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ALUNBRIG Drug Profile
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» See Plans and PricingWhich 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 sixty patent family members in thirty-two 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.
Indicators of Generic Entry
Summary for ALUNBRIG
| International Patents: | 60 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 24 |
| Clinical Trials: | 7 |
| 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 |
|---|---|
| Northwestern University | Phase 1 |
| National Cancer Institute (NCI) | Phase 1 |
| Takeda | 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 | ||||
| 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 | 208772-002 | Apr 28, 2017 | RX | Yes | No | 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 | ||||
| Ariad | ALUNBRIG | brigatinib | TABLET;ORAL | 208772-003 | Oct 2, 2017 | RX | Yes | Yes | 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 |
|---|---|---|
| European Patent Office | 3209647 | Start Trial |
| Canada | 2723961 | Start Trial |
| Spain | 2645689 | Start Trial |
| Lithuania | PA2019510 | Start Trial |
| Cyprus | 1119534 | Start Trial |
| Mexico | 353308 | Start Trial |
| Australia | 2015335950 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ALUNBRIG
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2300013 | 1990030-7 | Sweden | Start Trial | PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1264 20181126 |
| 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 | 122019000046 | Germany | Start Trial | PRODUCT NAME: BRIGATINIB, ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; 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 |
| 2300013 | 31/2019 | Austria | Start Trial | PRODUCT NAME: BRIGATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/18/1264 (MITTEILUNG) 20181126 |
| 2300013 | LUC00120 | Luxembourg | Start Trial | PRODUCT NAME: BRIGATINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/18/1264 20181126 |
| 2300013 | 300990 | Netherlands | Start Trial | PRODUCT NAME: BRIGATINIB, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1264 20181126 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
