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All About Generic Drugs

Generic Drugs: Safe. Effective. FDA-Approved.

QUESTION 1
I. How FDA assures that generics: are Safe. Effective. FDA-approved. are an affordable alternative can be used with confidence

QUESTION 2
II. How FDA and the administration are working to make more generic medicines available to the public

What do you want to know about ALL the medicines you use.
brand-name and generic? A generic drug (generic drugs, short: generics) is a drug which is produced and distributed without patent protection. safe and effective affordable and available use with confidence

What is a generic drug?


A copy of a brand-name drug, which must have the:
same quality same safety same strength

Generic Drug Example


ibuprofen is a generic version of the over the counter pain medicine ADVIL.. Fluoxetine is the generic of the prescription drug, Prozac. A generic must have the same quality, safety and strength as the brand name drug. But for an average brand-name drug that costs $72, the generic version costs about $17. At roughly 1/3rd the price of a brand-name medicine, a generic drug can bring (you) consumers a significant savings.

What You Want to Know About Generic Drugs


Brand-name drug
supplied by one drug company sold under drug companys trademarked name

Generic drug
may be supplied by more than one company may be sold under active ingredient(s) name(s)

What You Want to Know About Generic Drugs


Both brand name and generics drugs: are approved by the FDA must meet the same FDA standards for quality

Generic Competition
It is essential to have brand-name and generic drugs available.

Generic Competition
helps keep drug costs down encourages research helps keep insurance premiums down saves consumers $8 to $10 billion yearly

Patent Protection
A patent: protects the investment of the drug company that developed the drug (the manufacturer) gives the drug company the sole right to sell the drug while the patent is in effect

Patent Protection
When the patents on a brand-name drug near expiration, drug companies that want to manufacture a generic can apply to the FDA to sell a generic version of the drug.

PATENT CLIFF
is the potential sharp decline in revenues upon patent expiry of one or more leading products of a firm. A patent cliff is when a firm's revenues could "fall off a cliff when one or more established products go off-patent, since these products can be replicated and sold at much cheaper prices by competitors.

While it is applicable to any industry, in recent years the term "patent cliff" has come to be associated almost exclusively with the pharmaceutical industry.

PATENT CLIFF
The imminent arrival of the dreaded "patent cliff" has been haunting the pharmaceutical industry for years, and it's finally here. With patents on many blockbuster drugs about to expire, an estimated $250 billion in sales are at risk between now and 2015.

The 10 Biggest-Selling Drugs That Are About to Lose Their Patent


Condition Lipitor Zyprexa Levaquin Concerta Protonix cholesterol antipsychotic antibiotics ADHD/ADD antacid Condition Company Pfizer Eli Lily Johnson & Johnson Johnson & Johnson Pfizer Company

2010 U.S. Sales


$5,329,000,000 $2,496,000,000 $1,312,000,000 $929,000,000 $690,000,000 2010 U.S. Sales

Plavix Seroquel Singulair Actos

anti-platelet antipsychotic asthma type 2 diabetes

Bristol-Myers Squibb / Sanofi-Aventis


AstraZeneca Merck Takeda

$6,154,000,000 $3,747,000,000 $3,224,000,000 $3,351,000,000

Enbrel

arthritis

Amgen

$3,304,000,000

Once drugs lose patent protection, lower-price generics quickly siphon off as much as 90% of their sales. For consumers, the savings from generics can be substantial, as this price table of the top 25 brand-name drugs with available generic counterparts highlights. According to pharmaceutical analysts, generics now average about 30% of the price of the brand-name originals.

In 2010, the pharmaceutical industry had sales of $860 billion worldwide, up 3% from 2009. Just 133 blockbuster drugs accounted for $295 billion of those sales -- about 34% of the market. Of those blockbusters, 13 are set to lose patent protection through 2013. Although the generic industry will benefit in the short term, it will also see a slowdown in revenue growth after 2015 because fewer blockbusters will be coming off patent for them to replicate.

Cholesterol fighter Lipitor, (atorvastatin) was released in 1998, and by 2006 it had reached peak sales of $12.9 billion, accounting for 27% of the company's revenue, a "best-selling drug" for a few years, and a major source of income for the world's biggest drug company, Pfizer. In 2010, with $10.8 billion in sales, Lipitor still accounted for 15.8% of total revenue, even with the addition of Wyeth's operations.

Between 2010 and 2012, drugs that make up 42% of Pfizer's pharmaceutical revenue will lose patent protection, among them the antacid Protonix.
The loss of exclusivity on so many drugs -- among them antipsychotic Geodon, with $890 million in U.S. sales in 2010; dysfunction drug Viagra with $1.015 billion; overactive bladder drug Detrol/LA with $693 million; and eye pressure lowering medicine Xalatan with $616 million to name some -- will deeply impact Pfizer. In 2008, Pfizer reached an agreement with Indian generics manufacturer Ranbaxy Laboratories. Ranbaxy is having a license to sell atorvastatin in the U.S. effective Nov. 30, 2011, and have exclusivity for 180 days before other drugmakers can enter the market. Watson Pharmaceuticals will also introduce a generic for Lipitor.

