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Belinostat - Generic Drug Details
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What are the generic sources for belinostat and what is the scope of patent protection?
Belinostat
is the generic ingredient in one branded drug marketed by Acrotech and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Belinostat has fifty-nine patent family members in twenty-seven countries.
There are five drug master file entries for belinostat.
Summary for belinostat
| International Patents: | 59 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 5 |
| Bulk Api Vendors: | 101 |
| Clinical Trials: | 50 |
| Patent Applications: | 2,059 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for belinostat |
| DailyMed Link: | belinostat at DailyMed |
Recent Clinical Trials for belinostat
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 1 |
| University of Michigan Rogel Cancer Center | Phase 1 |
| Acrotech Biopharma | Phase 1 |
Paragraph IV (Patent) Challenges for BELINOSTAT
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| BELEODAQ | POWDER;INTRAVENOUS | belinostat | 206256 | 2018-07-03 |
US Patents and Regulatory Information for belinostat
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acrotech | BELEODAQ | belinostat | POWDER;INTRAVENOUS | 206256-001 | Jul 3, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Acrotech | BELEODAQ | belinostat | POWDER;INTRAVENOUS | 206256-001 | Jul 3, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Acrotech | BELEODAQ | belinostat | POWDER;INTRAVENOUS | 206256-001 | Jul 3, 2014 | RX | Yes | Yes | 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 belinostat
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 201370122 | Start Trial |
| Poland | 1901729 | Start Trial |
| European Patent Office | 2494969 | Start Trial |
| New Zealand | 525439 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
