Generic Launches

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

Third Quarter

GENERICally Speaking

This Generic Launches 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
Xyrem Jazz sodium oxybate Amneal  Used to treat cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with narcolepsy 7/3/2023
Ganirelix Organon ganirelix acetate Fresenius Kabi Used to inhibit premature surges in luteinizing hormone, or LH, a chemical in the body that triggers reproductive processes such as ovulation; used to treat women who are undergoing controlled ovarian hyperstimulation 7/10/2023
Aczone AbbVie dapsone Cosette Used for the topical treatment of acne vulgaris 7/13/2023
Cubicin Cubist daptomycin Camber Used to treat complicated skin and skin structure infections (cSSSI) in adult patients and pediatric patients (1 to 17 years of age) 7/27/2023
Symbicort AstraZeneca budesonide / formoterol fumarate dihydrate Viatris Used in certain patients to treat asthma or chronic obstructive pulmonary disease (COPD)  7/31/2023
Duexis Horizon ibuprophen / famotidine Camber Used  to (1) relieve signs and symptoms of rheumatoid arthritis and osteoarthritis and (2) decrease the risk of developing upper gastrointestinal ulcers, in patients who are taking ibuprofen for those indications 8/1/2023
Sabril Lundbeck vigabatrin Upsher-Smith Used for infantile spasms in patients 1 month to 2 years of age and Refractory Complex Partial Seizures (CPS) in adults and children 2 years and older with refractory complex partial seizures (CPS) 8/1/2023
Gadavist Bayer gadobutrol Fresenius Kabi Used as a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI) 8/8/2023
Luxiq Mylan betamethasone Xiromed Used to relieve inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp 8/2/2023
Cardura Viatris doxazosin mesylate Apotex Used to treat high blood pressure (hypertension) and symptoms of an enlarged prostate (benign prostatic enlargement)  
Toradol Roche ketorolac tromethamine Camber Used for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting 8/7/2023
Mozobil Genzyme plerixafor Fresenius Kabi Used in combination with granulocyte-colony stimulating factor in patients with non-Hodgkin's lymphoma or multiple myeloma 8/9/2023
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 (NTDT) syndromes exhibiting elevated liver and serum iron concentrations 8/8/2023
Spiriva HandiHaler Boehringer Ingelheim tiotropium bromide Lupin Used to treat chronic obstructive pulmonary disease (COPD) 8/16/2023
Pepcid Johnson & Johnson famotidine Upsher-Smith Used to treat active duodenal ulcer, active gastric ulcer, symptomatic non-erosive gastroesophageal reflux disease (GERD), and erosive esophagitis due to GERD, diagnosed by biopsy 8/15/2023
Balcoltra Avion  levonorgestrel / ethinyl estradiol Xiromed Used as an oral contraceptive 8/17/2023
Apriso Valeant  mesalamine Upsher-Smith Used to treat and prevent flare-ups of mild to moderately active ulcerative colitis (an inflammatory bowel disease) 8/21/2023
Zetia Organon ezetimibe Hetero Used to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin);
reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia in combination with fenofibrate;
reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin; reduce elevated sitosterol and campesterol in patients with homozygous sitosterolemia (phytosterolemia)
8/24/2023
Alphagan AbbVie brimonidine tartrate Apotex Used to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension 9/2/2023
Aubagio Sanofi teriflunomide Apotex Used to treat the relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease 9/6/2023
Zyprexa Eli Lilly olanzapine Camber Used to treat acute agitation associated with schizophrenia and bipolar I mania 9/25/2023
Rozerem Takeda ramelteon Ziromed Used to treat insomnia characterized by difficulty with sleep onset 9/29/2023

Related Publications

Fourth Quarter
GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Oren Langer, Christopher Pinahs, Emily Tremblay, and Christine May
December 29, 2023
Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc.
GENERICally Speaking Hatch Waxman Bulletin
December 13, 2023
Acadia Pharms. Inc. v. Aurobindo Pharma Ltd.
GENERICally Speaking Hatch Waxman Bulletin
December 7, 2023
H. Lundbeck A/S v. Lupin Ltd.
GENERICally Speaking Hatch Waxman Bulletin
November 7, 2023
Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc.
GENERICally Speaking Hatch Waxman Bulletin
Back to Top