I have previously written about the battle against generic Prilosec (omeprazole). AstraZeneca has ‘pulled out all stops’ to prevent this release. Today’s Wall Street Journal (available on the web only for money) has an article on this issue, from which I will quote.

The three drug makers — Andrx Corp., Genpharm Inc. and Kudco — have been in negotiations since a ruling on Oct. 11 by a federal judge that knockoff Prilosec pills made by Andrx and Genpharm both infringe on ancillary patents owned by AstraZeneca PLC, the maker of Prilosec.

However, Judge Barbara Jones, of U.S. District Court for the Southern District of New York, ruled that Kudco’s pill didn’t infringe on the patents. Kudco successfully argued that it coats omeprazole — the generic version of Prilosec — with a nonalkaline substance, and that it has its own patent on this method, valid until 2016.

That court win alone, though, wasn’t enough to clear the way for Kudco to begin selling the prescription drug. Kudco, a subsidiary of Schwarz Pharma AG of Germany, couldn’t launch first, because under a federal rule to encourage generic competition, Andrx and Genpharm had previously won exclusive rights to be first on the market with a generic Prilosec, which lost its main patent protection in October 2001.

Andrx and Genpharm are appealing Judge Jones’s ruling. But in the meantime, they are pressing ahead in the consortium with Kudco. Had they not decided to team up with Kudco, the two other generics makers could have delayed a generic launch by months or years.

…

Prilosec was once the biggest-selling drug in the world, with $6 billion in annual sales. Sales slumped somewhat in the past year to $5.7 billion, making it the world’s third-biggest seller behind cholesterol pills Lipitor and Zocor, made respectively by Pfizer Inc. and Merck & Co.

Prilosec costs nearly $4 a pill. A generic version of the drug will probably cost $3.50 in the first six months, but the price is expected to drop to below $2 within a year of launch.

Prilosec has been at the center of the debate over legal and regulatory moves by some major drug makers to delay generic competition against big sellers. AstraZeneca’s original patent protection on the purple pill ended a year ago, but the company sought additional protection from generic competition.

This story (and the entire story is worthwhile of you have access to the newspaper) highlights my disgust with the pharmaceutical industry. I understand that they deserve a profit and patent protection. However, their legal manipulations to extend that protection are disingenuous and harmful to patients. Hopefully, we will have generic omeprazole soon.

Related posts:

1. OTC Prilosec – one step closer
2. Should Prilosec go OTC
3. Senate moves on generic drug bill
4. Generic drug delays
5. Generic omeprazole

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