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 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

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

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

International Patents for BEROTRALSTAT HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	6915003
European Patent Office	3113772	INHIBITEURS DE LA KALLICRÉINE PLASMATIQUE HUMAINE (HUMAN PLASMA KALLIKREIN INHIBITORS)
Eurasian Patent Organization	036251	ИНГИБИТОРЫ КАЛЛИКРЕИНА ПЛАЗМЫ ЧЕЛОВЕКА (HUMAN PLASMA KALLIKREIN INHIBITORS)
Mexico	2021004917	SALES CRISTALINAS DE UN INHIBIDOR DE CALICREINA PLASMATICA. (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR.)
Israel	247518	מעכבים לקאליקראין של פלזמה אנושית (Human plasma kallikrein inhibitors)
Singapore	11201607267S	HUMAN PLASMA KALLIKREIN INHIBITORS

Supplementary Protection Certificates for BEROTRALSTAT HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3113772	PA2021524,C3113772	Lithuania		PRODUCT NAME: BEROTRALSTATAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772	2021C/544	Belgium		PRODUCT NAME: BEROTRALSTAT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1544/001 ET 002 20210504
3113772	LUC00233	Luxembourg		PRODUCT NAME: BEROTRALSTAT ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT; AUTHORISATION NUMBER AND 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
3113772	2190040-2	Sweden		PRODUCT NAME: BEROTRALSTAT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/21/1544 20210504