Generic Launches Second Quarter 2025

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Abbreviated New Drug Applications and 505(b)(2) Applications

This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications.

Reference Listed Drug ANDA Holder Generic Drug Name ANDA Applicant(s) Indication Launch Date
Vancomycin HCl Mylan vancomycin HCl Glenmark Used to treat a variety of serious bacterial infections, especially those caused by Gram-positive bacteria that are resistant to other antibiotics. 4/1/2025
Trokendi XR Supernus topiramate Par Used to treat and prevent seizures in individuals with epilepsy. It is also prescribed to prevent migraine headaches in adults and adolescents aged 12 and older. 4/1/2025
Suprep Bowel Prep Kit Sebela sodium sulfate / potassium sulfate / magnesium sulfate Camber Used to cleanse the colon in preparation for colonoscopy in adult patients. 4/3/2025
CellCept Roche mycophenolate mofetil Camber Used for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. 4/9/2025
Stromectol Merck ivermectin Rubicon Used to treat parasitic infections in humans and animals.  
Maxitrol Harrow neomycin / polymyxin b sulfates Nordic Pharma Used to treat and relieve bacterial eye infections. 4/24/2025
Percocet Endo oxycodone / acetaminophen Elite Used to relieve moderate to moderately severe pain. 4/30/2025
Vazculep Exela phenylephrine Camber Used to treat clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. 5/1/2025
Aptiom Sumitomo eslicarbazepine Camber Used to treat partial-onset seizures in patients 4 years of age and older. 5/6/2025
Aptiom Sumitomo eslicarbazepine Apotex Used to treat partial-onset seizures in patients 4 years of age and older. 5/6/2025
Aptiom Sumitomo eslicarbazepine Dr. Reddy's Labs Used to treat partial-onset seizures in patients 4 years of age and older. 5/6/2025
Aptiom Sumitomo eslicarbazepine Ascend Used to treat partial-onset seizures in patients 4 years of age and older. 5/6/2025
Aptiom Sumitomo eslicarbazepine Torrent Used to treat partial-onset seizures in patients 4 years of age and older. 5/6/2025
Aptiom Sumitomo eslicarbazepine Lupin Used to treat partial-onset seizures in patients 4 years of age and older. 5/7/2025
Qsymia Vivus phentermine / topimirate Teva Used for weight loss and long-term weight management for adults and children aged 12 and older who are considered obese (with a BMI of 30 kg/m² or greater). 5/7/2025
Jynarque Otsuka tolvaptan Lupin Used to treat slowing kidney function decline in adults with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). 5/13/2023
Promacta Novartis eltrombopag Camber Used to treat thrombocytopenia—a serious condition affecting platelet counts—and aplastic anemia, which impacts the production of new blood cells 5/14/2025
Temodar Merck temozolomide Camber Used to treat newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment, anaplastic astrocytoma, and adults with refractory anaplastic astrocytoma. 5/15/2025
Epinephrine Fresenius Kabi epinephrine Fresenius Kabi Used to treat allergic reactions (Type 1), including anaphylaxis, in adults and pediatric patients and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. 5/20/2025
Provay Blue Proveparm methylene blue Nexus Used to treat methemoglobinemia – a condition that affects the blood’s ability to carry oxygen. 5/22/2025
Tasigna Novartis nilotinib Apotex Used to treat certain types of leukemia, including newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia ("Ph+ CML") in chronic phase in adults and children aged 1 year and older. 5/27/2025
Fycompa Esai perampanel Teva Used to treat certain types of epilepsy. 5/29/2025
Byetta Amylin exenatide Amneal Used as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. 5/30/2025

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