The patent life of Provigil follow-on Nuvigil (armodafinil) received a major boost Nov. 7 after the U.S. Patent & Trademark Office issued Cephalon a composition-of-matter patent extending to Dec. 18, 2023.

Patent no. 7,132,570 covers a "method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil." Modafinil is the active ingredient in the awakening agent Provigil.

According to Cephalon, the patent covers the "Form I polymorph of armodafinil, as well as pharmaceutical formulations and methods of manufacturing."

Form I "is the most stable crystalline form of [several novel polymorphs], is present in the formulation that we expect to bring to market and is very likely to be present in any other formulation of armodafinil that may be developed," Cephalon R&D President Jeffrey Vaught said.

Nuvigil is currently pending before FDA and has a user fee date of Dec. 31 as a result of an agency "approvable" letter.

Based on settlements with ANDA filers for Provigil, Cephalon believes it can wait several years to begin heavy Nuvigil promotions while it secures a more robust label for the follow-on; Provigil will not face generic competition until 2011 (¹ Also see "Provigil Will Remain Cephalon’s Marketing Focus As Partner Takeda Adds Reps" - Pink Sheet, 3 November, 2006.).

In August, the Federal Trade Commission said it was investigating those generic settlements (² Also see "Cephalon Provigil Generics Settlements Under FTC Investigation" - Pink Sheet, 30 August, 2006.).

Cephalon General Counsel John Osborn said the settlements with generic companies over Provigil do not give the firms rights to the '570 patent. Before receiving its own patent, armodafinil had been covered by modafinil's composition of matter and particle size patents, which are impacted by the generic settlements.

-Jonathan M. Block (j.block@elsevier.com)

Nuvigil Gets Protection Until 2023 Under New Patent

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