QDIS Blog

I thought I would put together a list of brand name pharmaceuticals whose patents are due to expire this year. Many are expiring between now an 2010 and represent $75 BILLION in revenue; $17.7 billion in 2007. I’ll focus on the near term and those expiring in 2007.

1. Norvasc, prescribed for hypertension
2. Univasc, prescribed for hypertension
3. Zyrtec, prescribed for allergies.
4. Zoloft, prescribed for depression
5. Allegra, prescribed for allergies
6. Zocor, prescribed for lowering cholesterol
7. Pravachol, prescribed for lowering cholesterol
8. Coreg, prescribed to treat congestive heart failure
9. Toprol XL, prescribed for hypertension
10. Provigil, prescribed for narcolepsy
11. Imitrex, prescribed for migranes
12. Clarinex prescribed for allergies
13. Meridia, prescribed to treat obesity
14. Risperdal, prescribed for psychosis

Most of these, except for Norvasc, Meridia, and Clarinex already have a tentatively approved generic.

For a list of brand name drugs expiring from April 2006 through Deb 2008 see RxNews® Newsletter: Patent Expiration - RxSolutions.com

If there are others I have overlooked, please send me a note or leave a comment and let me know. Also, if you want to know when the patent expires in the US for a specific drug, you can use the Electronic Orange Book Home Page from the FDA. Just do a Search by Proprietary Name, then click on the specific Appl. No. on the left side for your specific formulation and strength and this will give you a page of data including the patent expiration.

Here is the page for 10 mg Norvasc tablets.

UPDATE: I recently came across another drug whose patent expires in 2007.

Betaloc (metoprolol), prescribed for hypertension which had sales of $1.9 billion in 2006

Technorati Tags: drug patent expiration, drug patents

Email Ed Vawter

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Seems Germany is not impressed with Acomplia from Sanofi-Aventis and it will be on there non-reimbursable drugs list.

PharmaLive: Sanofi-Aventis Intends to Contest in Court the Decision to Classify Acomplia Among Non-reimbursable Drugs in Germany

What this basically means from my understanding is that the drug is considered a “comfort drug” and will not be covered by German health insurance. this means the drug will not be prescribed as widely as it would otherwise. Sanofi has stated they feel the classification is unjustified and will contest the decision.

On another note, I have read that the drug, if approved in the US will likely be called Zimulti.

Other Resources:
Acomplia Report - Acomplia Turned Down for Coverage by German Health Insurance

Technorati Tags: Acomplia, Rimonabant, Sanofi, Sanofi-Aventis

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In what most consider a very risky move, GlaxoSmithKline will pit their cervical cancer vaccine Cervarix ,which is in late stage clinical trials, against Merck;s approved cancer vaccine Gardasil.

Glaxo Goes Head-To-Head With Merck - Forbes.com

GlaxoSmithKline is definitely behind in this regard; Merck’s Gardasil is already approved and on its way towards $700 million in sales it first year. GSK on the other hand won’t even submit an NDA until at earliest 2009 and so will be at least three years behind.

Another problem is that the proposed study is only 1,000 patients and some, including myself, wonder if this will even allow you to see if there is a difference. Also GSK is taking a shortcut and making the argument that testing the response generated by the immune system due to the vaccine will be an indicator that the vaccine works better and longer. This has not been proven to be the case and the FDA in general frowns on such approaches. It will definitely be an uphill battle and I see the likely outcome being the FDA asking for longer term data on how well it protects against cervical cancer and precancerous lesions. This would set back GSK by years. It is a risky gambit.

Many consider this risky and in general, the pharmaceutical industry avoids, at all cost, comparing their drug directly against a competitors. The main exception to this is in anticancer drugs where drugs are always tested against a comparator since it is consider unethical to not treat those affected. The choice of comparator, when it is used, is questionable. Many times the drug chosen as competitor is not the best in the field and few experts would suggest this drug as a first choice for there patients.

I often wonder and have actually asked in meetings why not test against the best in class. Many times upper level management touts their drug as a breakthrough in treatment of a disease and over-hype it to the media and the public. However, in private internal meetings, they want to choose a comparator (if used at all) that gives them the best chance of a positive outcome. I say if they have such confidence that they express in public why is it that behind closed doors they do everything they can to tilt the field in their favor. If they have confidence in public, why does that confidence evaporate in private planning meetings?

Technorati Tags: cancer vaccine, GlaxoSmithKline, Merck, cervical cancer, vaccine

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