BEROTRALSTAT HYDROCHLORIDE - Generic Drug Details

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What are the generic 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	214094-002	Dec 3, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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		Y		⤷ Sign Up
Biocryst	ORLADEYO	berotralstat hydrochloride	CAPSULE;ORAL	214094-001	Dec 3, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ 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
China	112969458	血浆激肽释放酶抑制剂的结晶盐 (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR)	⤷ Sign Up
Chile	2021001094		⤷ Sign Up
Canada	3164693	INHIBITEURS DE LA KALLICREINE 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	21C1048	France	⤷ Sign Up	PRODUCT NAME: BEROTRALSTAT ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1544 20210504
3113772	LUC00233	Luxembourg	⤷ Sign Up	PRODUCT NAME: BEROTRALSTAT ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT; AUTHORISATION NUMBER AND DATE: EU/1/21/1544 20210504
3113772	C20210031 00416	Estonia	⤷ Sign Up	PRODUCT NAME: BEROTRALSTAAT;REG NO/DATE: EU/1/21/1544 04.05.2021
3113772	PA2021524,C3113772	Lithuania	⤷ Sign Up	PRODUCT NAME: BEROTRALSTATAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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