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Last Updated: July 2, 2022

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 six patents protecting this drug.

This drug has fifty-eight patent family members in thirty-one countries.

The generic ingredient in ORLADEYO is berotralstat hydrochloride. 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:58
US Patents:6
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 7
Clinical Trials: 1
Patent Applications: 2
What excipients (inactive ingredients) are in ORLADEYO?ORLADEYO excipients list
DailyMed Link:ORLADEYO at DailyMed
Drug patent expirations by year for ORLADEYO
DrugPatentWatch® Estimated Generic Entry Opportunity 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 six US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORLADEYO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIODEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Human plasma kallikrein inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline salts of a plasma kallikrein inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIODEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Human plasma kallikrein inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIODEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Crystalline salts of a plasma kallikrein inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIODEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Human plasma kallikrein inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-001 Dec 3, 2020 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Biocryst ORLADEYO berotralstat hydrochloride CAPSULE;ORAL 214094-002 Dec 3, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 19374115
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2021008249
Estimated Expiration: See Plans and Pricing

Canada

Patent: 17123
Estimated Expiration: See Plans and Pricing

Chile

Patent: 21001094
Estimated Expiration: See Plans and Pricing

China

Patent: 2969458
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 21007172
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2191192
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 73463
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2454
Estimated Expiration: See Plans and Pricing

Japan

Patent: 22505670
Estimated Expiration: See Plans and Pricing

Peru

Patent: 211280
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 021550883
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 202103804T
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 210087037
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 2031255
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 438
Estimated Expiration: See Plans and Pricing

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
Japan 2022505670 血漿カリクレイン阻害剤の結晶塩 See Plans and Pricing
New Zealand 762034 Human plasma kallikrein inhibitors See Plans and Pricing
Japan 6574435 See Plans and Pricing
Japan 6915003 See Plans and Pricing
Singapore 10202001795X HUMAN PLASMA KALLIKREIN INHIBITORS See Plans and Pricing
Morocco 53399 PYRAZOLES SUBSTITUÉS EN TANT QU`INHIBITEURS DE LA KALLICRÉINE PLASMATIQUE HUMAINE See Plans and Pricing
Eurasian Patent Organization 201691803 ИНГИБИТОРЫ КАЛЛИКРЕИНА ПЛАЗМЫ ЧЕЛОВЕКА See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ORLADEYO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3113772 PA2021524 Lithuania See Plans and Pricing PRODUCT NAME: BEROTRALSTATAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430
3113772 CA 2021 00040 Denmark See Plans and Pricing PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504
3113772 LUC00233 Luxembourg See Plans and Pricing PRODUCT NAME: BEROTRALSTAT ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT; AUTHORISATION NUMBER AND DATE: EU/1/21/1544 20210504
3113772 CR 2021 00040 Denmark See Plans and Pricing PRODUCT NAME: BEROTRALSTAT OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/21/1544 20210504
3113772 42/2021 Austria See Plans and Pricing PRODUCT NAME: BEROTRALSTAT UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210504
3113772 132021000000164 Italy See Plans and Pricing PRODUCT NAME: BEROTRALSTAT E SUOI SALI FARMACEUTICAMENTE ACCETTABILI(ORLADEYO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1544/001-002, 20210504
3113772 301142 Netherlands See Plans and Pricing PRODUCT NAME: BEROTRALSTAT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/21/1544 20210504
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
AstraZeneca
Express Scripts
Colorcon
Medtronic

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.