The innovator, M/S Medicines Company announced (in a press release Here) that it has received Paragraph IV Certification notice letters from generic players M/S Teva Parenteral and M/S Pliva wherein, generic players informed the Company that they have submitted Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (USFDA) for approval to market generic versions of anti-clotting formulation Bivalirudin (Angiomax) 250 mg/vial IV injection.
The following patents are listed for this product:
US5196404 (Expiry: Sep 23, 2010): Which covers Bivalirudin as product
US7582727 (Expiry: Jan 27, 2029): Which covers pharmaceutical batches of a drug product comprising bivalirudin (SEQ ID NO: 1) and mannitol for use as an anticoagulant in a subject in need thereof, wherein the batches have a pH adjusted by sodium hydroxide, said pH is about 5-6 when reconstituted in an aqueous solution for injection, and wherein the batches have a maximum reconstitution time that does not exceed about 42 seconds and a maximum total impurity level that does not exceed about 2% as measured by HPLC.
The generic players have filed Para IV against ‘727 (Earlier, innovator announced grant of ‘727 patent Here). Probably, generic players have filed ANDA with Para III against ‘404 patent.
Earlier, innovator got final approval to market Bivalirudin (Angiomax) 250 mg/vial IV injection from USFDA on Dec 15, 2000.
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