API PRODUCT LIST
March 2024 UpdateRESEARCH & DEVELOPMENT PRODUCTS
| 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 |
ESTABLISHED PRODUCTS
| API Name | Proprietary Name | Main Indication | Route, Dosage Form | R&D - Status | US DMF - Status |
|---|---|---|---|---|---|
| Alprostadil | Muse | Erectile dysfunction | Urethral: Suppository | x | |
| Azelaic Acid | Azelex, Finacea | Anti-acne; Rosacea | Topical: Cream, Foam, Gel | x | |
| Bimatoprost | Durysta, Latisse, Lumigan | Antiglaucoma Helps eyelash growth | Ophthalmic: Implant - Solution,Drops Topical: Solution,Drops | x | |
| Carfilzomib | Kyprolis | Oncologic | Injectable: Powder for IV | x | |
| Carprofen | Rimadyl (veterinary) | NSAID | Oral: Caplets, Chewable tablets Injectable: Solution | x | |
| Ciclopirox Olamine | Loprox, Penlac | Antifungal | Topical: Cream, Shampoo, Suspension | x | |
| Colchicine | Colcrys, Gloperba, Lodoco, Mitigare | Antigout Heart Disease | Oral: Tablets, Capsules, Suspension | x | |
| Desmopressin Acetate | DDAVP, Stimate | Antidiuretic Hormone | Oral: Tablets Injectable: IV, Subcutaneous Nasal: Spray | x | |
| Dexlansoprazole | Dexilant | Anti-ulcer | Oral: DR Capsules | x | |
| Diclofenac Epolamine | Flector, Licart | Anti-rheumatic | Topical: Transdermal Patches | x | |
| Diclofenac Potassium | Cambia, Zipsor | NSAID | Oral: Powder for solution, Soft Gel Capsules, Tablets | x | |
| Diclofenac Sodium | Voltaren - Arthrotec- Pennsaid | NSAID | Oral: DR Tablets; ER Tablets Ophthalmic: Solution Topical: Gel; Solution | x | |
| Difluprednate | Durezol | Corticosteroid | Ophthalmic: Emulsion | x | |
| Docetaxel | Taxotere | Oncologic | Injectable: IV solution | x | |
| Droxidopa | Northera | Cardiovascular | Oral: Capsules | x | |
| Efinaconazole | Jublia | Antifungal | Topical: Solution | x | |
| Etodolac | Lodine - Lodine XL | Anti-rheumatic | Oral: Tablets, ER Tablets, Capsules | x | |
| Everolimus | Afinitor, Afinitor Disperz, Zortress | Oncologic; Immuno suppressant | Oral: Tablets, Tablets for Suspension | x | |
| Fesoterodine Fumarate | Toviaz | Urinary Incontinence | Oral: ER Tablets | x | |
| Flecainide Acetate | Tambocor | Anti-arrhythmic | Oral: Tablets | x | |
| Ganirelix Acetate | Antagon | Infertility | Injectable: Pre-filled Syringe | x | |
| Glipizide | Glucotrol, Glucotrol XL, Metaglip | Diabetes | Oral: Tablets, ER Tablets | x | |
| Icatibant Acetate | Firazyr | Angioedema | Injectable: Pre-filled Syringe (subcutaneous) | x | |
| Icosapent Ethyl (EPA) | Vascepa | Hyper triglyceridemia | Oral: Soft Gel Capsules | x | |
| Imiquimod | Zyclara | Keratosis | Topical: Cream | x | |
| Indomethacin | Indocin | Pain Treatment | Oral: Suspension, Capsules, ER Capsules | x | |
| Latanoprost | Xalatan, Iyuzeh, Rocklatan, Xelpros | Glaucoma Treatment | Ophthalmic: Solution; Emulsion | x | |
| Lidocaine Base | Lidoderm | Anesthetic | Topical: Ointment, Patch | x | |
