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Teva, Schering-Plough licensing deal ends patent litigation. (RX/Generic Drugs).

NEW YORK -- Teva Pharmaceuticals USA Inc. and Schering-Plough Corp. have entered into a licensing agreement that resolves all patent litigation between the two companies regarding the Schering-Plough's Rebetol, generically know as ribavirin.

Financial terms were not disclosed, although the firms stressed that no other products are involved in the arrangement, which is effective upon the dismissal of lawsuits by the courts.

The agreement does not affect Teva's patent dispute with Ribapharm Inc. In that case the litigation prohibits Food and Drug Administration approval of Teva's generic version until the expiration of the 30-month stay or a court ruling, which ever is earlier. That matter, of which summary judgments are pending, is slated for a June 2 trial.

Teva had an abbreviated new drug application pending with the FDA to market its generic version. The company notes that Schering-Plough's capsules posted sales last year of about $865 million.

Under the agreement Schering-Plough will give Teva a nonexclusive license to its United States ribavirin patents; Teva will pay Schering-Plough a royalty on its sales.

In a related announcement the World Health Organization has listed ICN Pharmaceuticals Inc.'s antiviral drug ribavirin as a treatment for severe acute respiratory syndrome, or SARS. An outbreak of the pneumonia-like virus has infected thousands of people. ICN makes an intravenous formulation of the product. The oral form is made by ICN's majority-owned Ribapharm and is sold by Schering-Plough as a hepatitis treatment.

Separately, Pharmaceutical Resources Inc. has entered into a licensing agreement with Roche Laboratories Inc. to market torsemide, a generic version of Demadex. Pharmaceutical Resources' Par Pharmaceutical unit developed and filed an ANDA for the product in conjunction with Kali Laboratories and received a tentative approval letter from the FDA last November. Par says that Demadex had sales of approximately $110 million before generic competition.

Par will pay Roche a onetime fee for its nonexclusive license. Marketing of the drug is anticipated to begin within the next several months.

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Title Annotation:Rebetol, ribavirin; Teva Pharmaceuticals USA Inc.
Publication:Chain Drug Review
Geographic Code:1USA
Date:Apr 28, 2003
Words:324
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