First-Time Generic Drug Approvals for 2024
January
- Nilotinib Hydrochloride Capsules 50mg (base), 150mg (base) and 200mg (base)
Approved: January 5, 2024 - Apotex Corp.
Treatment for: Chronic Myeloid Leukemia
Generic for: Tasigna - Fidaxomicin Tablets 200 mg
Approved: January 16, 2024 - Actavis Laboratories FL, Inc.
Treatment for: Clostridioides difficile-Associated Diarrhea
Generic for: Dificid - Pimavanserin Tartrate Capsules 34 mg (base)
Approved: January 16, 2024 - MSN Laboratories Private Limited; Zydus Pharmaceuticals USA Inc.
Treatment for: Parkinson's Disease Psychosis
Generic for: Nuplazid Capsules - Pimavanserin Tartrate Tablets 10 mg (base)
Approved: January 16, 2024 - Zydus Pharmaceuticals USA Inc.
Treatment for: Parkinson's Disease Psychosis
Generic for: Nuplazid Tablets - Dronedarone Hydrochloride Tablets 400 mg (base)
Approved: January 31, 2024 - Lupin Pharmaceuticals, Inc.
Treatment for: Atrial Fibrillation
Generic for: Multaq
February
- Bromfenac Sodium Sesquihydrate Ophthalmic Solution 0.075% (free acid)
Approved: February 2, 2024 - Lupin Pharmaceuticals, Inc.
Treatment for: Postoperative Ocular Inflammation
Generic for: BromSite - Cobicistat Tablets 150 mg
Approved: February 7, 2024 - Mylan Pharmaceuticals Inc.
Treatment for: HIV Infection
Generic for: Tybost - Deflazacort Tablets 6 mg, 18 mg, 30 mg and 36 mg
Approved: February 9, 2024 - Aurobindo Pharma Limited
Treatment for: Duchenne Muscular Dystrophy
Generic for: Emflaza - Ospemifene Tablets 60 mg
Approved: February 13, 2024 - Hetero Labs Limited
Treatment for: Menopause Symptoms
Generic for: Osphena - Brimonidine Tartrate Ophthalmic Solution 0.025%
Approved: February 16, 2024 - Dr.Reddy's Laboratories Inc.
Treatment for: Eye Redness
Generic for: Lumify - Nitroglycerin Intra-Anal Ointment 0.4%
Approved: February 16, 2024 - Cosette Pharmaceuticals, Inc.
Treatment for: Anal Fissure
Generic for: Rectiv
March
- Finasteride and Tadalafil Capsules 5 mg / 5 mg
Approved: March 15, 2024 - Zydus Worldwide DMCC
Treatment for: Benign Prostatic Hyperplasia
Generic for: Entadfi - Metronidazole Vaginal Gel 1.3%
Approved: March 18, 2024 - Encube Ethicals Private Limited
Treatment for: Bacterial Vaginosis
Generic for: Nuvessa
April
- Valbenazine Tosylate Capsules 40 mg (base) and 80 mg (base)
Approved: April 5, 2024 - Lupin Pharmaceuticals, Inc.
Treatment for: Huntington’s Disease, Tardive Dyskinesia
Generic for: Ingrezza - Eribulin Mesylate Intravenous Solution 1 mg/2 mL (0.5 mg/mL)
Approved: Approved: April 5, 2024 - Gland Pharma Limited
Treatment for: Breast Cancer, Liposarcoma
Generic for: Halaven - Doxycycline (Anhydrous) Immediate/Delayed Release Capsules 40 mg
Approved: April 8, 2024 - Dr. Reddys Laboratories Inc.; Lupin Pharmaceuticals, Inc.
Treatment for: Rosacea
Generic for: Oracea - Eltrombopag Olamine for Oral Suspension 12.5 mg/packet and 25 mg/packet
Approved: April 18, 2024 - Annora Pharma Private Limited
Treatment for: Thrombocytopenia, Aplastic Anemia
Generic for: Promacta for Suspension - Estradiol Transdermal Gel (Metered) 0.06% (1.25 g/activation)
Approved: April 22, 2024 - Solaris Pharma Corporation
Treatment for: Menopausal Symptoms
Generic for: EstroGel - Deflazacort Oral Suspension 22.75 mg/mL
Approved: April 25, 2024 - Tris Pharma Inc.
Treatment for: Duchenne Muscular Dystrophy
Generic for: Emflaza Suspension - Midostaurin Capsules 25 mg
Approved: April 29, 2024 - Teva Pharmaceuticals USA, Inc.
Treatment for: Acute Myeloid Leukemia, Systemic Mastocytosis
Generic for: Rydapt
May
- Edaravone Intravenous Solution 30 mg/100 mL and 60 mg/100 mL
Approved: May 6, 2024 - Gland Pharma Limited; Hikma Pharmaceuticals USA Inc. (30 mg/100 mL only); Long Grove Pharmaceuticals, LLC (30 mg/100 mL only); Dr. Reddy's Laboratories Limited (60 mg/100 mL only)
Treatment for: Amyotrophic Lateral Sclerosis
Generic for: Radicava - Emtricitabine and Tenofovir Alafenamide Fumarate Tablets 120 mg/15 mg (base) and 200 mg/25 mg (base)
Approved: May 17, 2024 - Apotex Corp.
Treatment for: HIV Infection
Generic for: Descovy - Lanreotide Acetate Injection 60 mg (base)/0.2 mL, 90 mg (base)/0.3 mL and 120 mg (base)/0.5 mL
Approved: May 21, 2024 - InvaGen Pharmaceuticals Inc.
Treatment for: Acromegaly, Gastroenteropancreatic Neuroendocrine Tumors, Carcinoid Syndrome
Generic for: Somatuline Depot - Sacubitril and Valsartan Tablets 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg
Approved: May 28, 2024 - Alembic Pharmaceuticals Limited; Crystal Pharmaceutical (Suzhou) Co., Ltd.; Laurus Labs
Treatment for: Heart Failure
Generic for: Entresto - Azelastine Hydrochloride Metered Nasal Spray (OTC) 0.2055 mg/spray
Approved: May 29, 2024 - Apotex Corp.
Treatment for: Allergic Rhinitis
Generic for: Astepro Allergy - Halcinonide Topical Solution 0.1%
Approved: May 29, 2024 - Encube Ethicals Private Limited
Treatment for: Inflammatory Skin Diseases
Generic for: Halog Solution
June
- Palbociclib Tablets 75 mg, 100 mg and 125 mg
Approved: June 5, 2024 - Synthon Pharmaceuticals, Inc.
Treatment for: Breast Cancer
Generic for: Ibrance Tablets - Avanafil Tablets 50 mg, 100 mg and 200 mg
Approved: June 14, 2024 - Hetero Labs Limited
Treatment for: Erectile Dysfunction
Generic for: Stendra - Phentermine Hydrochloride and Topiramate Extended Release Capsules 3.75 mg (base)/23 mg, 7.5 mg (base)/46 mg, 11.25 mg (base)/69 mg and 15 mg (base)/92 mg
Approved: June 25, 2024 - Actavis Laboratories FL, Inc.
Treatment for: Obesity
Generic for: Qsymia
July
- Indium In-111 Pentetreotide Injection Kit 3 mCi/mL
Approved: July 1, 2024 - Sun Pharmaceutical Industries, Inc.
Used for: Diagnosis and Investigation
Generic for: Octreoscan - Bupivacaine Liposome Injectable Suspension 133 mg/10 mL (13.3 mg/mL) and 266 mg/20 mL (13.3 mg/mL)
Approved: July 1, 2024 - Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Used for: Analgesia
Generic for: Exparel - L-Glutamine Powder for Oral Solution 5gm/packet
Approved: July 8, 2024 - Novitium Pharma LLC
Used for: Sickle Cell Disease
Generic for: Endari - Nimodipine Oral Solution 3 mg/mL
Approved: July 9, 2024 - Annora Pharma Private Limited
Used for: Subarachnoid Hemorrhage
Generic for: Nymalize - Tazarotene Topical Cream 0.05%
Approved: July 15, 2024 - Padagis Israel Pharmaceuticals Ltd.
Used for: Plaque Psoriasis
Generic for: Tazorac Cream 0.05% - Baricitinib Tablets 1 mg and 2 mg
Approved: July 22, 2024 - Aurobindo Pharma Limited
Used for: Rheumatoid Arthritis, Alopecia Areata
Generic for: Olumiant
August
- Prednisolone Acetate Ophthalmic Suspension 1%
Approved: August 2, 2024 - Lupin Pharmaceuticals, Inc.
Treatment for: Ocular Inflammation
Generic for: Pred Forte - Trametinib Dimethyl Sulfoxide Tablets 0.5 mg (base) and 2 mg (base)
Approved: August 6, 2024 - Novugen Pharma (USA) LLC
Treatment for: Cancer
Generic for: Mekinist - Lofexidine Hydrochloride Tablets 0.18mg (base)
Approved: August 20, 2024 - Indoco Remedies Ltd.
Treatment for: Opiate Withdrawal
Generic for: Lucemyra - Riluzole Oral Suspension 50 mg/10 mL
Approved: August 22, 2024 - Alkem Laboratories Ltd.
Treatment for: Amyotrophic Lateral Sclerosis
Generic for: Tiglutik - Methylnaltrexone Bromide Subcutaneous Solution 8 mg/0.4 mL and 12 mg/0.6 mL
Approved: August 26, 2024 - Actavis Pharma, Inc.
Treatment for: Opioid-Induced Constipation
Generic for: Relistor - Amantadine Hydrochloride Extended Release Capsules 68.5mg (base)
Approved: August 26, 2024 - Zydus Pharmaceuticals (USA) Inc.
Treatment for: Parkinson's Disease
Generic for: Gocovri
September
- Drospirenone Tablets 4 mg
Approved: September 30, 2024 - Lupin Ltd.
Treatment for: Prevention of Pregnancy
Generic for: Slynd
October
- Minocycline Hydrochloride Injection 100 mg (base)/vial
Approved: October 24, 2024 - Nexus Pharmaceuticals, Inc.
Treatment for: Bacterial Infections
Generic for: Minocin Injection - Topiramate Oral Solution 25mg/mL
Approved: October 31, 2024 - Alkem Laboratories Limited
Treatment for: Epilepsy; Preventive Treatment of Migraine
Generic for: Eprontia
November
- Exenatide Injection 300 mcg/1.2 mL (250 mcg/mL) and 600 mcg/2.4 mL (250 mcg/mL)
Approved: November 19, 2024 - Amneal Pharmaceuticals LLC
Treatment for: Type 2 Diabetes
Generic for: Byetta
December
- Aripiprazole for Extended Release Injectable Suspension 300 mg/vial and 400 mg/vial
Approved: December 3, 2024 - Mylan Pharmaceuticals Inc.
Treatment for: Schizophrenia; Bipolar I Disorder
Generic for: Abilify Maintena - Baclofen Oral Solution 5 mg/5 mL
Approved: December 6, 2024 - Rubicon Research Private Limited
Treatment for: Spasticity
Generic for: Ozobax - Tromethamine Injection 18 g/500 mL (3.6 g/100 mL)
Approved: December 9, 2024 - B. Braun Medical Inc.
Treatment for: Metabolic Acidosis
Generic for: Tham - Iobenguane Sulfate I-123 Injection 10 mCi/5 mL (2 mCi/mL)
Approved: December 9, 2024 - BWXT Medical Ltd.
Use: Diagnostic
Generic for: AdreView - Cefixime Tablets 400 mg
Approved: December 17, 2024 - FDC Limited
Treatment for: Bacterial Infections
Generic for: Suprax Tablets - Raltegravir Potassium Tablets 400mg (base)
Approved: December 19, 2024 - Hetero Labs Limited
Treatment for: HIV Infection
Generic for: Isentress - Liraglutide Subcutaneous Injection 18 mg/3 mL (6 mg/mL)
Approved: December 23, 2024 - Hikma Pharmaceuticals USA Inc.
Treatment for: Type 2 Diabetes
Generic for: Victoza - Deutetrabenazine Tablets 6 mg, 9 mg and 12 mg
Approved: December 26, 2024 - Aurobindo Pharma Limited
Treatment for: Huntington's Disease
Generic for: Austedo - Prucalopride Succinate Tablets 1 mg (base) and 2 mg (base)
Approved: December 26, 2024 - Novitium Pharma LLC
Treatment for: Chronic Idiopathic Constipation
Generic for: Motegrity