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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Berotralstat hydrochloride has seventy-nine patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for berotralstat hydrochloride
| International Patents: | 79 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 17 |
| Clinical Trials: | 4 |
| Patent Applications: | 5 |
| What excipients (inactive ingredients) are in berotralstat hydrochloride? | berotralstat hydrochloride excipients list |
| DailyMed Link: | berotralstat hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for berotralstat hydrochloride
Generic Entry Date for berotralstat hydrochloride*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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 berotralstat hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ionis Pharmaceuticals, Inc. | Phase 3 |
| BioCryst Pharmaceuticals | Phase 3 |
Pharmacology for berotralstat hydrochloride
| Drug Class | Plasma Kallikrein Inhibitor |
| Mechanism of Action | Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Kallikrein Inhibitors P-Glycoprotein Inhibitors |
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-001 | Dec 3, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-002 | Dec 3, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | Title | Estimated Expiration |
|---|---|---|---|
| Canada | 3164693 | INHIBITEURS DE LA KALLICREINE PLASMATIQUE HUMAINE (HUMAN PLASMA KALLIKREIN INHIBITORS) | ⤷ Try a Trial |
| Netherlands | 301142 | ⤷ Try a Trial | |
| Chile | 2021001094 | Sales cristalinas de un inhibidor de calicreína plasmática | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for berotralstat hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3113772 | 21C1048 | France | ⤷ Try a Trial | PRODUCT NAME: BEROTRALSTAT ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1544 20210504 |
| 3113772 | 2021C/544 | Belgium | ⤷ Try a Trial | PRODUCT NAME: BEROTRALSTAT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1544/001 ET 002 20210504 |
| 3113772 | C03113772/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: BEROTRALSTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68464 07.06.2022 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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