First-Time Generic Drug Approvals for 2021
January
- Ferumoxytol Intravenous Solution eq 510mg Iron/17mL
Approved: January 15, 2021 - Sandoz Inc.
Generic for: Feraheme - Imiquimod Topical Cream 3.75%
Approved: January 26, 2021 - Taro Pharmaceutical Industries Ltd.
Generic for: Zyclara
February
- Linaclotide Capsules 145 mcg and 290 mcg
Approved: February 9, 2021 - Mylan Pharmaceuticals Inc.
Generic for: Linzess - Loteprednol Etabonate Ophthalmic Gel 0.5%
Approved: February 10, 2021 - Akorn Operating Company LLC
Generic for: Lotemax Gel - Apremilast Tablets 10 mg, 20 mg and 30 mg
Approved: February 17, 2021 - Unichem Laboratories Ltd.
Generic for: Otezla - Droxidopa Capsules 100 mg, 200 mg and 300 mg
Approved: February 18, 2021 - Ajanta Pharma Limited; Alkem Laboratories Limited; Annora Pharma Private Limited; Aurobindo Pharma Limited; Hikma Pharmaceuticals USA Inc.; Lundbeck Pharmaceuticals LLC; Lupin Pharmaceuticals, Inc.; MSN Laboratories Private Limited; ScieGen Pharmaceuticals, Inc.; Sun Pharmaceutical Industries, Inc.; Tasman Pharma Inc.; Teva Pharmaceuticals USA, Inc.; Zydus Pharmaceuticals (USA) Inc.
Generic for: Northera
March
- Hydrocodone Bitartrate Extended Release Tablets 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120mg
Approved: March 1, 2021 - Alvogen, Inc.
Generic for: Hysingla ER - Isotretinoin Capsules USP, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg
Approved: March 31, 2021 - Actavis Pharma, Inc.
Generic for: Absorica
April
- Deoxycholic Acid Subcutaneous Solution 20 mg / 2mL
Approved: April 2, 2021 - Slayback Pharma LLC
Generic for: Kybella - Macitentan Tablets 10 mg
Approved: April 6, 2021 - Zydus Pharmaceuticals (USA) Inc.
Generic for: Opsumit - Tiopronin Tablets 100 mg
Approved: April 26, 2021 - Teva Pharmaceuticals USA, Inc.
Generic for: Thiola
May
- Enzalutamide Capsules 40 mg
Approved: May 14, 2021 - Actavis Pharma, Inc.
Generic for: Xtandi - Lenalidomide Capsules 5 mg, 10 mg, 15 mg and 25 mg
Approved: May 21, 2021 - Natco Pharma Ltd.
Generic for: Revlimid
June
- Tofacitinib Citrate Tablets 10 mg (base)
Approved: June 1, 2021 - Ajanta Pharma Limited
Generic for: Xeljanz - Lopinavir and Ritonavir Tablets 100 mg / 25 mg and 200 mg / 50 mg
Approved: June 4, 2021 - Hetero Labs Limited
Generic. for: Kaletra Tablets - Etravirine Tablets 25 mg, 100 mg and 200 mg
Approved: June 14, 2021 - Amneal Pharmaceuticals LLC
Generic for: Intelence - Formoterol Fumarate Inhalation Solution 0.02 mg / 2 mL
Approved: June 22, 2021 - Teva Pharmaceuticals USA, Inc.
Generic for: Perforomist - Arformoterol Tartrate Inhalation Solution 0.015mg (base) / 2 mL
Approved: June 22, 2021 - Axar Pharmaceuticals, Inc.; Cipla USA Inc.; Glenmark Pharmaceuticals Inc., USA
Generic for: Brovana - Eslicarbazepine Acetate Tablets 200 mg, 400 mg, 600 mg and 800 mg
Approved: June 29, 2021 - Dr. Reddys Laboratories Inc.
Generic for: Aptiom
July
- Paliperidone Palmitate Extended Release Intramuscular Suspension 39 mg / 0.25 mL, 78 mg / 0.5 mL, 117 mg / 0.75 mL, 156 mg / mL, 234 mg / 1.5 mL
Approved: July 6, 2021 - Teva Pharmaceuticals USA, Inc.
Generic for: Invega Sustenna
August
- Ibuprofen and Famotidine Tablets 800 mg / 26.6 mg
Approved: August 3, 2021 - Alkem Laboratories Ltd.
Generic for: Duexis - Difluprednate Ophthalmic Emulsion 0.05%
Approved: August 9, 2021 - Cipla Ltd.
Generic for: Durezol - Glycopyrrolate Oral Solution 1 mg / 5mL
Approved: August 9, 2021 - Par Pharmaceutical Inc.
