Generic Launches

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

Fourth 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
Apriso Sunovion mesalamine Teva Used to maintain remission of ulcerative colitis in patients 18 years of age and older 10/1/2021
Afinitor Novartis everolimus Breckenridge Used to treat postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole 10/1/2021
Afinitor Novartis everolimus Biocon Used to treat postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole 10/4/2021
BiCNU Emcure carmustine Dr. Reddy's Used to treat certain types of brain tumors; glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma and metastatic brain tumors 10/15/2021
Doxil Baxter doxorubicin Padagis Used to treat Ovarian Cancer, AIDS-related Kaposi’s Sarcoma and Multiple Myeloma 10/21/2021
Emerphed Nexus ephedrine sulfate Par Used to treat clinically important hypotension occurring in the setting of anesthesia 10/26/2021
Decadron Merck dexamethasone Amneal Used to treat several medical conditions, including respiratory complications associated with COVID-19 10/27/2021
Akovaz Exela ephedrine Dr. Reddy's Used to treat clinically important hypotension occurring in the setting of anesthesia 10/29/2021
Antara Lupin fenofibrate Lupin Used as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolopoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia 11/3/2021
Desferal Novartis deferoxamine Apotex Used to treat acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias 11/10/2021
Samsca Otsuka tolvaptan Camber / Hetero Used to treat hyponatremia (low levels of sodium in your blood) in people with heart failure, and certain hormonal imbalances 11/10/2021
Targretin Eisai bexarotene Teva Used to treat cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy 11/11/2021
Zaditor Alcon ketotifen Bayshore Used to treat itchy eyes 11/15/2021
Zomig iPR Pharmaceuticals zolmitriptan Padagis Used to treat migraine headaches with or without aura in adults and pediatric patients (12 to 17 years of age) 11/16/2021
Zoloft Pfizer sertraline Camber / Hetero Used to treat major depressive disorder, obsessive-compulsive disorder (OCD), panic disorder, social anxiety disorder (SAD), and post-traumatic stress disorder (PTSD) 11/19/2021
Epiduo Forte Galderma adapalene / benzoyl peroxide Teva Used to treat acne vulgaris 12/1/2021
Brovana Sunovion arformoterol Teva Used for the long-term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema 12/6/2021
Diovan Novartis valsartan Dr. Reddy's Used to lower blood pressure, treat heart failure, or increase chances of survival after a heart attack 12/9/2021
Venlafaxine ER Osmotica venlafaxine Dr. Reddy's Used to treat Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), and Panic Disorder (PD) with or without agoraphobia 12/9/2021
Daraprim Vyera pyrimethamine Teva Used to treat acute malaria in combination with other antimalarials only 12/15/2021
Carbaglu Recordati carglumic acid Eton / ANI Useed to treat acute and chronic hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency 12/20/2021
Marcaine Hospira bupivacaine Hikma Used in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures 12/20/2021
Northera Lundbeck droxidopa Camber / Hetero Used to treat low blood pressure that causes severe dizziness or a light-headed feeling 12/21/2021
Narcan Adapt naloxone HCl Teva Used to treat an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond 12/22/2021
Sutent Pfizer sunitinib Teva Used to treat advanced renal cell carcinoma 12/22/2021
Narcan Adapt naloxone HCl Sandoz Used to treat an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond 12/22/2021
Butrans Purdue buprenorphine Teva Used to manage pain severe enough to require daily, around-the- clock, long-term opioid treatment and for which alternative treatment options are inadequate 12/27/2021

Oren D. Langer

Partner

Managing Partner, New York Office

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