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 |
