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Last Updated: February 4, 2023

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 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 fifty-three 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.

Recent Clinical Trials for ibrutinib

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

SponsorPhase
Janssen Research & Development, LLCPhase 2/Phase 3
Pharmacyclics LLC.Phase 2/Phase 3
Beigene (Beijing) Biotechnology Co., LtdPhase 2

See all ibrutinib clinical trials

Generic filers with tentative approvals for IBRUTINIB
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing140MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing140MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing560MGTABLET;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 ClassKinase 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 210563-001 Feb 16, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib SUSPENSION;ORAL 217003-001 Aug 24, 2022 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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

Supplementary Protection Certificates for ibrutinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2201840 233 5006-2015 Slovakia See Plans and Pricing PRODUCT NAME: IBRUTINIB; REGISTRATION NO/DATE: EU/1/14/945 20141023
2526934 122016000093 Germany See Plans and Pricing PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20160526
2529621 CA 2017 00012 Denmark See Plans and Pricing PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2015)4704 20150707
2201840 92692 Luxembourg See Plans and Pricing PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023
2526934 CA 2016 00056 Denmark See Plans and Pricing PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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