First-Time Generic Drug Approvals for 2023
February
- Doxepin Hydrochloride Topical Cream 5%
Approved: February 17, 2023 - Teva Pharmaceuticals USA, Inc.
Treatment for: Pruritus
Generic for: Zonalon - Tiopronin Delayed Release Tablets 100 mg and 300 mg
Approved: February 24, 2023 - Par Pharmaceutical, Inc.
Treatment for: Cystinuria
Generic for: Thiola EC - Acetaminophen and Ibuprofen Tablets 250 mg / 125 mg
Approved: February 28, 2023 - L. Perrigo Company
Treatment for: Pain / Fever
Generic for: Advil Dual Action with Acetaminophen
March
- Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules 140mg / 125mg / 125mg
Approved: March 6, 2023 - Par Pharmaceutical Inc.
Treatment for: Helicobacter Pylori Infection
Generic for: Pylera - Betamethasone Dipropionate and Calcipotriene Topical Aerosol Foam 0.064% / 0.005%
Approved: March 21, 2023 - Glenmark Pharmaceuticals Ltd.
Treatment for: Plaque Psoriasis
Generic for: Enstilar - Tenofovir Alafenamide Fumarate Tablets 25 mg (base)
Approved: March 30, 2023 - Lupin Pharmaceuticals, Inc.
Treatment for: Hepatitis B
Generic for: Vemlidy
April
- Budesonide Rectal Foam 2mg/actuation
Approved: April 12, 2023 - Padagis Israel Pharmaceuticals Ltd.
Treatment for: Ulcerative Colitis
Generic for: Uceris - Loteprednol Etabonate Ophthalmic Suspension 0.2%
Approved: April 12, 2023 - Akorn Operating Company LLC
Treatment for: Seasonal Allergic Conjunctivitis
Generic for: Alrex - Estradiol Transdermal System 0.014mg/24hr
Approved: April 17, 2023 - Zydus Pharmaceuticals USA, Inc.
Treatment for: Prevention of Postmenopausal Osteoporosis
Generic for: Menostar - Thalidomide Capsules 150 mg
Approved: April 27, 2023 - Natco Pharma Limited
Treatment for: Multiple Myeloma and Erythema Nodosum Leprosum
Generic for: Thalomid
May
- Methsuximide Capsules 300 mg
Approved: May 1, 2023 - Novitium Pharma LLC
Treatment for: Seizures
Generic for: Celontin - Obeticholic Acid Tablets 5 mg and 10 mg
Approved: May 30, 2023 - Apotex Corp.; Lupin Pharmaceuticals, Inc.; MSN Laboratories Private Limited
Treatment for: Primary Biliary Cholangitis
Generic for: Ocaliva - Diazepam Rectal Gel 10mg/2mL (5mg/mL) and 20mg/4mL (5mg/mL)
Approved: May 30, 2023 - Novel Laboratories, Inc.
Treatment for: Seizures
Generic for: Diastat AcuDial
June
- Baclofen Oral Suspension 25 mg/5 mL
Approved: June 8, 2023 - Slayback Pharma LLC
Treatment for: Spasticity
Generic for: Fleqsuvy - Sugammadex Sodium Intravenous Solution 200 mg (base)/2 mL and 500 mg (base)/5 mL
Approved: June 9, 2023 - Aspiro Pharma Ltd.
Treatment for: Reversal of Neuromuscular Blockade
Generic for: Bridion - Tipiracil Hydrochloride and Trifluridine Tablets 6.14 mg (base)/15 mg and 8.19 mg (base)/20 mg
Approved: June 13, 2023 - Natco Pharma Ltd.
Treatment for: Colorectal Cancer/Gastric Cancer
Generic for: Lonsurf - Amlodipine Benzoate Oral Suspension 1 mg (base)/mL
Approved: June 13, 2023 - Amneal Pharmaceuticals LLC
Treatment for: Hypertension/Coronary Artery Disease
Generic for: Katerzia - Safinamide Mesylate Tablets 50mg (base) and 100 mg (base)
Approved: June 14, 2023 - Aurobindo Pharma Limited
Treatment for: Parkinson’s Disease
Generic for: Xadago - Mometasone Furoate Metered Nasal Spray 0.05 mg/spray (OTC)
Approved: June 14, 2023 - Amneal Pharmaceuticals LLC
Treatment for: Allergic Rhinitis
Generic for: Nasonex 24HR Allergy - Tiotropium Bromide Inhalation Powder 0.018mg (base) per inhalation
Approved: June 20, 2023 - Lupin Pharmaceuticals, Inc.
Treatment for: COPD
Generic for: Spiriva - Amphetamine Extended-Release Orally Disintegrating Tablets 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg and 18.8 mg
Approved: June 22, 2023 - Actavis Pharma, Inc.
Treatment for: ADHD
Generic for: Adzenys XR-ODT - Alcaftadine Ophthalmic Solution 0.25%
Approved: June 23, 2023 - Eugia Pharma Specialities Limited
Treatment for: Allergic Conjunctivitis
Generic for: Lastacaft - Cyanocobalamin Metered Nasal Spray 0.5mg/spray
Approved: June 30, 2023 - Lupin Pharmaceuticals, Inc.
Treatment for: Vitamin B12 Deficiency
Generic for: Nascobal
July
- Naltrexone for Extended-Release Injectable Suspension 380 mg/vial
Approved: July 6, 2023 - Teva Pharmaceuticals USA, Inc.
Treatment for: Alcohol Dependence; Opioid Dependence
Generic for: Vivitrol - Ertugliflozin Tablets 5 mg and 15 mg
Approved: July 13, 2023 - Aurobindo Pharma Limited
Treatment for: Type 2 Diabetes
Generic for: Steglatro - Ponatinib Hydrochloride Tablets 15 mg (base) and 45 mg (base)
Approved: July 14, 2023 - ApoPharma USA, Inc.
Treatment for: Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia
Generic for: Iclusig - Plerixafor Injection 24 mg/1.2 mL (20 mg/mL)
Approved: July 24, 2023 - Amneal Pharmaceuticals LLC; Dr. Reddy's Laboratories, Inc.; Eugia Pharma Specialities Limited; Kindos Pharmaceuticals Co. Ltd.; MSN Laboratories Private Ltd.; Teva Pharmaceuticals USA, Inc.
Treatment for: Peripheral Blood Progenitor Cell Therapy
Generic for: Mozobil - Saxagliptin Hydrochloride Tablets 2.5mg (base) and 5 mg (base)
Approved: July 31, 2023 - Amneal Pharmaceuticals LLC; Aurobindo Pharma Limited; Glenmark Pharmaceuticals Inc.; Mylan Pharmaceuticals Inc.; Sun Pharmaceutical Industries, Inc.
Treatment for: Type 2 Diabetes
Generic for: Onglyza - Saxagliptin Hydrochloride and Metformin Hydrochloride Extended-Release Tablets , 5 mg (base) / 500 mg, 5 mg (base) / 1000 mg, 2.5 mg (base) / 1000 mg
Approved: July 31, 2023 - Mylan Pharmaceuticals Inc.; Sun Pharmaceutical Industries, Inc.
Treatment for: Type 2 Diabetes
Generic for: Kombiglyze XR
August
- Lifitegrast Ophthalmic Solution 5%
Approved: August 4, 2023 - Micro Labs Limited
Treatment for: Dry Eye Disease
Generic for: Xiidra - Halobetasol Propionate Aerosol Foam 0.05%
Approved: August 11, 2023 - Padagis Israel Pharmaceuticals Ltd.
Treatment for: Plaque Psoriasis
Generic for: Lexette - Joyeaux Tablets ethinyl estradiol 0.02 mg / levonorgestrel 0.1 mg with ferrous fumarate 75 mg
Approved: August 16, 2023 - Xiromed, LLC
Treatment for: Birth Control
Generic for: Balcoltra - Tretinoin Gel (Microsphere) 0.08%
Approved: August 22, 2023 - Encube Ethicals Private Limited
Treatment for: Acne Vulgaris
Generic for: Retin-A Micro 0.08% - Lisdexamfetamine Dimesylate Capsules 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg
Approved: August 25, 2023 - Actavis Elizabeth LLC; Alkem Laboratories Limited; Amneal Pharmaceuticals LLC (excl. 10 mg); Apotex Corp.; Ascent Pharmaceuticals, Inc.; Hikma Pharmaceuticals USA Inc. (excl. 10 mg); Lannett Company, Inc.; Mylan Pharmaceuticals Inc.; Norwich Pharmaceuticals, Inc.; Prinston Pharmaceutical Inc.; Rhodes Pharmaceuticals L.P.; SpecGx LLC; Sun Pharmaceutical Industries, Inc.
Treatment for: ADHD; Binge Eating Disorder
Generic for: Vyvanse Capsules - Lisdexamfetamine Dimesylate Chewable Tablets 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg
Approved: August 25, 2023 - Ascent Pharmaceuticals, Inc.; Sun Pharmaceutical Industries, Inc.; Teva Pharmaceuticals USA, Inc.
Treatment for: ADHD; Binge Eating Disorder
Generic for: Vyvanse Chewable Tablets - Palbociclib Tablets 75mg, 100 mg and 125 mg
Approved: August 28, 2023 - Synthon Pharmaceuticals, Inc.
Treatment for: Breast Cancer
Generic for: Ibrance Tablets
September
- Spironolactone Oral Suspension 25mg/5mL
Approved: September 5, 2023 - Amneal Pharmaceuticals LLC
Treatment for: NYHA Class III-IV Heart Failure and Reduced Ejection Fraction
Generic for: Carospir - Tofacitinib Citrate Oral Solution 1mg (base)/mL
Approved: September 25, 2023 - Slayback Pharma LLC
Treatment for: Polyarticular Course Juvenile Idiopathic Arthritis
Generic for: Xeljanz Oral Solution
October
- Pazopanib Hydrochloride Tablets 200 mg (base)
Approved: October 19, 2023 - Apotex Corp.; Sun Pharmaceutical Industries, Inc.; Teva Pharmaceuticals USA, Inc.
Treatment for: Renal Cell Carcinoma; Soft Tissue Sarcoma
Generic for: Votrient
November
- Teriparatide Injection 600 mcg/2.4 mL (250 mcg/mL)
Approved: November 16, 2023 - Apotex Corp.; Teva Pharmaceuticals USA, Inc.
Treatment for: Osteoporosis
Generic for: Forteo - Podofilox Topical Gel 0.5%
Approved: November 22, 2023 - Padagis US LLC
Treatment for: Anogenital Warts
Generic for: Condylox Gel - Bromfenac Sodium Sesquihydrate Ophthalmic Solution 0.07% (free acid)
Approved: November 22, 2023 - Lupin Pharmaceuticals, Inc.
Treatment for: Ocular Inflammation and Pain After Cataract Surgery
Generic for: Prolensa
December
- Methylene Blue Intravenous Solution 10mg/2mL (5mg/mL) and 50mg/10mL (5mg/mL)
Approved: December 5, 2023 - Zydus Worldwide DMCC
Treatment for: Methemoglobinemia
Generic for: ProvayBlue