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IMBRUVICA Drug Profile

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When do Imbruvica patents expire, and when can generic versions of Imbruvica launch?

Imbruvica is a drug marketed by Pharmacyclics Inc and is included in two NDAs. There are thirty-nine patents protecting this drug and four Paragraph IV challenges.

This drug has two hundred and ninety-seven patent family members in forty-one countries.

The generic ingredient in IMBRUVICA is ibrutinib. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Imbruvica

A generic version of IMBRUVICA was approved as ibrutinib by ZYDUS on March 31^st, 2021.

Summary for IMBRUVICA

International Patents:	297
US Patents:	39
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	133
Patent Applications:	3,039
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for IMBRUVICA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMBRUVICA
What excipients (inactive ingredients) are in IMBRUVICA?	IMBRUVICA excipients list
DailyMed Link:	IMBRUVICA at DailyMed

See drug prices for IMBRUVICA

Recent Clinical Trials for IMBRUVICA

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1
Bayer	Phase 2
Loxo Oncology, Inc.	Phase 3

See all IMBRUVICA clinical trials

Pharmacology for IMBRUVICA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

ATC Classes for IMBRUVICA

L01EL	Bruton's tyrosine kinase (BTK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IMBRUVICA

Tradename	Dosage	Ingredient	NDA	Submissiondate
IMBRUVICA	TABLET;ORAL	ibrutinib	210563	2018-12-14
IMBRUVICA	CAPSULE;ORAL	ibrutinib	205552	2018-12-14
IMBRUVICA	TABLET;ORAL	ibrutinib	210563	2018-11-05
IMBRUVICA	CAPSULE;ORAL	ibrutinib	205552	2017-11-13

US Patents and Regulatory Information for IMBRUVICA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	No			Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013	AB	RX	Yes	Yes
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No			Y	Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No

International Patents for IMBRUVICA

Country	Patent Number	Estimated Expiration
Israel	223181
Spain	2537399
Ecuador	SP14033163
Poland	2081435

Supplementary Protection Certificates for IMBRUVICA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2526934	93321	Luxembourg		PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/945 - IMBRUVICA - IBRUTINIB
2529621	PA2017009	Lithuania		PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
2201840	18/2015	Austria		PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ; REGISTRATION NO/DATE: EU/1/14/945 20141021
2529621	C20170010 00272	Estonia		PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014