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Last Updated: January 22, 2020

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ALUNBRIG Drug Profile

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When do Alunbrig patents expire, and when can generic versions of Alunbrig launch?

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

This drug has fifty-seven patent family members in thirty-one countries.

The generic ingredient in ALUNBRIG is brigatinib. Two suppliers are 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.

  Start Trial

Summary for ALUNBRIG
International Patents:57
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 24
Clinical Trials: 6
Drug Prices: Drug price information for ALUNBRIG
DailyMed Link:ALUNBRIG at DailyMed
Drug patent expirations by year for ALUNBRIG
Drug Prices for ALUNBRIG

See drug prices for ALUNBRIG

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
TakedaPhase 1
University of California, San FranciscoPhase 1
Array BioPharmaPhase 1

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
>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 122019000046 Germany   Start Trial PRODUCT NAME: BRIGATINIB, ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013 PA2019510 Lithuania   Start Trial PRODUCT NAME: BRIGATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/18/1264 20181122
2300013 LUC00120 Luxembourg   Start Trial PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1264 20181126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

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McKinsey

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