Details for New Drug Application (NDA): 211155
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The generic ingredient in COPIKTRA is duvelisib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the duvelisib profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Suppliers and Packaging for NDA: 211155
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-215 | 73116-215-28 | 28 CAPSULE in 1 PACKAGE (73116-215-28) |
| COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Secura Bio, Inc | 73116-215 | 73116-215-56 | 56 CAPSULE in 1 PACKAGE (73116-215-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
| Approval Date: | Sep 24, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 11,312,718 | Patent Expiration: | Jan 10, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 12,213,983 | Patent Expiration: | Apr 26, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR SMALL LYMPHOCYTIC LEUKEMIA (SLL) | ||||||||
| Patent: | 8,193,182 | Patent Expiration: | Sep 24, 2032 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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