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Mylan wants the FDA to ban generic drug interference

| Saturday, July 3, 2004

Days after filing a lawsuit against the Food and Drug Administration over permission to sell a generic pain patch, Mylan Laboratories Inc. stepped up its pressure on the agency this week by demanding the FDA ban encroachment by branded drug companies in the generic market.

So-called "authorized generic" deals, under which a branded drug company manufactures a drug and sells it simultaneously under its original brand name and as a generic through a third-party licensee, undercut the generic companies that spend millions to earn the right to sell drugs coming off patent.

In a filing with the Securities and Exchange Commission Wednesday, Mylan insisted the FDA respond by Tuesday to a petition Mylan first made in February to end the authorized generic practice.

FDA officials could not be reached for comment Friday.

Mylan spokeswoman Heather Bresch said the practice deters generic companies from challenging patents and bringing lower-priced medicines to consumers more quickly.

"All we're seeking is a level playing field," she said.

Since February, Mylan said Procter & Gamble Co. licensed a generic version of its Macrobid drug to Watson Pharmaceuticals on the same day Mylan launched its generic version of the drug.

Under the laws governing the pharmaceutical industry, the first company to successfully receive FDA permission to market a generic knock-off of a drug about to come off patent receives six months of market exclusivity.

This is designed to give generics companies incentive to challenge patents, since during the six months of exclusivity, they can earn a higher margin on their generics. During that period, the companies can charge about 25 percent less than the branded drugs, but still more than when the exclusivity expires and other generics enter the market, driving the price down to typically less than 50 percent of the branded drugs.

In its February letter, Mylan acknowledged that in the past it collaborated with a branded company to provide an authorized generic, the practice it now condemns.

Bresch said that in the case of Mylan's deal with Pfizer Inc. to distribute a generic version of its nifepidine drug, Mylan already had received first-to-file status on the drug, meaning it was not denying another competitor the six-month exclusivity.

On June 24, Mylan sued the FDA for revoking approval given in November to begin selling a generic form of Johnson & Johnson's Duragesic pain patch.

Mylan is arguing the FDA erred in using a Vermont District Court ruling this spring to revoke the approval. Mylan believes it should be able to begin selling the drug on July 23.

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