Duvelisib - Generic Drug Details

What are the generic drug 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:	42
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

See drug prices for duvelisib

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for duvelisib

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

Sponsor	Phase
Peking Union Medical College Hospital	Phase 1/Phase 2
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1/Phase 2
Secura Bio, Inc.	Early Phase 1

See all duvelisib clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for duvelisib

L01EM	Phosphatidylinositol-3-kinase (Pi3K) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	No			Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	No
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	No				Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		RX	Yes	No			Y	Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	No
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		RX	Yes	No

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

International Patents for duvelisib

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)
China	106188059	某些化学实体、组合物和方法 (Certain chemical entities, compositions and methods)
Croatia	P20150586
Poland	2456444
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.
Japan	6133452
Ukraine	115767	СПОСОБИ ОТРИМАННЯ ІЗОХІНОЛІНОНІВ І ТВЕРДІ ФОРМИ ІЗОХІНОЛІНОНІВ (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES)

Supplementary Protection Certificates for duvelisib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2456444	2190502-1	Sweden		PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521
2456444	LUC00237	Luxembourg		PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU1/21/1542 20210521
2456444	21C1052	France		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521
2456444	2021C/546	Belgium		PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542/001-002 20210521
2456444	CA 2021 00045	Denmark		PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521
2456444	C202130064	Spain		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		PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519