FDA reponds to Warner Chilcott’s request for delay of generic approval
HAMILTON, Bermuda The Food and Drug Administration has delivered a response to Warner Chilcott’s citizen petition requesting a delay of approval of generic versions of one of the drug maker’s medications, Warner Chilcott announced Tuesday.
The company requested a 30-month stay of approval on applications for generic versions of the oral antibiotic Doryx in the 75 mg and 100 mg extended-release strengths. The FDA declined to grant the stay.
The FDA said that a 30-month stay applies to an application referencing an old antibiotic if the application contains a paragraph IV certification to a patent submitted to the FDA before the submission of the application, and the company holding the patent sues the applicant for patent infringement. Warner Chilcott said that based on the FDA’s statement, it will probably be entitled to a 30-month stay of approval on Doryx in the 150 mg strength after it files an infringement lawsuit against Impax Labs.
Doryx, which Warner Chilcott markets and sells in the United States under a license agreement with Mayne Pharma International, is protected under the 161 patent, which expires in 2022.
Congress introduces new biosimilars bill
WASHINGTON Members of Congress have introduced a second biosimilars bill to compete with the one introduced earlier this month by Democratic Rep. Henry Waxman of California and others.
Reps. Anna Eshoo, D-Calif., Jay Inslee, D-Wash., and Joe Barton, R-Texas, introduced H.R. 1548, the Pathway for Biosimilars Act Tuesday afternoon. The Biotechnology Industry Organization had announced Monday that it expected the bill’s introduction.
While the Waxman bill, the Promoting Innovation and Access to Life-Saving Medicine Act, provides for a five-year market exclusivity period for branded biotech drugs, Eshoo’s bill provides for 12 years of exclusivity.
BIO, which favors an exclusivity period of 14 years, opposed the Waxman bill, describing it as “filled with potholes,” but expressed support for the Eshoo bill.
Pfizer granted patent renewal for Lipitor
NEW YORK Pfizer announced Tuesday that the U.S. Patent and Trademark Office has granted reissue patent RE40667, relating to Lipitor.
The company had applied for the reissue patent in January 2007, in order to correct a technical defect in the ‘995 enantiomer patent for atorvastatin calcium, the salt form of atorvastatin sold as Lipitor.
On Jan. 6, the company announced that the U.S. Patent & Trademark Office had issued a “Notice of Allowance” accepting the company’s application to correct the technical defect in the ‘995 patent.
The reissue patent will have the same force and effect as the original ‘995 patent and the same June 2011 expiration date (including the six-month pediatric exclusivity period).