004

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Trade Holder Expiry Expiry Exclusivity Generic 20001
Name Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Claritin Loratadine Schering 4/21/04 4/12/98 NCE 06/21/04 1340

4-659-716 U-77 1360

Claritin-D Loratadine Schering 4/21/04 - U-77 04/21/04 340

/D NC 345.
4-282-233 4/21/98

Claritin-D Loratadine Schering 4/21/04 8/23/99 U-77 04/21/04 320

/D NP 335
24 4-282-233

Claritin Loratadine Schering 4/21/04 4/12/98 NCE 04/21/04 110

U-142 115
ReadyTab 4-659-716

Duragesic Fentanyl JNJ- 7/13/04 M/D/YY U-43 07/13/04 290

4-588-580 289
Janssen

Diflucan Fluco- PFizer 1/29/04 M/D/YY -- 01/29/04 495

azole 4-404-216 555

Carbplatin Paraplatin BMS 04/14/04 M/D/YY U-175 04/14/04 399

4-657-927 435.

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity
NDF = New Dosage Form
U = Code for Therapeutic Use still
under Patent Protection
NE = New Active Salt or Ester
NC = New Combination
I = Code for specific Indication
under Exclusivity Protection
NP = New Drug Product
1
2000 USA + EU Sales
D = New Dosing Schedule

Drugs Off-Patent Reports 15 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2005

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Quinapril Accupril WLambert 4/10/05 M/D/YY U210 04/10/05 357
5-747-504 - 386.
Pamidro- Aredia Novartis 07/29/05 07/16/99 - 07/29/05 242
nate DiNa 4-711-880 251
I-158
Retrovir Zidovudine Glaxo 9/17/05 M/D/YY -- 09/17/05 127
Wellcome 4-837-208 157
Zithromax Azithro- Pfizer 10/14/05 M/D/YY -- 10/14/05 1080
mycin (Pliva) 4-517-359 1255.
Pravachol Pravastin BMS 10/20/05 M/D/YY 10/20/05 1130
sodium 4-346-227 1210
Zocor Simvastatin Merck 12/23/05 M/D/YY U-59 12/23/05 1920
& Co. 4-444-784 I-128 2090

Lorabid Loracarbef E. Lilly 11/24/05 M/D/YY -- 12/24/05 129

4-708-956 165
Zofran Ondan- Glaxo- 06/25/05 04/19/98 U-183 06/25/05 510
setron Wellcome 4-695-578 D-20 550.
I-9 + I-151
Lupron Luprolide TAP 07/03/05 - - 07/03/05 270
Depot-3 Acetate Pharm 4-677-191 03/07/00 NP 298
Lupron Luprolide TAP 07/03/05 - 07/03/05 122
Depot-4 Acetate Pharm 4-677-191 05/30/00 NS 125
Lupron Luprolide TAP 07/03/05 M/D/YY -- 07/03/05 255
Depot Acetate Pharm 4-677-191 264
CEFZIL Cefprozil BMS 11/28/05 M/D/YY U-4 11/28/05 358
4-520-022 390
Sporonox Itraconazole J&J 12/23/05 11/28/05 195
4-791-111 238

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug Product
NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales
U = Code for Therapeutic Use still I = Code for specific Indication D = New Dosing Schedule
under Patent Protection under Exclusivity Protection

Drugs Off-Patent Reports 16 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2006

Drug OFF Generic Patent Patent Exclusivit Patent & Earliest 1999
Patent Name Holder Expiry y Exclusivit Generic 20001
Marketer Expiry y
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Proscar Finasteride Merck 6/19/06 6/19/97 06/19/06 255
NCE 000
& Co. 4-760-071