After bringing the world the iconic anti-depressant Prozac, Eli Lilly introduced the antipsychotic Zyprexa in 1996. In the U.S., Zyprexa (olanzapine) is approved by the FDA for the treatment of schizophrenia and bipolar disorder. In 2010, Zyprexa's worldwide revenues were just over $5 billion, or nearly 22% of Lilly's full year sales. Since 2003, Zyprexa consistently had revenues of over $4 billion.

But Zyprexa has generated controversy as well as revenues. In 2009, Lilly agreed to pay $1.415 billion to settle criminal and civil allegations for the offlabel promotion of Zyprexa to treat dementia. Also in 2005 and 2007, Lilly settled lawsuits with patients over claims that Lilly withheld information about the drug's link to high blood sugar level and diabetes. Price tags: $700 million and $500 million, respectively.
Zyprexa's patent is set to expire in October, and according to analysts, Lilly is one of the worst positioned companies to compete after the patent cliff.

This anti-clot to prevent heart attack or stroke claims the title of second-best selling drug in the world, with $9.4 billion in global sales in 2010. Plavix (clopidogrel) was discovered by French pharmaceutical Sanofi-Aventis and was co-developed with Bristol-Myers Squibb. The drug is marketed jointly by both. In 2010, Bristol recorded $6.7 billion in Plavix sales, or 34% of its total revenues of $19.5 billion. Sanofi recorded sales of over 2 billion euros (roughly $2.7 billion), or 7% of its 2010 revenues of 30 billion euros. Plavix's patent is set to expire on May 17, 2012. Bristol-Myers Squibb is facing 2012 patent expirations for two of its three top sellers, Plavix and high blood pressure med Avapro, with global sales in 2010 of $1.2 billion, and its deal to market Abilify is also due to expire in 2012 ($2.6 billion in worldwide 2010 sales). Sanofi already lost patent protection in the U.S. on its top seller, Lovenox (enoxaparin), a blood thinner. In 2010, the company said generic competition caused loss of more than 2 billion euros in sales. Sandoz, the generic pharmaceutical division of Novartis, is already marketing generic enoxaparin.

Seroquel
British pharmaceutical AstraZeneca's antipsychotic Seroquel was introduced in 1997, and has been approved for a variety of conditions from depression to bipolar disorder to schizophrenia. Worldwide sales amounted to $5.3 billion in 2010, or nearly 16% of Astra's revenues. Seroquel was originally going to expire in September 2011 but received a six-month extension from the FDA through a pediatric exclusivity. Astras situation could hardly be worse: Medicines that generated 62% of it's 2009 revenue will face competition from lower-priced copies by 2014. Further, the company's pipeline doesn't appear strong enough to offset the impending generic onslaught. Hopes that Brillinta (anti-platelet) could develop into a major blockbuster.

Merck's oral asthma and allergy treatment Singulair (montelukast) was first cleared by the FDA in 1998. Its growth has been consistent despite the FDA adding warnings to its label about side effects including depression and increased suicidal thoughts. In 2010, worldwide sales for Singulair were $5 billion, a 7% increase, and nearly 11% of Merck's total revenue.
Merck is already reeling from the loss of exclusivity for its blood pressure drugs Cozaar/Hyzaar. The two have seen sales slump by 41% in 2010 to $2.1 billion. Still, analysts says "Merck is potentially the best positioned among large pharma companies as the patent cliff nears." Merck has already overcome lost revenue from several major products due to patent expiry or product withdrawal, including Vioxx (withdrawn in 2004), Proscar (2005), Zocor (2006), Fosamax (2008) and Cozaar (2010). The company's diverse late stage pipeline and promising earlier stage candidates should offset Singulair patent expiry and support near and longer term growth.

Actos
The patent on the type 2 diabetes medication from Japan's Takeda, which was launched in 1999, already expired in January. But Takeda came to an agreement with generic drug makers Ranbaxy, Watson and Mylan under which they won't start marketing Actos until August 2012. Sandoz, Teva Pharmaceutical Industries and a few others will enter the market 180 days later.
Over the first nine months ending in December of its fiscal 2010, Actos recorded sales of 293 billion yen ($3.58 billion), or 27% of its total revenue. Sales were also affected by a sharp decrease in Prevacid sales due to the loss of exclusivity in the U.S.

