ORLADEYO Drug Patent Profile
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Which patents cover Orladeyo, and when can generic versions of Orladeyo launch?
Orladeyo is a drug marketed by Biocryst and is included in one NDA. There are eight patents protecting this drug.
This drug has eighty-one 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: | 81 |
| 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
*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
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-002 | Dec 3, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Biocryst | ORLADEYO | berotralstat hydrochloride | CAPSULE;ORAL | 214094-001 | Dec 3, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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: ⤷ Sign Up
Australia
Patent: 19374115
Patent: Crystalline salts of a plasma kallikrein inhibitor
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2021008249
Patent: sais cristalinos de um inibidor de calicreína plasmática
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 17123
Patent: SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICREINE PLASMATIQUE (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 21001094
Patent: Sales cristalinas de un inhibidor de calicreína plasmática
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Colombia
Patent: 21007172
Patent: Sales cristalinas de un inhibidor de calicreína plasmática
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2191192
Patent: КРИСТАЛЛИЧЕСКИЕ СОЛИ ИНГИБИТОРА ПЛАЗМЕННОГО КАЛЛИКРЕИНА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 73463
Patent: SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICRÉINE PLASMATIQUE (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 2454
Patent: מלחים גבישיים של מעכב פלזמה קאליקרין (Crystalline salts of a plasma kallikrein inhibitor)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 22505670
Patent: 血漿カリクレイン阻害剤の結晶塩
Estimated Expiration: ⤷ Sign Up
Patent: 24109860
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 21004917
Patent: SALES CRISTALINAS DE UN INHIBIDOR DE CALICREINA PLASMATICA. (CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 087
Patent: SELS CRISTALLINS D'UN INHIBITEUR DE LA KALLICRÉINE PLASMATIQUE
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 211280
Patent: SALES CRISTALINAS DE UN INHIBIDOR DE CALICREINA PLASMATICA
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 021550883
Patent: CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202103804T
Patent: CRYSTALLINE SALTS OF A PLASMA KALLIKREIN INHIBITOR
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 210087037
Patent: 혈장 칼리크레인 억제제의 결정성 염
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 2031255
Patent: Crystalline salts of a plasma kallikrein inhibitor
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 438
Patent: SALES CRISTALINAS DE UN INHIBIDOR DE CALICREÍNA PLASMÁTICA
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 |
|---|---|---|---|
| Australia | 2022259742 | ⤷ Sign Up | |
| Eurasian Patent Organization | 036251 | ⤷ Sign Up | |
| Serbia | 61159 | PIRAZOLI SUPSTITUISANI TRIFLUOROMETILOM KAO INHIBITORI HUMANOG KALIKREINA PLAZME (TRIFLUOROMETHYL SUBSTITUTED PYRAZOLES AS 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 | PA2021524,C3113772 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BEROTRALSTATAS IR FARMACINIU POZIURIU PRIIMTINOS JO DRUSKOS ; REGISTRATION NO/DATE: EU/1/21/1544 20210430 |
| 3113772 | C03113772/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BEROTRALSTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68464 07.06.2022 |
| 3113772 | SPC/GB21/061 | United Kingdom | ⤷ Sign Up | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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