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 ⤷ 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 | |||
>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 |
---|---|---|---|
Israel | 247518 | מעכבים לקאליקראין של פלזמה אנושית (Human plasma kallikrein inhibitors) | ⤷ Try a Trial |
Canada | 2941380 | INHIBITEURS DE LA KALLICREINE PLASMATIQUE HUMAINE (HUMAN PLASMA KALLIKREIN INHIBITORS) | ⤷ Try a Trial |
Morocco | 39719 | Pyrazoles substitués par un trifluoromethyle en tant qu`inhibiteurs de la kallicréine plasmatique humaine | ⤷ Try a Trial |
Canada | 3164693 | INHIBITEURS DE LA KALLICREINE PLASMATIQUE HUMAINE (HUMAN PLASMA KALLIKREIN INHIBITORS) | ⤷ 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 | 132021000000164 | Italy | ⤷ Try a Trial | PRODUCT NAME: BEROTRALSTAT E SUOI SALI FARMACEUTICAMENTE ACCETTABILI(ORLADEYO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1544/001-002, 20210504 |
3113772 | 2021C/544 | Belgium | ⤷ Try a Trial | PRODUCT NAME: BEROTRALSTAT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1544/001 ET 002 20210504 |
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 | SPC/GB21/061 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: BEROTRALSTAT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/21/1544(FOR NI) 20210504; UK FURTHER MA ON IPSUM 20210504 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |