DUVELISIB - Generic Drug Details

What are the generic drug sources for duvelisib and what is the scope of patent protection?

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
Secura Bio, Inc.	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1
Secura Bio	Early Phase 1

See all DUVELISIB clinical trials

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		DISCN	Yes	No
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		DISCN	Yes	No
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		DISCN	Yes	No
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		DISCN	Yes	No				Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-002	Sep 24, 2018		DISCN	Yes	No			Y	Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		DISCN	Yes	No			Y	Y
Secura	COPIKTRA	duvelisib	CAPSULE;ORAL	211155-001	Sep 24, 2018		DISCN	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
Mexico	351028	DETERMINADADAS ENTIDADES, COMPOSICIONES Y METODOS QUIMICOS. (CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS.)
Israel	242192	חומרים כימיים מסוימים, תכשירים ושיטות (Certain chemical entities, compositions and methods)
Peru	20180318	PROCEDIMIENTO PARA PREPARAR ISOQUINOLINONAS Y FORMAS SOLIDAS DE ISOQUINOLINONAS
European Patent Office	3441392	COMPOSITION PHARMACEUTIQUE POUR ADMINISTRATION ORALE (A PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION)
Japan	2011509259
European Patent Office	2456444	DÉRIVÉ D'ADENINE COMME INHIBITEUR DE PI3K (ADENINE DERIVATIVE AS PI3K INHIBITOR)
Ukraine	109878

Supplementary Protection Certificates for DUVELISIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122021000069	Germany		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210519
2456444	132021000000173	Italy		PRODUCT NAME: DUVELISIB(COPIKTRA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1542, 20210521
2456444	PA2021526	Lithuania		PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519
2456444	LUC00237	Luxembourg		PRODUCT NAME: DUVELISIB; AUTHORISATION NUMBER AND DATE: EU1/21/1542 20210521
2456444	301140	Netherlands		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521