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Generated: January 16, 2019

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Details for New Drug Application (NDA): 211155

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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.
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:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Sep 24, 2018TE: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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