Generic Drug Launches and 505b2 Applications

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

First 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
Hetlioz	Vanda	tasimelteon	Apotex	Used to treat non-24 hour sleep-wake disorder in adult patients and for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome in patients ≥16 years old.	1/05/2024
Prolensa	Bausch & Lomb	bromfenac ophthalmic solution, 0.07%	Lupin	Used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.	1/09/2024
Chantix	PF Prism	varenicline	Lupin	Used as an aid to smoking cessation treatment.	1/10/2024
Chantix	PF Prism	varenicline	Apotex	Used as an aid to smoking cessation treatment.	1/15/2024
Korlym	Corcept Therapeutics	mifepristone	Teva	Used to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type II diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.	1/19/2024
Orfadin	Swedish Orphan	nitisinone	Eton	Used to treat hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.	2/02/2024
Alphagan P Ophthalmic Solution	AbbVie	brimonidine tartrate	Alembic	Used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.	2/06/2024
Invega	Janssen	paliperidone	Camber	Used to treat schizophrenia, schizoaffective disorder as monotherapy, and as an adjunct to mood stabilizers and/or antidepressants.	2/12/2024
Entereg	Cubist	alvimopan	Hikma	Used to help restore normal bowel function in patients who have just had bowel resection surgery.	2/13/2024
Pradaxa	Boehringer Ingelheim	dabigatran etexilate	Apotex	Used to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days, to reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated, for the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery.	2/13/2024
Ganirelix Acetate	Organon	ganirelix acetate	Lupin	Used to inhibit premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.	2/15/2024
BiCNU	Avent Lifesciences	carmustine	Alembic	Used alone or together with other medicines to treat certain type of brain tumors (e.g., glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors), cancer of the lymph system (e.g., Hodgkin's disease, non-Hodgkin's lymphoma), and a certain type of cancer in the bone marrow (e.g., multiple myeloma).	2/21/2024
Cytoxan	Baxter	cyclophosphamide	Fresenius Kabi	Used to treat cancer of the ovaries, breast, blood and lymph system, and nerves (mainly in children). Also used for retinoblastoma (a type of eye cancer mainly in children), multiple myeloma (cancer in the bone marrow), and mycosis fungoides (tumors on the skin).	2/28/2024
Trileptal	Novartis	oxcarbazepine	Camber	Used for adults as monotherapy or adjunctive therapy in the treatment of partial-onset seizures. Pediatrics use as monotherapy in the treatment of partial-onset seizures in children 4 to 16 years of age, and as adjunctive therapy in the treatment of partial-onset seizures in children 2 to 16 years of age.	2/29/2025
Lipitor	Pfizer	atorvastatin	Camber	Used to lower lipid levels and reduce the risk of cardiovascular disease including myocardial infarction and stroke.	2/29/2024
Vascepa	Amarin	icosapent	Camber	Used as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalizing in adult patients with elevated triglycerides and established cardiovascular disease or who have diabetes mellitus and ≥2 other risk factors for cardiovascular disease. It is also indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.	3/08/2024
Gralise	Chemo Research	gabapentin	Camber	Used to manage Postherpetic Neuralgia (PHN).	3/18/2024
Theophylline	Bausch	theophylline	Camber	Used to treat symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases.	3/20/2024
Duexis	Horizon Therapeutics	ibuprophen / famotidine	Endo	Used to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis while decreasing the risk of developing ulcers of the stomach and upper intestines people may experience from ibuprofen alone.	3/26/2024
Zomig	IPR Pharmaceuticals	zolmitriptan	Alembic	Used for the acute treatment of migraine with or without aura in adults.	3/28/2024
Zyloprim	Casper Pharma	allopurinol	Camber	Used to manage patients with signs and symptoms of primary or secondary gout, the management of patients with conditions requiring therapies which cause elevations of serum and urinary uric acid levels, and the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds specific thresholds.	3/29/2024