Endo receives para IV certification notice from Watson for lidocaine topical patch

Endo Pharmaceuticals and its partners, Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc. have received a Paragraph IV Certification Notice from Watson Laboratories. Watson has filed an ANDA for a generic version of LIDODERM® (lidocaine topical patch 5%). The certification refers to U.S. Patent No. 5,827,529, which covers the formulation of LIDODERM, a topical patch to relieve the pain of postherpetic neuralgia launched in 1999 wherein the patent shall expire in 2015. The company is currently reviewing the details of this notice from Watson. Endo intends to vigorously defend LIDODERM's intellectual property rights and pursue all available legal and regulatory pathways in defense of LIDODERM. 

Watson files ANDA for generic LoSeasonique® [(levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg)]

Watson has filed an ANDA with the USFDA seeking approval to market its levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg) oral contraceptive product prior to the expiration of US Patent No. 7,615,545, which is owned by Duramed Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceutical Industries, Ltd.

On November 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, Inc. filed suit against Watson on January 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.

Watson filed ANDA for generic armodafinil

Watson's subsidiary, Watson Laboratories, Inc. has filed an ANDA with the USFDA seeking approval to market its 50 mg, 100 mg, 150mg, 200 mg, and 250mg strength armodafinil tablets prior to the expiration of patents owned by Cephalon France. Watson's 50 mg, 100 mg, 150mg, 200 mg and 250mg armodafinil tablet products are generic versions of Cephalon, Inc.'s Nuvigil(R), which is indicated for the improvement of wakefulness in adults who experience excessive sleepiness (ES) associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), or narcolepsy.

Cephalon, Inc. and Cephalon France filed suit against Watson on January 5, 2010 in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 7,132,570. Cephalon's suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Watson claims to be a "first applicant" to file an ANDA for the 100 mg and 200 mg strengths of a generic version of Nuvigil(R) and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for those strengths.

Watson Receives FDA Approval for Generic Razadyne ER Capsules

Watson has received approval from the USFDA on its ANDA for galantamine hydrobromide ER capsules, eq. to 8 mg, 16 mg and 24 mg (galantamine base). Galantamine hydrobromide extended-release capsules are the generic equivalent to Ortho McNeil Janssen's Razadyne(R) ER, galantamine HBr extended-release capsules, which are indicated for the treatment of Alzheimer's disease.

Watson intends to launch the product immediately. Razadyne(R) ER had annual sales of approximately $112 million for the twelve months ending September 2008, according to IMS sales data.