DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 211155
NDA 211155 describes COPIKTRA, which is a drug marketed by Verastem Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the COPIKTRA profile page.
The generic ingredient in COPIKTRA is duvelisib. One supplier is listed for this compound. Additional details are available on the duvelisib profile page.
The generic ingredient in COPIKTRA is duvelisib. One supplier is listed for this compound. Additional details are available on the duvelisib profile page.
Summary for 211155
| Tradename: | COPIKTRA |
| Applicant: | Verastem Inc |
| Ingredient: | duvelisib |
| Patents: | 4 |
Generic Entry Opportunity Date for 211155
Generic Entry Date for 211155*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) AFTER AT LEAST TWO PRIOR THERAPIES 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 | ||||||||
| 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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