GEMZAR Gemcitabine E Lilly 2/28/06 5/15/01 NCE 02/28/06 215

229
4-808-614

TIMOPTIC Timolol Merck 08/29/06 08/29/06 100

M/D/YY
XE maleate 111
& Co. 4-861-769

Ambien Zolpiderm Searle 10/21/06 12/16/97 U-74 10/21/06 575

Monsanto NCE
Tartrate 4-382-938 638

K-DUR KCl S Plough 09/05/06 U-99 09/05/06 240

M/D/YY 264
4-863-743

PAXIL Paroxitine SKB 12/29/06 12/29/97 NCE 12/29/06 1205

HCl 4-721-723 U-12 1374

02/05/06 460
Prempro- Estrogen AHP 02/05/06 M/D/YY
498
14/14 conjugated Wyeth Ar 4-826-831

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity
NDF = New Dosage Form
U = Code for Therapeutic Use still
under Patent Protection
NE = New Active Salt or Ester NP = New Drug Product
1
NC = New Combination 2000 USA + EU Sales
I = Code for specific Indication D = New Dosing Schedule
under Exclusivity Protection

Drugs Off-Patent Reports 17 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2007

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)

QUET- Seroquel Astra - 03/20/07 9/26/02 - 03/20/07 105

IAPINE Zen NCE 112
4-879-288
Sibutramin MERIDIA KNOLL 5/29/07 11/22/02 - 05/29/07 155
e HCl NCE 165
4-929-629
Propulsid Cisapride JNJ- 10/9/07 07/29/98 U-79 10/09/07 500
560
Mono- Janssen 4-962-115 NCE
hydrate
Kytril Grani- S-K-B 12/29/07 12/29/98 NCE 12/29/07 269
setron 4-886-808 299
U-89
Risperdal Risperi - JNJ- 12/29/07 U-90 12/29/07 690
4-804-663 10/17/00 D-37
done Janssen [10/29/09] 733
5-158-952 NCE
Zytrec Cetirazine Pfizer 06/25/07 12/08/0O NCE 06/25/07 525
Tabs/Syrup HCl 4-525-358 601

Fosamax Allendro- Merck 08/06/07 09/29/07 U-114 08/06/07 505

nate Na Co. 4-621-077 NCE [06/06/15] 756
5-849-726
Aerobid Flunisolide Forrest 06/12/07 - 06/12/07 220
4-933-168 M/D/YY
245
LOTREL Amlodipine Novartis 3/25/07 07/31/97 NC 03/25/07 166
187
Besylate 4-879-303
NORVASC Amlodipine Pfizer 3/25/07 07/31/97 NCE 03/25/07 1205
1270
Besylate 4-879-303
Camptosar irinotecan Pharm- 08/20/07 06/14/01 NCE 08/20/07 293
HCL acia 299
(oncology) 4-604-463

Effexor XR Venlafaxine AHP- 12/13/07 10/20/00 NDF 12/13/07 210

Wyeth 233
4-535-186
Suprane Desflurane BOC 2/2/07 9/18/97 U-67 02/02/07 80
Ohmeda 4-762-856 NCE 89

Drugs Off-Patent Reports 18 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2008

Drug OFF Generic Patent Patent Exclusivit Patent & Earliest 1999
Patent Name Holder Expiry y Exclusivity Generic 20001
Marketer Expiry
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Depakote Divalproex Abbott 1/29/08 - 01/20/08 694
sodium 5-212-326 6/20/99 I-181 765
DR Tablets
Casodex Bicalut- Zenaca 10/01/08 10/4/00 - 10/01/08 135
amide 4-636-505 NCE 144
Serevent Salmeterol Allen 2/12/08 01/10/12 NCE 02/12/08 280
Xinafoate Hanburys 4-922-474 310
[01/10/12]
5-380-922
Neurontin Gabapentin WLA 05/02/08 12/30/98 NCE 05/02/08 500
P Davis 4-894-476 504
Neurontin Gabapentin WLA 01/16/00 12/30/98 U-106 [01/16/00] 500
Parke 4-087-544 480
Davis
ZERIT Stavudine BMS 06/25/08 06/24/99 NCE 06/25/08 241
4-978-655 U-94 265
DDAVP Desmopressin Rhone 9/10/08 M/D/YY 170
Acetate 09/10/08
Poulenc 5-407-398 198
Rorer
[12/23/13]
5-763-407
Lamictal Lamot- Cerenex 07/22/08 08/24/05 U106 07/22/08 135
rigine 4-602-017 NCE+ODE 155
I-247
[12/14/01]
Lamictal Lamot- Cerenex 07/22/08 08/24/05 [12/14/01] n/a
CD rigine 4-602-017 I-247
TRUSOPT Dorzol- Merck Co. 04/28/08 - 04/28/08 115
amide HCl 4-479-413 12/09/99 NCE 133
PROGRA Tacrolimus Fujisawa 04/08/08 M/D/YY 04/08/08 135
F 4-894-366 139
Zemuron Rocuronium Akzo-Organ 04/13/08 03/17/99 - 04/13/08 115
Br 4-894-369 NCE 126
Altace Ramipril Hoescht 10/29/08 08/22/98 - 10/29/08 121
Roussel 5-061-722 I-134 144
VALTREX Valacyclovir Glaxo-W 08/05/08 06/23/98 - 08/05/08 165
4-957-924 NE 178

