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Generic Orladeyo Availability

Last updated on Nov 7, 2023.

Orladeyo is a brand name of berotralstat, approved by the FDA in the following formulation(s):

ORLADEYO (berotralstat hydrochloride - capsule;oral)

  • Manufacturer: BIOCRYST
    Approval date: December 3, 2020
    Strength(s): EQ 110MG BASE [RLD], EQ 150MG BASE [RLD]

Has a generic version of Orladeyo been approved?

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.

  • 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
      ✓ 
      Patent use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug substance
  • 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
      ✓ 
      Drug substance
  • 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
      ✓ 
      Patent use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug substance
  • 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
      ✓ 
      Patent use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
  • Patent 11,117,867
    Issued: November 30, -0001

    Patent expiration dates:

    • November 1, 2039
      ✓ 
      Patent use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug product
  • 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
      ✓ 
      Patent use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
  • Patent 11,618,733
    Issued: November 30, -0001

    Patent expiration dates:

    • November 1, 2039
      ✓ 
      Patent use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
  • Patent 11,708,333
    Issued: November 30, -0001

    Patent expiration dates:

    • March 9, 2035
      ✓ 
      Patent use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

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

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.

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