Thursday, August 1, 2013

Lupin Receives FDA Approval for Generic Ranexa® Extended‐release Tablets

Pharma Major Lupin Limited announced today that its U.S. subsidiary, Lupin Pharmaceuticals, Inc. (LPI) has received final approval for its Ranolazine Extended‐release tablets, 500 mg and 1000 mg
from the United States Food and Drugs Administration (FDA).  Patent protecting Ranexa expire in 2019 and currently a litigation around these patents is ongoing.

Lupin’s Ranolazine Extended‐release tablets are the AB‐rated generic equivalent of Gilead Sciences, Inc.’s (Gilead) Ranexa® Extended‐release tablets, 500 mg and 1000 mg strengths. Ranolazine

Extended‐release tablets is indicated for treatment of chronic angina.

Ranexa® tablets, 500 mg and 1000 mg had U.S sales of approximately USD 443.4 million, for the twelve months ending March, 2013 (IMS Health data).

Lupin believes that it is the first applicant to file an ANDA for Ranexa® Extended‐release tablets 500 mg and 1000 mg strengths and as such will be entitled to 180 days of marketing exclusivity.
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