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Generic Jadenu Availability

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

See also: Generic Jadenu Sprinkle

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

JADENU (deferasirox - tablet;oral)

  • Manufacturer: NOVARTIS PHARMS CORP
    Approval date: March 30, 2015
    Strength(s): 90MG [RLD] [AB], 180MG [RLD] [AB], 360MG [RLD] [AB]

Has a generic version of Jadenu been approved?

A generic version of Jadenu 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 Jadenu and have been approved by the FDA:

deferasirox tablet;oral

  • Manufacturer: ACTAVIS ELIZABETH
    Approval date: December 13, 2019
    Strength(s): 90MG [AB], 180MG [AB], 360MG [AB]
  • Manufacturer: ALEMBIC PHARMS LTD
    Approval date: November 20, 2019
    Strength(s): 90MG [AB], 360MG [AB]
  • Manufacturer: ALEMBIC PHARMS LTD
    Approval date: June 15, 2020
    Strength(s): 180MG [AB]
  • Manufacturer: ALKEM LABS LTD
    Approval date: March 30, 2020
    Strength(s): 90MG [AB], 360MG [AB]
  • Manufacturer: ALKEM LABS LTD
    Approval date: July 2, 2020
    Strength(s): 180MG [AB]
  • Manufacturer: AMNEAL
    Approval date: December 27, 2019
    Strength(s): 90MG [AB], 360MG [AB]
  • Manufacturer: AMNEAL
    Approval date: June 15, 2020
    Strength(s): 180MG [AB]
  • Manufacturer: CIPLA
    Approval date: February 11, 2020
    Strength(s): 90MG [AB], 360MG [AB]
  • Manufacturer: CIPLA
    Approval date: June 15, 2020
    Strength(s): 180MG [AB]
  • Manufacturer: MSN
    Approval date: November 20, 2019
    Strength(s): 360MG [AB], 90MG [AB]
  • Manufacturer: MSN
    Approval date: June 16, 2020
    Strength(s): 180MG [AB]
  • Manufacturer: PIRAMAL HLTHCARE UK
    Approval date: December 30, 2019
    Strength(s): 90MG [AB], 360MG [AB]
  • Manufacturer: PIRAMAL HLTHCARE UK
    Approval date: June 15, 2020
    Strength(s): 180MG [AB]
  • Manufacturer: SUN PHARM
    Approval date: January 2, 2020
    Strength(s): 90MG [AB], 360MG [AB]
  • Manufacturer: SUN PHARM
    Approval date: June 15, 2020
    Strength(s): 180MG [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: November 25, 2019
    Strength(s): 90MG [AB], 360MG [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: April 24, 2020
    Strength(s): 180MG [AB]
  • Manufacturer: ZYDUS PHARMS
    Approval date: November 20, 2019
    Strength(s): 90MG [AB], 360MG [AB]
  • Manufacturer: ZYDUS PHARMS
    Approval date: June 15, 2020
    Strength(s): 180MG [AB]

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

  • Oral formulations of deferasirox
    Patent 9,283,209
    Issued: March 15, 2016
    Assignee(s): NOVARTIS AG

    Orally administerable deferasirox formulations are disclosed having reduced release under gastric conditions and fast release at near neutral pH or at neutral pH.

    Patent expiration dates:

    • November 21, 2034
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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 12, 2021 - INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A TRIAL CONDUCTED IN TREATMENT NAIVE PEDIATRIC PATIENTS, AGES 2 YEARS TO < 18 YEARS WITH TRANSFUSIONAL IRON OVERLOAD
    • July 24, 2022 - INFORMATION ADDED TO THE LABELING FOR SAFETY & EFFICACY STUDY ENTITLED, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED CLINICAL TRIAL OF DEFERASIROX IN PATIENTS WITH MYELODYSPLASTIC SYNDROMES (LOW/INT-1 RISK) & TRANSFUSIONAL IRON OVERLOAD
    • July 23, 2023 - REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3

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.
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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.