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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.
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 |
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 |
|---|---|
| Takeda | Phase 1 |
| University of California, San Francisco | Phase 1 |
| Array BioPharma | Phase 1 |
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 | 208772-002 | 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 |
International Patents for ALUNBRIG
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2010012703 | Start Trial |
| South Korea | 20110010801 | Start Trial |
| China | 102105150 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
