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 |
---|---|---|---|---|---|---|---|---|---|---|---|
Cipla Usa | ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303-001 | Jun 25, 2018 | RX | Yes | Yes | ⤷ Try a Trial | NEW CHEMICAL ENTITY | |
Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-002 | Mar 19, 2020 | RX | Yes | No | ⤷ Try a Trial | INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT | |
Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | TABLET;ORAL | 208341-001 | Jun 28, 2016 | RX | Yes | Yes | ⤷ Try a Trial | INFORMATION ADDED TO THE LABELING DESCRIBING A PHASE 2, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY/EFFICACY OF SOFOSBUVIR/VELPATASVIR IN SUBJECTS WITH CHRONIC HCV INFECTION WHO HAVE RECEIVED A LIVER TRANSPLANT | |
Tetraphase Pharms | XERAVA | eravacycline dihydrochloride | POWDER;INTRAVENOUS | 211109-001 | Aug 27, 2018 | RX | Yes | Yes | ⤷ Try a Trial | NEW CHEMICAL ENTITY | |
Tetraphase Pharms | XERAVA | eravacycline dihydrochloride | POWDER;INTRAVENOUS | 211109-002 | Jun 3, 2020 | RX | Yes | Yes | ⤷ Try a Trial | NEW CHEMICAL ENTITY | |
Paratek Pharms Inc | NUZYRA | omadacycline tosylate | POWDER;INTRAVENOUS | 209817-001 | Oct 2, 2018 | RX | Yes | Yes | ⤷ Try a Trial | NEW CHEMICAL ENTITY | |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |