Biotech Values

[DewDiligence]

FDA Approves Generic Yasmin from BRL

http://biz.yahoo.com/prnews/080509/nyf078.html

[Yasmin is a patent case where BRL undoubtedly benefited from the new “non-obviousness” standard in the Supreme Court’s KSR ruling (#msg-19250528). The patent in question pertains to the formulation of drospirenone (one of the two active ingredients in Yasmin) in which the particle size was reduced to increase bioavailability. Branded Yasmin from Bayer sells about $600M annually in the US.

Yasmin should not be confused with Yaz, a newer, lower-dose oral contraceptive from Bayer that BRL hopes to market as a generic. Yaz is vulnerable on the same formulation patent that failed to protect Yasmin; however, Bayer has H-W marketing exclusivity for Yaz until Mar 2009, so there can’t be any generic on the market until then.]

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Friday May 9, 3:35 pm ET

MONTVALE, N.J., May 9 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) to manufacture and market a generic version of Yasmin® (drospirenone and ethinyl estradiol), an oral contraceptive product manufactured and marketed by Bayer Schering Pharma, AG.

On March 3, 2008 Barr announced that the U.S. District Court for the District of New Jersey had ruled in favor of its subsidiary, Barr Laboratories, Inc., in the challenge of the patent listed by Bayer Schering Pharma, AG for its Yasmin product. In his ruling, Judge Peter G. Sheridan found that the patent at issue was invalid, because it was obvious. On April 1, 2008, Bayer Schering appealed this ruling to the U.S. Court of Appeals for the Federal Circuit.

Yasmin is a 28-day oral contraceptive consisting of 21 active tablets each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol and 7 inert tablets. Yasmin is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive. The product had annual sales of approximately $575 million for the twelve months ended February 2008, based on IMS sales data.
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