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 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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

See all berotralstat hydrochloride clinical trials

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

B06AC	Drugs used in hereditary angioedema
B06A	OTHER HEMATOLOGICAL AGENTS
B06	OTHER HEMATOLOGICAL AGENTS
B	Blood and blood forming organs

US Patents and Regulatory Information for berotralstat hydrochloride

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Glossary

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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	214094-001	Dec 3, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Country	Patent Number	Title	Estimated Expiration
Lithuania	3113772		⤷ Sign Up
Taiwan	202031255	Crystalline salts of a plasma kallikrein inhibitor	⤷ Sign Up
Australia	2022259742	Human plasma kallikrein inhibitors	⤷ Sign Up
Morocco	54087	SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICRÉINE PLASMATIQUE	⤷ Sign Up
European Patent Office	3113772	INHIBITEURS DE LA KALLICRÉINE PLASMATIQUE HUMAINE (HUMAN PLASMA KALLIKREIN INHIBITORS)	⤷ Sign Up
Japan	6574435		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for berotralstat hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3113772	122021000062	Germany	⤷ Sign Up	PRODUCT NAME: BEROTRALSTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772	CA 2021 00040	Denmark	⤷ Sign Up	PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504
3113772	132021000000164	Italy	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: BEROTRALSTATAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772	PA2021524,C3113772	Lithuania	⤷ Sign Up	PRODUCT NAME: BEROTRALSTATAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772	C03113772/01	Switzerland	⤷ Sign Up	PRODUCT NAME: BEROTRALSTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68464 07.06.2022
>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.