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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
Generic drug
may be supplied by more than one company may be sold under active ingredient(s) name(s)
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.
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.
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
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.
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.
new regulatory processes to reduce time and cost of generic drug approvals