IBRUTINIB - Generic Drug Details

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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 fifty-four 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 ninety-one patent family members in forty-seven 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:	391
US Patents:	54
Tradenames:	2
Applicants:	2
NDAs:	4
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	356
Patent Applications:	6,199
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 Inc.	Phase 2
Merck Sharp & Dohme LLC	Phase 3
Assistance Publique - Hôpitaux de Paris	Phase 2

See all IBRUTINIB clinical trials

Generic filers with tentative approvals for IBRUTINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	140MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	140MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	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

Anatomical Therapeutic Chemical (ATC) Classes for IBRUTINIB

L01EL	Bruton's tyrosine kinase (BTK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	560 mg	210563	1	2018-11-05
IMBRUVICA	Capsules	ibrutinib	140 mg	205552	8	2017-11-13

US Patents and Regulatory Information for IBRUTINIB

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Glossary

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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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Zydus	IBRUTINIB	ibrutinib	CAPSULE;ORAL	211344-002	Mar 31, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for IBRUTINIB

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for IBRUTINIB

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Country	Patent Number	Title	Estimated Expiration
Taiwan	I810588		⤷ Sign Up
Mexico	347525	INHIBIDORES DE TIROSINA CINASA DE BRUTON. (INHIBITORS OF BRUTON'S TYROSINE KINASE.)	⤷ Sign Up
Israel	285843	איברוטיניב לשימוש בטיפול של שתל נגד מחלה פונדקאית כרונית (Ibrutinib for use in the treatment of chronic graft versus host disease)	⤷ Sign Up
South Korea	20090091115	INHIBITORS OF BRUTON'S TYROSINE KINASE	⤷ Sign Up
Mexico	2020004438	EL USO DE INHIBIDORES DE LA TIROSINA QUINASA DE BRUTON (BTK). (THE USE OF INHIBITORS OF BRUTON'S TYROSINE KINASE (BTK).)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for IBRUTINIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2201840	CA 2015 00021	Denmark	⤷ Sign Up	PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141021
2526934	C20160038 00313	Estonia	⤷ Sign Up	PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 30.05.2016
2201840	C 2015 016	Romania	⤷ Sign Up	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	233 5006-2015	Slovakia	⤷ Sign Up	PRODUCT NAME: IBRUTINIB; REGISTRATION NO/DATE: EU/1/14/945 20141023
2529621	PA2017009	Lithuania	⤷ Sign Up	PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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