Enbrel
Unlike the other top drugs losing patent protection, Amgen's arthritis and psoriasis treatment Enbrel is a large-molecule biologic. As such, it will be much harder to duplicate. Even with the FDA trying to put in place procedures to ease the entry of generic biologics, or biosimilars, into the market, the process is just beginning. Hence the attraction of biotech to Big Pharma: it's the reason Roche bought Genentech, and Sanofi-Aventis acquired Genzyme.

Enbrel
With Enbrel's total sales in 2010 coming to $3.5 billion -- 23% of Amgen's total revenue -- it, too, would have felt the vulnerability of the patent cliff. Would take yet another hit, as it markets Enbrel outside the U.S., Canada and Japan. Pfizer's 2010 sales of Enbrel were $3.2 billion. Both [the generic and brand-name pharmaceutical] industries are increasing their emphasis on biologic drugs, which are harder to replicate, but were recently given a 12 year limit on patent protection via the Patient Protection and Affordable Care Act. The brand name industry sees a lot of potential revenue here, and the generic industry is already increasing their R&D investment to find ways to create biosimilars.

Myths about Generic Drugs


Genericsare not as safe Genericsare not as potent Genericstake longer to act in the body Genericsare made in sub-standard facilities

Generic Drugs
Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts. Source: Medicinenet.com

BRANDED DRUGS
This is the output of an invention and does not exist anywhere else in the world before its release into the market. The general procedure followed by a company before releasing this new drug into market is 1. Applying for patent. 2. Carrying out preclinical tests on animals 3. Lead optimization. 4. Clinical trials ( Phase I, Phase II and Phase III). All these steps result in increase of cost of manufacturing and subsequently cause a hike in the drug price.

Generic Vs Brand
Brand Name Tylenol Valium Dilantin Topamax Generic Acetaminophen Diazepam Phenytoin Topirmate

NEED FOR GENERIC MEDICINE


Encouraging invention of new drugs is good for progress of science but encouraging generics is necessary for bringing down prices. The proportion of elderly people, who consume more prescription medicines, is on the rise. Efficacious therapies and medical procedures are regularly being invented and are coming at costlier prices and are contributing to a raise in pharmaceuticals costs. So if generic medicines can be introduced at an early date as an alternative to patented medicines there will be good saving in economy

International perspective with respect to generics


In the USA when a company wants to introduce generic drug product it submits to the FDA an Abbreviated New Drug Application which shows that its product is bioequivalent to the innovators product and satisfy other requirements and market the generic product. In the UK and the USA the average price difference between generics and branded drugs is high (between 50-90%) and the penetration of generics by volume is also high (48-49% in 1997)(4,5).

INDIAN PERSPECTIVE
Indian perspective with respect to generics: Almost all the Indian drug products are generics only, but as the statute on medicines, i.e. The Drugs and Cosmetics Act 1950 and Rules 1945, allows generic companies to give brand names to their products, these products become branded generics. So in India there are two classes of drugs products

INDIAN PERSPECTIVE
1. Branded generics : Generic equivalents with a name given by the particular company). 2. Generics : Drugs products being sold under the generic name only (rare). According to Indian law these generic drugs companies have to do bioequivalent studies and prove to the drug control administration that their drug is equivalent to the inventor drug ( if the drug has been introduced into the market recently that is less than four years ago).After four years bioequivalent studies are not necessary.

GENERIC GENERICS
Generic generics in India refers to those drugs which do not carry a brand name but are sold by their chemical names. Internationally, drugs sold by their chemical names are known merely as generics because brand names are given only to drugs protected by a patent. In India, companies give brand names to almost all off-patent drugs generics in international parlance and call them 'branded generics'. Since branded products in India themselves are what are called generics globally, companies call drugs without a brand name as 'generic generics' to emphasise that they belong to a distinct market segment.

Generic Drug Review


Much the same as new, brand name drug review 8 major parts

Generic Drug Review


1. FDA-approved generic drugs must have same active ingredient(s) same labeled strength same dosage form same administration

Generic Drug Review


Generic Drug is also called as referenced drug. In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. The shape or color may be different, and colorings, flavors, and certain other inactive ingredients may be different. The generic drug must have the same dosage form. Tablets, capsules, patches and liquids are examples of different dosage forms. The generic drug must be administered the same way, for example, swallowed as a pill, or injected as a shot, rubbed on the skin, as the drug it copies. (also could be said to the drug to which it is referenced.

Generic Drug Review


2. The drug company must show the generic drug is bioequivalent to the brand-name drug. active ingredient works in the same way active ingredient works in the same amount of time

Generic Drug Review


Rather than repeating very costly research, the generic drug companies instead must show the FDA that their drug is bioequivalent to the brand-name drug. When a drug is bioequivalent to another, it means that its active ingredient works in the same way and in the same amount of time as the brand-name drug. (The generic version must deliver the same amount of active ingredient into a patients bloodstream in the same amount of time as the brand-name drug.)

