Generic Accrufer Availability
Last updated on Sep 10, 2026.
Accrufer is a brand name of ferric maltol, approved by the FDA in the following formulation:
| Manufacturer | Approval date | Strengths [RLD] |
|---|---|---|
| SHIELD TX | July 25, 2019 |
|
Has a generic version of Accrufer been approved?
No, the FDA has not approved a generic version of Accrufer.
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.
Patent protection
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development. These patents may include claims related to the drug's formulation, manufacturing process, or other aspects.
| Patent Title | Dosage regimen of ferric trimaltol |
|---|---|
| Patent Number | 10,179,120 |
| Issue Date | January 15, 2019 |
| Inventor | Schweiger Christian & Sterritt Carl Andrew & Howell Julian David |
| Current Assignee | Iron Therapeutics Holdings AG |
| Patent Description |
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 Expiry Dates |
January 6, 2035
Patent Use: METHOD OF TREATING IRON DEFICIENCY |
| Patent Title | H. pylori |
|---|---|
| Patent Number | 9,248,148 |
| Issue Date | February 2, 2016 |
| Inventor | Stockham Michael Arthur |
| Current Assignee | Iron Therapeutics Holdings AG |
| Patent Description |
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...
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 Expiry Dates |
March 29, 2031
Patent Use: METHOD OF TREATING IRON DEFICIENCY |
| Patent Title | Crystalline forms of ferric maltol |
|---|---|
| Patent Number | 9,802,973 |
| Issue Date | October 31, 2017 |
| Inventor | Childs David Paul |
| Current Assignee | SHIELD TX (UK) LTD. |
| Patent Description |
There is provided polymorphs of ferric maltol. Such forms may be useful in the treatment of iron deficiency with or without anaemia, such as iron deficiency anaemia.
|
| Patent Expiry Dates |
October 23, 2035
Patent Use: METHOD OF TREATING IRON DEFICIENCY Drug Substance: Yes Drug Product: Yes |
FDA exclusivity
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.
| Expiration Date | Description |
|---|---|
| December 19, 2028 | NEW PATIENT POPULATION |
More about Accrufer (ferric maltol)
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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.