Details for New Drug Application (NDA): 211155
✉ Email this page to a colleague
NDA 211155 describes COPIKTRA, which is a drug marketed by Secura and is included in one NDA. There are four patents protecting this drug. Additional details are available on the COPIKTRA profile page.
The generic ingredient in COPIKTRA is duvelisib. Additional details are available on the duvelisib profile page.
The generic ingredient in COPIKTRA is duvelisib. Additional details are available on the duvelisib profile page.
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 211155
Generic Entry Date for 211155*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
| Approval Date: | Sep 24, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 24, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) AFTER AT LEAST TWO PRIOR THERAPIES | ||||||||
| Regulatory Exclusivity Expiration: | Sep 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) AFTER AT LEAST TWO PRIOR SYSTEMIC THERAPIES | ||||||||
Complete Access Available with Subscription
