~ Buy the ORLADEYO (berotralstat hydrochloride) Drug Profile, 2024 PDF Report in the Report Store ~

ORLADEYO Drug Patent Profile

Which patents cover Orladeyo, and when can generic versions of Orladeyo launch?

Orladeyo is a drug marketed by Biocryst and is included in one NDA. There are eight patents protecting this drug.

This drug has seventy-nine patent family members in thirty-four countries.

The generic ingredient in ORLADEYO is berotralstat hydrochloride. One supplier is listed for this compound. Additional details are available on the berotralstat hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Orladeyo

Orladeyo will be eligible for patent challenges on December 3, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 1, 2039. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ORLADEYO

International Patents:	79
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	1
Patent Applications:	3
Drug Prices:	Drug price information for ORLADEYO
What excipients (inactive ingredients) are in ORLADEYO?	ORLADEYO excipients list
DailyMed Link:	ORLADEYO at DailyMed

See drug prices for ORLADEYO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ORLADEYO

NDA:

214094

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 ORLADEYO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
BioCryst Pharmaceuticals	Phase 3

See all ORLADEYO clinical trials

Pharmacology for ORLADEYO

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 ORLADEYO

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 ORLADEYO

ORLADEYO is protected by eight US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ORLADEYO

FDA Regulatory Exclusivity protecting ORLADEYO

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

International Patents for ORLADEYO

When does loss-of-exclusivity occur for ORLADEYO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Morocco

Peru

Philippines

Singapore

South Korea

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ORLADEYO around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2932406
Eurasian Patent Organization	202191192	КРИСТАЛЛИЧЕСКИЕ СОЛИ ИНГИБИТОРА ПЛАЗМЕННОГО КАЛЛИКРЕИНА
Eurasian Patent Organization	202091668	ИНГИБИТОРЫ КАЛЛИКРЕИНА ПЛАЗМЫ ЧЕЛОВЕКА
Peru	20211280	SALES CRISTALINAS DE UN INHIBIDOR DE CALICREINA PLASMATICA
Hungary	E060660

Supplementary Protection Certificates for ORLADEYO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2190040-2	Sweden		PRODUCT NAME: BEROTRALSTAT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/21/1544 20210504
3113772	CR 2021 00040	Denmark		PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504
3113772	PA2021524,C3113772	Lithuania		PRODUCT NAME: BEROTRALSTATAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430
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