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 nine patents protecting this drug.
This drug has eighty-five patent family members in thirty-six 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 was eligible for patent challenges on December 3, 2024.
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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Questions you can ask:
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Summary for ORLADEYO
International Patents: | 85 |
US Patents: | 9 |
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 |


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
Sponsor | Phase |
---|---|
BioCryst Pharmaceuticals | Phase 3 |
US Patents and Regulatory Information for ORLADEYO
ORLADEYO is protected by nine US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORLADEYO is ⤷ Try for Free.
This potential generic entry date is based on patent 10,662,160.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 11,117,867 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-002 | Dec 3, 2020 | RX | Yes | Yes | 11,618,733 | ⤷ Try for Free | ⤷ Try for Free | ||||
Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-001 | Dec 3, 2020 | RX | Yes | No | 11,618,733 | ⤷ Try for Free | ⤷ Try for Free | ||||
Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-001 | Dec 3, 2020 | RX | Yes | No | 10,125,102 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-002 | Dec 3, 2020 | RX | Yes | Yes | 11,117,867 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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: ⤷ Try for Free
Australia
Patent: 19374115
Patent: Crystalline salts of a plasma kallikrein inhibitor
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2021008249
Patent: sais cristalinos de um inibidor de calicreína plasmática
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 17123
Patent: SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICREINE PLASMATIQUE (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR)
Estimated Expiration: ⤷ Try for Free
Chile
Patent: 21001094
Patent: Sales cristalinas de un inhibidor de calicreína plasmática
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
Colombia
Patent: 21007172
Patent: Sales cristalinas de un inhibidor de calicreína plasmática
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 2191192
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛИ ИНГИБИТОРА ПЛАЗМЕННОГО КАЛЛИКРЕИНА
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 73463
Patent: SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICRÉINE PLASMATIQUE (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR)
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 2454
Patent: מלחים גבישיים של מעכב פלזמה קאליקרין (Crystalline salts of a plasma kallikrein inhibitor)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 22505670
Patent: 血漿カリクレイン阻害剤の結晶塩
Estimated Expiration: ⤷ Try for Free
Patent: 24109860
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 21004917
Patent: SALES CRISTALINAS DE UN INHIBIDOR DE CALICREINA PLASMATICA. (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR.)
Estimated Expiration: ⤷ Try for Free
Morocco
Patent: 087
Patent: SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICRÉINE PLASMATIQUE
Estimated Expiration: ⤷ Try for Free
Peru
Patent: 211280
Patent: SALES CRISTALINAS DE UN INHIBIDOR DE CALICREINA PLASMATICA
Estimated Expiration: ⤷ Try for Free
Philippines
Patent: 021550883
Patent: CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR
Estimated Expiration: ⤷ Try for Free
Singapore
Patent: 202103804T
Patent: CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 210087037
Patent: 혈장 칼리크레인 억제제의 결정성 염
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 2031255
Patent: Crystalline salts of a plasma kallikrein inhibitor
Estimated Expiration: ⤷ Try for Free
Uruguay
Patent: 438
Patent: SALES CRISTALINAS DE UN INHIBIDOR DE CALICREÍNA PLASMÁTICA
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Canada | 2941380 | ⤷ Try for Free | |
South Korea | 102510427 | ⤷ Try for Free | |
Australia | 2015226855 | Human plasma kallikrein inhibitors | ⤷ Try for Free |
Netherlands | 301142 | ⤷ Try for Free | |
Portugal | 3828173 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ORLADEYO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3113772 | C202130056 | Spain | ⤷ Try for Free | 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 | ⤷ Try for Free | PRODUCT NAME: BEROTRALSTAT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/21/1544 20210504 |
3113772 | 42/2021 | Austria | ⤷ Try for Free | PRODUCT NAME: BEROTRALSTAT UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210504 |
3113772 | PA2021524 | Lithuania | ⤷ Try for Free | PRODUCT NAME: BEROTRALSTATAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430 |
3113772 | 2021C/544 | Belgium | ⤷ Try for Free | PRODUCT NAME: BEROTRALSTAT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1544/001 ET 002 20210504 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for ORLADEYO
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