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
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 |


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
Sponsor | Phase |
---|---|
Intergroupe Francophone de Cancerologie Thoracique | Phase 2 |
Princess Maxima Center for Pediatric Oncology | Phase 1/Phase 2 |
Takeda | Phase 1/Phase 2 |
Pharmacology for ALUNBRIG
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 3A Inducers Tyrosine Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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
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 |