Generic Launches

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

Fourth Quarter

GENERICally Speaking

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

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