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Last Updated: June 25, 2022

DUVELISIB - Generic Drug Details


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What are the generic drug sources for duvelisib and what is the scope of patent protection?

Duvelisib is the generic ingredient in one branded drug marketed by Secura and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Duvelisib has one hundred and forty-seven patent family members in thirty-four countries.

Summary for DUVELISIB
International Patents:147
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 66
Clinical Trials: 40
Patent Applications: 1,911
Drug Prices: Drug price trends for DUVELISIB
What excipients (inactive ingredients) are in DUVELISIB?DUVELISIB excipients list
DailyMed Link:DUVELISIB at DailyMed
Drug Prices for DUVELISIB

See drug prices for DUVELISIB

Recent Clinical Trials for DUVELISIB

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Secura Bio, Inc.Early Phase 1
National Cancer Institute (NCI)Early Phase 1
Secura BioEarly Phase 1

See all DUVELISIB clinical trials

US Patents and Regulatory Information for DUVELISIB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-002 Sep 24, 2018 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-002 Sep 24, 2018 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-001 Sep 24, 2018 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-002 Sep 24, 2018 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-002 Sep 24, 2018 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-001 Sep 24, 2018 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-001 Sep 24, 2018 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for DUVELISIB

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Secura Bio Limited Copiktra duvelisib EMEA/H/C/005381
Copiktra monotherapy is indicated for the treatment of adult patients with: Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies. Follicular lymphoma (FL) that is refractory to at least two prior  systemic therapies.
Authorised no no no 2021-05-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for DUVELISIB

Country Patent Number Title Estimated Expiration
Mexico 351028 DETERMINADADAS ENTIDADES, COMPOSICIONES Y METODOS QUIMICOS. (CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS.) See Plans and Pricing
Israel 242192 חומרים כימיים מסוימים, תכשירים ושיטות (Certain chemical entities, compositions and methods) See Plans and Pricing
Peru 20180318 PROCEDIMIENTO PARA PREPARAR ISOQUINOLINONAS Y FORMAS SOLIDAS DE ISOQUINOLINONAS See Plans and Pricing
European Patent Office 3441392 COMPOSITION PHARMACEUTIQUE POUR ADMINISTRATION ORALE (A PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION) See Plans and Pricing
Japan 2011509259 See Plans and Pricing
European Patent Office 2456444 DÉRIVÉ D'ADENINE COMME INHIBITEUR DE PI3K (ADENINE DERIVATIVE AS PI3K INHIBITOR) See Plans and Pricing
Ukraine 109878 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DUVELISIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2456444 46/2021 Austria See Plans and Pricing PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 (MITTEILUNG) 20210521
2456444 CA 2021 00045 Denmark See Plans and Pricing PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521
2456444 122021000069 Germany See Plans and Pricing PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210519
2456444 132021000000173 Italy See Plans and Pricing PRODUCT NAME: DUVELISIB(COPIKTRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1542, 20210521
2456444 PA2021526 Lithuania See Plans and Pricing PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519
2456444 LUC00237 Luxembourg See Plans and Pricing PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU1/21/1542 20210521
2456444 301140 Netherlands See Plans and Pricing PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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