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Last Updated: September 23, 2020

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BRIGATINIB - Generic Drug Details

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What are the generic sources for brigatinib and what is the scope of patent protection?

Brigatinib is the generic ingredient in one branded drug marketed by Ariad and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brigatinib has sixty-seven patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for BRIGATINIB
International Patents:67
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 42
Clinical Trials: 19
Patent Applications: 19
DailyMed Link:BRIGATINIB at DailyMed
Recent Clinical Trials for BRIGATINIB

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

SponsorPhase
TakedaPhase 1/Phase 2
Scott R. Plotkin, MD, PhDPhase 2
The Children's Tumor FoundationPhase 2

See all BRIGATINIB clinical trials

Pharmacology for BRIGATINIB

US Patents and Regulatory Information for BRIGATINIB

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ariad ALUNBRIG brigatinib TABLET;ORAL 208772-002 Apr 28, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Ariad ALUNBRIG brigatinib TABLET;ORAL 208772-002 Apr 28, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Ariad ALUNBRIG brigatinib TABLET;ORAL 208772-003 Oct 2, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ariad ALUNBRIG brigatinib TABLET;ORAL 208772-002 Apr 28, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Ariad ALUNBRIG brigatinib TABLET;ORAL 208772-001 Apr 28, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Ariad ALUNBRIG brigatinib TABLET;ORAL 208772-001 Apr 28, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for BRIGATINIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2300013 19C1033 France   Start Trial PRODUCT NAME: BRIGATINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1264 20181126
2300013 1990030-7 Sweden   Start Trial PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1264 20181126
2300013 300990 Netherlands   Start Trial PRODUCT NAME: BRIGATINIB, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1264 20181126
2300013 LUC00120 Luxembourg   Start Trial PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1264 20181126
2300013 C201930036 Spain   Start Trial PRODUCT NAME: BRIGATINIB, O SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/18/1264; DATE OF AUTHORISATION: 20181122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1264; DATE OF FIRST AUTHORISATION IN EEA: 20181122
2300013 PA2019510 Lithuania   Start Trial PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson

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