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Last Updated: May 26, 2022

COPIKTRA Drug Patent Profile


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When do Copiktra patents expire, and what generic alternatives are available?

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

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

The generic ingredient in COPIKTRA is duvelisib. Additional details are available on the duvelisib profile page.

DrugPatentWatch® Generic Entry Outlook for Copiktra

Copiktra will be eligible for patent challenges on September 24, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:147
US Patents:4
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 66
Clinical Trials: 11
Patent Applications: 983
What excipients (inactive ingredients) are in COPIKTRA?COPIKTRA excipients list
DailyMed Link:COPIKTRA at DailyMed
Drug patent expirations by year for COPIKTRA
DrugPatentWatch® Estimated Generic Entry Opportunity 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
National Cancer Institute (NCI)Early Phase 1
Secura BioEarly Phase 1
Emory UniversityEarly Phase 1

See all COPIKTRA clinical trials

US Patents and Regulatory Information for COPIKTRA

COPIKTRA is protected by six US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of COPIKTRA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Substituted isoquinolin-1(2H)-ones, and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Certain chemical entities, compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH FOLLICULAR LYMPHOMA (FL)

Certain chemical entities, compositions and methods
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting COPIKTRA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) AFTER AT LEAST TWO PRIOR SYSTEMIC THERAPIES
Exclusivity Expiration: 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
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-001 Sep 24, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-001 Sep 24, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-001 Sep 24, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-002 Sep 24, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Secura COPIKTRA duvelisib CAPSULE;ORAL 211155-002 Sep 24, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

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: See Plans and Pricing

Patent: 7467
Estimated Expiration: See Plans and Pricing

Australia

Patent: 12205669
Estimated Expiration: See Plans and Pricing

Patent: 15258280
Estimated Expiration: See Plans and Pricing

Canada

Patent: 24197
Estimated Expiration: See Plans and Pricing

Chile

Patent: 13002007
Estimated Expiration: See Plans and Pricing

China

Patent: 3648499
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 63309
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 63309
Estimated Expiration: See Plans and Pricing

Patent: 38722
Estimated Expiration: See Plans and Pricing

Patent: 81574
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 45110
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7387
Estimated Expiration: See Plans and Pricing

Japan

Patent: 54672
Estimated Expiration: See Plans and Pricing

Patent: 14501790
Estimated Expiration: See Plans and Pricing

Patent: 17061547
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 7708
Estimated Expiration: See Plans and Pricing

Patent: 13008065
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2909
Estimated Expiration: See Plans and Pricing

Peru

Patent: 141303
Estimated Expiration: See Plans and Pricing

Patent: 180318
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 018500960
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 26883
Estimated Expiration: See Plans and Pricing

Patent: 13137424
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 1897
Estimated Expiration: See Plans and Pricing

Patent: 201600179R
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1305150
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1875720
Estimated Expiration: See Plans and Pricing

Patent: 140020249
Estimated Expiration: See Plans and Pricing

Patent: 180080358
Estimated Expiration: See Plans and Pricing

Spain

Patent: 37113
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 46305
Estimated Expiration: See Plans and Pricing

Patent: 59956
Estimated Expiration: See Plans and Pricing

Patent: 74262
Estimated Expiration: See Plans and Pricing

Patent: 1247670
Estimated Expiration: See Plans and Pricing

Patent: 1700475
Estimated Expiration: See Plans and Pricing

Patent: 1906841
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 5767
Estimated Expiration: See Plans and Pricing

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
China 106188059 某些化学实体、组合物和方法 (Certain chemical entities, compositions and methods) See Plans and Pricing
China 101965336 Certain chemical entities, compositions and methods See Plans and Pricing
Japan 2012533541 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009088990 See Plans and Pricing
Malaysia 172151 CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for COPIKTRA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2456444 LUC00237 Luxembourg See Plans and Pricing PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU1/21/1542 20210521
2456444 122021000069 Germany See Plans and Pricing PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210519
2456444 301140 Netherlands See Plans and Pricing PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521
2456444 2021C/546 Belgium See Plans and Pricing PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542/001-002 20210521
2456444 PA2021526 Lithuania See Plans and Pricing PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519
>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.