2025 First Generic Drug Approvals

91 202327 Sitagliptin Phosphate Tablet Watson Laboratories Inc. Januvia Tablet 12/30/2025 Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 90 218854 Pseudoephrdrine Hydrochloride ER Tablet Aurobindo Pharma Limited Sudafed 24 Hour ER Tablet 12/29/2025 For temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies. 89 213811 Beclomethasone Dipropionate Aerosol Metered Inhalation Amneal Ireland Limited Qvar Aerosol Metered Inhalation 12/16/2025 For the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. 88 217597 Loteprednol Etabonate and Tobramycin Suspension/Drop Alembic Pharmaceuticals Limited Zylet Suspension/Drop 12/10/2025 For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. 87 214137 Estradiol Vaginal Insert Teva Pharmaceuticals USA, Inc. Imvexxy Vaginal Insert 12/8/2025 For the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. 86 202388 Sitagliptin and Metformin Hydrochloride Tablet Sandoz Inc. Janumet Tablet 12/2/2025 Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 85 218425 Cladribine Tablet Apotex Inc. Mavenclad Tablet 11/24/2025 For the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. 84 220043 Voriconazole Injection Hainan Poly Pharm. Co., Ltd. Vfend Injection 11/14/2025 For the treatment of invasive aspergillosis (IA) in adults and pediatric patients (2 years of age and older). 83 217468 Diazepam Rectal Gel Delivery System
  Navinta LLC    Diastat and Diastat Acudial Rectal Gel 11/14/2025 For the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older. 82 217737 Iohexol Injection Amneal EU, Limited Omnipaque Injection 11/13/2025     For myelography and computerized tomography (CT) myelography (lumbar, thoracic, cervical, total columnar) in adults and pediatric patients aged 2 weeks and older. 81 218596 Diroximel Fumarate Delayed-Release Capsule Zydus Worldwide DMCC      Vumerity Delayed-Release Capsule 11/12/2025 For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 80 218273 Ciprofloxacin Hydrochloride and Hydrocortisone Suspension/Drop Cosette Pharmaceuticals NC Laboratories, LLC Cipro HC Suspension/Drop 11/10/2025 For the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa, Staphylococcus aureus, and Proteus mirabilis. 79 211650 Axitinib Tablet Apotex Inc. Inlyta Tablet 10/30/2025 For the first-line treatment of patients with advanced renal cell carcinoma (RCC) in combination with avelumab. 78 218031 Drospirenone and Estradiol Tablet  Novast Laboratories Ltd. Angeliq Tablet 10/28/2025 For the treatment of moderate to severe vasomotor symptoms due to menopause and for moderate to severe vulvar and vaginal atrophy symptoms due to menopause.    77 219265 Lomustine Capsule Carnegie Pharmaceuticals LLC Gleostine Capsule 10/27/2025 For the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. 76 219465 Dalbavancin Hydrochloride Powder, For  Injection Teva Pharmaceuticals, Inc. Dalvance Powder, For Injection 10/23/2025 For the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin susceptible isolates). 75 218845 Gallium Ga 68 Edotreotide Injection
  The Methodist Hospital Research Institute Gallium Ga 68 Edotreotide Injection   10/10/2025 For use with positron emission tomography (PET) for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients. 74 218391 Progesterone Vaginal Insert Xiromed Pharma Espana, S.L. Endometrin Vaginal Insert 9/19/2025 Indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.  73 219684 Ketamine Hydrochloride Injection Baxter Healthcare Corporation Ketalar Injection 9/17/2025 Indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. 72 219922 Pazopanib Hydrochloride Tablet Torrent Pharmaceuticals Limited Votrient Tablet 9/4/2025 For the treatment of adults with advanced renal cell carcinoma (RCC). 71 214568 Liraglutide Injection Teva Pharmaceuticals Development, Inc. Saxenda Injection 8/27/2025  For use in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity and overweight adults in the presence of at least one weight-related comorbid condition. 