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
Aggrastat	Medicure	tirofiban	Nexus	Used to present early myocardial infarction in adult patients presenting with acute coronary syndromes without ST elevation (NSTE-ACS) with the last episode of chest pain occurring within 12 hours and with ECG changes and/or elevated cardiac enzymes	1/1/2023
Duexis	Horizon	ibuprofen / famotidine	Par / Endo	Used to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis	1/3/2023
Suboxone	Indivior	buprenorphine / naloxone	Par / Endo	Used to treat opioid dependence	1/3/2023
Xyrem	Jazz	sodium oxybate	Hikma	Used to treat cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy	1/3/2023
Nexavar	Bayer	sorafenib	Teva	Used to treat patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment	1/3/2023
Amitiza	Sucampo	lubiprostone	Teva	Used to treat adult patients with chronic idiopathic constipation, or opioid-induced constipation in patients with chronic non-cancer pain	1/3/2023
Flector	IBSA	diclofenac	Yaral	Used to treat pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma	1/3/2023
Kuvan	Biomarin	sapropterin	Camber / Hetero	Used to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU)	1/4/2023
Trokendi XR	Supernus	topiramate	Zydus	Used to manage and treat epilepsy and migraine	1/4/2023
Narcan	Emergent	naloxone	Hikma	Used for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression	1/4/2023
Cambia	Assertio	diclofenac	Par / Endo	Used to treat pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma	1/5/2023
Haloette / NuvaRing	Merck	etonogestrel / ethinyl estradiol	Mayne	Used for the prevention of pregnancy in women who elect to use this product as a method of contraception	1/13/2023
Cambia	Assertio	diclofenac	Camber / Hetero	Used to treat pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma	1/14/2023
Tenex	Unichem	guanfacine HCL	TWi	Used to treat Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications	1/23/2023
Theophylline	Akorn	theophylline	Teva	Used to prevent and treat wheezing, shortness of breath, and chest tightness caused by asthma, chronic bronchitis, emphysema, and other lung diseases	1/27/2023
Zioptan	Akorn	tafluprost	Prasco	Used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension	11/18/2022
Lupron Depot	AbbVie	leuprolide acetate	Cipla	Used to manage endometriosis, including pain relief and reduction of endometriotic lesions	11/29/2022
Namenda	Allergan	memantine HCL	Camber / Hetero	Used to treat moderate to severe dementia of the Alzheimer's type	1/30/2023
Doryx MPC	Mayne	doxycycline	Mayne	Used to treat many different bacterial infections including acne, urinary and respiratory tract infections, eye infections, gum disease, gonorrhea, chlamydia, and syphilis. It can also be used prevent malaria and treat infections caused by mites, ticks, or lice	2/15/2023
Cardizem	Bausch	diltiazem	Mayne	Used to treat high blood pressure and to control angina (chest pain)	2/15/2023
Zonalon	Mylan	doxepin	Teva	Used to treat insomnia (difficulty falling asleep or staying asleep) in people who have trouble staying asleep	2/17/2023
Latuda	Sunovion	lurasidone	Lupin	Used to treat schizophrenia in patients ≥13 years old. It is also indicated as a monotherapy for the treatment of bipolar depression in patients ≥10 years old, or in combination with lithium or valproate for the treatment of bipolar depression in adults	2/21/2023
Combigan	AbbVie	brimonidine / timolol	Apotex	Used to treat increased eye pressure from either open-angle glaucoma or ocular hypertension	2/23/2023
Zyprexa Zydis	Eli Lilly	olanzapine	Apotex	Used in the management of schizophrenia, bipolar 1 disorder, and agitation associated with these disorders	2/24/2023
Valcyte	Roche	valganciclovir	Camber / Hetero	Used to treat cytomegalovirus (CMV) retinitis (eye infection that can cause blindness) in people who have acquired immunodeficiency syndrome (AIDS)	3/1/2023
Cystadane	Recordati	betaine	Cosette/ANI	Used to treat homocystinuria in pediatric and adult patients to decrease elevated homocysteine blood levels	3/2/2023
Axiron	Eli Lilly	testosterone	TWi	Used for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone	3/2/2023
Ranexa	Gilead	ranolazine	Camber / Hetero	Used to treat chronic angina	3/3/2023
Bentyl	AbbVie	dicyclomine	Upsher-Smith / CorePharma	Used to treat functional bowel disorder and irritable bowel syndrome	3/6/2023
Revlimid	Celgene	lenalidomide	Teva	Used to treat patients with multiple myeloma (MM) in combination with dexamethasone	3/8/2023
Zyvox	Hetero	linezolid	Camber / Hetero	Used to treat infections, including pneumonia, and infections of the skin	3/9/2023
Revlimid	Celgene	lenalidomide	Natco	Used to treat adult patients with multiple myeloma (MM) in combination with dexamethasone	3/9/2023
Pylera	AbbVie	bismuth subcitrate potassium / metronidazole / tetracycline	Endo	Used to treat ulcers in the stomach caused by the bacteria H. pylori	3/10/2023
Aubagio	Sanofi	teriflunomide	Accord	Used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults	3/13/2023
Aubagio	Sanofi	teriflunomide	Camber / Hetero	Used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults	3/13/2023
Aubagio	Sanofi	teriflunomide	Teva	Used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults	3/13/2023
Lexiscan	Astellas	regadenoson	Apotex	Used as a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress	3/13/2023
Thyro-Tabs	Alvogen	levothyroxine sodium	Camber / Hetero	Used to treat primary, secondary, and tertiary hypothyroidism	3/21/2023
Vascepa	Amarin	icosapent	Hikma	Used to reduce the risk of heart attack, stroke, and certain types of heart problems that require treatment in a hospital	3/21/2023
Protonix	Wyeth	pantoprazole	Camber / Hetero	Used to treat damage from gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 5 years of age and older	3/23/2023
Adrenalin	Par	epinephrine	American Regent	Used in the emergency treatment of type I allergic reactions, including anaphylaxis	3/30/2023
Trokendi XR	Supernus	topiramate	Teva	Used to manage and treat epilepsy and migraine	3/31/2023
Amicar	Clover	aminocaproic acid	Camber / Hetero	Used to treat excessive postoperative bleeding	3/31/2023