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Generic Exondys 51 Availability

Exondys 51 is a brand name of eteplirsen, approved by the FDA in the following formulation(s):

EXONDYS 51 (eteplirsen - solution;iv (infusion))

  • Manufacturer: SAREPTA THERAPS INC
    Approval date: September 19, 2016
    Strength(s): 100MG/2ML (50MG/ML) [RLD], 500MG/10ML (50MG/ML) [RLD]

Has a generic version of Exondys 51 been approved?

No. There is currently no therapeutically equivalent version of Exondys 51 available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Exondys 51. 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: About generic drugs.

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.

  • Antisense oligonucleotides for inducing exon skipping and methods of use thereof
    Patent 8,486,907
    Issued: July 16, 2013
    Assignee(s): The University of Western Australia
    An antisense molecule capable of binding to a selected target site to induce exon skipping in the dystrophin gene, as set forth in SEQ ID NO: 1 to 202.
    Patent expiration dates:
    • June 28, 2025
  • Antisense oligonucleotides for inducing exon skipping and methods of use thereof
    Patent 9,018,368
    Issued: April 28, 2015
    Assignee(s): The University of Western Australia
    An antisense molecule capable of binding to a selected target site to induce exon skipping in the dystrophin gene, as set forth in SEQ ID NO: 1 to 202.
    Patent expiration dates:
    • June 28, 2025
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      Drug substance
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      Drug product
  • Splice-region antisense composition and method
    Patent 9,416,361
    Issued: August 16, 2016
    Assignee(s): Sarepta Therapeutics, Inc.
    Antisense compositions targeted against an mRNA sequence coding for a selected protein, at a region having its 5′ end from 1 to about 25 base pairs downstream of a normal splice acceptor junction in the preprocessed mRNA, are disclosed. The antisense compound is RNase-inactive, and is preferably a phosphorodiamidate-linked morpholino oligonucleotide. Such targeting is effective to inhibit natural mRNA splice processing, produce splice variant mRNAs, and inhibit normal expression of the protein.
    Patent expiration dates:
    • May 4, 2021
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      Drug substance

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 19, 2021 - NEW CHEMICAL ENTITY
    • September 19, 2023 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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