Generic Launches

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

First 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
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

Oren D. Langer

Partner

Managing Partner, New York Office

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