Generic Launches

Summer 2015

Reference Listed Drug	NDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Exforge	Novartis	Amlodipine / Valsartan	Lupin Pharmaceuticals	treatment of hypertension and to lower blood pressure	4/1/2015
FemHRT	Warner Chilcott	Norethindrone Acetate / Ethinyl Estradiol	Glenmark Generics	moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis in women at significant risk of osteoporosis	4/7/2015
Generess Fe Tablets	Warner Chilcott	Norethindrone / Ethinyl Estradiol / Ferrous Fumarate	Mylan	prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception	4/7/2015
Exalgo	Mallinckrodt	Hydromorphone Extended-Release Tablets	Perrigo	treatment of chronic pain in opioid-tolerant patients requiring continuous around-the-clock opioid analgesia for an extended amount of time	4/8/2015
Lybrel	Wyeth	Levonorgestrel / Ethinyl Estradiol Tablets USP	Glenmark Generics	prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception	4/10/2015
Kenalog Topical Spray	Sun Pharma	Triamcinolone Acetonide Topical Aerosol	Perrigo	relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses	4/16/2015
Abilify	Otsuka Pharmaceutical	Aripiprazole	Teva Pharmaceutical Industries	treatment of schizophrenia and for the acute treatment of manic and mixed episodes associated with bipolar I disorder	4/28/2015
Seasonale	Teva Women's Health	Levonorgestrel / Ethinyl Estradiol Tablets	Mylan	prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception	5/5/2015
Pulmicort Respules	AstraZeneca	Budesonide Inhalation Suspension	Allergan	maintenance medicine to control and prevent asthma symptoms in children ages 12 months to 8 years	5/7/2015
Lotronex	Prometheus Laboratories	Alosetron Hydrochloride Tablets	Roxane Laboratories	for some women with severe Irritable Bowel Syndrome (IBS)	5/21/2015
DDAVP	Ferring Pharmaceuticals	Desmopressin Acetate Tablets	Glenmark Pharmaceuticals	antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of temporary polyuria and polydipsia following head trauma or surgery in the pituitary region	5/29/2015
Lomedia 24 Fe	Amneal	Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate	Teva	for prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception	5/29/2015
Actonel	Actavis	Risedronate Sodium Tablets	Teva	help increase bone mass and help reduce the chance of having a spinal or non-spinal fracture (break) and are also used to treat or prevent osteoporosis in either men or women who are taking corticosteroid medicines, and to treat Paget's disease of the bone	6/1/2015
Intuniv	Shire	Guanfacine Hydrochloride Extended-Release Tablets	Mylan	treatment of Attention Deficit Hyperactivity Disorder (ADHD)	6/2/2015
Seasonique	Teva	Levonorgestrel / Ethinyl Estradiol Tablets	Mylan (Famy Care)	prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception	6/2/2015
Intuniv	Shire	Guanfacine Hydrochloride Extended-Release Tablets	Teva	treatment of Attention Deficit Hyperactivity Disorder (ADHD)	6/2/2015
Intuniv	Shire	Guanfacine Hydrochloride Extended-Release Tablets	Sandoz	treatment of Attention Deficit Hyperactivity Disorder (ADHD)	6/4/2015
Dovonex Cream	Leo Pharma	Calcipotriene Cream	Glenmark Pharmaceuticals	treatment for psoriasis	6/11/2015
Seasonale	Teva Women's Health	Levonorgestrel / Ethinyl Estradiol Tablets	Glenmark Pharmaceuticals	prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception	6/15/2015
Copaxone	Teva	Glatiramer Acetate	Sandoz	treatment for relapsing forms of Multiple Sclerosis	6/18/2015

GENERICally Speaking Summer 2015

First Quarter

ANDA Litigation Settlements