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Last Updated: February 28, 2024

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
Drug Prices for ORLADEYO

See drug prices for ORLADEYO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ORLADEYO
Generic Entry Date for ORLADEYO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
BioCryst PharmaceuticalsPhase 3

See all ORLADEYO clinical trials

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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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


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


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 19374115
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2021008249
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 17123
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 21001094
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2969458
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 21007172
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 2191192
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 73463
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2454
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 22505670
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 21004917
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 087
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 211280
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 021550883
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 202103804T
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 210087037
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 2031255
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 438
Estimated Expiration: ⤷  Try a Trial

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
South Korea 20160130254 인간 혈장 칼리크레인 저해제 (HUMAN PLASMA KALLIKREIN INHIBITORS) ⤷  Try a Trial
Singapore 11201607267S HUMAN PLASMA KALLIKREIN INHIBITORS ⤷  Try a Trial
Mexico 2016011468 INHIBIDORES DE CALICREÍNA PLASMÁTICA HUMANA. (HUMAN PLASMA KALLIKREIN INHIBITORS.) ⤷  Try a Trial
Mexico 2020013059 INHIBIDORES DE CALICREINA PLASMATICA HUMANA. (HUMAN PLASMA KALLIKREIN INHIBITORS.) ⤷  Try a Trial
Australia 2022259742 Human plasma kallikrein inhibitors ⤷  Try a Trial
Argentina 116951 SALES CRISTALINAS DE UN INHIBIDOR DE CALICREÍNA PLASMÁTICA ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ORLADEYO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3113772 PA2021524,C3113772 Lithuania ⤷  Try a Trial PRODUCT NAME: BEROTRALSTATAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772 122021000062 Germany ⤷  Try a Trial PRODUCT NAME: BEROTRALSTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772 CA 2021 00040 Denmark ⤷  Try a Trial PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504
3113772 C202130056 Spain ⤷  Try a Trial 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 21C1048 France ⤷  Try a Trial PRODUCT NAME: BEROTRALSTAT ET SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; REGISTRATION NO/DATE: EU/1/21/1544 20210504
3113772 CR 2021 00040 Denmark ⤷  Try a Trial PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.