Cephalon, Inc. announced that the US Patent and Trademark Office has issued US Patent No. 7,132,570 (the '570 patent) covering a novel polymorphic form of armodafinil, the active pharmaceutical ingredient in Nuvigil (armodafinil) tablets, which is pending approval with the US Food and Drug Administration (FDA). The issued patent will expire on Dec. 18, 2023, and specifically claims compositions of matter of the Form I polymorph of armodafinil, as well as pharmaceutical formulations and methods of manufacturing.
"Our scientists have discovered several novel polymorphs associated with armodafinil. Significantly, we believe polymorphic Form I is the most stable crystalline form of these, 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," said Dr. Jeffry Vaught, executive vice president and president of Research & Development. "We believe this patent will provide strong protection for Nuvigil."
John E. Osborn, executive vice president and General Counsel, said, "Our Provigil patent litigation settlements of the past year, and the associated licenses to certain intellectual property, do not grant any rights to this important patent. This new protection provides us with the confidence to continue to develop this market and expand our wakefulness franchise."
The company submitted a new drug application in 2005 seeking to market Nuvigil for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSA/HS) and shift work sleep disorder (SWSD). The company received an approvable letter for Nuvigil earlier this year from the FDA, and a response from the agency is expected no later than December 31, 2006.