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Last Updated: March 1, 2024

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

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 ⤷  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 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 214094-001 Dec 3, 2020 RX Yes No ⤷  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 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
European Patent Office 3828173 PYRAZOLES SUBSTITUÉS EN TANT QU`INHIBITEURS DE LA KALLICRÉINE PLASMATIQUE HUMAINE (SUBSTITUTED PYRAZOLES AS HUMAN PLASMA KALLIKREIN INHIBITORS) ⤷  Try a Trial
France 21C1048 ⤷  Try a Trial
New Zealand 762034 Human plasma kallikrein inhibitors ⤷  Try a Trial
Peru 20211280 SALES CRISTALINAS DE UN INHIBIDOR DE CALICREINA PLASMATICA ⤷  Try a Trial
Japan 2017507160 ヒト血漿カリクレイン阻害剤 ⤷  Try a Trial
Portugal 3828173 ⤷  Try a Trial
Israel 247518 מעכבים לקאליקראין של פלזמה אנושית (Human plasma kallikrein inhibitors) ⤷  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 LUC00233 Luxembourg ⤷  Try a Trial PRODUCT NAME: BEROTRALSTAT ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT; AUTHORISATION NUMBER AND DATE: EU/1/21/1544 20210504
3113772 42/2021 Austria ⤷  Try a Trial PRODUCT NAME: BEROTRALSTAT UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210504
3113772 301142 Netherlands ⤷  Try a Trial PRODUCT NAME: BEROTRALSTAT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1544 20210504
3113772 CR 2021 00040 Denmark ⤷  Try a Trial PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. 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 C202130056 Spain ⤷  Try a Trial 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 132021000000164 Italy ⤷  Try a Trial PRODUCT NAME: BEROTRALSTAT E SUOI SALI FARMACEUTICAMENTE ACCETTABILI(ORLADEYO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1544/001-002, 20210504
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.