70 219692 Norepinephrine Bitartrate in 5% Dextrose Injection Sagent Pharmaceuticals Norepinephrine Bitartrate in 5% Dextrose Injection 8/11/2025 Indicated to raise blood pressure in adult patients with severe, acute hypotension. 69 213551 Cangrelor Powder, For Injection Gland Pharma Limited Kengreal  Powder, For Injection 8/11/2025 Indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. 68 208977 Iron Sucrose Injection International Medication Systems, Limited Venofer Injection 8/8/2025 For the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). 67 212340 Iron Sucrose Injection Sandoz Inc. Venofer Injection 8/8/2025 For the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). 66 212559 Iron Sucrose Injection Mylan Laboratories Limited Venofer Injection 8/8/2025 For the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). 65 217585 Baricitinib Tablet MSN Laboratories Private Limited Olumiant Tablet 8/8/2025 For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers. 64 217131 Ascorbic Acid Injection Fresenius Kabi USA, LLC Ascor Injection 8/7/2025 For the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated. 63 215393 Tazarotene Lotion Padagis Israel Pharmaceuticals Ltd. Arazlo Lotion 7/29/2025 For the topical treatment of acne vulgaris in patients 9 years of age and older. 62 202136 Darunavir Tablet Mylan Pharmaceuticals Inc. Prezista Tablet 7/22/2025 For the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older, co-administered with ritonavir (Prezista/ritonavir) and with other antiretroviral agents. 61 218853 Sertraline Hydrochloride Capsule Zenara Pharma Private Limited Sertraline Hydrochloride Capsule 7/16/2025 For the treatment of major depressive disorder (MDD) in adults. 60 218152 Perampanel Suspension MSN Laboratories Private Limited Fycompa Suspension 7/11/2025 For treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. 59 217583 Manganese Chloride Injection Fresenius Kabi USA, LLC Manganese Chloride in Plastic Container 7/7/2025 Indicated in adult patients as a supplement to intravenous solutions given for TPN. 58 218087 Loteprednol Etabonate Gel Lupin Limited Lotemax SM Gel 6/30/2025 For the treatment of postoperative inflammation and pain following ocular surgery. 57 218502 Rivaroxaban Granule, For Suspension Alkem Laboratories Limited Xarelto Granule, For Suspension 6/26/2025 To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 56 217845 Dehydrated Alcohol Injection Accord Healthcare Inc. Ablysinol Injection 6/23/2025 To induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. 55 219084 Meropenem Powder, For Injection Brooks Steriscience Limited Meropenem Powder, For Injection  6/23/2025 For the treatment of bacterial meningitis in pediatric patients 3 months of age and older only. 54 219400 Dehydrated Alcohol Injection XGen Pharmaceuticals DJB, Inc. Ablysinol Injection 6/23/2025 To induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.  53 219444 Dehydrated Alcohol Injection Breckenridge Pharmaceutical, Inc. Ablysinol Injection 6/23/2025 To induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy.  52 219633 Selenious Acid Injection Aspiro Pharma Limited Selenious Acid Injection 6/11/2025 Indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. 51 204144 Sitagliptin and Metformin ER Tablet PH Health Limited Janumet XR Tablet 6/4/2025 Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 50 216966 Angiotensin II Acetate Injection Gland Pharma Limited Giapreza Injection 6/3/2025 To increase blood pressure in adults with septic or other distributive shock. 49 208592 Methylnaltrexone Bromide Injection Mylan Laboratories Limited Relistor Injection 5/28/2025 For the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. 48 219777 Magnesium Sulfate Injection Aspiro Pharma Limited Magnesium Sulfate Injection 5/28/2025 For replacement therapy in magnesium deficiency, especially in acute hypomagnesemia accompanied by signs of tetany similar to those observed in hypocalcemia. 