Israel's Teva Pharmaceutical Industries Ltd, which is the world's largest generic drug maker, announced on Wednesday that they have received final approval from the U. S. Food and Drug Administration, FDA for their Abbreviated New Drug Application, or ANDA, to market the generic version of acne drug Solodyn or Minocycline HCl, Extended-Release Tablets, 45 mg, 90 mg and 135 mg.
The company said it has started the shipment of the product.
Medicis Pharmaceutical Corp.'s acne drug Solodyn, is an oral antibiotic approved to specifically treat moderate-to-severe acne in patients 12 years of age and older.Medicis and Teva in a joint statement announced on Wednesday that they have decided to end all legal disputes between them in connection with the drug Solodyn. Teva is currently involved in a patent litigation concerning this product in the US District Court for the District of Delaware.
Teva confirmed that Medicis' patents relating to Solodyn Extended Release Tablets are valid and enforceable and has agreed to stop all further shipments of its generic version of the drug. Medicis agreed to release Teva from liability arising from prior sales of its generic Solodyn.
Teva can market its generic version beginning in November 2011 or earlier under certain conditions.
According to analysts the drug constitutes 50 % of the company's total revenue. According to IMS sales data, annual US sales of Solodyn were about $365 million for the twelve months ended January 31, 2009.
As Teva is one of the first companies to file an ANDA containing a paragraph IV certification for the product, it has also been awarded a 180-day period of marketing exclusivity.
Medicis had said in a regulatory filing that the FDA denied its petition seeking a 30-month ban on making of generic versions of Solodyn.
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