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug Product
NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales
U = Code for Therapeutic Use still I = Code for specific Indication D = New Dosing Schedule
under Patent Protection under Exclusivity Protection

Drugs Off-Patent Reports 19 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2009

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
EPIVIR Lami- Glaxo 02/08/09 11/17/00 - 02/08/09 260
vudine 5-047-407 NCE 298
Tylenol Acetamino JNJ- 8/11/09 NDF 0/00/09 699
phen McNeil 4-000-000 M/D/YY 780
Prevacid Lanso- TAPP 05/10/09 - 05/10/09 2038
prazol Pharm 4-628 098 05/10/00 NCE 2290

COZAAR Losartan Merck 10/06/09 - 10/06/09 350

Pot. Co 5-153-197 4/14/00 NCE 398

Rispedal Risperi- J&J 10/27/09 U-90 10/27/09 990

done Jansen 5-158-952 12/29/98 NCE 1106

Hydochlor- 08/11/09 U-3 08/11/09 140

HYZAAR thiazide Merck 5-153-197 4/14/99 NCE 178

Year of Expiration - 2010

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusiv Generic 20001
Marketer ity
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Neurontin Gabapentin WLA 01/02/10 - 1/02/010 755
Parke 5-084-479 12/30/98 NCE 902
Davis
Famvir Famciclovir SKB 09/21/10 6/29/99 U-96 09/21/10 155
5-246-937 NCE 185
Inverase Saquinavir Roche 11/19/10 M/D/YY NCE 160
mesalate
0/00/10
4-000-000 178
Aricept Donepezil Pfizer 11/25/10 11/25/01 - 11/25/10 300
4-895-841 NCE 334
Sigular Montelukast Merck 11/30/10 2/20/03 - 11/30/10 198
Na 5-565-473 NCE 240

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug Product
NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales
U = Code for Therapeutic Use still I = Code for specific Indication D = New Dosing Schedule
under Patent Protection under Exclusivity Protection

Drugs Off-Patent Reports 20 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2011

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Magnevist Gadopen- BERLEX 11/08/11 M/D/YY 99
tetate
0/00/11
4-000-000 108
Dimeg-
lumine
VIAGRA Sildenafil Pfizer 06/18/11 03/27/03 - 06/18/11 990
5-250-534 NCE 1289

