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
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 |
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 |
Pharmacology for ORLADEYO
Anatomical Therapeutic Chemical (ATC) Classes for ORLADEYO
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
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
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
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
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
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: ⤷ Sign Up
Australia
Patent: 19374115
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2021008249
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 17123
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 21001094
Estimated Expiration: ⤷ Sign Up
China
Patent: 2969458
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 21007172
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2191192
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 73463
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 2454
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 22505670
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 21004917
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 087
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 211280
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 021550883
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202103804T
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 210087037
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 2031255
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 438
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 282454 | מלחים גבישיים של מעכב פלזמה קאליקרין (Crystalline salts of a plasma kallikrein inhibitor) | ⤷ Sign Up |
Uruguay | 38438 | SALES CRISTALINAS DE UN INHIBIDOR DE CALICREÍNA PLASMÁTICA | ⤷ Sign Up |
Hungary | E060660 | ⤷ Sign Up | |
Brazil | 112016020199 | Composto inibidor de calicreína plasmática de humano, composição farmacêutica compreendendo o referido composto, kit e seu uso | ⤷ Sign Up |
South Korea | 20230042384 | 인간 혈장 칼리크레인 저해제 (HUMAN PLASMA KALLIKREIN INHIBITORS) | ⤷ Sign Up |
New Zealand | 724250 | Human plasma kallikrein inhibitors | ⤷ Sign Up |
Israel | 280785 | מעכבים לקאליקראין של פלזמה אנושית (Human plasma kallikrein inhibitors) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ORLADEYO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3113772 | 42/2021 | Austria | ⤷ Sign Up | PRODUCT NAME: BEROTRALSTAT UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210504 |
3113772 | PA2021524 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BEROTRALSTATAS IR JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430 |
3113772 | 301142 | Netherlands | ⤷ Sign Up | PRODUCT NAME: BEROTRALSTAT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION 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 |
3113772 | C03113772/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BEROTRALSTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68464 07.06.2022 |
3113772 | PA2021524,C3113772 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BEROTRALSTATAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430 |
3113772 | 122021000062 | Germany | ⤷ Sign Up | PRODUCT NAME: BEROTRALSTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1544 20210430 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |