Generic Drug Launches and 505b2 Applications

Abbreviated New Drug Applications and 505(b)(2) Applications

Fourth Quarter

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	ANDA Holder	Generic Drug Name	ANDA Applicant(s)	Indication	Launch Date
Dotarem	Guerbet	gadoterate meglumine	Fesenius Kabi	For use in MRI of the brain (intracranial), spine and associated tissues in adults and children (including term neonates) to detect and visualize areas with disruption of the blood brain barrier and/or abnormal vascularity	10/4/2022
Zovirax	Bausch	acyclovir	Camber / Hetero	Used for the prophylaxis of herpes simplex infections in immunocompromised patients	10/5/2022
Combigan	AbbVie	brimonidine / timolol	Teva	Used to treat the symptoms of Elevated IOP in patient with Glaucoma or Ocular Hypertension	10/11/2022
Cardura	Viatris	doxazosin	Apotex	Used to treat hypertension, to lower blood pressure	10/18/2022
Gilenya	Novartis	fingolimod	Apotex	Used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older	10/19/2022
Gilenya	Novartis	fingolimod	Camber / Hetero	Used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older	10/20/2022
Daliresp	Astra-Zeneca	roflumilast	Camber / Hetero	Used to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis	10/20/2022
Invega	J&J	paliperidone	Lupin	Used to treat schizophrenia	10/20/2022
Zytiga	J&J	abiraterone	Apotex	Used to treat patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel	10/28/2022
Gilenya	Novartis	fingolimod	Glenmark	Used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older	10/31/2022
Aggrastat	Medicure	tirofiban	Nexus	Used to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS)	11/1/2022
Naprelan	Almatica	naproxen	Teva	Used to treat the symptoms of Rheumatoid Arthritis, Osteoarthritis, Ankylosin Spondylitis, Dysmenorrhea, Acute Gout and Pain	11/1/2022
Esbriet	Genentech	pirfenidone	Camber / Hetero	Used to treat idiopathic pulmonary fibrosis (IPF)	11/10/2022
Folotyn	Allos	pralatrexate	Fresenius Kabi / Sandoz	Used to treat patients with relapsed or refractory peripheral T-cell lymphoma	11/14/2022
Denavir	Mylan	penciclovir	Teva	Used to treat recurrent herpes labialis (cold sores) in adults and children 12 years of age or older	11/14/2022
Zioptan	Akorn	tafluprost	Prasco	Used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension	11/18/2022
Lupron Depot	AbbVie	leuprolide acetate	Cipla	Used to manage endometriosis, including pain relief and reduction of endometriotic lesions	11/29/2022
Perforomist	Mylan	formoterol	Lupin	Used for the long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema	11/29/2022
Afinitor	Novartis	everolimus	Par / Endo	Used to treat hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor	11/30/2022
Folotyn	Allos	pralatrexate	Dr. Reddy's Labs	Used to treat patients with relapsed or refractory peripheral T-cell lymphoma	12/1/2022
Folotyn	Allos	pralatrexate	Teva	Used to treat patients with relapsed or refractory peripheral T-cell lymphoma	12/1/2022
Banzel	Eisai	rufinamide	Lupin	Used for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults	12/5/2022
Folotyn	Allos	pralatrexate	Fresenius Kabi	Used to treat patients with relapsed or refractory peripheral T-cell lymphoma	12/8/2022
Pennsaid 2%	Horizon	diclofenac	Lupin	Used to treat signs and symptoms of osteoarthritis of the knee(s)	12/9/2022
Vimpat	UCB	lacosamide	Camber / Hetero	Used to treat partial-onset seizures in patients 4 years of age and older	12/14/2022
Levothyroxine	Fresenius Kabi	levothyroxine sodium	Hikma	Used to treat hypothyroidism	12/14/2022
Vimpat	UCB	lacosamide	Fresenius Kabi	Used to treat partial-onset seizures in patients 4 years of age and older	12/15/2022
Vascepa	Amarin	icosapent	Teva	Used as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and o established cardiovascular disease or o diabetes mellitus and 2 or more additional risk factors for cardiovascular disease.; as an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia	12/15/2022
Emla	Teva	prilocaine / lidocaine	Padagis	Used as a topical anaesthetic for use on: - normal intact skin for local analgesia - genital mucous membranes for superficial minor surgery and as pre-treatment for infiltration anaesthesia	12/21/2022
Rayos	Horizon	prednisone	Teva	Used as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation; for the treatment of certain endocrine conditions; for palliation of certain neoplastic conditions	12/23/2022
Hetlioz	Teva	tasimelteon	Teva	Used to treat Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) patients 16 years of age and older	12/29/2022