Generic Launches - Third 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
Atrovent Boehringer Ingelheim ipratropium bromide Lupin Used as a bronchodilator for maintenance treatment of bronchospasms associated with chronic obstructive pulmonary disease including chronic bronchitis and emphysema. 7/4/2025
Entresto Novartis sacubitril / valsartan Alkem Used to reduce the risk of cardiovascular death and hospitalization for adult patients with chronic heart failure. 7/2025?
Entresto Novartis sacubitril / valsartan Zydus Used to reduce the risk of cardiovascular death and hospitalization for adult patients with chronic heart failure. 7/2025?
Methadone HCl Injection Mylan methadone HCl injection Long Grove Used to treat moderate-to-severe pain that has not responded well to other forms of pain management and for the detoxification and treatment of opioid use disorder. 7/9/2025
Morphine Sulfate Hospira morphine sulfate Hikma Used to treat pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 7/14/2025
Leqselvi Incyte deuruxolitinib Sun Used to treat severe alopecia in adults. 7/14/2025
Dificid Cubist fidaxomicin Teva Used to treat Clostridioides difficile-associated diarrhea (CDAD) in adults and children 6 months of age and older. 7/15/2025
Lotemax Bausch loteprednol etabonate Lupin Used to treat steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitis, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. 7/16/2025
Entresto Novartis sacubitril / valsartan Novadoz Used to reduce the risk of cardiovascular death and hospitalization for adult patients with chronic heart failure. 7/22/2025
Mitigare Hikma colchicine Camber Used to treat gout flares in adults. 7/29/2025
Riomet Sun metformin Camber Used as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. 7/31/2025
Sertraline Hydrochloride Almatica sertraline hydrochloride Zenara Used to manage and treat the major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, and social anxiety disorder.  
Glucagon Eli Lilly glucagon Lupin Used to treat severe hypoglycemia in pediatric and adult patients with diabetes mellitus and as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. 8/11/2025
Entresto Novartis sacubitril / valsartan MSN Used to reduce the risk of cardiovascular death and hospitalization for adult patients with chronic heart failure and reduced ejection fraction. 8/19/2025
Tracleer Actelion bosentan Lupin / Natco Used to treat pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. 8/20/2025
Saxenda Novo Nordisk liraglutide Teva Indicated for weight loss. 8/28/2025
Halaven Eisai eribulin mesylate Glenmark Used to treat metastatic breast cancer and liposarcoma. 9/2/2025
Entresto Novartis sacubitril / valsartan Novugen Used to reduce the risk of cardiovascular death and hospitalization for adult patients with chronic heart failure and reduced ejection fraction. 9/4/2025
Vitamin K Hospira phytonadione Xiromed Used to treat blood clotting disorders and to treat and prevent bleeding. 9/4/2025
Dymista Mylan azelastine Teva Used to treat allergy symptoms by blocking histamine. 9/8/2025
Targretin Bausch bexarotene Camber Used to treat cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. 9/11/2025
Sprycel Bristol Myers Squibb dasatinib Teva Used to treat a certain type of chronic myeloid leukemia (CML; a type of cancer of the white blood cells) as a first treatment and in adults who can no longer benefit from other leukemia medications including imatinib (Gleevec®) or in those who cannot take these medications because of side effects. 9/18/2025
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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