Regulatory Exclusivity Expiring in 2024
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Drugs with Regulatory Exclusivity Expiring in 2024
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Hikma | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 216159-001 | Apr 17, 2023 | AP | RX | No | No | ⤷ Try a Trial | PATENT CHALLENGE |
| Hikma | MIDAZOLAM IN 0.9% SODIUM CHLORIDE | midazolam | SOLUTION;INTRAVENOUS | 216159-002 | Apr 17, 2023 | AP | RX | No | No | ⤷ Try a Trial | PATENT CHALLENGE |
| Casper Pharma Llc | EDETATE CALCIUM DISODIUM | edetate calcium disodium | INJECTABLE;INJECTION | 216435-001 | May 3, 2023 | RX | No | Yes | ⤷ Try a Trial | COMPETITIVE GENERIC THERAPY | |
| Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-001 | Aug 26, 2011 | RX | Yes | No | ⤷ Try a Trial | TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE | |
| Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-002 | Aug 26, 2011 | RX | Yes | Yes | ⤷ Try a Trial | TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE | |
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-002 | Mar 19, 2020 | RX | Yes | No | ⤷ Try a Trial | PEDIATRIC EXCLUSIVITY | |
| Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | ⤷ Try a Trial | PEDIATRIC EXCLUSIVITY | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
