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 |
| Pataday | Alcon | olopatadine | Dr. Reddy's Labs | Used for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander. | 1/14/2026 |
| Sprycel | Bristol-Myers Squibb | dasatinib | Lupin | Used to treat adults and children (1 year+) with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase. It is also approved for acute lymphoblastic leukemia and CML (accelerated/blast phase) resistant or intolerant to prior therapy, including imatinib. | 2/2/2026 |
| Dificid | Cubist | fidaxomicin | Apotex | Used to treat Clostridioides difficile-associated diarrhea (CDAD) in adults and pediatric patients aged 6 months and older. | 2/3/2026 |
| Trokendi XR | Supernus | topiramate | Lupin | Used to treat partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older, as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 6 years of age and older, and for the preventive treatment of migraine in patients 12 years of age and older. | 2/4/2026 |
| Teflaro | AbbVie | ceftaroline | Apotex | Used to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) in adults and children. | 2/12/2026 |
| Xyrem | Jazz | sodium oxybate | Camber | Used to treat cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. | 2/26/2026 |
| Saxenda | Novo-Nordisk | liraglutide | Cipla | Used to control blood sugar, prevent cardiovascular conditions in diabetes, and manage obesity. | 2/27/2026 |
| Pomalyst | Bristol-Myers Squibb | pomalidomide | Natco / Breckinridge | Used to treat adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. | 3/3/2026 |
| Pomalyst | Bristol-Myers Squibb | pomalidomide | Teva | Used to treat adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. | 3/3/2026 |
| Pomalyst | Bristol-Myers Squibb | pomalidomide | Camber | Used to treat adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. | 3/3/2026 |
| Pomalyst | Bristol-Myers Squibb | pomalidomide | Aurobindo | Used to treat adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. | 3/4/2026 |
| Nucynta | Collegium | tapentadol | Hikma | Used to manage severe and persistent pain in adults that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioid. | 3/11/2026 |
| Dalvance | AbbVie | dalbavancin | Long Grove | Used to treat acute bacterial skin and skin structure infections caused by susceptible Gram-positive bacteria. | 3/11/2026 |
| Pomalyst | Bristol-Myers Squibb | pomalidomide | Apotex | Used to treat adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. | 3/11/2026 |
| Savella | AbbVie | milnacipran | Glenmark | Used to treat fibromyalgia, typically at doses of 100-200 mg/day, by reducing pain and improving daily function. | 3/19/2026 |
| Citalopram | Almatica | citalopram | Aurobindo | Used to treat major depressive disorder (MDD) in adults. | 3/25/2026 |
