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Brigatinib - Generic Drug Details
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What are the generic sources for brigatinib and what is the scope of freedom to operate?
Brigatinib
is the generic ingredient in one branded drug marketed by Ariad and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Brigatinib has seventy-five patent family members in thirty-five countries.
One supplier is listed for this compound.
Summary for brigatinib
| International Patents: | 75 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 46 |
| Clinical Trials: | 21 |
| Patent Applications: | 433 |
| DailyMed Link: | brigatinib at DailyMed |
Recent Clinical Trials for brigatinib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fondazione per la Medicina Personalizzata | Phase 2 |
| Takeda | Phase 1/Phase 2 |
| The Children's Tumor Foundation | Phase 2 |
Pharmacology for brigatinib
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Tyrosine Kinase Inhibitors Cytochrome P450 3A Inducers |
US Patents and Regulatory Information for brigatinib
| 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 | Y | Start Trial | |||
| Ariad | ALUNBRIG | brigatinib | TABLET;ORAL | 208772-003 | Oct 2, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Ariad | ALUNBRIG | brigatinib | TABLET;ORAL | 208772-002 | 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 | Y | 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 brigatinib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2010012703 | Start Trial |
| Japan | 2019094344 | Start Trial |
| Denmark | 2300013 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009143389 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for brigatinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2300013 | LUC00120 | Luxembourg | Start Trial | PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1264 20181126 |
| 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 | C20190026 00287 | Estonia | Start Trial | PRODUCT NAME: BRIGATINIIB;REG NO/DATE: EU/1/18/1264 26.11.2018 |
| 2300013 | 19C1033 | France | Start Trial | PRODUCT NAME: BRIGATINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/18/1264 20181126 |
| >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.
ISSN: 2162-2639
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