Generic Feraheme Availability
Last updated on Oct 6, 2021.
FERAHEME (ferumoxytol - solution;intravenous)
Approval date: June 30, 2009
Strength(s): EQ 510MG IRON/17ML (EQ 30MG IRON/ML) [RLD] [AB]
Has a generic version of Feraheme been approved?
A generic version of Feraheme has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Feraheme and have been approved by the FDA:
Manufacturer: SANDOZ INC
Approval date: January 15, 2021
Strength(s): EQ 510MG IRON/17ML (EQ 30MG IRON/ML) [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Feraheme. 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.
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.
Heat stable colloidal iron oxides coated with reduced carbohydrates and carbohdrate derivatives
Issued: July 29, 2003
Inventor(s): Ernest V.; Groman & Kenneth G.; Paul & Timothy B.; Frigo & Howard; Bengele & Jerome M.; Lewis
Assignee(s): Advanced Magnetics, Inc.
Compositions, methods of making the compositions, and methods of using the compositions are provided for an enhanced magnetic resonance imaging agent and a hematinic agent, the agents comprising carboxyalkylated reduced polysaccharides coated ultrasmall superparamagnetic iron oxides. Methods of use of the carboxymethyl reduced dextran as a plasma extender are provided.
Patent expiration dates:
- June 30, 2023✓✓
- June 30, 2023
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:
- February 2, 2021 - TREATMENT OF IRON DEFICIENCY ANEMIA IN ADULT PATIENTS WHO HAVE INTOLERANCE TO ORAL IRON OR HAVE HAD UNSATISFACTORY RESPONSE TO ORAL IRON
More about Feraheme (ferumoxytol)
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- 7 Reviews
- Drug class: iron products
- FDA Approval History
Related treatment guides
|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.|
|AB||Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.