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Berotralstat hydrochloride - Generic Drug Details
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What are the generic drug sources for berotralstat hydrochloride and what is the scope of freedom to operate?
Berotralstat hydrochloride
is the generic ingredient in one branded drug marketed by Biocryst and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Berotralstat hydrochloride has twenty-two patent family members in fifteen countries.
Summary for berotralstat hydrochloride
| International Patents: | 22 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| What excipients (inactive ingredients) are in berotralstat hydrochloride? | berotralstat hydrochloride excipients list |
| DailyMed Link: | berotralstat hydrochloride at DailyMed |
US Patents and Regulatory Information for berotralstat hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-002 | Dec 3, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-002 | Dec 3, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-002 | Dec 3, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-002 | Dec 3, 2020 | 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 berotralstat hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 3113772 | Start Trial |
| China | 106257976 | Start Trial |
| Eurasian Patent Organization | 036251 | Start Trial |
| Japan | 6574435 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
