Teva Pharmaceuticals (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration (FDA) has awarded tentative approval for its Fluoxetine anti depressant drug, the generic version of Eli Lilly (NYSE:LLY)¿s Prozac.
The FDA approved the distribution of the 10, 20 and 40 mg capsules of the drug.
The approval followed the refusal of the Supreme Court to extend the patent on Eli Lilly's Prozac. The original patent expired in August 2001, and the FDA has since approved various generic versions of the drug by Barr Labs, Teva, Geneva ¿ a giant subsidiary of Novartis Pharmaceuticals, Alphapharm ¿ a division of the German firm Merck, and the Indian firm Doctor Ready.
Barr Labs waged a long legal battle with Eli Lilly to receive approval for its generic version of Prozac. The battle peaked in August 2000 when the Court of Appeals decided Eli Lilly had a "double patent" on Prozac, and shortened its expiry date from December of 2003 to August of 2001. But the story was not over yet.
In May 2001 the court had to suspend its decision. Eli Lilly had gone to the Supreme Court arguing the Court of Appeals had used a different test than the one approved by Congress to determine the legality of the patent. Today the Supreme Court's final decision was to uphold the decision of the Court of Appeals.
In August 2001 Teva received approval for the liquid 20 mg oral version of the drug (with an exclusive distribution period of six months), sales of which last year reached an estimated $30 million. The original Prozac market totaled $2.6 billion in 2000. Teva also received tentative approval for the solid version, to be distributed beginning February of 2002.
The company to benefit most from the expiry of the patent is Barr Labs, which received exclusive distribution rights for the pill version of Prozac, its primary version, for a 180-day period to end in February.