Altace ANDAs On Hold Till June; Colbalt Gets Exclusivity, Not “Parking” Ticket
Lupin Pharmaceuticals and five other pharma companies will have to wait at least until June to market their versions of ramipril capsules (King's Altace), as FDA ruled that Cobalt Pharmaceuticals is entitled to the 180-day generic drug exclusivity it was granted in 2005
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FDA is continuing its case-by-case review of the 180-day exclusivity status for ANDAs as they approach marketing - most recently for generics of Bayer's Precose (acarbose), King's Altace (ramipril) and Roche's Kytril (granisetron)
King is hoping to delay entry of generics versions of its ACE inhibitor Altace (ramipril) with a motion for hearing and rehearing en banc following a Federal Circuit decision, which invalidated King's '722 patent on the basis of obviousness. The Federal Circuit overturned an earlier decision that had upheld the validity of King's patent, instead ruling in favor of appellant Lupin. Teva, Actavis, Sandoz, Roxane and Dr. Reddy's each have a tentative approval for generic ramipril. King is hoping to spark growth of its top product, which has accounted for 32 percent of the firm's sales over the last 12 months, by launching a new tablet formulation and by gaining approval of a ramipril/hydrochlorothiazide combination (1"The Pink Sheet" Aug. 13, 2007, p. 12)...
Drug manufacturers made a pledge to contribute $80 bil. in a mix of savings and revenue-raising initiatives to help fund health reform. In return, they could see a wide range of new business depending on how you look at the numbers.