Generic Launches Q1 2012

Reference Listed Drug, NDA Holder, Generic Drug Name, ANDA Applicant(s), Indication and Launch Date

April 04, 2012

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Reference Listed Drug NDA Holder Generic Drug Name ANDA Applicant(s) Indication Launch Date
Yaz Bayer HealthCare Pharmaceuticals Inc.'s Vestura(TM) (3 mg drospirenone and 0.02 mg ethinyl estradiol) Watson Pharmaceuticals prevention of pregnancy and for the treatment of moderate acne in women Jan. 18, 2012
Zanaflex Watson Pharmaceuticals tizanidine hydrochloride capsules Acorda Therapeutics, short-acting drug indicated for the management of spasticity. Feb. 6, 2012
Zanaflex Acorda Therapeutics tizanidinehydrochloride Apotex Multiple sclerosis skeletal muscle relaxants Feb. 9, 2012
Lexapro Forest Laboratory Escitalopram Tablets USP, 5 mg, 10 mg and 20 mg Mylan Pharmaceuticals Inc. depression and generalized anxiety disorder treatment Feb. 29, 2012
Geodon Pfizer Inc.'s ziprasidone Dr. Reddy's Laboratories antipsychotic drug Mar. 2, 2012
Prometrium Abbott Laboratories Progesterone Capsules, 100 & 200 mg Teva Pharmaceutical Industries Ltd. secondary amenorrhea due to a decrease in progesterone as well as in conjunction with estrogen-containing medications in postmenopausal women with a uterus. Mar. 2, 2012
Prometrium Abbott Laboratories Progesterone Capsules, 100 & 200 mg Watson Pharmaceuticals secondary amenorrhea due to a decrease in progesterone as well as in conjunction with estrogen-containing medications in postmenopausal women with a uterus. Mar. 2, 2012
Geodon Pfizer Inc.'s ziprasidone Lupin Pharmaceuticals antipsychotic drug Mar. 3, 2012
Lexapro Forest Laboratory Escitalopram Oxalate Tablets Teva Pharmaceutical Industries Ltd. depression and generalized anxiety disorder treatment Mar. 14, 2012
Lexapro Forest Laboratory Escitalopram Oxalate Tablets Amneal Pharmaceuticals depression and generalized anxiety disorder treatment Mar. 15, 2012
Seroquel AstraZeneca quetiapine fumarate tablets Teva Pharmaceutical Industries Ltd. antidepressants in major depressive disorder and acute depressive episodes in bipolar disorder Mar. 28, 2012
Seroquel AstraZeneca quetiapine fumarate tablets Mylan Pharmaceuticals Inc. antidepressants in major depressive disorder and acute depressive episodes in bipolar disorder Mar. 28, 2012

Ryan M. Schultz

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