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
Adderall XR	Takeda	amphetamine	Camber / Hetero	Used to treat attention deficit hyperactivity disorder (ADHD)	1/4/2022
Cuvposa	Merz	glycopyrrolate	Endo	Used to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g., cerebral palsy)	1/4/2022
Protopic	LEO	tacrolimus	Mayne	Used to treat atopic dermatitis	1/12/2022
Vasostrict	Endo	vasopressin	Eagle	Used to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines	1/17/2022
Colcrys	Takeda	colchicine	Camber / Hetero	Used to treat and for prophylaxis of gout flares in adults and Familial Mediterranean fever (FMF) in adults and children 4 years or older	1/19/2022
Combigan	AbbVie	brimodine / timolol	Apotex	Used to reduce elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension	1/19/2022
Purified Cortrophin gel	ANI	repository corticotropin	ANI	Used to treat certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (MS) and rheumatoid arthritis (RA), and excess urinary protein due to nephrotic syndrome	1/24/2022
Nitropress	Hospira	sodium nitroprusside	Xiromed	Used to treat the symptoms of acute heart failure, hypertensive crisis and controlled hypotension during surgery	1/24/2022
Focalin XR	Novartis	dexmethylphenidate	Camber / Hetero	Used to treat attention deficit hyperactivity disorder (ADHD)	1/26/2022
Alphagan P	AbbVie	brimonidine	Apotex	Used to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension	1/31/2022
Pemfexy	Eli Lilly	pemetrexed	Eagle	Used in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non- squamous, non-small cell lung cancer (NSCLC)	2/1/2022
Vasostrict	Endo/Par	vasopressin	American Regent	Used to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines	2/3/2022
Vasopressin RTU	Endo	vasopressin	Par	Used to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines	2/7/2022
Restasis	AbbVie	cyclosporine	Apotex	Used to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca	2/7/2022
Cubicin	Merck	daptomycin	Apotex	Used to treat complicated skin and skin structure infections (cSSSI). It is also used to treat infections in the bloodstream (bacteremia), including right-sided infective endocarditis	2/7/2022
Vasostrict	Endo	vasopressin	Dr. Reddy's Labs	Used to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines	2/9/2022
Emend	Merck	fosaprepitant	Camber / Hetero	Used to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin; delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)	2/9/2022
AmBisome	Astellas	amphotericin B liposome	Sun	Used for empirical therapy for presumed fungal infection in febrile, neutropenic patients; treatment of cryptococcal meningitis in HIV-infected patients; treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections; and treatment of visceral leishmaniasis	2/15/2022
Digoxin	Almirall	lanoxin	Aurobindo	Used to treat mild to moderate heart failure in adults; increases myocardial contractility in pediatric patients with heart failure; and for the control of ventricular response rate in adult patients with chronic atrial fibrillation	2/21/2022
Compazine	Glaxo	prochlorperazine edisylate	Cosette	Used to control severe nausea and vomiting. Prochlorperazine edisylate is also used for the treatment of schizophrenia	2/22/2022
Epaned O.S.	Azurity	enalapril	Camber / Hetero	Used for the treatment of hypertension, to lower blood pressure in adults and children older than one month	2/25/2022
Naftin	Sebela	naftifine	Xiromed	Used for the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum	2/25/2022
Renagel	Genzyme	sevelamer	Lupin	Used for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis	3/1/2022
Apokyn	Supernus	apomorphine	TruPharma	Used to treat loss of control of body movements in people with advanced Parkinson's disease	3/1/2022
Myfortic	Novartis	mycophenolate	TWi	Used for the prophylaxis of organ rejection in adult patients receiving a kidney transplant	3/1/2022
Revlimid	Celgene	lenalidomide	Natco / Teva	Used in adults for the treatment of multiple myeloma in combination with the medicine dexamethasone, certain myelodysplastic syndromes, and mantle cell lymphoma following specific prior treatment	3/7/2022
Rezipres	Eton	ephedrine	Eton / XGEN Pharms	Used to treat clinically important hypotension occurring in the setting of anesthesia	3/14/2022
Tobradex	Novartis	dexamethasone / tobramycin	Padagis	Used for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists	3/21/2022
Advair Diskus	Glaxo	fluticasone / salmeterol	Teva	Used for the twice-daily treatment of asthma in patients aged 4 years and older; of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema	3/23/2022
Zipsor	Assertio	diclofenac	Teva	Used to relieve mild to moderate acute pain in adult and pediatric patients 12 years of age and older	3/24/2022