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
Carnitor	Leadiant	levocarnitine	Hikma	Used for the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency. It is also indicated to prevent and treat carnitine deficiency in patients with end stage renal disease who are undergoing dialysis.	10/5/2023
Mydayis	Takeda	amphetamine / dextroamphetamine	Teva	Used to treat attention deficit hyperactivity disorder (ADHD) in patients 13 years and older.	10/10/2023
Jadenu Sprinkle	Novartis	deferasirox	Camber	Used to treat chronic iron overload (1) due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older, and (2) in patients 10 years of age and older with non-transfusion-dependent thalassemia syndromes exhibiting elevated liver and serum iron concentrations.	10/12/2023
Azopt	Novartis	brinzolamide	Padagis	Used to decrease elevated intraocular pressure (IOP) in adult patients with ocular hypertension or open-angle glaucoma, as monotherapy in patients unresponsive to betablockers or in patients in whom beta-blockers are contraindicated, or as adjunctive therapy to betablockers.	10/13/2023
Prezista	Johnson & Johnson	darunavir	Camber	Used to treat HIV-1 infection in adult and pediatric patients 3 years of age and older.	10/18/2023
Tranexamic Acid Sodium Chloride Injection	Exela	tranexamic acid	Amneal	Used for heavy menstrual bleeding and short-term prevention in patients with hemophilia; this includes tooth extractions in patients with hemophilia as well as menorrhagia in these patients.	10/19/2023
Votrient	Novartis	pazopanib	Apotex	Used to treat adults with advanced renal cell carcinoma (RCC).	10/20/2023
Afinitor	Novartis	everolimus	Teva	Used to treat patients with advanced hormone receptor—positive, HER2-negative breast cancer in postmenopausal women; advanced renal cell carcinoma; progressive neuroendocrine tumors (NETs) of pancreatic origin; and progressive, well-differentiated, non-functional NETs of gastrointestinal or lung origin that are unresectable; and renal angiomyolipoma and tuberous sclerosis complex.	10/23/2023
Inspra	Pfizer	eplerenone	Camber	Used to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction and for the treatment of hypertension, to lower blood pressure.	10/25/2023
Calcium Gluconate	Fresenius Kabi	calcium gluconate	Somerset	Used to treat acute symptomatic hypocalcemia in pediatric and adult patients.	10/27/2023
Diastat AcuDial	Bausch Health	diazepam	Novel Laboratories (Lupin)	Used to control seizures (eg, seizure clusters, acute repetitive seizures) in patients who have epilepsy.	11/2/2023
Mitigare	Hikma	colchicine	Par	Used for prophylaxis of gout flares in adults.	11/2/2023
Livalo	Kowa	pitavastatin	Teva	Used to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia.	11/2/2023
Livalo	Kowa	pitavastatin	Upsher-Smith Labs	Used to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia and adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia.	11/6/2023
Zemuron	Organon	rocuronium bromide	Caplin Steriles (Lupin)	Used for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.	11/8/2023
Jadenu Sprinkle	Novartis	deferasirox	Teva	Used to treat chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.	11/10/2023
Locoid	Bausch Health	hydrocortisone butyrate	J. Molner	Used to treat symptoms of dermatoses.	11/15/2023
Forteo	Eli Lilly	teriparatide	Teva	Used to treat osteoporosis.	11/17/2023
Forteo	Eli Lilly	teriparatide	Apotex	Used to treat osteoporosis.	11/21/2023
Pepcid	Johnson & Johnson	famotidine	Camber	Used to treat active duodenal ulcer, active gastric ulcer, GERD, erosive esophagitis due to GERD, treatment of pathological hypersecretory conditions, reduction of the rusk of DU recurrence in adults. Used to treat peptic ulcer disease, GERD in pediatric patients 1 year or older. Used to treat GERD for pediatric patients less than 1 year of age.	11/27/2023
Vascepa	Amarin	icosapent	Amneal / Strides	Used as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.	12/1/2023
Turqoz	Wyeth	norgestrel / ethinyl estradiol	Lupin	Used to prevent pregnancy.	12/1/2023
Dexamethasone	Hikma	dexamethasone	Apotex	Used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, kidney problems, skin conditions, and flare-ups of multiple sclerosis.	12/12/2023
Vidaza	Bristol-Myers Squibb	azacitidine	Apotex	Used for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.	12/13/2023
Cetrotide	Merck Serono	cetrorelix	Teva	Used to prevent premature ovulation (early release of eggs from the ovary). It is given to women having ovarian stimulation (fertility treatment where the ovaries are stimulated to produce more eggs).	12/14/2023
Immphentiv	Hikma	phenylephrine	Hikma	Used to increase blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.	12/19/2023