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Last Updated: March 29, 2024

Duvelisib - Generic Drug Details


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What are the generic sources for duvelisib and what is the scope of freedom to operate?

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

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

One supplier is listed for this compound.

Summary for duvelisib
International Patents:148
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 76
Clinical Trials: 41
Patent Applications: 1,869
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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for duvelisib
Generic Entry Date for duvelisib*:
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.

Recent Clinical Trials for duvelisib

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

SponsorPhase
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Phase 1/Phase 2
NovartisEarly Phase 1
Secura Bio, Inc.Early 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 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-002 Sep 24, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-001 Sep 24, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-002 Sep 24, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-001 Sep 24, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Denmark 2663309 ⤷  Try a Trial
Peru 20141303 PROCEDIMIENTO PARA PREPARAR ISOQUINOLINONAS Y FORMAS SOLIDAS DE ISOQUINOLINONAS ⤷  Try a Trial
Singapore 187426 CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS ⤷  Try a Trial
New Zealand 706506 Heterocyclic compounds and uses thereof ⤷  Try a Trial
South Korea 20100126287 CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for duvelisib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2456444 2190502-1 Sweden ⤷  Try a Trial PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521
2456444 21C1052 France ⤷  Try a Trial PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521
2456444 301140 Netherlands ⤷  Try a Trial PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521
2456444 132021000000173 Italy ⤷  Try a Trial PRODUCT NAME: DUVELISIB(COPIKTRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1542, 20210521
2456444 2021C/546 Belgium ⤷  Try a Trial PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542/001-002 20210521
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.