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Details for New Drug Application (NDA): 211155
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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 |
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