Regulatory Exclusivity Expiring in 2028
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Drugs with Regulatory Exclusivity Expiring in 2028
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Strongbridge | RECORLEV | levoketoconazole | TABLET;ORAL | 214133-001 | Dec 30, 2021 | RX | Yes | Yes | ⤷ Sign Up | FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE | |
| Astrazeneca Ab | WAINUA (AUTOINJECTOR) | eplontersen sodium | SOLUTION;SUBCUTANEOUS | 217388-001 | Dec 21, 2023 | RX | Yes | Yes | ⤷ Sign Up | NEW CHEMICAL ENTITY | |
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Sign Up | NEW CHEMICAL ENTITY | |
| Global Blood Theraps | OXBRYTA | voxelotor | TABLET, FOR SUSPENSION;ORAL | 216157-001 | Dec 17, 2021 | DISCN | Yes | No | ⤷ Sign Up | FOR TREATMENT OF SICKLE CELL DISEASE (SCD) IN PEDIATRIC PATIENTS 4 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE | |
| Global Blood Theraps | OXBRYTA | voxelotor | TABLET;ORAL | 213137-002 | Oct 14, 2022 | DISCN | Yes | No | ⤷ Sign Up | FOR TREATMENT OF SICKLE CELL DISEASE (SCD) IN PEDIATRIC PATIENTS 4 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