Generic Drug Review


Scientists measure a generic drugs bioavailability, or the amount of the generic drug in the bloodstream and how long it takes to get there. Then they compare that measurement to the brand-name drug. When drug companies develop a new drug, they submit full new drug applications or NDAs. Generic drug companies submit what are known as abbreviated new drug applications or ANDAs.

Generic Drug Review


3. The generic drugs labeling must be basically the same as that of the approved brand-name drug.

Generic Drug Review


4. The drug company must: fully document the generic drugs chemistry, manufacturing steps, and quality control measures detail each step of the process

Generic Drug Review


5. The raw materials and the finished product must meet specifications, if these have been set. USP-United States Pharmacopeia

Generic Drug Review


6. The drug company must: show that its generic drug maintains stability continue to monitor drugs stability

Generic Drug Review


7. The drug company must: comply with federal regulations for current good manufacturing practices give a full description of the facilities it uses to manufacture, process, test, package, label, and control the drug

Generic Drug Review


8. Inspection at the proposed manufacturing site ensures that the firm: is capable of meeting commitments of the application can manufacture the product consistently

FDA Requirements for Brand-Name and Generic Drugs


Brand Name Drug For reformulations of a brand-name drug or generic versions of a drug, FDA reviews data showing the drug is bioequivalent to the one used in the original safety and efficacy testing. FDA evaluates the manufacturer's adherence to good manufacturing practices before the drug is marketed. FDA reviews the active and inactive ingredients used in the formulation before the drug is marketed. FDA reviews the actual drug product. FDA reviews the drug's labeling. Manufacturer must seek FDA approval before making major manufacturing changes or reformulating the drug. Generic Drug

Manufacturer must report adverse reactions and serious adverse health effects to the FDA.
FDA periodically inspects manufacturing plants. FDA monitors drug quality after approval.

Question??
II. What the FDA and the administration are doing to make more generic medicines available to public.

Making More Generics Available


A. Hatch-Waxman Act, or the Patent Term Restoration Act of 1984 B. Presidents 2003 budget increased FDAs funding to speed up generic drug reviews (more reviewers, etc.)

Making More Generics Available


C. Improving Access to Generic Drugs initiative

new regulatory processes to reduce time and cost of generic drug approvals

Making More Generics Available


C. Improving Access to Generic Drugs initiative (continued) enhanced public and professional education

Making More Generics Available


C. Improving Access to Generic Drugs initiative (continued)

enhanced scientific study of generic drugs

Making More Generics Available


C. Improving Access to Generic Drugs initiative (continued) enhanced monitoring of the safety of generic drugs

Print Public Service Ads for Consumers

Public Transportation Ads in U.S. Cities

Consumer Brochure in English and Spanish

Posters in English and Spanish

Blue Cross Blue Shield of Michigan Billboards

Posters Appearing in 4,000 Walgreens Pharmacies Nationwide

Making More Generics Available


D. FDAs generic drug Final Rule, 8-18-03 seeks to close legal loopholes in the Hatch Waxman Act that delay generic drug approval

Making More Generics Available


D. FDAs generic drug Final Rule, 8-18-03 (continued)
implements an Federal Trade Commission recommendation to tighten the patent submission and listing process

Making More Generics Available


D. FDAs generic drug Final Rule, 8-18-03 (continued) clarifies the types of patents that must be submitted to the FDA

Making More Generics Available


E. House and Senate passed a bill, Greater Access to Affordable Pharmaceuticals Act complements FDAs final rule.

Myths and Facts about Generic Drugs

Myths and Facts about Generic Drugs


MYTH #1
Generics are not as safe as brand-name drugs.

Myths and Facts about Generic Drugs


FACT #1
Generics use the same ingredients, and work the same in the body have the same risk-benefit profile

Myths and Facts about Generic Drugs


MYTH #2
Generics are not as potent as brand-name drugs.

Myths and Facts about Generic Drugs


FACT #2
Generic drugs have the same quality, strength, purity and stability.

Myths and Facts about Generic Drugs


MYTH #3
Generics take longer to act in the body.

Myths and Facts about Generic Drugs


FACT #3
The generic drug delivers the same amount of active ingredient in the same time as the original drug.

Myths and Facts about Generic Drugs


MYTH #4
Brand-name drugs are made in modern manufacturing facilities, and generics are often made in sub-standard facilities.

Myths and Facts about Generic Drugs


FACT #4
Sub-standard facilities are not permitted by the FDA.

What you want to know about Generic Drugs


Contact your physician, pharmacist, or insurance company for more information about your generic drugs.

Generic Drugs: Safe. Effective. FDA-Approved.


DEEPAK R. GUPTA