RESEARCH & DEVELOPMENT PRODUCTS
MARCH 2024 UPDATE| API Name | Proprietary Name | Main Indication | Route, Dosage Form | R&D - Status | US DMF - Status | NCE |
|---|---|---|---|---|---|---|
| Abaloparatide | Tymlos | Osteoporosis | Injectable: Solution (subcutaneous) | x | Expired | |
| Afamelanotide | Scenesse | increase pain-free light exposure | Implant (subcutaneous) | x | October 8, 2024 | |
| Aripiprazole Lauroxil | Aristada, Aristada Initio Kit | Antipsychotic (schizophrenia) | Injectable: ER IM Susp. (in kit: prefilled syringes) | x | Expired | |
| Aripiprazole Monohydrate | Abilify Maintena | Antipsychotic | Injectable: ER IM Susp. | x | - | |
| Baricitinib | Olumiant | Autoimmune diseases | Oral: Tablets | x | Expired | |
| Brexanolone | Zultresso | Antidepressant, Post-Partum Depression | Injectable: IV solution | x | June 17, 2024 | |
| Bupivacaine Base | Exparel, Posimir | Anesthetic | Injectable: Liposomal Susp. Infiltration: Solution | x | - | |
| Bupivacaine HCl | Marcaine HCl, Xaracoll | Anesthetic | Injectable: Solution Implant | x | - | |
| Cabazitaxel | Jevtana Kit | Oncologic | Injectable: Solution (IV, Kit) | x | Expired | |
| Cabotegravir | Cabenuva Kit | Anti-HIV | Injectable: Suspension | x | January 21, 2026 | |
| Cannabidiol | Epidiolex | Anti-epileptic | Oral: Solution | x | Expired | |
| Cantharidin | Ycanth | Treatment of molluscum contagiosum | Topical: Solution | x | Expected (07/21/28) | |
| Corticotropin | Acthar Gel (H.P.), Purified Cortrophin Gel | Antiallergic, various | Injectable: IM, Subcutaneous | x | - | |
| Dalbavancin HCl | Dalvance | Antibacterial | Injectable: Powder for IV | x | Expired | |
| Daprodustat | Jesduvroq | Anemia Treatment | Oral: Tablets | x | February 1, 2028 | |
| Daridorexant HCl | Quviviq | Sleep disorders | Oral: Tablets | x | April 7, 2027 | |
| Difelikefalin Acetate | Korsuva | Anti-pruritic | Injectable: IV solution | x | August 23, 2026 | |
| Edaravone | Radicava - Radicava ORS | ALS | Oral: Suspension Injectable: IV Solution | x | Expired | |
| Edoxaban Tosylate | Savaysa | Anti-thrombotic | Oral: Tablets | x | Expired | |
| Elagolix Sodium | Orilissa, Oriahnn (copackaged) | Female reproductive System Disorders | Oral: Tablets, Capsules | x | Expired | |
| Esketamine HCl | Spravato | Antidepressant | Nasal: Spray | x | March 5, 2024 | |
| Etelcalcetide HCl | Parsabiv | Kidney Disease | Injectable: IV solution | x | Expired | |
| Etrasimod Arginine | Velsipity | Ulcerative colitis | Oral: Tablets | x | October 12, 2028 | |
| Ferric Carboxymaltose | Injectafer | Anti-anemic | Injectable: IV Solution | x | - | |
| Ferric Derisomaltose | Monoferric | Anti-anemic | Injectable: IV Solution | x | - | |
| Ferric Maltol | Accrufer | Anti-anemic | Oral: Capsules | x | July 25, 2024 | |
| Gepirone HCl | Exxua | Antidepressant | Oral: ER Tablets | x | September 22, 2028 | |
| Glucagon Synthetic | Baquisimi, Gvoke | Hypoglycemia treatment | Nasal: Powder Injectable: Pre-filled Syringe | x | - | |
| Ixazomib Citrate | Ninlaro | Oncologic | Oral: Capsules | x | Expired | |
| Lanreotide Acetate | Somatuline Depot | Endocrine Gland Disease | Injectable: Single Use Syringe (subcutaneous) | x | - | |
| Lasmiditan Succinate | Reyvow | Anti-migraine | Oral: Tablets | x | January 31, 2025 | |
| Latanoprostene Bunod | Vyzulta | Glaucoma Treatment | Ophthalmic: Solution | x | - | |
| Lenvatinib | Lenvima | Oncologic | Oral: Capsules | x | Expired | |
| Levomilnacipran HCl | Fetzima | Antidepressant | Oral: ER Capsules | x | Expired | |
| Lurbinectedin | Zepzelca | Oncologic | Injectable: Lyophilized Powder | x | June 15, 2025 | |
