Pharma Blog Watch

Authorized Generics (Patent Baristas)
In their guest post, Gautam Bakshi and Ashu Gautm Bakshi discuss authorized generics, which are "in the forefront once again" in light of a recent agreement between GlaxoSmithKline and Dr. Reddy's in which "Dr. Reddy's will sell an authorized generic version of Imitrex in late 2008, before GSK's patents on Imitrex expire in February 2009."

"One problem with [authorized generics] is that they do not have to abide by the 180-day market exclusivity provision granted by the Hatch-Waxman Act to the first generic on the market," they write. "The brand companies may choose to launch an authorized generic for a variety of reasons, including settling patent litigation with a generic company by partnering with it, to participate in the generic market once generic competition starts, or to maintain manufacturing capacity for the drug substance or the drug product."

KV Pharma's Generic Toprol Troubles (Orange Book Blog)
In his blog, Aaron Barkoff reports that KV Pharmaceutical has filed a citizen petition with the FDA asking the agency to relist AstraZeneca's patent on Toprol XL, 100 and 200 mg, and asking the FDA to "refrain from approving any [abbreviated new drug application (ANDA)] for 100 mg and 200 mg Toprol XL filed after KV's ANDA … and to confirm that KV's right to 180 days of exclusivity based on its ANDA has not been affected by FDA's delisting of" the patent.

"KV argues in its citizen petition that FDA's delisting of the '714 patent was in error because delisting occurred after (1) KV filed its Paragraph IV certification, and (2) the '714 patent had been subject to a lawsuit," he writes. "Based on its belief that it was the first ANDA applicant to file a Paragraph IV certification on the '714 patent, KV further argues that it is entitled to 180 days of marketing exclusivity for generic Toprol XL."