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 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
Janssen Research & Development, LLC	Phase 2/Phase 3
Pharmacyclics 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	210563-003	Feb 16, 2018		RX	Yes	Yes					Y
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	205552-002	Dec 20, 2017		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No					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
Japan	5718890
Portugal	2526771
Netherlands	300728
China	106102745	治疗和预防移植物抗宿主病的方法 (Methods of treating and preventing graft versus host disease)
Dominican Republic	P2017000152	FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Taiwan	201402122	Crystalline forms of a Bruton's tyrosine kinase inhibitor
Cyprus	1117897

Supplementary Protection Certificates for IBRUTINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2201840	PA2015017,C2201840	Lithuania		PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 20141021
2526934	C20160038 00313	Estonia		PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 30.05.2016
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	1590021-0	Sweden		PRODUCT NAME: IBRUTINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/14/945 20141023
2201840	122015000027	Germany		PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20141021
2526934	273 5026-2016	Slovakia		PRODUCT NAME: IBRUTINIB VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/945 20160530
2201840	300728	Netherlands		DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), SAMENVOEGEN