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. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the COPIKTRA profile page.
The generic ingredient in COPIKTRA is duvelisib. Two suppliers are listed for this compound. Additional details are available on the duvelisib profile page.
The generic ingredient in COPIKTRA is duvelisib. Two suppliers are 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 | Verastem, Inc. | 71779-115 | 71779-115-01 | 56 CAPSULE in 1 BOTTLE (71779-115-01) |
| COPIKTRA | duvelisib | CAPSULE;ORAL | 211155 | NDA | Verastem, Inc. | 71779-115 | 71779-115-02 | 2 PACKAGE in 1 CARTON (71779-115-02) / 28 BLISTER PACK in 1 PACKAGE (71779-115-03) / 1 CAPSULE in 1 BLISTER PACK |
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 | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 10, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
