Regulatory Exclusivity: MISCELLANEOUS
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Drugs with Miscellaneous Regulatory Exclusivity
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Applicant | Tradename | Generic Name | NDA | Approval Date | Type | Patent No. | Patent Expiration | Exclusivity Expiration | Patented / Exclusive Use |
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Gilead Sciences Inc | EPCLUSA | sofosbuvir; velpatasvir | 208341 | Mar 19, 2020 | RX | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | 208341 | Mar 19, 2020 | RX | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | 208341 | Mar 19, 2020 | RX | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 | 208341 | Mar 19, 2020 | RX | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
>Applicant | >Tradename | >Generic Name | >NDA | >Approval Date | >Type | >Patent No. | >Patent Expiration | >Exclusivity Expiration | >Patented / Exclusive Use |