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Last Updated: August 8, 2020

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ALUNBRIG Drug Profile

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Which patents cover Alunbrig, and what generic alternatives are available?

Alunbrig is a drug marketed by Ariad and is included in one NDA. There are four patents protecting this drug.

This drug has sixty-four patent family members in thirty-three countries.

The generic ingredient in ALUNBRIG is brigatinib. One supplier is listed for this compound. Additional details are available on the brigatinib profile page.

US ANDA Litigation and Generic Entry Outlook for Alunbrig

Alunbrig will be eligible for patent challenges on April 28, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 10, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ALUNBRIG
Drug patent expirations by year for ALUNBRIG
Drug Prices for ALUNBRIG

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Generic Entry Opportunity Date for ALUNBRIG
Generic Entry Date for ALUNBRIG*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ALUNBRIG

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

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

See all ALUNBRIG clinical trials

Pharmacology for ALUNBRIG

US Patents and Regulatory Information for ALUNBRIG

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 208772-001 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   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 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 208772-002 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
>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 ALUNBRIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 19C1033 France   Start Trial PRODUCT NAME: BRIGATINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1264 20181126
2300013 2019C/525 Belgium   Start Trial PRODUCT NAME: BRIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1264 20181126
2300013 CA 2019 00028 Denmark   Start Trial PRODUCT NAME: BRIGATINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/18/1264 20181126
2300013 C20190026 00287 Estonia   Start Trial PRODUCT NAME: BRIGATINIIB;REG NO/DATE: EU/1/18/1264 26.11.2018
2300013 LUC00120 Luxembourg   Start Trial PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1264 20181126
2300013 2019/031 Ireland   Start Trial PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/18/1264 20181122
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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