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ORLADEYO Drug Patent Profile

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Which patents cover Orladeyo, and what generic alternatives are available?

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

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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

Drug patent expirations by year for ORLADEYO

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

Generic Entry Date for ORLADEYO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

US Patents and Regulatory Information for ORLADEYO

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORLADEYO is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Human plasma kallikrein inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Human plasma kallikrein inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Crystalline salts of a plasma kallikrein inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

FDA Regulatory Exclusivity protecting ORLADEYO

PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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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	214094-002	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				⤷ 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 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

Patent: 6951
Patent: SALES CRISTALINAS DE UN INHIBIDOR DE CALICREÍNA PLASMÁTICA
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 19374115
Patent: Crystalline salts of a plasma kallikrein inhibitor
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2021008249
Patent: sais cristalinos de um inibidor de calicreína plasmática
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 17123
Patent: SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICREINE PLASMATIQUE (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR)
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 21001094
Patent: Sales cristalinas de un inhibidor de calicreína plasmática
Estimated Expiration: ⤷ Sign Up

China

Patent: 2969458
Patent: 血浆激肽释放酶抑制剂的结晶盐 (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR)
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 21007172
Patent: Sales cristalinas de un inhibidor de calicreína plasmática
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 2191192
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛИ ИНГИБИТОРА ПЛАЗМЕННОГО КАЛЛИКРЕИНА
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 73463
Patent: SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICRÉINE PLASMATIQUE (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR)
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 2454
Patent: מלחים גבישיים של מעכב פלזמה קאליקרין (Crystalline salts of a plasma kallikrein inhibitor)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 22505670
Patent: 血漿カリクレイン阻害剤の結晶塩
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 21004917
Patent: SALES CRISTALINAS DE UN INHIBIDOR DE CALICREINA PLASMATICA. (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR.)
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 087
Patent: SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICRÉINE PLASMATIQUE
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 211280
Patent: SALES CRISTALINAS DE UN INHIBIDOR DE CALICREINA PLASMATICA
Estimated Expiration: ⤷ Sign Up

Philippines

Patent: 021550883
Patent: CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 202103804T
Patent: CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 210087037
Patent: 혈장 칼리크레인 억제제의 결정성 염
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 2031255
Patent: Crystalline salts of a plasma kallikrein inhibitor
Estimated Expiration: ⤷ Sign Up

Uruguay

Patent: 438
Patent: SALES CRISTALINAS DE UN INHIBIDOR DE CALICREÍNA PLASMÁTICA
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Uruguay	38438	SALES CRISTALINAS DE UN INHIBIDOR DE CALICREÍNA PLASMÁTICA	⤷ Sign Up
Poland	3828173		⤷ Sign Up
Philippines	12021550883	CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR	⤷ Sign Up
Philippines	12016501750	HUMAN PLASMA KALLIKREIN INHIBITORS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ORLADEYO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3113772	2021C/544	Belgium	⤷ Sign Up	PRODUCT NAME: BEROTRALSTAT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1544/001 ET 002 20210504
3113772	21C1048	France	⤷ Sign Up	PRODUCT NAME: BEROTRALSTAT ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1544 20210504
3113772	CR 2021 00040	Denmark	⤷ Sign Up	PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504
3113772	C202130056	Spain	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description