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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 seventy-five patent family members in thirty-five 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 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
Summary for ALUNBRIG
International Patents: | 75 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 45 |
Clinical Trials: | 8 |
Patent Applications: | 292 |
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 |
---|---|
The Children's Tumor Foundation | Phase 2 |
Scott R. Plotkin, MD, PhD | Phase 2 |
Takeda | Phase 2 |
Pharmacology for ALUNBRIG
Drug Class | Kinase Inhibitor |
Mechanism of Action | Tyrosine Kinase Inhibitors Cytochrome P450 3A Inducers |
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 | 208772-003 | Oct 2, 2017 | RX | Yes | Yes | 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 |
International Patents for ALUNBRIG
Country | Patent Number | Estimated Expiration |
---|---|---|
Japan | 2011523646 | Start Trial |
European Patent Office | 3760618 | Start Trial |
Lithuania | 3209647 | Start Trial |
Norway | 2019024 | Start Trial |
Japan | 2017186345 | Start Trial |
>Country | >Patent Number | >Estimated 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 | CA 2019 00028 | Denmark | Start Trial | PRODUCT NAME: BRIGATINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/18/1264 20181126 |
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 | 2019/031 | Ireland | Start Trial | PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/18/1264 20181122 |
2300013 | 2019C/525 | Belgium | Start Trial | PRODUCT NAME: BRIGATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/18/1264 20181126 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |