Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Johnson and Johnson
Moodys
Boehringer Ingelheim
Baxter

Last Updated: December 2, 2022

Berotralstat hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Berotralstat hydrochloride has sixty patent family members in thirty-one countries.

Summary for berotralstat hydrochloride
International Patents:60
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 4
What excipients (inactive ingredients) are in berotralstat hydrochloride?berotralstat hydrochloride excipients list
DailyMed Link:berotralstat hydrochloride at DailyMed
Recent Clinical Trials for berotralstat hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ionis Pharmaceuticals, Inc.Phase 3
BioCryst PharmaceuticalsPhase 3

See all berotralstat hydrochloride clinical trials

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Morocco 54087 SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICRÉINE PLASMATIQUE See Plans and Pricing
Eurasian Patent Organization 036251 ИНГИБИТОРЫ КАЛЛИКРЕИНА ПЛАЗМЫ ЧЕЛОВЕКА (HUMAN PLASMA KALLIKREIN INHIBITORS) See Plans and Pricing
Canada 3117123 SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICREINE PLASMATIQUE (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR) See Plans and Pricing
Denmark 3113772 See Plans and Pricing
Australia 2020260400 Human plasma kallikrein inhibitors See Plans and Pricing
Serbia 61159 PIRAZOLI SUPSTITUISANI TRIFLUOROMETILOM KAO INHIBITORI HUMANOG KALIKREINA PLAZME (TRIFLUOROMETHYL SUBSTITUTED PYRAZOLES AS HUMAN PLASMA KALLIKREIN INHIBITORS) See Plans and Pricing
European Patent Office 3828173 PYRAZOLES SUBSTITUÉS EN TANT QU`INHIBITEURS DE LA KALLICRÉINE PLASMATIQUE HUMAINE (SUBSTITUTED PYRAZOLES AS HUMAN PLASMA KALLIKREIN INHIBITORS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for berotralstat hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3113772 C03113772/01 Switzerland See Plans and Pricing PRODUCT NAME: BEROTRALSTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68464 07.06.2022
3113772 LUC00233 Luxembourg See Plans and Pricing PRODUCT NAME: BEROTRALSTAT ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT; AUTHORISATION NUMBER AND DATE: EU/1/21/1544 20210504
3113772 132021000000164 Italy See Plans and Pricing PRODUCT NAME: BEROTRALSTAT E SUOI SALI FARMACEUTICAMENTE ACCETTABILI(ORLADEYO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1544/001-002, 20210504
3113772 PA2021524 Lithuania See Plans and Pricing PRODUCT NAME: BEROTRALSTATAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772 CR 2021 00040 Denmark See Plans and Pricing PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504
3113772 C202130056 Spain See Plans and Pricing PRODUCT NAME: BEROTRALSTAT Y SALES FARMACEUTICAMENTE ACEPTABLES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1544; DATE OF AUTHORISATION: 20210430; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1544; DATE OF FIRST AUTHORISATION IN EEA: 20210430
3113772 122021000062 Germany See Plans and Pricing PRODUCT NAME: BEROTRALSTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210430
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Mallinckrodt
Merck
McKesson
Medtronic

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.