Year of Expiration - 2012

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivit Generic 20001
Marketer y
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Eldepryl Selegiline MYL & 04/23/12 06/05/96 180
WATS- 04/23/12
5-242-950 220
Somerset
Zoloft Setraline Pfizer 08/13/12 07/08/00 U-12 08/13/12 1900
Roerig 5-248-699 1995
Serevent Salmeterol Allen 01/10/12 02/04/99 - [02/12/08] 345
Xinafoate Hanburys 4-922-474 01/10/12 NCE 388
01/10/12
5-380-922
DETROL Tolterodine Pharmacia 01/17/12 - 01/17/12 329
Tartrate UpJohn 5-382-600 03/25/03 NCE 360
03/21/12 12/23/01 U-12 03/21/12 155
DIOVAN Valsartan Novartis 5-399-578 NCE 180
05/08/12 - - 05/08/12 115
PLATINOL Cisplatin BMS 5-562-925 - 140
05/15/12 11/17/00- U-248 05/15/12 305
COMBIVI Lamivudine GW 5-859-021 NCE 355
R
Docetaxel 07/03/12 05/14/01 - 07/03/12 125
TAXOTERE for Inj. RPR 5-403-858 NCE 240
ZOMEC Zolmitripta Astra 11/14/12 11/25/02- - 11/14/12 98
n Zeneca 5-466-699 NCE 115
SUSTIVA Efavirenz 07/08/12 07/08/12 N/A
5-811-423 U-256

Drugs Off-Patent Reports 21 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2013

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivit Generic 20001
Marketer + y
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Wellbutrin Bupropion Cerenex 08/12/13 M/D/YY - 08/12/13 155
HCl 4-507-323 310
ZYBAN Bupropion Cerenex 08/12/13 05/14/00 08/12/13 200
HCl 5-731-000 NP 289
ALLEGRA Fexo- Hoechst 11/26/13 07/25/01 U-138 11/26/13 360
fenadine Marion 5-578-610 NCE 420
HCl Roussel
ALLEGRA Fexo- Hoechst 11/26/13 12/24/00 U-138 11/26/13 105
D fenadine Marion 5-578-610 NC 140
HCl Roussel
Zoloft Sertraline Pfizer 8/13/12 NCE 08/13/12 1629
Roerig 5-249-699 08/07/00 1780

Imitrex Sumatriptan Cerenex 8/26/00

09/10/13 NDF 09/10/13 898
Succinate Glaxo 5-554-639 U-72 990
DDAVP Desmopressin Rhone 9/10/08 M/D/YY 170
Acetate
[09/10/08]
Poulenc 5-407-398 210
Rorer
12/23/13
5-763-407
Accolate Zafirlukast Astra 01/06/13 - - 01/09/13 146
Zeneca 5-482-963 159
CRIXIVAN Indinavir Merck 05/07/13 3/13/01 U-132 05/07/13 335
Sulfate Co 5-413-999 NCE 356
ASACOL Mesalamine P&G 07/30/13 8/18/00 U-141 07/30/13 163
5-541-171 I-203 183
REZULIN Troglitazone Warner-L 09/13/13 01/29/02 U-163 09/13/13 855
5-478-852 NCE 930
Magnevist Gadapentetate Berlex 10/01/13 - - 10/1/13 128
Di-meglumine 5-560-903 - 155
Viracept Nelfinavir Agguron 10/07/13 03/14/02 - 10/07/13 399
Mesalate 5-484-926 NCE 410

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug Product
NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales
U = Code for Therapeutic Use still I = Code for specific Indication D = New Dosing Schedule
under Patent Protection under Exclusivity Protection

Drugs Off-Patent Reports 22 Over USD$ 100 million

 Drugs Off-Patent Reports

D R U G S Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2014

Mometasone Hoechst 01/27/14 - 01/27/14 120
NASONEX Fumarate Marion 5-837-699 10/01/00 NDF
monohydrate Roussel
PLAVIX Clopidogrel BMS 01/31/14 11/17/02 - 01/31/14 141
bisulfate 5-576-328 NCE 188
ZYPREXA Olanzapine E Lilly 2/25/14 09/30/01 U-176 2/25/14 1344
5-605-897 U-149 1455
LIPITOR Atorvastatin WL 5/4/14 12/17/01 - 5/4/14 2010
Ca Pfizer 5-385-929 NCE 2112
EVISTA Raloxifene E Lilly 06/24/14 12/09/02 - 06/24/14 121
5-641-790 NCE 141