47 209543 Bosutinib Monohydrate Tablet Alembic Pharmaceuticals Limited Bosulif Tablet 5/23/2025 For the treatment of: Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy. 46 209801 Perampanel Tablet Teva Pharmaceuticals USA, Inc. Fycompa Tablet 5/23/2025 For the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. 45 208452 Emtricitabine, Rilpivirine and Tenofovir Disoproxil Fumarate Tablet Mylan Pharmaceuticals Inc. Complera Tablet 5/20/2025 Indicated for use as a complete regimen for the treatment of HIV-1 infection in (1) patients 12 years of age and older with no antiretroviral treatment history and with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy, and (2) in certain virologically-suppressed (HIV-1 RNA < 50 copies/mL) patients on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen. 44 208534 Rivaroxaban Tablet Dr. Reddy’s Laboratories Limited Xarelto Tablet 5/14/2025 To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 43 208543 Rivaroxaban Tablet InvaGen Pharmaceuticals, Inc. Xarelto Tablet 5/14/2025 To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 42 208555   Rivaroxaban Tablet Lupin Limited Xarelto Tablet 5/14/2025 To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation.   41 210301 Rivaroxaban Tablet Alembic Pharmaceuticals Limited Xarelto Tablet 5/14/2025 To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 40 213114 Rivaroxaban Tablet Macleods Pharmaceuticals Limited Xarelto Tablet 5/14/2025 To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 39 213348 Rivaroxaban Tablet Sunshine Lake Pharma Co., Ltd. Xarelto Tablet 5/14/2025 To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 38 216995 Rivaroxaban Tablet AiPing Pharmaceutical, Inc. Xarelto Tablet 5/14/2025 To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 37 218107 Rivaroxaban Tablet Biocon Pharma Limited
  Xarelto Tablet 5/14/2025 To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 36 219332 Rivaroxaban Tablet Ascent Pharmaceuticals Inc. Xarelto Tablet 5/14/2025 To reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 35 217990 Raltegravir Potassium Tablet Lupin Limited Isentress HD Tablet   5/6/2025  For the treatment of human immunodeficiency virus (HIV-1) infection in adult patients in combination with other antiretroviral agents. 34 217190 Halobetasol Propionate and Tazarotene Lotion Sun Pharma Canada Inc. Duobrii Lotion  5/2/2025 For the topical treatment of plaque psoriasis in adults. 33 218454 Midazolam in 0.8% Sodium Chloride Injection B. Braun Medical Inc. Midazolam in 0.8% Sodium Chloride Injection 5/1/2025 For sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting via continuous intravenous infusion. 32 217387 Latanoprostene Bunod Solution/Drop Gland Pharma Limited Vyzulta Solution/Drop 4/29/2025 For the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. 31 217733 Pilocarpine Hydrochloride Solution/Drop Amneal EU, Limited Vuity Solution/Drop 4/28/2025 For the treatment of presbyopia in adults. 30 216719 Naloxone Hydrochloride Nasal Spray Padagis Israel Pharmaceuticals Ltd Kloxxado Nasal Spray 4/24/2025 For the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. 29 216063 Tolvaptan Tablet Lupin Limited Jynarque Tablet 4/23/2025 To slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). 28 218444 Siponimod Tablet RiconPharma LLC Mayzent Tablet 4/22/2025 For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults 27 218235 Nitroglycerin Ointment Encube Ethicals Private Limited Nitroglycerin Ointment 4/15/2025 For the prevention of angina pectoris due to coronary artery disease. 26 219215
