Regulatory Exclusivity Expiring in 2029
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Drugs with Regulatory Exclusivity Expiring in 2029
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mirati Theraps | KRAZATI | adagrasib | TABLET;ORAL | 216340-001 | Dec 12, 2022 | RX | Yes | Yes | ⤷ Sign Up | TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY | |
| Organon Llc | XACIATO | clindamycin phosphate | GEL;VAGINAL | 215650-001 | Dec 7, 2021 | RX | Yes | Yes | ⤷ Sign Up | GENERATING ANTIBIOTIC INCENTIVES NOW | |
| Rigel Pharms Inc | REZLIDHIA | olutasidenib | CAPSULE;ORAL | 215814-001 | Dec 1, 2022 | RX | Yes | Yes | ⤷ Sign Up | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST | |
| Sun Pharm Inds Inc | SEZABY | phenobarbital sodium | POWDER;INTRAVENOUS | 215910-001 | Nov 17, 2022 | RX | Yes | Yes | ⤷ Sign Up | TREATMENT OF NEONATAL SEIZURES IN TERM AND PRETERM INFANTS | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
