Valeant Pharmaceuticals International’s (“Valeant’s”) EFUDEX (fluorouracil) Topical Cream, 5%, (also known as 5-FU) is a locally-acting antineoplastic drug product FDA first approved in July 1970 for the topical treatment of multiple actinic or solar keratoses (“AK”). In 1976, FDA approved the drug for a second …
We previously reported (here and here) on FDA’s efforts to resolve 180-day exclusivity forfeiture issues concerning generic versions of Bayer Pharmaceuticals’ (“Bayer’s”) diabetes drug PRECOSE (acarbose) Tablets by establishing a public docket. (FDA has also taken similar actions to resolve 180-day exclusivity issues concerning ramipril …
On May 7, 2008, the U.S. Court of Appeals for the Federal Circuit is scheduled to hear oral argument in Lupin Ltd. v. Abbott Labs. This is a patent infringement action concerning U.S. Patent #4,935,507 (“the ‘507 patent”) with respect to Abbott’s antibiotic drug product …
Under Title II of the Hatch-Waxman Act, certain patents related to products regulated by FDA are eligible for extension by the U.S. Patent and Trademark Office (“PTO”) if patent life was lost during a period when the product was undergoing regulatory review. The “regulatory review …
On April 11, 2008, we reported that Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia issued a 2-page order in Teva Pharmaceuticals USA, Inc. v. Leavitt siding with Teva over the reslisting of U.S. Patent #5,158,952 (“the ‘952 patent”) …
Earlier this month, we reported on the status of litigation in the U.S. Court of Appeals for the District of Columbia Circuit concerning Nu-Pharm Inc.’s efforts to get FDA to approve the company’s ANDA for a generic version of Abbott Laboratories’ DEPAKOTE (divalproex sodium) Delayed-Release …
Earlier today, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia issued a 2-page order in Teva Pharmaceuticals USA, Inc. v. Leavitt siding with Teva. This case concerns the relisting of U.S. Patent #5,158,952 (“the ‘952 patent”) in the Orange …
Earlier this year, we reported on the U.S. District Court for the District of Columbia’s January 24, 2008 order dismissing Nu-Pharm Inc.’s complaint against FDA seeking declaratory and emergency injunctive relief with respect to Nu-Pharm’s ANDA #77-615 for a generic version of Abbott Laboratories’ DEPAKOTE …
Earlier this month, we reported on a lawsuit filed by Teva Pharmaceuticals USA against FDA in the U.S. District Court for the District of Columbia concerning the relisting of U.S. Patent #5,158,952 (“the ‘952 patent”) in the Orange Book covering Janssen Phaemaceutica’s RISPERDAL (risperidone) Tablets. …
Last year, in our post titled “180-Day Exclusivity Forfeiture – A Zen Moment,” we reported on a case in which FDA took a stance with respect to the forfeiture of 180-day exclusivity eligibility that is reminiscent of the old “if a tree falls in the …
Last Friday, Representatives Anna Eshoo (D-CA) and Joe Barton (R-TX) announced the introduction of H.R. 5629, the “Pathway for Biosimilars Act.” We previously reported on a draft version of the bill circulated on Capitol Hill in February 2008. H.R. 5629 will be referred to the …
Under the Hatch-Waxman Act, certain patents related to products regulated by FDA are eligible for extension if patent life was lost during a period when the product was undergoing regulatory review. The “regulatory review period” is composed of a “testing phase” and a “review phase.” …
Last week, Apotex Inc. submitted an interesting Petition for Stay of Action to FDA requesting that the Agency recognize the company’s remaining 180-day exclusivity for its generic version of Sanofi-Synthelabo’s PLAVIX (clopidogrel bisulfate) by staying the effective date of final approval of other ANDAs (and …
The debate over biogenerics legislation has intensified with the anticipated introduction of legislation to create a “generic biologics” approval pathway and that would grant innovators (i.e., reference product sponsors) and certain generic sponsors market exclusivity. The draft legislation obtained by FDA Law Blog is titled …
On February 4, 2008, FDA announced that the Bush Administration is requesting nearly $2.4 billion ($1.77 billion in budget authority and $628 million in user fees) for the Agency as part of the Fiscal Year 2009 budget. Of particular interest in the proposed FY2009 budget …