  Acetaminophen Injection Gland Pharma Limited Acetaminophen Injection 4/2/2025 For management of mild to moderate pain in adult and pediatric patients 2 years and older. 25 215146 Technetium TC-99M Pentetate Acid Kit Injection Curium US LLC Drazimage DTPA Kit Injection 3/26/2025 For brain imaging in adults. 24 217221 Lidocaine Patch Aveva Drug Delivery Systems, Inc. Ztlido Patch 3/25/2025 For relief of pain associated with post-herpetic neuralgia (PHN) in adults. 23 217113 Apalutamide Tablet Zydus Worldwide DMCC Erleada Tablet 3/17/2025 For the treatment of patients with metastatic castration-sensative prostate cancer and non-metastatic castration-resistant prostate cancer. 22 218196 Bimatoprost Drops Mankind Pharma Limited Lumigan Drops 3/17/2025 For the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. 21 213522 Eluxadoline Tablet Zydus Pharmaceuticals (USA) Inc. Viberzi Tablet 3/14/2025 For the treatment of irritable bowel syndrome with diarrhea (IBS-D). 20 218628 Buspirone Hydrochloride Capsule Pangea Pharmaceuticals LLC Buspar Capsule 3/13/2025 For the management of anxiety disorders or the short-term relief of the symptoms of anxiety. 19 216125 Fludeoxyglucose F-18 Injection BAMF Health Inc. Fludeoxyglucose F18 Injection 3/11/2025 For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. 18 206183 Pralatrexate Injection Dr. Reddy’s Laboratories Limited Folotyn Injection 3/10/2025 For the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). 17 208555 Rivaroxaban Tablet Lupin Limited Xarelto Tablet 3/3/2025 For indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 16 208557 Rivaroxaban Tablet Taro Pharmaceutical Industries Ltd. Xarelto Tablet 3/3/2025 For indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation. 15 216418 Mercaptopurine Suspension Hikma Pharmaceuticals USA Inc. Purixan Suspension 2/26/2025 For the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen. 14 215617 Phenylephrine Hydrochloride Injection Somerset Therapeutics, LLC Biorphen Injection 2/14/2025 For the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. 13 218749 Gadoteridol Injection Hainan Poly Pharm. Co., Ltd. Prohance Injection 2/11/2025 For indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates. 12 218779 Selenious Acid Injection Fresenius Kabi USA, LLC Selenious Acid Injection 2/10/2025 For indicated in adult and pediatric patients as a source of selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. 11 219239 Epinephrine Injection Gland Pharma Limited Epinephrine Injection 2/6/2025 For indicated to increase mean arterial blood pressure in adult patients with hypotension asociated with septic shock. 10 213154 Bosentan Tablet, For Suspension Natco Pharma Limited Tracleer Tablet, For Suspension 2/5/2025 For the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-toright shunts (18%). 9 215922 Ivermectin Tablet Rubicon Research Private Limited Stromectol Tablet 1/22/2025 For the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis. 8 213409 Nimodipine Solution Alkem Laboratories Limited Nymalize Solution 1/22/2025 For the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in adult patients with subarachnoid hemorrhage (SAH) from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V). 7 217490 Azilsartan Medoxomil and Chlorthalidone Tablet Alkem Laboratories Limited Edarbyclor Tablet 1/21/2025 For the treatment of hypertension, to lower blood pressure. 6 206788 Eltrombopag Olamine Tablet Hetero Labs Limited Unit V Promacta Tablet 1/17/2025 For the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. 5 218211 Ephedrine Sulfate Injection Gland Pharma Limited Emerphed Injection 1/16/2025 For the treatment of clinically important hypotension occurring in the setting of anesthesia. 4 218871 Mesna Tablet Novast Laboratories Limited Mesnex Tablet 1/13/2025 For prophylactic agent in reducing the incidence of ifosfamide-induced hemorrhagic cystitis. 3 209728 Regorafenib Tablet Teva Pharmaceuticals USA Stivarga Tablet 1/13/2025 For the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. 2 217714 Esomeprazole Magnesium For Suspension Cipla Limited Nexium For Suspension 1/7/2025 For short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. 1 214966 Phytonadione Injection Cipla Limited Phytonadione Injection 1/3/2025 For the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by viamin K-deficiency or interference with vitamin K activity: anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives.

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