logo
Share SHARE
FONT-SIZE Plus   Neg

Mylan Files Suit Against FDA Over Generic Provigil

Mylan Inc. (MYL) has filed a lawsuit against U.S Food and Drug Administration, seeking to overturn its decision which awarded Teva Pharmaceutical Industries Ltd. (TEVA) an 180-days sole exclusivity for the generic version of Cephalon's Provigil.

Provigil is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness due to sleep disorders. According to IMS Health, Provigil had U.S. sales of about $1.1 billion for the full year ended December 31, 2011.

Mylan's subsidiary, Mylan Pharmaceuticals has filed the suit against FDA in the U.S. District Court for the District of Columbia.

Earlier Thursday, Teva said the FDA decided that its subsidiary Teva Pharmaceuticals USA is the sole first-to-file for both Orange Book patents listed for Provigil, and therefore Teva alone is entitled for the 180-day exclusivity.

Mylan alleged that Teva did not maintain valid paragraph IV (PIV) certifications as a result of its acquisition of Cephalon last year. Mylan's complaint states that after the acquisition of Cephalon, Teva could no longer infringe its own patents and therefore is not entitled to exclusivity based on patent certifications.

Mylan also alleged that FDA should have found that Mylan is the sole first filer on one of the Orange Book Patents for Provigil.

The complaint also says that FDA's decision, which blocks Mylan and other generic entrants from launching their generic Provigil products, is unlawful. Mylan believes the Federal Trade Commission did not contemplate the current outcome when it imposed its conditions on the Teva/Cephalon merger.

Mylan is seeking immediate equitable relief from the Court requiring FDA to approve Mylan's ANDA.

MYL is currently trading on the NYSE at $22.55, down 2.63%, on a volume of 3.6 million shares. TEVA is currently trading at $45.00, up $0.25%, on a volume of 1.36 million shares, on the Nasdaq.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Embark Veterinary Inc., a startup that makes dog DNA-testing kits for pet owners, vets and breeders, said it has raised $4.5 million in funding from investors and relocated its headquarters to Boston. The company intends to use the new funding to expand its canine genetic testing suite for pet owners, breeders, and veterinarians. Intel Corp. has completely shut down its wearables division about two weeks ago, CNBC reported, citing a person familiar with the matter. The company reportedly intends to focus on augmented reality. According to the CNBC report, Intel laid off about 80 percent of the team that made the Basis fitness watch in November 2016 and has now eliminated the division entirely. The Federal Trade Commission is investigating allegations that Amazon.com Inc. misled consumers about its pricing discounts, Reuters reported, citing a source close to the probe. The FTC probe is reportedly part of the agency's review of Amazon's proposed $13.4 billion deal to buy grocery chain Whole Foods Market Inc.
comments powered by Disqus
Follow RTT