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 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for COPIKTRA
*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
| Sponsor | Phase |
|---|---|
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Phase 1/Phase 2 |
| Emory University | Early Phase 1 |
| Novartis | Early Phase 1 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Substituted isoquinolin-1(2H)-ones, and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Certain chemical entities, compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: FOR THE TREATMENT OF PATIENTS WITH FOLLICULAR LYMPHOMA (FL)
Certain chemical entities, compositions and methods
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-001 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-001 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-002 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-002 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-001 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Secura | COPIKTRA | duvelisib | CAPSULE;ORAL | 211155-001 | Sep 24, 2018 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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
Patent: PROCESOS PARA PREPARAR ISOQUINOLINONAS Y FORMAS SOLIDAS DE ISOQUINOLINONAS
Estimated Expiration: ⤷ Sign Up
Patent: 7467
Patent: PROCESOS PARA PREPARAR ISOQUINOLINONAS Y FORMAS SÓLIDAS DE ISOQUINOLINONAS
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 12205669
Patent: Processes for preparing isoquinolinones and solid forms of isoquinolinones
Estimated Expiration: ⤷ Sign Up
Patent: 15258280
Patent: PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2013017670
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 24197
Patent: PROCEDES DE PREPARATION D'ISOQUINOLINONES ET DE FORMES SOLIDES D'ISOQUINOLINONES (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 13002007
Patent: Compuesto polimorfo (s)-3-(1-(9h-purin-6-ilamino)etil)-8-cloro-2-fenilisoquinolin-1-(2h)-ona de formas b-j, amorfa, sal, solvato o hidrato del mismo; mezclas de estos compuestos; metodo para preparar el polimorfo de forma c; composicion farmaceutica; metodo de tratamiento; uso para el tratamiento de un trastorno mediado por pi3k.
Estimated Expiration: ⤷ Sign Up
China
Patent: 3648499
Patent: Processes for preparing isoquinolinones and solid forms of isoquinolinones
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 63309
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 63309
Patent: PROCÉDÉS DE PRÉPARATION D'ISOQUINOLINONES ET DE FORMES SOLIDES D'ISOQUINOLINONES (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES)
Estimated Expiration: ⤷ Sign Up
Patent: 38722
Patent: FORMES SOLIDES D'ISOQUINOLINONES (SOLID FORMS OF ISOQUINOLINONES)
Estimated Expiration: ⤷ Sign Up
Patent: 81574
Patent: COMPOSITION POUR ADMINISTRATION ORALE À UTILISER DANS LE TRAITEMENT DU CANCER, D'UNE MALADIE INFLAMMATOIRE OU D'UNE MALADIE AUTO-IMMUNE (A COMPOSITION FOR ORAL ADMINISTRATION FOR USE IN THE TREATMENT OF CANCER, AN INFLAMMATORY DISEASE OR AN AUTO-IMMUNE DISEASE)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 45110
Patent: 異喹啉酮的固體形式 (SOLID FORMS OF ISOQUINOLINONES)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 7387
Patent: תהליכים להכנת איזוקווינולינונים וצורת מוצקות של איזוקווינולינונים (Processes for preparing isoquinolinones and solid forms of isoquinolinones)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 54672
Estimated Expiration: ⤷ Sign Up
Patent: 14501790
Estimated Expiration: ⤷ Sign Up
Patent: 17061547
Patent: イソキノリノンの調製方法及びイソキノリノンの固体形態 (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 7708
Patent: PROCESO PARA PREPARAR ISOQUINOLINONAS Y FORMAS SOLIDAS DE ISOQUINOLINONAS. (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES.)
