Generic Launches 505(b)(2)

Drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications

Summer 2020

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.

Reference Listed Drug NDA Holder Generic Drug Name ANDA
Applicant(s)
Indication Launch Date
Myfortic Novartis mycophenolic acid Lupin used for Prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant 4/6/2020
Evekeo Arbor amphetamine Dr. Reddy's used to treat narcolepsy, attention deficit disorder with hyperactivity as an integral part of a total treatment program and exogenous obesity as a short term adjunct in a regimen of weight reduction 4/14/2020
NitroDur US Pharma nitroglycerin Dr. Reddy's used to prevent angina pectoris due to coronary artery disease 4/14/2020
Istodax Celgene romidepsin Teva used to treat peripheral T-cell lymphoma and cutaneous T-cell lymphoma in patients that the cancer comes back or does not respond to other cancer treatment 4/16/2020
Tricor AbbVie fenofibrate Dr. Reddy's used to treat high cholesterol and triglycerides (fatty acids) in the blood 4/27/2020
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 4/27/2020
Rapamune Pfizer sirolimus Apotex  used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant 4/29/2020
Buprenex Indivior buprenorphine Hikma used to manage pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate 5/4/2020
DDAVPP Ferring desmopressin Dr. Reddy's  used to control bleeding in people with mild hemophilia A. 5/6/2020
Riomet Sun metformin Saptalis used as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus 5/13/2020
Sabril Lundbeck vigabatrin Teva used to treat refractory complex partial seizures (CPS) as an adjunctive therapy in patients 10 years of age and older who have responded inadequately to several alternative treatments 5/15/2020
Mycamine Astellas micafungin Fresenius Kabi used to treat candidemia, acute disseminated candidiasis, and certain other invasive Candida infections, as well as esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation 5/12/2020
Robinul  Hikma glycopyrrolate Apotex used as a preoperative antimuscarinic to reduce salivary,
tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric
secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and
intubation and as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic
effect is desired or when oral medication is not tolerated
5/20/2020
Apriso Bausch & Lomb mesalamine Lupin used to maintain remission of ulcerative colitis in patients 18 years of age and older 5/19/2020
Bentyl Allergan dicyclomine HCl Hikma used to treat irritable bowel syndrome 5/28/2020
Coreg CR GlaxoSmithKline carvedilol Apotex used to treat high blood pressure; left ventricular dysfunction; heart failure; angina and belongs to the drug class non-cardioselective beta blockers 6/1/2020
Migranal Bausch & Lomb dihydroergotamine mesylate Custopharm used to treat a migraine or cluster headache attack 6/10/2020
Afinitor Novartis everolimus Mylan used to treat advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer; used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked; used to treat adults with a type of pancreatic cancer known as pancreatic euroendocrine tumor (PNET) that has progressed and cannot be treated with surgery; used to treat adults with a type of cancer known as neuroendocrine tumor (NET) of the stomach and intestine (gastrointestinal) or lung that has progressed and cannot be treated with surgery; used to treat adults with a kidney tumor called angiomyolipoma, seen with a genetic condition called tuberous sclerosis complex (TSC), when their kidney tumor does not require surgery right away; used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery. 6/10/2020
Afinitor Novartis everolimus Hikma used to treat advanced hormone receptor-positive, HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal women who have already received certain other medicines for their cancer; used to treat adults with advanced kidney cancer (renal cell carcinoma or RCC) when certain other medicines have not worked; used to treat adults with a type of pancreatic cancer known as pancreatic euroendocrine tumor (PNET) that has progressed and cannot be treated with surgery; used to treat adults with a type of cancer known as neuroendocrine tumor (NET) of the stomach and intestine (gastrointestinal) or lung that has progressed and cannot be treated with surgery; used to treat adults with a kidney tumor called angiomyolipoma, seen with a genetic condition called tuberous sclerosis complex (TSC), when their kidney tumor does not require surgery right away; used to treat adults and children with a genetic condition called tuberous sclerosis complex (TSC) who have a brain tumor called subependymal giant cell astrocytoma (SEGA) when the tumor cannot be removed completely by surgery. 6/11/2020
Colcrys Takeda colchicine Dr. Reddy's used to treat gout flares in adults and Familial Mediterranean fever (FMF) in adults and children 4 years or
older
6/12/2020
Zytiga J&J abiraterone Dr. Reddy's used to treat men with prostate cancer that has spread to other parts of the body 6/19/2020
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