Drug makers send letters to FDA over Cobalt's generic Altace

WASHINGTON According to letters to the Food and Drug Administration, Cobalt Pharmaceuticals should not be allowed to keep its 180-day exclusivity for the generic version of the hypertension drug Altace.

When Cobalt agreed with King Pharmaceuticals to launch an authorized generic version of the drug, a certification for Cobalt’s approval was changed to a different level that voided the exclusivity, according to one of the letters.

The U.S. Court of Appeals for the Federal Circuit ruled in a separate case that the Altace patent is invalid due to obviousness, and since Cobalt has not marketed its product yet, its application is listed as discontinued.

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