IMBRUVICA Drug Patent Profile

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

Imbruvica is a drug marketed by Pharmacyclics Llc and is included in three NDAs. There are forty-one patents protecting this drug and four Paragraph IV challenges.

This drug has three hundred and sixty-four patent family members in forty-three 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^® Generic Entry Outlook for Imbruvica

Imbruvica was eligible for patent challenges on November 13, 2017.

There have been twelve patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are six tentative approvals for the generic drug (ibrutinib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for IMBRUVICA

International Patents:	364
US Patents:	41
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	151
Patent Applications:	491
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
Peter MacCallum Cancer Centre, Australia	Phase 2
Oncternal Therapeutics, Inc	Phase 3
Academic and Community Cancer Research United	Phase 2

See all IMBRUVICA clinical trials

Pharmacology for IMBRUVICA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (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	Strength	NDA	ANDAs Submitted	Submissiondate
IMBRUVICA	Capsules	ibrutinib	70 mg	205552	1	2018-12-14
IMBRUVICA	Tablets	ibrutinib	280 mg and 420 mg	210563	1	2018-12-14
IMBRUVICA	Tablets	ibrutinib	140 mg and 560 mg	210563	1	2018-11-05
IMBRUVICA	Capsules	ibrutinib	140 mg	205552	8	2017-11-13

US Patents and Regulatory Information for IMBRUVICA

IMBRUVICA is protected by forty-four US patents and twelve FDA Regulatory Exclusivities.

Patents protecting IMBRUVICA

FDA Regulatory Exclusivity protecting IMBRUVICA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	No
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No					Y

EU/EMA Drug Approvals for IMBRUVICA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Imbruvica	ibrutinib	EMEA/H/C/003791 IMBRUVICA as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).IMBRUVICA as a single agent or in combination with rituximab or obinutuzumab or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.	Authorised	no	no	no	2014-10-21

International Patents for IMBRUVICA

When does loss-of-exclusivity occur for IMBRUVICA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Israel

Japan

Jordan

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Russian Federation

Singapore

South Africa

South Korea

Taiwan

Tunisia

Ukraine

Uruguay

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 IMBRUVICA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2020202752	The use of inhibitors of Bruton's tyrosine kinase (Btk)
Israel	282367	צורות גבישיות של מעכב ברוטון טירוסין קינאז (Crystalline forms of a bruton's tyrosine kinase inhibitor)
Australia	2022202686	Methods of treating and preventing graft versus host disease
Mexico	2016005294	METODOS PARA TRATAR Y PREVENIR ENFERMEDAD INJERTO CONTRA HUÉSPED. (METHODS OF TREATING AND PREVENTING GRAFT VERSUS HOST DISEASE.)
Denmark	2526933
Eurasian Patent Organization	201000599	ИНГИБИТОРЫ ТИРОЗИНКИНАЗЫ БРУТОНА
Israel	223181	(r)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin 1-yl)prop-2-en-1-one for use as a medicament for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma

Supplementary Protection Certificates for IMBRUVICA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2526934	CA 2016 00056	Denmark		PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530
2526934	300844	Netherlands		PRODUCT NAME: IBRUTINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 - C(2016)3293 20160530
2201840	C 2015 016	Romania		PRODUCT NAME: IBRUTINIB SAU O SARE FARMACEUTIC ACCEPTABILA A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/945; DATE OF NATIONAL AUTHORISATION: 20141021; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/945; DATE OF FIRST AUTHORISATION IN EEA: 20141021
2201840	15C0029	France		PRODUCT NAME: IBRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/14/945 20141023
2529621	CA 2017 00012	Denmark		PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2015)4704 20150707
2201840	18/2015	Austria		PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840	122015000027	Germany		PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20141021