Berotralstat hydrochloride - Generic Drug Details
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What are the generic drug sources for berotralstat hydrochloride and what is the scope of patent protection?
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 eighty-one patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for berotralstat hydrochloride
International Patents: | 81 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for berotralstat hydrochloride
US Patents and Regulatory Information for berotralstat hydrochloride
International Patents for berotralstat hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Brazil | 112016020199 | Composto inibidor de calicreína plasmática de humano, composição farmacêutica compreendendo o referido composto, kit e seu uso | ⤷ Subscribe |
Australia | 2022259742 | ⤷ Subscribe | |
Peru | 20211280 | ⤷ Subscribe | |
Mexico | 2020013059 | INHIBIDORES DE CALICREINA PLASMATICA HUMANA. (HUMAN PLASMA KALLIKREIN INHIBITORS.) | ⤷ Subscribe |
European Patent Office | 3828173 | PYRAZOLES SUBSTITUÉS EN TANT QU`INHIBITEURS DE LA KALLICRÉINE PLASMATIQUE HUMAINE (SUBSTITUTED PYRAZOLES AS HUMAN PLASMA KALLIKREIN INHIBITORS) | ⤷ Subscribe |
China | 106257976 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for berotralstat hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3113772 | 122021000062 | Germany | ⤷ Subscribe | PRODUCT NAME: BEROTRALSTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210430 |
3113772 | PA2021524,C3113772 | Lithuania | ⤷ Subscribe | PRODUCT NAME: BEROTRALSTATAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430 |
3113772 | 2190040-2 | Sweden | ⤷ Subscribe | PRODUCT NAME: BEROTRALSTAT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/21/1544 20210504 |
3113772 | CA 2021 00040 | Denmark | ⤷ Subscribe | PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504 |
3113772 | PA2021524 | Lithuania | ⤷ Subscribe | PRODUCT NAME: BEROTRALSTATAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430 |
3113772 | C03113772/01 | Switzerland | ⤷ Subscribe | PRODUCT NAME: BEROTRALSTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68464 07.06.2022 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Berotralstat hydrochloride Market Analysis and Financial Projection Experimental
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