| Lidocaine HCl | Multiple | Anesthetic | Injectable: Solution Ophthalmic: Gel Oral: Solution Topical: Solution, Jelly | x | |
| Loteprednol Etabonate | Alrex, Eysuvis, Inveltys, Lotemax, Lotemax SM | Anti-allergy | Ophthalmic: Gel, Suspension, Ointment | x | |
| Lubiprostone | Amitiza | Laxative | Oral: Soft Gel Capsules | x | |
| Lurasidone HCl | Latuda | Antipsychotic | Oral: Tablets | x | |
| Meloxicam | Mobic, Vivlodex | NSAID | Oral: Tablets, Capsules, Suspension | x | |
| 1% Misoprostol HPMC | Arthrotec, Cytotec | Antiulcerant | Oral: Tablets, DR Tablets | x | |
| Mycophenolate Mofetil | Cellcept | Immuno suppressant | Oral: Tablets, Capsules, Suspension | x | |
| Mycophenolate Mofetil HCl | Cellcept | Immuno suppressant | Injectable: IV Infusion | x | |
| Mycophenolate Sodium | Myfortic | Immuno suppressant | Oral: DR Tablets | x | |
| Nepafenac | Ilevro, Nevanac | NSAID | Ophthalmic: Solution, Suspension | x | |
| Obeticholic Acid | Ocaliva | GI Diseases | Oral: Tablets | x | |
| Paclitaxel | Abraxane, Taxol | Oncologic | Injectable: IV Solution, Lyophilized Powder for IV | x | |
| Paliperidone | Invega | Schizophrenia | Oral: ER Tablets | x | |
| Paliperidone Palmitate | Invega Sustenna, Invega Trinza, Invega Hafyera | Schizophrenia | Injectable: ER Suspension (IM) | x | |
| Prilocaine Base | Emla, Oraqix | Local Anesthetic | Topical: Cream, Periodontal Gel | x | |
| Prilocaine HCl | Citanest, Citanest Forte, Citanest Forte Dental | Local Anesthetic | Injectable: Solution | x | |
| Ranolazine | Ranexa, Aspruzyo Sprinle | Antianginal | Oral: ER Tablets, ER Granules (sachets) | x | |
| Risperidone | Risperdal, Risperdal Consta, Rykindo, Perseris Kit, Uzedy | Antipsychotic | Oral: Tablets Injectable: Powder for Suspension (IM - subcut.), ER Suspension (prefilled syringe) | x | |
| Rivastigmine Base | Exelon | Dementia treatment | Transdermal: Patches | x | |
| Roflumilast | Daliresp, Zoryve | COPD - Psoriasis | Oral: Tablets Topical: Cream, Foam | x | |
| Rotigotine | Neupro | Parkinson, Restless Leg Syndrome | Transdermal: Patches | x | |
| Rufinamide | Banzel | Antiepileptic | Oral: Tablets | x | |
| Sirolimus | Rapamune, Fyarro, Hyftor | Immuno suppressant | Oral: Tablets, Solution Injectable: Powder (IV) Topical: Gel | x | |
| Solifenacin Succinate | VESicare, VESicare LS | Overreactive bladder and other genitourinary system diseases | Oral: Tablet, Suspension | x | |
| Spironolactone | Aldactazide, Aldactone, CaroSpir | Antihypertensive | Oral: Tablets, Suspension | x | |
| Tacrolimus | Prograf, Protopic, Astragraf XL | Immuno suppressant (Prograf) Dermatitis (Protropic) | Oral: Capsules, Granules for Suspension, ER Capsules Injectable: Solution (IV) Topical: Ointment | x | |
| Tafluprost | Zioptan | Glaucoma Treatment | Ophthalmic: Solution | x | |
| Tofacitinib Citrate | Xeljanz, XeljanzXR | Rheumatoid Arthritis | Oral: Tablets, ER Tablets, Solution | x | |
| Tolterodine Tartrate | Detrol, Detrol LA | Overactive Bladder | Oral: Tablets, ER Capsules | x |