| Mavacamten | Camzyos | Hypertrophic cardiomyopathy | Oral: Capsules | x | April 28, 2027 | |
| Midostaurin | Rydapt | Leukemia Treatment | Oral: Soft Gel Capsules | x | Expired | |
| Milnacipran HCl | Savella | Fibromyalgia Treatment | Oral: Tablets | x | - | |
| Octreotide Acetate | Mycapssa, Sandostatin, Sandostatin LAR, Oclaiz | Acromegaly | Injectable: Subcutaneous or IV, Injectable Kit, Subcut. injection depot Oral: DR Capsules | x | - Oclaiz PDUFA date: 10/21/2024 |
|
| Omidenepag Isopropyl | Omlonti | Glaucoma Treatment | Ophthalmic: Solution | x | September 22, 2027 | |
| Oxymetazoline HCl | Rhofade, Upneeq | Skin and Eye Diseases | Topical: Cream Ophthalmic: Solution | x | - | |
| Ozanimod | Zeposia | MS Treatment | Oral: Capsules | x | March 25, 2025 | |
| Pasireotide Diaspartate | Signifor | Cushing’s Disease | Injectable: Solution subcutaneous | x | Expired | |
| Patiromer Sorbitex Calcium | Veltassa | Hyperkalemia | Oral: Powder for Suspension | x | Expired | |
| Plecanatide | Trulance | Constipation | Oral: Tablets | x | Expired | |
| Pramlintide Acetate | Symlin | Antidiabetic | Injectable: Solution (subcutaneous, pen) | x | - | |
| Remimazolam Besylate | Byfavo | Sedative | Injectable: Lyophilized Powder | x | October 6, 2025 | |
| Ribociclib Succinate | Kisqali | Oncologic | Oral: Tablets | x | Expired | |
| Rifaximin | Xifaxan | Antibacterial | Oral: Tablets | x | - | |
| Rilpivirine | Cabenuva Kit | Anti-HIV | Injectable: Suspension | x | January 21, 2026 | |
| Rimegepant Sulfate | Nurtec ODT | Antimigraine | Oral: Oral Disintegrating Tablets | x | February 27, 2025 | |
| Salmon Calcitonin | Miacalcin | Calcium metabolism modifier | Nasal: Spray Injectable: Solution | x | - | |
| Selumetinib | Koselugo | Neurofibromatosis | Oral: Capsules | x | April 10, 2025 | |
| Semaglutide Recombinant | Ozempic, Rybelus, Wegovy | Type II diabetes, Obesity | Oral: Tablets Injectable: Solution | x | Expired | |
| Setmelanotide Acetate | Imcivree | Obesity | Injectable: Solution (Subcutaneous) | x | November 25, 2025 | |
| Tapinarof | Vtama | Psoriasis Treatment | Topical: Cream | x | May 23, 2027 | |
| Teduglutide | Gattex Kit | Short Bowel Syndrome Treatment | Injectable: Solution (subcutaneous) | x | Expired | |
| Tipiracil HCl /Trifluridine | Lonsurf | Anticancer | Oral: Tablets | x | Expired | |
| Tirbanibulin | Klisyri | Keratosis Treatment | Topical: Ointment | x | December 14, 2025 | |
| Tirzepatide | Mounjaro, Zepbound | Antidiabetis (Mounjaro) Weight management (Zepbound) | Injectable: Solution (subcutaneous) | x | Mounjaro: 5/13/2027 Zepbound: TBD |
|
| Treprostinil Diolamine | Orenitram | Treatment of pulmonary arterial hypertension | Oral: ER Tablets | x | - | |
| Trilaciclib Dihydrochloride | Cosela | Decrease of chemotherapy-induced myelo suppression | Injectable: Lyophilized Powder (IV) | x | February 12, 2026 | |
| Viloxazine HCl | Qelbree | ADHD Treatment | Oral: ER Capsules | x | April 2, 2026 | |
| Voclosporin | Lupkynis | Lupus Treatment | Oral: Softgel Capsules | x | January 22, 2026 | |
| Vonoprazam Fumarate | Voquezna | GI Diseases | Oral: Tablets | x | Expected (5/3/2027) | |
| Vosoritide | Voxzogo | Treatment of achondroplasia | Injectable: Lyophilized Powder (subcutaneous) | x | November 19, 2026 | |
| Xanomeline | KartXT | Treatment of schizophrenia | Oral: Capsules | x | PDUFA Date: 9/26/2024 | |
| Zavegepant HCl | Zavzpret | Antimigraine | Nasal: Spray | x | March 9, 2028 | |
| Zuranolone | Zurzuvae | Antidepressant, Post-Partum Depression | Oral: Capsules | x | October 31, 2028 |