Generic Orladeyo Availability
Last updated on Apr 10, 2025.
Orladeyo is a brand name of berotralstat, approved by the FDA in the following formulation(s):
ORLADEYO (berotralstat hydrochloride - capsule;oral)
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Manufacturer: BIOCRYST
Approval date: December 3, 2020
Strength(s): EQ 110MG BASE [RLD], EQ 150MG BASE [RLD]
Is there a generic version of Orladeyo available?
No. There is currently no therapeutically equivalent version of Orladeyo available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Orladeyo. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Human plasma kallikrein inhibitors
Patent 10,125,102
Issued: November 13, 2018
Inventor(s): Kotian Pravin L. & Babu Yarlagadda S. & Wu Minwan & Chintareddy Venkat R. & Kumar V. Satish & Zhang Weihe
Assignee(s): BioCryst Pharmaceuticals, Inc.Disclosed are compounds of formula I
Patent expiration dates:
- April 7, 2035✓✓
- April 7, 2035
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Human plasma kallikrein inhibitors
Patent 10,329,260
Issued: June 25, 2019
Inventor(s): Kotian Pravin L. & Babu Yarlagadda S. & Wu Minwan & Chintareddy Venkat R. & Kumar V. Satish & Zhang Weihe
Assignee(s): BioCryst Pharmaceuticals, Inc.Disclosed are compounds of formula I
Patent expiration dates:
- March 9, 2035✓
- March 9, 2035
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Crystalline salts of a plasma kallikrein inhibitor
Patent 10,662,160
Issued: May 26, 2020
Inventor(s): El-Kattan Yahya & Babu Yarlagadda S.
Assignee(s): BioCryst Pharmaceuticals, Inc.Disclosed are crystalline salts of Compound I, methods of preparing them, and related pharmaceutical preparations thereof. Also disclosed are methods of treatment using the crystalline salts of the invention.
Patent expiration dates:
- November 1, 2039✓✓
- November 1, 2039
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Human plasma kallikrein inhibitors
Patent 10,689,346
Issued: June 23, 2020
Inventor(s): Kotian Pravin L. & Babu Yarlagadda S. & Wu Minwan & Chintareddy Venkat R. & Kumar V. Satish & Zhang Weihe
Assignee(s): BioCryst Pharmaceuticals, Inc.Disclosed are compounds of formula I
Patent expiration dates:
- March 9, 2035✓
- March 9, 2035
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Crystalline salts of a plasma kallikrein inhibitor
Patent 11,117,867
Issued: September 14, 2021
Inventor(s): El-Kattan; Yahya et al.
Assignee(s): BioCryst Pharmaceuticals, Inc. (Durham, NC)Disclosed are crystalline salts of Compound I, methods of preparing them, and related pharmaceutical preparations thereof. Also disclosed are methods of treatment using the crystalline salts of the invention. ##STR00001##
Patent expiration dates:
- November 1, 2039✓✓
- November 1, 2039
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Human plasma kallikrein inhibitors
Patent 11,230,530
Issued: January 25, 2022
Inventor(s): Kotian Pravin L. & Babu Yarlagadda S. & Wu Minwan & Chintareddy Venkat R. & Kumar V. Satish & Zhang Weihe
Assignee(s): BioCryst Pharmaceuticals, Inc.Disclosed are compounds of formula I:
Patent expiration dates:
- March 9, 2035✓
- March 9, 2035
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Crystalline salts of a plasma kallikrein inhibitor
Patent 11,618,733
Issued: April 4, 2023
Inventor(s): El-Kattan; Yahya et al.
Assignee(s): BioCryst Pharmaceuticals, Inc. (Durham, NC)Disclosed are crystalline salts of Compound I, methods of preparing them, and related pharmaceutical preparations thereof. Also disclosed are methods of treatment using the crystalline salts of the invention. ##STR00001##
Patent expiration dates:
- November 1, 2039✓
- November 1, 2039
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Human plasma kallikrein inhibitors
Patent 11,708,333
Issued: July 25, 2023
Inventor(s): Kotian; Pravin L. et al.
Assignee(s): BioCryst Pharmaceuticals, Inc. (Durham, NC)Disclosed are compounds of formula I: ##STR00001## as described herein, and pharmaceutically acceptable salts thereof. The compounds are inhibitors of plasma kallikrein. Also provided are pharmaceutical compositions comprising at least one such compound, and methods involving use of the compounds and compositions in the treatment and prevention of diseases and conditions characterized by unwanted plasma kallikrein activity.
Patent expiration dates:
- March 9, 2035✓
- March 9, 2035
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Human plasma kallikrein inhibitors
Patent 12,116,346
Issued: October 15, 2024
Inventor(s): Kotian; Pravin L. et al.
Assignee(s): BioCryst Pharmaceuticals, Inc. (Durham, NC)Disclosed are compounds of formula I ##STR00001## as described herein, and pharmaceutically acceptable salts thereof. The compounds are inhibitors of plasma kallikrein. Also provided are pharmaceutical compositions comprising at least one compound of the invention, and methods involving use of the compounds and compositions of the invention in the treatment and prevention of diseases and conditions characterized by unwanted plasma kallikrein activity.
Patent expiration dates:
- March 9, 2035✓
- March 9, 2035
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- December 3, 2025 - NEW CHEMICAL ENTITY
- December 3, 2027 - PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
More about Orladeyo (berotralstat)
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- FDA approval history
- Drug class: hereditary angioedema agents
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