NORVIR Ritonavir Abbot 07/15/14 03/01/01 U-190 07/15/14 138

5-648-497 NCE 159
SUSTIVA Efavirenz 09/02/14 21/05/13 N/A
5-648-497 U-257
09/02/14
5-663-169
Year of Expiration - 215
rug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
Sporanox Itraconazole JNJ- 01/13/15 2/21/00 NCE/ NDF 01/13/15 1219
Janssen 5-707-975 I-04, I-155 1334
Diprivan Propofol Astra 030/22/15 6/11/199 - 03/22/15 349
Zenacca 5-714-520 NP 388
Prempro- estrogen AHP 1/17/15 M/D/YY - 01/17/15 460
14/14 conjugated Wyeth Ar 5-547-948 498
Miacalcin Calcitonin Novartis 03/31/15 08/17/98 U-227 13/31/15 185
Salmon 5-733-569 NDF 220
COREG Carvedilol SKB 06/07/15 - - 06/07/15 158
5-760-069 U-233 199
FOSAMAX Alendronate Merck 06/06/15 09/29/00 - 06/06/15 600
Na Co 5-849-726 NCE 689
ALLEGRA Fexo- Hoechst 02/28/15 12/24/00 U-138 02/28/15 [105+]
fenadine Marion 5-855-912 NC 185
HCl Roussel 5-738-872
PEPCID Famotodine Merck 06/06/15 09/29/00 U-267 06/06/15 600
AC & Co. 5-854-267 680

NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength

NCE = New Chemical Entity
NDF = New Dosage Form
U = Code for Therapeutic Use still
under Patent Protection
U-Codes apply to
patent expiry only
NE = New Active Salt or Ester NP = New Drug Product
NC = New Combination 20001 USA + EU Sales
I = Code for specific Indication D = New Dosing Schedule
under Exclusivity Protection
I-Codes apply to exclusivity, ODE and all NEW
presentations and forms

Drugs Off-Patent Reports 23 Over USD$ 100 million

 Drugs Off-Patent Reports

D r u g s Off-Patent
Reports
ISSN 0793694X

Year of Expiration - 2016

Drug OFF Generic Patent Patent Exclusivity Patent & Earliest 1999
Patent Name Holder Expiry Expiry Exclusivity Generic 20001
Marketer
Trade Generic NAME Patent # DATE CODES DATE USD$
(Mil)
REBETOL Ribavirin ICN 01/23/16 12/09/01 - 01/23/16 100
5-767-097 I-249 00
AGGRAS Tibofiban Merck 10/23/16 05/14/03 - 10/23/16 16
TAT HCl 5-733-919 NCE 32

Year of Expiration - 2017

PRELAY Trolitazone Sankyo 11/13/17 01/29/02 U-251 11/13/17 N/A

5-859-037 NCE N/A

US GENERIC DRUG SALES FORCAST

25

21.8

20

16.9 17.1

14.5
USD$ (Billions)

15
13

10.93

10 9.34
8.24

0
1998 1999 2000 2001 2002 2003 2004 2005
Sales Year

Drugs Off-Patent Reports 24 Over USD$ 100 million

 Drugs Off-Patent Reports

Generic Market Share of Total Rx Business

60 50.5
47 47.2 48.4 49.1
% Market Share 50 42 43 43 44
40
40 35
30
20
10
0
1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002
Sales Year

Total $ Sales of Expiring Drugs - Next 10 Years

8
7.1 7.3
7
7 6.6
Market Value ($Billions)

5
3.8 4
4 3.6
3.1 3.2
2.8
3
2
2 1.6
1.1
1

0
1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010
Expiration Year

World Retail Rx Sales - $216.3 ($ Billions)

Cardiovascular products
Argentinia 3.4 amount to $42 billion of total

Mexico 4.6

Brazil 5.1
Fastest growing segment
musculoskeletal - $12 billion
S America 13.1

Spain 5.5

UK 9.2
REGION

Italy 9.3

France 13.8

Germany 14.9
Retail Rx sales in Europe
Europe 52.7 and Japan almost equal

Japan 51.7

North Am. 98.9

Canada 5.3

US 94

0 10 20 30 40 50 60 70 80 90 100
Rx Market Value - Key Markets
Drugs Off-Patent Reports 25 Over USD$ 100 million