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Last Updated: May 20, 2022

ALUNBRIG Drug Patent Profile


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

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

This drug has eighty-four patent family members in thirty-seven countries.

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

DrugPatentWatch® Generic Entry Outlook for Alunbrig

Alunbrig was eligible for patent challenges on April 28, 2021.

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
International Patents:84
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 54
Clinical Trials: 10
Patent Applications: 548
Drug Prices: Drug price information for ALUNBRIG
What excipients (inactive ingredients) are in ALUNBRIG?ALUNBRIG excipients list
DailyMed Link:ALUNBRIG at DailyMed
Drug patent expirations by year for ALUNBRIG
Drug Prices for ALUNBRIG

See drug prices for ALUNBRIG

DrugPatentWatch® Estimated 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
Intergroupe Francophone de Cancerologie ThoraciquePhase 2
Princess Maxima Center for Pediatric OncologyPhase 1/Phase 2
TakedaPhase 1/Phase 2

See all ALUNBRIG clinical trials

Pharmacology for ALUNBRIG

US Patents and Regulatory Information for ALUNBRIG

ALUNBRIG is protected by four US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ALUNBRIG is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ALUNBRIG

Crystalline forms of 5-chloro-N4-[-2-(dimethylphosphoryl)phenyl]-N2-{2-methoxy-4-[4-(4-methylp- iperazin-1-YL) piperidin-1-YL]phenyl}pyrimidine-2,4-diamine
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)

Phosphorous derivatives as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Phosphorus derivatives as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)

Methods for inhibiting cell proliferation in ALK-driven cancers
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC)

FDA Regulatory Exclusivity protecting ALUNBRIG

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB
Exclusivity Expiration: See Plans and Pricing

FOR THE TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA-APPROVED TEST, NOT INCLUDING PATIENTS WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB
Exclusivity Expiration: See Plans and Pricing

EXPANDED INDICATION OF THE TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: 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
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-001 Apr 28, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-003 Oct 2, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-003 Oct 2, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-001 Apr 28, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-001 Apr 28, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa ALUNBRIG brigatinib TABLET;ORAL 208772-002 Apr 28, 2017 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

International Patents for ALUNBRIG

When does loss-of-exclusivity occur for ALUNBRIG?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 15335950
Estimated Expiration: See Plans and Pricing

Canada

Patent: 65169
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17000979
Estimated Expiration: See Plans and Pricing

China

Patent: 7108559
Estimated Expiration: See Plans and Pricing

Patent: 1825717
Estimated Expiration: See Plans and Pricing

Patent: 1888368
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17004714
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 170146
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0201343
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 09647
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 017000101
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 17030878
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5145
Estimated Expiration: See Plans and Pricing

Patent: 1790892
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 09647
Estimated Expiration: See Plans and Pricing

Patent: 60618
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 51693
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1818
Estimated Expiration: See Plans and Pricing

Patent: 9910
Estimated Expiration: See Plans and Pricing

Japan

Patent: 33072
Estimated Expiration: See Plans and Pricing

Patent: 17535538
Estimated Expiration: See Plans and Pricing

Patent: 20063276
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 09647
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17005120
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0940
Estimated Expiration: See Plans and Pricing

Peru

Patent: 171344
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 017500732
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 09647
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 737
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201702980Q
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 09647
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1702737
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2331856
Estimated Expiration: See Plans and Pricing

Patent: 170072905
Estimated Expiration: See Plans and Pricing

Patent: 210142781
Estimated Expiration: See Plans and Pricing

Spain

Patent: 13726
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 17000157
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 9794
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ALUNBRIG around the world.

Country Patent Number Title Estimated Expiration
Mexico 2017005120 FORMAS CRISTALINAS DE 5-CLORO-N4-[-2-(DIMETILFOSFORIL) FENIL]-N2-{2-METOXI-4-[4-(4-METILPIPERAZIN-1-IL)PIPERIDIN-1-IL] PIRIMIDIN-2,4-DIAMINA. (CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL) PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL) PIPERIDIN-1-YL] PYRIMIDINE-2,4-DIAMINE.) See Plans and Pricing
Peru 20171344 FORMAS CRISTALINAS DE 5-CLORO-N4-[2-(DIMETILFOSFORIL)FENIL]-N2-{2-METOXI-4-[4-(4-METILPIPERAZIN-1-IL)PIPERIDIN-1-IL]PIRIMIDINA-2,4-DIAMINA See Plans and Pricing
South Korea 20180014882 키나아제 억제제로서 포스포러스 유도체 (PHOSPHOROUS DERIVATIVES AS KINASE INHIBITORS) See Plans and Pricing
Slovenia 2300013 See Plans and Pricing
Norway 2300013 See Plans and Pricing
Eurasian Patent Organization 035145 КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 5-ХЛОР-N4-[2-(ДИМЕТИЛФОСФОРИЛ)ФЕНИЛ]-N2-{2-МЕТОКСИ-4-[4-(4-МЕТИЛПИПЕРАЗИН-1-ИЛ)ПИПЕРИДИН-1-ИЛ]ФЕНИЛ}ПИРИМИДИН-2,4-ДИАМИНА (CRYSTALLINE FORMS OF 5-CHLORO-N4-[-2-(DIMETHYLPHOSPHORYL)PHENYL]-N2-{2-METHOXY-4-[4-(4-METHYLPIPERAZIN-1-YL)PIPERIDIN-1-YL]PYRIMIDINE-2,4-DIAMINE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALUNBRIG

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2300013 31/2019 Austria See Plans and Pricing PRODUCT NAME: BRIGATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1264 (MITTEILUNG) 20181126
2300013 2019024 Norway See Plans and Pricing PRODUCT NAME: BRIGATINIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/18/1264 20181218
2300013 2019C/525 Belgium See Plans and Pricing DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2300013 19C1033 France See Plans and Pricing PRODUCT NAME: BRIGATINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1264 20181126
2300013 363 50014-2019 Slovakia See Plans and Pricing PRODUCT NAME: BRIGATINIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1264/001 - EU/1/18/1264/012 20181126
2300013 C201930036 Spain See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.