Regulatory Exclusivity Expiring in 2023
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Drugs with Regulatory Exclusivity Expiring in 2023
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Zogenix Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | ⤷ Try a Trial | PEDIATRIC EXCLUSIVITY | |
| Biogen Idec | SPINRAZA | nusinersen sodium | SOLUTION;INTRATHECAL | 209531-001 | Dec 23, 2016 | RX | Yes | Yes | ⤷ Try a Trial | TREATMENT OF SPINAL MUSCULAR ATROPHY IN PEDIATRIC AND ADULT PATIENTS | |
| Clovis Oncology Inc | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-001 | Dec 19, 2016 | RX | Yes | No | ⤷ Try a Trial | AS MONOTHERAPY FOR THE TREATMENT OF PATIENTS WITH DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC) ASSOCIATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH TWO OR MORE CHEMOTHERAPIES | |
| Clovis Oncology Inc | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | RX | Yes | No | ⤷ Try a Trial | AS MONOTHERAPY FOR THE TREATMENT OF PATIENTS WITH DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC) ASSOCIATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH TWO OR MORE CHEMOTHERAPIES | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