Generic for: Cuvposa - Enalapril Maleate Oral Solution 1 mg / mL
Approved: August 10, 2021 - Bionpharma Inc.
Generic for: Epaned - Varenicline Tablets 0.5 mg (base) and 1 mg (base)
Approved: August 11, 2021 - Par Pharmaceutical Inc.
Generic for: Chantix - Sunitinib Malate Capsules 12.5 mg (base), 25 mg (base), 37.5 mg (base), 50 mg (base)
Approved: August 16, 2021 - Sun Pharmaceutical Industries, Inc.
Generic for: Sutent - Tofacitinib Citrate Extended Release Tablets 11 mg (base) and 22 mg (base)
Approved: August 19, 2021 - Zydus Pharmaceuticals USA Inc.
Generic for: Xeljanz XR - Linagliptin and Metformin Hydrochloride Tablets 2.5mg / 500mg, 2.5mg / 850mg and 2.5mg / 1000 mg
Approved: August 30, 2021 - Sunshine Lake Pharma Co., Ltd.
Generic for: Jentadueto - Linagliptin Tablets 5 mg
Approved: August 31, 2021 - Sunshine Lake Pharma Co., Ltd.
Generic for: Tradjenta
September
- Paroxetine Hydrochloride Oral Suspension 10mg (base) / 5 mL
Approved: September 3, 2021 - Novitium Pharma LLC
Treatment for: Depression
Generic for: Paxil Oral Suspension - Eliglustat Tartrate Capsules 84 mg (base)
Approved: September 8, 2021 - Aizant Drug Research Solutions Pvt Ltd.
Treatment for: Type 1 Gaucher Disease
Generic for: Cerdelga - Vortioxetine Hydrobromide Tablets 5 mg (base), 10 mg (base) and 20 mg (base)
Approved: September 17, 2021 - Zydus Pharmaceuticals USA Inc.
Treatment for: Depression
Generic for: Trintellix - Ceftaroline Fosamil for Injection 400 mg /vial and 600mg /vial
Approved: September 21, 2021 - Apotex Inc.
Treatment for: Pneumonia, Skin and Structure Infection
Generic for: Teflaro - Brimonidine Tartrate Topical Gel 0.33% (base)
Approved: September 23, 2021 - Padagis Israel Pharmaceuticals Ltd.
Treatment for: Rosacea
Generic for: Mirvaso - Zolmitriptan Nasal Spray 2.5 mg/spray and 5 mg/spray
Approved: September 30, 2021 - Padagis Israel Pharmaceuticals Ltd.
Treatment for: Migraine
Generic for: Zomig
October
- Oxymetazoline Hydrochloride Topical Cream 1%
Approved: October 4, 2021 - Taro Pharmaceuticals U.S.A., Inc.
Treatment for: Rosacea
Generic for: Rhofade (discontinued) - Carglumic Acid Tablets for Oral Suspension 200 mg
Approved: October 13, 2021 - Novitium Pharma LLC
Treatment for: Hyperammonemia
Generic for: Carbaglu
November
- Valsartan Oral Solution 20 mg/5 mL
Approved: November 2, 2021 - Novitium Pharma LLC
Treatment for: Hypertension; Heart Failure
Generic for: Prexxartan - Nelarabine Injection 250 mg/50 mL (5 mg/mL)
Approved: November 17, 2021 - Zydus Pharmaceuticals (USA) Inc.
Treatment for: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma
Generic for: Arranon - Dasatinib Tablets 80 mg and 140 mg
Approved: November 23, 2021 - Apotex Corp.
Treatment for: Ph+ Chronic Myeloid Leukemia; Ph+ Acute Lymphoblastic Leukemia
Generic for: Sprycel - Betaine for Oral Solution 1gm/scoopful
Approved: November 23, 2021 - Novitium Pharma LLC
Treatment for: Homocystinuria
Generic for: Cystadane - Lubiprostone Capsules 8 mcg and 24 mcg
Approved: November 30, 2021 - Amneal Pharmaceuticals LLC
Treatment for: Chronic Idiopathic Constipation; Opioid-Induced Constipation; Irritable Bowel Syndrome with Constipation
Generic for: Amitiza
December
- Glycerol Phenylbutyrate Oral Liquid 1.1 g/mL
Approved: December 2, 2021 - Par Pharmaceutical Inc.
Treatment for: Urea Cycle Disorders
Generic for: Ravicti (discontinued) - Ivabradine Hydrochloride Tablets 5 mg (base) and 7.5 mg (base)
Approved: December 30, 2021 - Centaur Pharmaceuticals Private Limited
Treatment for: Heart Failure
Generic for: Corlanor