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Generic Accrufer Availability

Last updated on Jun 8, 2022.

Accrufer is a brand name of ferric maltol, approved by the FDA in the following formulation(s):

ACCRUFER (ferric maltol - capsule;oral)

  • Manufacturer: SHIELD TX
    Approval date: July 25, 2019
    Strength(s): 30MG IRON [RLD]

Has a generic version of Accrufer been approved?

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

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

  • Dosage regimen of ferric trimaltol
    Patent 10,179,120
    Issued: January 15, 2019
    Assignee(s): Iron Therapeutics Holdings AG

    The present invention relates to a dosage regimen of ST10 (ferric trimaltol) for the treatment of patients suffering from iron deficiency with or without anaemia. Specifically the invention relates to the treatment of patients with 30 mg ST10 twice daily.

    Patent expiration dates:

    • January 6, 2035
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      Patent use: METHOD OF TREATING IRON DEFICIENCY
  • Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI inflammation inhibiting agents) compositions for anaemia or H. pylori infections
    Patent 9,248,148
    Issued: February 2, 2016
    Assignee(s): Iron Therapeutics Holdings AG

    There is provided a composition or kit of parts comprising: one or more compounds capable of treating and/or preventing an inflammatory disease of the gastrointestinal tract: and an iron hydroxypyrone, for increasing the level of iron in a patient's bloodstream and/or treating and/or preventing anaemia such as iron deficiency anaemia. A composition comprising iron hydroxypyrone is also provided for administration to a subject: having or at risk of having achlorhydria; wherein the gastric pH of the subject is equal to or greater than about 4; or wherein the subject has an inflammatory disease of the gastrointestinal tract.

    Patent expiration dates:

    • March 29, 2031
      ✓ 
      Patent use: METHOD OF TREATING IRON DEFICIENCY
  • Patent 9,802,973

    Patent expiration dates:

    • October 23, 2035
      ✓ 
      Patent use: METHOD OF TREATING IRON DEFICIENCY
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      Drug substance
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      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:

    • July 25, 2024 - 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.