COPIKTRA Drug Patent Profile

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. Two suppliers are 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

Summary for COPIKTRA

International Patents:	148
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
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

See drug prices for COPIKTRA

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

NDA:

211155

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

Sponsor	Phase
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 1/Phase 2
Secura Bio, Inc.	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all COPIKTRA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for COPIKTRA

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

US Patents and Regulatory Information for COPIKTRA

COPIKTRA is protected by seven US patents and two FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting COPIKTRA

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

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

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

Australia

Canada

Chile

China

Denmark

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Peru

Philippines

Russian Federation

Singapore

South Africa

South Korea

Spain

Taiwan

Ukraine

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
Hungary	S2100048
San Marino	T201500141	Derivato di adenina come inibitore di pi3k
Japan	2017061547	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)
New Zealand	587004	HETEROCYCLIC CONTAINING ENTITIES, COMPOSITIONS AND METHODS
Mexico	2010007419	CIERTAS ENTIDADES QUIMICAS, COMPOSICIONES Y METODOS. (CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS.)
Mexico	2010007418	CIERTAS ENTIDADES QUIMICAS, COMPOSICIONES Y METODOS. (CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS.)
Mexico	2012000626	DETERMINADAS ENTIDADES, COMPOSICIONES Y MÉTODOS QUÍMICOS. (CERTAIN CHEMICAL ENTITIES, COMPOSITIONS AND METHODS.)

Supplementary Protection Certificates for COPIKTRA

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	CA 2021 00045	Denmark		PRODUCT NAME: DUVELISIB; REG. NO/DATE: EU/1/21/1542 20210521
2456444	PA2021526	Lithuania		PRODUCT NAME: DUVELISIBAS; REGISTRATION NO/DATE: EU/1/21/1542 20210519
2456444	46/2021	Austria		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 (MITTEILUNG) 20210521
2456444	122021000069	Germany		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210519
2456444	301140	Netherlands		PRODUCT NAME: DUVELISIB; REGISTRATION NO/DATE: EU/1/21/1542 20210521