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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for duvelisib

International Patents:	147
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	40
Patent Applications:	1,911
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

Recent Clinical Trials for duvelisib

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

Sponsor	Phase
Emory University	Early Phase 1
Novartis	Early Phase 1
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	211155-001	Sep 24, 2018		RX	Yes	No
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		RX	Yes	No				Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	Yes
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	Yes				Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		RX	Yes	Yes
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		RX	Yes	No

International Patents for duvelisib

Country	Patent Number	Title	Estimated Expiration
New Zealand	613219	Heterocyclic containing entities, compositions and methods
New Zealand	717410	Heterocyclic containing entities, compositions and methods
Canada	2824197	PROCEDES DE PREPARATION D'ISOQUINOLINONES ET DE FORMES SOLIDES D'ISOQUINOLINONES (PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES)
Taiwan	201906841	Processes for preparing isoquinolinones and solid forms of isoquinolinones
Singapore	191897	PROCESSES FOR PREPARING ISOQUINOLINONES AND SOLID FORMS OF ISOQUINOLINONES
South Korea	20140020249	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	132021000000173	Italy		PRODUCT NAME: DUVELISIB(COPIKTRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1542, 20210521
2456444	2021C/546	Belgium		PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU/1/21/1542/001-002 20210521
2456444	46/2021	Austria		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 (MITTEILUNG) 20210521
2456444	CA 2021 00045	Denmark		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	PA2021526	Lithuania		PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519