Generic Launches

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

Third 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
Klor-Con Upsher-Smith potassium chloride Hetero / Camber used to treat patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis 7/6/2021
Ambien CR Sanofi zolpidem Breckenridge used to treat insomnia in adults 7/8/2021
Lescol XL Novartis fluvastatin Lannett used as an adjunctive therapy with changes to diet to lower cholesterol, slow the progression of heart disease, and reduce the risk of needing procedures to improve blood flow to the heart 7/12/2021
Kerydin Anacor tavaborole Lupin used topically to treat onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes 7/13/2021
Zytiga Johnson & Johnson abiraterone Apotex used to treat metastatic prostate cancer 7/14/2021
Feraheme AMAG/Covis ferumoxytol Sandoz used to treat iron deficiency anemia (IDA) in adult patients who have an intolerance to oral iron or have had an unsatisfactory response to oral iron, or who have chronic kidney disease 7/16/2021
Revatio Pfizer sildenafil Hetero / Camber used to treat erectile dysfunction (impotence) in men 7/19/2021
Chantix Pfizer varenicline Apotex used as an aid to smoking cessation treatment 7/20/2021
Levitra Bayer vardenafil Alembic used to treat erectile dysfunction 7/30/2021
Extina Mylan ketoconazole Xiromed used topically to treat seborrheic dermatitis in immunocompetent patients 12 years of age and older 8/2/2021
Lioresal Novartis baclofen Hetero / Camber used to treat muscle pain, spasms, and stiffness in people with multiple sclerosis or spinal cord injury or disease 8/2/2021
Duexis Horizon ibuprofen / famotidine Alkem used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications 8/4/2021
Kloxxado Hikma naloxone nasal spray Hikma used in an emergency to treat known or suspected opioid overdose for adult and pediatric patients 8/4/2021
Taysofy AbbVie ethinyl estradiol / norethindrone / ferrous fumarate Amneal used to prevent pregnancy 8/5/2021
Isuprel Bausch & Lomb isoproterenol Amring used for mild or transient episodes of heart block that do not require electric shock or pacemaker therapy 8/5/2021
Tegretol XR Novartis carbamazepine Upsher-Smith used as an anticonvulsant and specific analgesic for trigeminal neuralgia 8/16/2021
Lovenox Sanofi enoxaparin Zydus used for prophylaxis of deep vein thrombosis in patients undergoing abdominal, hip or knee replacement surgery 8/17/2021
Levophed Hospira noreinephrine bitartrate Breckenridge used to restore blood pressure control in certain acute hypotensive states 8/20/2021
Clindagel Bausch & Lomb clindamycin Solaris used topically to treat acne vulgaris 8/23/2021
Sodium Acetate Pfizer sodium acetate Milla used as a source of sodium for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake 8/26/2021
Axiron Eli Lilly testosterone Acrux / Dash Pharma used for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone 8/26/2021
Northera Lundbeck droxidopa Aurobindo used to treat orthostatic dizziness, light headedness in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy 8/27/2021
CellCept Roche mycophenolate Lannett used for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immune-suppressants 8/30/2021
Librax Bausch & Lomb chlordiazepoxide / clidinium bromide Dr. Reddy's used to control emotional and somatic factors in gastrointestinal disorders. It may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis 8/31/2021
Jadenu Novartis deferasirox Hetero / Camber used to treat iron overload caused by blood transfusions in adults and children at least 2 years old; also used to treat chronic iron overload syndrome caused by a genetic blood disorder in adults and children who are at least 10 years old 8/31/2021
Paxil O.S. Glaxo paroxetine ANI / Novitium used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, and post-traumatic stress disorder 9/10/2021
Duexis Horizon ibuprofen / famotidine Lupin used for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications 9/15/2021
Trisenox Teva arsenic trioxide Amneal used for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression 9/16/2021
Bystolic AbbVie nebivilol ANI used to treat hypertension, to lower blood pressure and may be used alone or in combination with other antihypertensive agents 9/17/2021
Bystolic AbbVie nebivilol Hetero / Camber used to treat hypertension, to lower blood pressure and may be used alone or in combination with other antihypertensive agents 9/17/2021
Chantix Pfizer varenicline Par used to aid smoking cessation treatment 9/22/2021
Taxotere Sanofi docetaxel Xiromed / Insud used to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy 9/27/2021
Northera Lundbeck droxidopa Lupin used to treat orthostatic dizziness, light headedness in adult patients with symptomatic neurogenic orthostatic hypotension (nOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy 9/28/2021
Absorica Sun isotretinoin Mayne used to treat severe recalcitrant nodular acne 9/29/2021
Butrans Purdue buprenorphine Apotex used to manage pain severe enough to require daily, around-the- clock, long-term opioid treatment and for which alternative treatment options are inadequate 9/30/2021
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