Mylan confirms first-to-file patent challenge for Nuvigil generic
PITTSBURGH Drug maker Cephalon and its French subsidiary sued generic drug maker Mylan in connection with the latter’s filing of an approval application for a generic version of a sleep disorder drug, Mylan said Monday.
Cephalon filed a lawsuit in U.S. district courts in Delaware and the northern district of West Virginia after Mylan sought Food and Drug Administration approval for armodafinil tablets in the 50-mg, 150-mg and 250-mg strengths, a generic version of Nuvigil. Nuvigil is used to improve wakefulness in patients with obstructive sleep apnea and hypnea syndrome, narcolepsy and shift work sleep disorder.
Mylan said it was the first company to file for approval of a generic version of Nuvigil, meaning that it will have six months in which to compete directly with the branded version after the FDA grants final approval, under regulations governing generic drugs.
The New York Times reported Wednesday that Cephalon is seeking an additional approval for Nuvigil, as a preventive treatment for jet lag. Gaining the approval would allow it to extend its market exclusivity for the drug.
Nuvigil had sales of $42.3 million during the six-month period ending Sept. 30, according to IMS Health.
Walgreens offering free review sessions to Medicare Part D beneficiaries
DEERFIELD, Ill. Walgreens now is offering free review sessions to Medicare Part D beneficiaries at all of its more than 7,100 pharmacies throughout the country.
Following the open enrollment period for Medicare Part D insurance plans, Walgreens is assisting those beneficiaries who’ve made changes to their prescription drug coverage. Review sessions with Walgreens pharmacists are available daily by appointment through Jan. 31, and are designed to help patients maximize their plan benefits.
Review sessions include:
- A review of beneficiary’s current medications, tiers within their selected plan, co-pays and cost-savings opportunities
- Discussion of available health and wellness services including pneumonia and shingles vaccinations and 90-day prescription benefits
- Checks for potential drug interactions
Watson files FDA application for generic LoSeasonique
MORRISTOWN, N.J. Watson Labs, a subsidiary of specialty pharmaceutical company Watson Pharmaceuticals, has filed an abbreviated new drug application to the Food and Drug Administration for an oral contraceptive.
Watson is seeking approval to market its levonorgestrel and ethinyl estradiol (0.10-mg/0.02-mg) oral contraceptive product prior to the expiration of U.S. Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, a subsidiary of Teva. Watson’s levonorgestrel and ethinyl estradiol product is a generic version of Teva’s LoSeasonique, which is indicated for the prevention of pregnancy.
On Nov. 23, 2009, pursuant to the Hatch-Waxman Act, Watson notified Duramed that its ANDA requesting approval from the FDA for a generic version of LoSeasonique contained a paragraph IV certification asserting that the LoSeasonique patent is invalid, unenforceable and/or not infringed. Teva Women’s Health filed suit against Watson on Jan. 6, 2010 in the U.S. District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 7,615,545. Based on available information, Watson believes it may be entitled to 180 days of generic market exclusivity or shared exclusivity should its product receive approval.