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King Pharmaceuticals Files Citizen Petition Relating to New Patent on Altace (Ramipril)

By Aaron Barkoff

King Pharmaceuticals markets Altace (ramipril), which is indicated for the treatment of high blood pressure.  Until last year, when the Federal Circuit invalidated King's compound patent on ramipril, King earned about $700 million annually from U.S. sales of Altace.

Although Lupin was the ANDA filer who prevailed against King in the patent litigation, Cobalt Labs, as the first ANDA filer, won the 180-day exclusivity rights.  In a letter dated January 29, 2008, to attorneys for Lupin, FDA explained that Cobalt's exclusivity was triggered on December 10, 2007, and will expire on June 7, 2008.

Recently, on May 16, 2008, King submitted a citizen petition requesting that FDA require ANDA applicants for generic ramipril to submit a paragraph III or IV certification to U.S. Patent No. 7,368,469, which issued May 6, 2008, prior to final approval.  The '469 patent claims methods "for reducing the risk of a cardiovascular event" by administering an ACE inhibitor such as ramipril.

According to the FDA website, at least seven ANDA filers have tentative approval for ramipril and thus appear to have planned on obtaining final approval on June 7, when Cobalt's 180-day exclusivity expires.  Those plans may now be in doubt, as it may take FDA some time to decide how to rule on King's petition.

RELATED READING:

• Sept. 11, 2007 OBB post on Fed. Cir. decision
• Oct. 8, 2007 OBB post on FDA request for comments re: 180-day exclusivity
• Nov. 6, 2007 OBB post on comments submitted to FDA
• Feb. 4, 2008 OBB post on FDA decision re: 180-day exclusivity

Full post as published by Orange Book Blog: At the Intersection of Patent Law and FDA Law on May 27, 2008 (boomark / email).