Berotralstat hydrochloride - Generic Drug Details

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

Sponsor	Phase
Ionis Pharmaceuticals, Inc.	Phase 3
BioCryst Pharmaceuticals	Phase 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
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes				Y
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-002	Dec 3, 2020		RX	Yes	Yes			Y
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No				Y
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No

International Patents for berotralstat hydrochloride

Country	Patent Number	Title	Estimated Expiration
Morocco	54087	SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICRÉINE PLASMATIQUE
Eurasian Patent Organization	036251	ИНГИБИТОРЫ КАЛЛИКРЕИНА ПЛАЗМЫ ЧЕЛОВЕКА (HUMAN PLASMA KALLIKREIN INHIBITORS)
Canada	3117123	SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICREINE PLASMATIQUE (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR)
Denmark	3113772
Australia	2020260400	Human plasma kallikrein inhibitors
Serbia	61159	PIRAZOLI SUPSTITUISANI TRIFLUOROMETILOM KAO INHIBITORI HUMANOG KALIKREINA PLAZME (TRIFLUOROMETHYL SUBSTITUTED PYRAZOLES AS HUMAN PLASMA KALLIKREIN INHIBITORS)
European Patent Office	3828173	PYRAZOLES SUBSTITUÉS EN TANT QU`INHIBITEURS DE LA KALLICRÉINE PLASMATIQUE HUMAINE (SUBSTITUTED PYRAZOLES AS HUMAN PLASMA KALLIKREIN INHIBITORS)

Supplementary Protection Certificates for berotralstat hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3113772	C03113772/01	Switzerland		PRODUCT NAME: BEROTRALSTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68464 07.06.2022
3113772	LUC00233	Luxembourg		PRODUCT NAME: BEROTRALSTAT ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT; AUTHORISATION NUMBER AND DATE: EU/1/21/1544 20210504
3113772	132021000000164	Italy		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		PRODUCT NAME: BEROTRALSTATAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772	CR 2021 00040	Denmark		PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504
3113772	C202130056	Spain		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		PRODUCT NAME: BEROTRALSTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210430