Estimated Expiration: ⤷ Sign Up
Patent: 13008065
Patent: PROCESO PARA PREPARAR ISOQUINOLINONAS Y FORMAS SOLIDAS DE ISOQUINOLINONAS. (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2909
Patent: Processes for preparing isoquinolinones and solid forms of isoquinolinones
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 141303
Patent: PROCEDIMIENTO PARA PREPARAR ISOQUINOLINONAS Y FORMAS SOLIDAS DE ISOQUINOLINONAS
Estimated Expiration: ⤷ Sign Up
Patent: 180318
Patent: PROCEDIMIENTO PARA PREPARAR ISOQUINOLINONAS Y FORMAS SOLIDAS DE ISOQUINOLINONAS
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 018500960
Patent: PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 26883
Patent: СПОСОБЫ ПОЛУЧЕНИЯ ИЗОХИНОЛИНОНОВ И ТВЕРДЫЕ ФОРМЫ ИЗОХИНОЛИНОНОВ (METHODS OF PRODUCTION ISOQUINOLINONES AND SOLID FORMS ISOQUINOLINONES)
Estimated Expiration: ⤷ Sign Up
Patent: 13137424
Patent: СПОСОБЫ ПОЛУЧЕНИЯ ИЗОХИНОЛИНОНОВ И ТВЕРДЫЕ ФОРМЫ ИЗОХИНОЛИНОНОВ
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 1897
Patent: PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES
Estimated Expiration: ⤷ Sign Up
Patent: 201600179R
Patent: PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1305150
Patent: PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1875720
Estimated Expiration: ⤷ Sign Up
Patent: 140020249
Patent: PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES
Estimated Expiration: ⤷ Sign Up
Patent: 180080358
Patent: 이소퀴놀린온 및 이의 고체 형태의 제조 방법 (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 37113
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 46305
Estimated Expiration: ⤷ Sign Up
Patent: 59956
Estimated Expiration: ⤷ Sign Up
Patent: 74262
Estimated Expiration: ⤷ Sign Up
Patent: 1247670
Patent: Processes for preparing isoquinolinones and solid forms of isoquinolinones
Estimated Expiration: ⤷ Sign Up
Patent: 1700475
Patent: Processes for preparing isoquinolinones and solid forms of isoquinolinones
Estimated Expiration: ⤷ Sign Up
Patent: 1906841
Patent: Processes for preparing isoquinolinones and solid forms of isoquinolinones
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 5767
Patent: СПОСОБИ ОТРИМАННЯ ІЗОХІНОЛІНОНІВ І ТВЕРДІ ФОРМИ ІЗОХІНОЛІНОНІВ (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| European Patent Office | 2240451 | Dérivés d'isoquinoléinone substitués par une purine utiles en tant qu'inhibiteurs de PI3K (Isoquinolinone derivatives substituted with a purine useful as PI3K inhibitors) | ⤷ Sign Up |
| China | 106188059 | 某些化学实体、组合物和方法 (Certain chemical entities, compositions and methods) | ⤷ Sign Up |
| Croatia | P20150586 | ⤷ Sign Up | |
| Poland | 2456444 | ⤷ Sign Up | |
| Chile | 2013002007 | Compuesto polimorfo (s)-3-(1-(9h-purin-6-ilamino)etil)-8-cloro-2-fenilisoquinolin-1-(2h)-ona de formas b-j, amorfa, sal, solvato o hidrato del mismo; mezclas de estos compuestos; metodo para preparar el polimorfo de forma c; composicion farmaceutica; metodo de tratamiento; uso para el tratamiento de un trastorno mediado por pi3k. | ⤷ Sign Up |
| Japan | 6133452 | ⤷ Sign Up | |
| Ukraine | 115767 | СПОСОБИ ОТРИМАННЯ ІЗОХІНОЛІНОНІВ І ТВЕРДІ ФОРМИ ІЗОХІНОЛІНОНІВ (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES) | ⤷ Sign Up |
| >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 | ⤷ Sign Up | PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521 |
| 2456444 | LUC00237 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU1/21/1542 20210521 |
| 2456444 | 21C1052 | France | ⤷ Sign Up | PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521 |
| 2456444 | 2021C/546 | Belgium | ⤷ Sign Up | PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542/001-002 20210521 |
| 2456444 | CA 2021 00045 | Denmark | ⤷ Sign Up | PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521 |
| 2456444 | C202130064 | Spain | ⤷ Sign Up | PRODUCT NAME: DUVELISIB; NATIONAL AUTHORISATION NUMBER: EU/1/21/1542; DATE OF AUTHORISATION: 20210519; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1542; DATE OF FIRST AUTHORISATION IN EEA: 20210519 |
| 2456444 | PA2021526 | Lithuania | ⤷ Sign Up | 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.
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