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Last Updated: March 29, 2024

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COPIKTRA Drug Patent Profile


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When do Copiktra patents expire, and when can generic versions of Copiktra launch?

Copiktra is a drug marketed by Secura and is included in one NDA. There are five patents protecting this drug.

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

The generic ingredient in COPIKTRA is duvelisib. One supplier is listed for this compound. Additional details are available on the duvelisib profile page.

DrugPatentWatch® Generic Entry Outlook for Copiktra

Copiktra was eligible for patent challenges on September 24, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 17, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for COPIKTRA
International Patents:148
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 69
Clinical Trials: 12
Drug Prices: Drug price information for COPIKTRA
What excipients (inactive ingredients) are in COPIKTRA?COPIKTRA excipients list
DailyMed Link:COPIKTRA at DailyMed
Drug patent expirations by year for COPIKTRA
Drug Prices for COPIKTRA

See drug prices for COPIKTRA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COPIKTRA
Generic Entry Date for COPIKTRA*:
Constraining patent/regulatory exclusivity:
NDA:
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 COPIKTRA

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

SponsorPhase
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Phase 1/Phase 2
Secura Bio, Inc.Early Phase 1
National Cancer Institute (NCI)Early Phase 1

See all COPIKTRA clinical trials

US Patents and Regulatory Information for COPIKTRA

COPIKTRA is protected by seven US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of COPIKTRA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting COPIKTRA

Formulations of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-on- e
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Substituted isoquinolin-1(2H)-ones, and methods of use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Certain chemical entities, compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH FOLLICULAR LYMPHOMA (FL)

Certain chemical entities, compositions and methods
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR SMALL LYMPHOCYTIC LEUKEMIA (SLL)

Solid forms of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1 (2H)-one and methods of use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH FOLLICULAR LYMPHOMA (FL)

Solid forms of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1 (2H)-one and methods of use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR SMALL LYMPHOCYTIC LEUKEMIA (SLL)

Processes for preparing isoquinolinones and solid forms of isoquinolinones
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting COPIKTRA

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) AFTER AT LEAST TWO PRIOR THERAPIES
Exclusivity Expiration: ⤷  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
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 211155-001 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
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 211155-002 Sep 24, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  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 COPIKTRA

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 COPIKTRA

When does loss-of-exclusivity occur for COPIKTRA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4824
Estimated Expiration: ⤷  Try a Trial

Patent: 7467
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 12205669
Estimated Expiration: ⤷  Try a Trial

Patent: 15258280
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2013017670
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 24197
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 13002007
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3648499
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 63309
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 63309
Estimated Expiration: ⤷  Try a Trial

Patent: 38722
Estimated Expiration: ⤷  Try a Trial

Patent: 81574
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 45110
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 7387
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 54672
Estimated Expiration: ⤷  Try a Trial

Patent: 14501790
Estimated Expiration: ⤷  Try a Trial

Patent: 17061547
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 7708
Estimated Expiration: ⤷  Try a Trial

Patent: 13008065
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 2909
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 141303
Estimated Expiration: ⤷  Try a Trial

Patent: 180318
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 018500960
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 26883
Estimated Expiration: ⤷  Try a Trial

Patent: 13137424
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 1897
Estimated Expiration: ⤷  Try a Trial

Patent: 201600179R
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1305150
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1875720
Estimated Expiration: ⤷  Try a Trial

Patent: 140020249
Estimated Expiration: ⤷  Try a Trial

Patent: 180080358
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 37113
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 46305
Estimated Expiration: ⤷  Try a Trial

Patent: 59956
Estimated Expiration: ⤷  Try a Trial

Patent: 74262
Estimated Expiration: ⤷  Try a Trial

Patent: 1247670
Estimated Expiration: ⤷  Try a Trial

Patent: 1700475
Estimated Expiration: ⤷  Try a Trial

Patent: 1906841
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 5767
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering COPIKTRA around the world.

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 COPIKTRA

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.