IBRUTINIB - Generic Drug Details

What are the generic drug sources for ibrutinib and what is the scope of freedom to operate?

Ibrutinib is the generic ingredient in two branded drugs marketed by Zydus and Pharmacyclics Inc, and is included in three NDAs. There are forty 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 thirty-one 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:	331
US Patents:	40
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	344
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
Shayna Sarosiek, MD	Phase 2
ADC Therapeutics	Phase 2
Genmab	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
		140MG	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	TABLET;ORAL	210563-004	Feb 16, 2018		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			Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	No				Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No			Y	Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	No
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No

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 is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).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.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 obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).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
Israel	285843
Israel	239156
Luxembourg	C00011
Philippines	12020500028	CRYSTALLINE FORMS OF A BRUTON`S TYROSINE KINASE INHIBITOR
South Korea	20130086957	THE USE OF INHIBITORS OF BRUTON'S TYROSINE KINASE (BTK)
South Korea	20090091115	INHIBITORS OF BRUTON'S TYROSINE KINASE
Canada	3001152	INHIBITEURS DE LA TYROSINE KINASE DE BRUTON (INHIBITORS OF BRUTON'S TYROSINE KINASE)

Supplementary Protection Certificates for IBRUTINIB

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
2201840	233 5006-2015	Slovakia		PRODUCT NAME: IBRUTINIB; REGISTRATION NO/DATE: EU/1/14/945 20141023
2201840	300728	Netherlands		DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), SAMENVOEGEN
2526934	C20160038 00313	Estonia		PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 30.05.2016