Generic Launches

Winter 2020

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Remodulin United Therapeutics treprostinil Teva Used to treat Pulmonary Arterial Hypertension (PAH). 10/1/2019
Xyzal UCB levocetirizine Camber (Hetero) Used to treat symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age; for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older. 10/1/2019
Invega Johnson and Johnson paliperidone Amneal Used to treat the symptoms of schizophrenia. 10/10/2019
OsmoPrep Salix sodium phosphate monobasic monohydrate / sodium phosphate dibasic anhydrous Novel/Teva Used for cleansing of the colon as a preparation for colonoscopy in adults. 10/16/2019
Bentyl Allergan dicyclomine Camber (Hetero) Used to treat the symptoms of irritable bowel syndrome. 11/4/2019
Tarceva Genentech erlotinib Breckenridge Used to treat patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen and also for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine. 11/12/2019
Emend Merck fosaprepitant Fresenius Kabi Used along with other medications to prevent nausea and vomiting in adults that may occur within 24 hours or several days after receiving certain cancer chemotherapy treatments. 11/13/2019
Tarceva Genentech erlotinib Armas Used to treat patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen and also for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine. 11/13/2019
Potassium Chloride Pharma Research Software Solution potassium chloride Lupin Used to treat or prevent low amounts of potassium in the blood. 11/19/2019
BiCNU Avet Pharma (Emcure) carmustine STI Pharma Used to treat brain tumors, multiple myeloma, Hodgkin's disease and Non-Hodgkin's lymphomas. 11/21/2019
Hectorol Sanofi doxercalciferol Dr. Reddy's Used to treat secondary hyperparathyroidism in certain people with chronic kidney disease and in those treated with dialysis. 11/22/2019
Westcort Sun hydrocortisone valerate cream 0.2% Lupin Used for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients. 11/22/2019
Jadenu Novartis deferasirox Teva Used to treat chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. 11/26/2019
Revatio Pfizer sildenafil Amneal Used to treat erectile dysfunction in men. 12/2/2019
Exelon Patch Novartis rivastigmine Breckenridge Used to treat dementia associated with mild, moderate and severe Alzheimer's Disease and the treatment of mild to moderate dementia associated with Parkinson's Disease. 12/3/2019
Velcade Millenium bortezomib Dr. Reddy's Used to treat adults with multiple myeloma and the treatment of adults with mantle cell lymphoma. 12/4/2019
Exjade Novartis deferasirox Dr. Reddy's Used for the treatment of chronic iron overload due to blood transfusions inpatients two years of age and older. 12/6/2019
Jadenu Novartis deferasirox Dr. Reddy's Used to treat chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. 12/6/2019
Afinitor Novartis everolimus Par Used to treat advanced renal cell carcinoma that has already been treated unsuccessfully with other medications; to treat a certain type of advanced breast cancer that has already been treated with at least one other medication; to treat a certain type of cancer of the pancreas, stomach, intestines, or lungs that has spread or progressed and that cannot be treated with surgery; to treat kidney tumors in people with tuberous sclerosis complex; to treat subependymal giant cell astrocytoma in adults and children 1 year of age and older who have TSC. 12/10/2019
NuvaRing Merck etonogestrel / ethinyl estradiol Amneal Used to prevent pregnancy. 12/12/2019
Invanz Merck ertapenem Fresenius Kabi Used to treat adult patients and pediatric patients (3 months of age and older) with the moderate to severe infections caused by susceptible isolates of the designated microorganisms in complicated intra-abdominal infections, complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis, community acquired pneumonia, compicated urinary tract infections including pyelonephritis and acute pelvic infections including postpartum endomyometritis, septic abortion and post surgical gynecologic infections. 12/12/2019
NuvaRing Merck etonogestrel / ethinyl estradiol Prasco Used to prevent pregnancy. 12/16/2019
Hectorol Genzyme doxercalciferol Lupin Used to treat secondary hyperparathyroidism in certain people with chronic kidney disease and in those treated with dialysis. 12/19/2019
Travatan Z Alcon (Novartis) travoprost Apotex Used for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. 12/19/2019
Nitopress Hospira sodium nitroprusside Dr. Reddy's Used for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized; for producing controlled hypotension in order to reduce bleeding during surgery; for the treatment of acute congestive heart failure. 12/30/2019
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