Ibrutinib - Generic Drug Details

What are the generic drug 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 Inc, and is included in four NDAs. There are fifty-five 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 forty-nine patent family members in forty-three countries.

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

Summary for ibrutinib

International Patents:	349
US Patents:	55
Tradenames:	2
Applicants:	2
NDAs:	4
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	347
Patent Applications:	620
Formulation / Manufacturing:	see details
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

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
Oncternal Therapeutics, Inc	Phase 3

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 Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No					Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes					Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes					Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No					Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	No					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
Mexico	2012014049	EL USO DE INHIBIDORES DE LA TIROSINA QUINASA DE BRUTON (BTK). (THE USE OF INHIBITORS OF BRUTON'S TYROSINE KINASE (BTK).)
Philippines	12021550758	THE USE OF INHIBITORS OF BRUTON`S TYROSINE KINASE (BTK)
Singapore	10202102078V	PHARMACEUTICAL FORMULATIONS OF A BRUTON’S TYROSINE KINASE INHIBITOR
European Patent Office	2081435	INHIBITEURS DE LA TYROSINE KINASE DE BRUTON (INHIBITORS OF BRUTON'S TYROSINE KINASE)
Mexico	347525	INHIBIDORES DE TIROSINA CINASA DE BRUTON. (INHIBITORS OF BRUTON'S TYROSINE KINASE.)
Poland	2526771
Dominican Republic	P2014000274	FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON

Supplementary Protection Certificates for ibrutinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2526934	PA2016034	Lithuania		PRODUCT NAME: IBRUTINIBAS ARBA FARMACISKAI PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2016)3293 20160526
2529621	C20170010 00272	Estonia		PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
2526934	93321	Luxembourg		PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/945 - IMBRUVICA - IBRUTINIB
2201840	92692	Luxembourg		PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023
2529621	132017000036530	Italy		PRODUCT NAME: IBRUTINIB O SUO SALE FARMACEUTICAMENTE ACCETTABILE(IMBRUVICA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/4/945, 20150707
2201840	CA 2015 00021	Denmark		PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141021
2201840	15C0029	France		PRODUCT NAME: IBRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/14/945 20141023