First-Time Generic Drug Approvals for 2022
January
- Pirfenidone Capsules 267 mg
Approved: January 3, 2022 - Amneal Pharmaceuticals LLC
Treatment for: Idiopathic Pulmonary Fibrosis
Generic for: Esbriet - Sofosbuvir Tablets 400 mg
Approved: January 27, 2022 - Teva Pharmaceuticals USA, Inc.
Treatment for: Hepatitis C
Generic for: Sovaldi - Brimonidine Tartrate Ophthalmic Solution 0.15%
Approved: January 31, 2022 - Apotex Inc.
Treatment for: Glaucoma
Generic for: Alphagan P
February
- Cyclosporine Ophthalmic Emulsion 0.05%
Approved: February 2, 2022 - Mylan Pharmaceuticals, Inc.
Treatment for: Dry Eye Disease
Generic for: Restasis - Maraviroc Tablets 150 mg and 300 mg
Approved: February 7, 2022 - Hetero Labs Limited
Treatment for: HIV Infection
Generic for: Selzentry - Nalmefene Hydrochloride Injection 2 mg base /2 mL
Approved: February 8, 2022 - Purdue Pharma LP
Treatment for: Opioid Overdose
Generic for: Revex - Dapagliflozin Tablets 5 mg and 10 mg
Approved: February 22, 2022 - Zydus Pharmaceuticals USA, Inc.
Treatment for: Type 2 Diabetes
Generic for: Farxiga - Apomorphine Hydrochloride Injection 30 mg /3 mL (10 mg /mL)
Approved: February 23, 2022 - Sage Chemicals, Inc.
Treatment for: Parkinson's Disease
Generic for: Apokyn
March
- Methylphenidate Extended Release Transdermal Film 10 mg, 15 mg, 20 mg and 30 mg
Approved: March 14, 2022 - Mylan Pharmaceuticals Inc.
Treatment for: ADHD
Generic for: Daytrana - Budesonide and Formoterol Fumarate Dihydrate Metered Inhalation Aerosol 0.08 mg/0.0045 mg per inhalation and 0.16 mg/0.0045 mg per inhalation
Approved: March 15, 2022 - Mylan Pharmaceuticals Inc.
Treatment for: Asthma; COPD
Generic for: Symbicort - Lacosamide Tablets 50 mg, 100 mg, 150 mg and 200 mg
Approved: March 17, 2022 - Alembic Pharmaceuticals Ltd.; Amneal Pharmaceuticals LLC; Glenmark Pharmaceuticals Inc.; Hetero Labs Limited; Indoco Remedies Limited; MSN Laboratories Private Limited; ScieGen Pharmaceuticals Inc., Sun Pharmaceutical Industries, Inc.
Treatment for: Seizures
Generic for: Vimpat - Ioflupane I-123 Injection for Intravenous Use 185 MBq (5 mCi) in 2.5 mL
Approved: March 30, 2022 - Curium US LLC
Treatment for: Computed Tomography
Generic for: DaTscan
April
- Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution 0.2% / 0.5% (base)
Approved: April 4, 2022 - Sandoz Inc.
Treatment for: Glaucoma
Generic for: Combigan - Lacosamide Injection 200 mg/20 mL (10 mg/mL)
Approved: April 7, 2022 - Indoco Remedies Limited
Treatment for: Seizures
Generic for: Vimpat Injection - Cysteine Hydrochloride Injection 500 mg/10 mL (50 mg/mL)
Approved: April 8, 2022 - Eton Pharmaceuticals, Inc.
Treatment for: Total Parenteral Nutrition
Generic for: Elcys - Regadenoson Intravenous Solution 0.4 mg/5 mL (0.08 mg/mL)
Approved: April 11, 2022 - Accord Healthcare, Inc.; Apotex Inc.; Hong Kong King-Friend Industrial Co. Ltd.; Dr. Reddy's Laboratories Ltd.
Treatment for: Myocardial Perfusion Imaging
Generic for: Lexiscan - Bexarotene Topical Gel 1%
Approved: April 27, 2022 - Amneal Pharmaceuticals LLC
Treatment for: Cutaneous T-Cell Lymphoma
Generic for: Targretin Gel
May
- Estradiol and Progesterone Capsules 1 mg / 100 mg
Approved: May 16, 2022 - Amneal Pharmaceuticals LLC
Treatment for: Vasomotor Symptoms Due to Menopause
Generic for: Bijuva - Iodixanol Injection 55% and 65.2%
Approved: May 19, 2022 - Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Treatment for: Radiographic Procedures
Generic for: Visipaque 270 and Visipaque 320 - Lacosamide Oral Solution 10 mg /mL
Approved: May 19, 2022 - Alkem Laboratories Ltd.
Treatment for: Seizures
Generic for: Vimpat Oral Solution - Pemetrexed Disodium Injection 100 mg (base)/vial and 500 mg (base)/vial
Approved: May 25, 2022 - Accord Healthcare, Inc.; Apotex Corp.; Dr. Reddys Laboratories Inc.; Eugia Pharma Specialities Limited; Fresenius Kabi USA, LLC; Hospira, Inc.; Jiangsu Hansoh Pharmaceutical Group Co., Ltd.; Nang Kuang Pharmaceutical Co., Ltd.; Qilu Pharmaceutical Co., Ltd.; Waverley Pharma Inc.; Zydus Pharmaceuticals (USA) Inc.
Treatment for: Mesothelioma, Non-Small Cell Lung Cancer
Generic for: Alimta
June
- Brivaracetam Tablets 10 mg, 25 mg, 50 mg, 75 mg and 100 mg
Approved: June 9, 2022 - Sunshine Lake Pharma Co., Ltd.
Treatment for: Epilepsy
Generic for: Briviact - Cabazitaxel Intravenous Solution 60 mg/1.5 mL (40 mg/mL)
Approved: June 23, 2022 - Breckenridge Pharmaceutical, Inc.
Treatment for: Prostate Cancer
Generic for: Jevtana - Abiraterone Acetate Tablets 125 mg
Approved: June 24, 2022 - Teva Pharmaceuticals USA, Inc.
Treatment for: Prostate Cancer
Generic for: Yonsa
July
- Empagliflozin and Metformin Hydrochloride Tablets 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5mg/1000 mg
Approved: July 7, 2022 - Zydus Pharmaceuticals (USA) Inc.
Treatment for: Type 2 Diabetes
Generic for: Synjardy - Citric Acid, Magnesium Oxide and Sodium Picosulfate for Oral Solution 12gm/3.5gm/10mg per packet
Approved: July 18, 2022 - Hetero Labs Limited
Treatment for: Bowel Preparation
Generic for: Prepopik - Azilsartan Kamedoxomil Tablets 40 mg and 80 mg (azilsartan medoxomil equivalent)
Approved: July 20, 2022 - Lupin Pharmaceuticals, Inc.
Treatment for: Hypertension
Generic for: Edarbi
August
- Empagliflozin Tablets 10 mg and 25 mg
Approved: August 3, 2022 - Zydus Pharmaceuticals USA Inc.
Treatment for: Type 2 Diabetes
Generic for: Jardiance - Estradiol Transdermal Gel 0.1%
Approved: August 10, 2022 - Chemo Research, S.L.
Treatment for: Menopausal Vasomotor Symptoms
Generic for: Divigel - Brexpiprazole Tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg
Approved: August 11, 2022 - Teva Pharmaceuticals USA, Inc.
Treatment for: Depression
Generic for: Rexulti - Cetrorelix Acetate Powder for Subcutaneous Injection 0.25mg base/vial
Approved: August 12, 2022 - Akorn Operating Company LLC
Treatment for: Ovulation Induction
Generic for: Cetrotide
September
- Riociguat Tablets 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg
Approved: September 1, 2022 - MSN Laboratories Private Ltd.
Treatment for: Pulmonary Hypertension
Generic for: Adempas - Cariprazine Hydrochloride Capsules 1.5 mg (base), 3 mg (base), 4.5 mg (base) and 6 mg (base)
Approved: September 9, 2022 - Zydus Pharmaceuticals (USA) Inc.
Treatment for: Schizophrenia
Generic for: Vraylar - Tazarotene Topical Gel 0.05%
Approved: September 13, 2022 - Cosette Pharmaceuticals, Inc.
Treatment for: Plaque Psoriasis
Generic for: Tazorac Gel 0.05% - Tazarotene Topical Gel 0.1%
Approved: September 13, 2022 - Cosette Pharmaceuticals, Inc.
Treatment for: Plaque Psoriasis; Acne Vulgaris
Generic for: Tazorac Gel 0.1% - Nebivolol Hydrochloride and Valsartan Tablets (Vyduo) 5 mg / 80 mg
Approved: September 19, 2022 - Prinston Pharmaceutical Inc.
Treatment for: Hypertension
Generic for: Byvalson - Gefitinib Tablets 250 mg
Approved: September 23, 2022 - Apotex Inc.
Treatment for: Non-Small Cell Lung Cancer
Generic for: Iressa
November
- Penciclovir Cream 1%
Approved: November 9, 2022 - Teva Pharmaceuticals USA, Inc.
Treatment for: Cold Sores
Generic for: Denavir - Vancomycin Hydrochloride for Oral Solution 25 mg (base)/mL and 50 mg (base)/mL
Approved: November 14, 2022 - Alkem Laboratories Ltd.
Treatment for: Bacterial Infection
Generic for: Firvanq - Gadobutrol Intravenous Solution 1.20944 gm/2mL, 4.5354 gm/7.5mL, 6.0472 gm/10mL and 9.0708 gm/15mL
Approved: November 17, 2022 - Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Treatment for: Contrast Agent for Magnetic Resonance Imaging (MRI)
Generic for: Gadavist
December
- Bendamustine Hydrochloride Lyophilized Powder for Injection 25 mg/vial and 100 mg/vial
Approved: December 7, 2022 - Accord Healthcare Inc.; Dr. Reddys Laboratories Inc.
Treatment for: Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma
Generic for: Treanda - Tasimelteon Capsules 20 mg
Approved: December 12, 2022 - Teva Pharmaceuticals USA, Inc.
Treatment for: Non-24-Hour Sleep Wake Disorder
Generic for: Hetlioz - Selexipag Tablets 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg and 1.6 mg
Approved: December 21, 2022 - Zydus Pharmaceuticals USA Inc.
Treatment for: Pulmonary Arterial Hypertension
Generic for: Uptravi - Dichlorphenamide Tablets 50 mg
Approved: December 29, 2022 - Torrent Pharma Inc.
Treatment for: Hypokalemic Periodic Paralysis; Hyperkalemic Periodic Paralysis
Generic for: Keveyis