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Generic Rybelsus Availability

Medically reviewed by Drugs.com. Last updated on May 11, 2021.

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

RYBELSUS (semaglutide - tablet;oral)

  • Manufacturer: NOVO
    Approval date: September 20, 2019
    Strength(s): 3MG [RLD], 7MG [RLD], 14MG [RLD]

Has a generic version of Rybelsus been approved?

No. There is currently no therapeutically equivalent version of Rybelsus available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Rybelsus. 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.

  • Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
    Patent 10,086,047
    Issued: October 2, 2018
    Assignee(s): Novo Nordisk A/S

    The present invention relates to solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and their use in medicine.

    Patent expiration dates:

    • December 16, 2031
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      Drug product
  • Oral dosing of GLP-1 compounds
    Patent 10,278,923
    Issued: May 7, 2019
    Assignee(s): Novo Nordisk A/S

    The present invention relates to improved uses of GLP-1 peptides in oral therapy.

    Patent expiration dates:

    • May 2, 2034
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
  • Patent 10,933,120

    Patent expiration dates:

    • March 15, 2033
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      Drug product
  • Patent 10,960,052

    Patent expiration dates:

    • December 16, 2031
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      Drug product
  • Acylated GLP-1 compounds
    Patent 8,129,343
    Issued: March 6, 2012
    Inventor(s): Lau; Jesper & Bloch; Paw & Hansen; Thomas Kruse
    Assignee(s): Novo Nordisk A/S

    Protracted GLP-1 compounds and therapeutic uses thereof.

    Patent expiration dates:

    • January 29, 2029
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
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      Drug substance
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      Drug product
  • Acylated GLP-1 compounds
    Patent 8,536,122
    Issued: September 17, 2013
    Assignee(s): Novo Nordisk A/S

    Protracted GLP-1 compounds and therapeutic uses thereof.

    Patent expiration dates:

    • March 20, 2026
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      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
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      Drug substance
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      Drug product
  • Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid
    Patent 9,278,123
    Issued: March 8, 2016
    Assignee(s): Novo Nordisk A/S

    The present invention relates to solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and their use in medicine.

    Patent expiration dates:

    • December 16, 2031
      ✓ 
      Patent use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS
      ✓ 
      Drug product

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:

    • September 20, 2022 - NEW PRODUCT
    • December 5, 2022 - NEW CHEMICAL ENTITY
    • January 16, 2023 - ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME

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.