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Generic Orladeyo Availability

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 FAQs.

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
    Assignee(s): BioCryst Pharmaceuticals, Inc.

    Disclosed are compounds of formula I as described herein, and pharmaceutically acceptable salts thereof. The compounds are inhibitors of plasma kallikrein. Also disclosed 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
      ✓ 
      Patent use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIODEMA (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
    Assignee(s): BioCryst Pharmaceuticals, Inc.

    Disclosed are compounds of formula I as described herein, and pharmaceutically acceptable salts thereof. The compounds are inhibitors of plasma kallikrein. Also disclosed 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
      ✓ 
      Drug substance
  • Patent 10,662,160

    Patent expiration dates:

    • November 1, 2039
      ✓ 
      Patent use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIODEMA (HAE) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
      ✓ 
      Drug substance
  • Patent 10,689,346

    Patent expiration dates:

    • March 9, 2035
      ✓ 
      Patent use: PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIODEMA (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

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.