Generic Drug Launches and 505b2 Applications of Q3 - Fall 2023

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

Third Quarter

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