IBRUTINIB - Generic Drug Details

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

Ibrutinib is the generic ingredient in two branded drugs marketed by Zydus and Pharmacyclics Llc, and is included in four NDAs. There are forty-one patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ibrutinib has three hundred and eighty-one patent family members in forty-five countries.

There are sixteen drug master file entries for ibrutinib. One supplier is listed for this compound. There are six tentative approvals for this compound.

Summary for IBRUTINIB

International Patents:	381
US Patents:	41
Tradenames:	2
Applicants:	2
NDAs:	4
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	351
Patent Applications:	677
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for IBRUTINIB
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IBRUTINIB
What excipients (inactive ingredients) are in IBRUTINIB?	IBRUTINIB excipients list
DailyMed Link:	IBRUTINIB at DailyMed

See drug prices for IBRUTINIB

Recent Clinical Trials for IBRUTINIB

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

Sponsor	Phase
Pharmacyclics LLC.	Phase 2/Phase 3
Janssen Research & Development, LLC	Phase 2/Phase 3
LanZhou University	Phase 2

See all IBRUTINIB clinical trials

Generic filers with tentative approvals for IBRUTINIB

Applicant	Application No.	Strength	Dosage Form
		140MG	CAPSULE;ORAL
		140MG	CAPSULE;ORAL
		560MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for IBRUTINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for IBRUTINIB

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 IBRUTINIB

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	TABLET;ORAL	210563-004	Feb 16, 2018		DISCN	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-004	Feb 16, 2018		DISCN	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes					Y

EU/EMA Drug Approvals for IBRUTINIB

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 IBRUTINIB

Country	Patent Number	Title	Estimated Expiration
South Korea	20220093389	브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Uruguay	39740	FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Japan	6376416
Australia	2018211201	Crystalline forms of a Bruton's tyrosine kinase inhibitor
Mexico	2021009400	USO DE IBRUTINIB EN EL TRATAMIENTO DE ENFERMEDAD INJERTO CONTRA HUESPED CRONICA. (METHODS OF TREATING AND PREVENTING GRAFT VERSUS HOST DISEASE.)
Japan	2023162162	ブルトン型チロシンキナーゼ阻害剤の結晶形態 (CRYSTALLINE FORMS OF BRUTON TYROSINE KINASE INHIBITOR)

Supplementary Protection Certificates for IBRUTINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2529621	PA2017009	Lithuania		PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
2526934	300844	Netherlands		PRODUCT NAME: IBRUTINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 - C(2016)3293 20160530
2201840	15C0029	France		PRODUCT NAME: IBRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/14/945 20141023
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	C20150014 00145	Estonia		PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014