Generic Exondys 51 Availability

Last updated on Sep 11, 2024.

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

EXONDYS 51 (eteplirsen - solution;intravenous)

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.

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.

Compositions for treating muscular dystrophy
Patent 10,337,003
Issued: July 2, 2019
Inventor(s): Kaye Edward M.
Assignee(s): Sarepta Therapeutics, Inc.
Improved compositions and methods for treating muscular dystrophy by administering antisense molecules capable of binding to a selected target site in the human dystrophin gene to induce exon skipping are described.
Patent expiration dates:
- March 14, 2034
  ✓
  Patent use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
Compositions for treating muscular dystrophy
Patent 10,364,431
Issued: July 30, 2019
Inventor(s): Kaye Edward M.
Assignee(s): Sarepta Therapeutics, Inc.
Improved compositions and methods for treating muscular dystrophy by administering antisense molecules capable of binding to a selected target site in the human dystrophin gene to induce exon skipping are described.
Patent expiration dates:
- March 14, 2034
  ✓
  Patent use: RESTORING AN MRNA READING FRAME TO INDUCE DYSTROPHIN PROTEIN PRODUCTION IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
- March 14, 2034
  ✓
  Patent use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent 10,781,451
Issued: September 22, 2020
Inventor(s): Wilton Stephen Donald & Fletcher Sue & McClorey Graham
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
  ✓
  Drug substance
  ✓
  Drug product
Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent 9,018,368
Issued: April 28, 2015
Inventor(s): Wilton Stephen Donald & Fletcher Sue & McClorey Graham
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
  ✓
  Drug substance
  ✓
  Drug product
Means and methods for counteracting muscle disorders
Patent 9,243,245
Issued: January 26, 2016
Inventor(s): De Kimpe Josephus Johannes & Platenburg Gerard Johannes & Van Deutekom Judith Christina Theodora & Aartsma-Rus Annemieke & Van Ommen Garrit-Jan Boudewijn
The invention provides means and methods for alleviating one or more symptom(s) of Duchenne Muscular Dystrophy and/or Becker Muscular Dystrophy. Therapies using compounds for providing patients with functional muscle proteins are combined with at least one adjunct compound for reducing inflammation, preferably for reducing muscle tissue inflammation, and/or at least one adjunct compound for improving muscle fiber function, integrity and/or survival.
Patent expiration dates:
- October 27, 2028
  ✓
  Patent use: TREATMENT OF DMD IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
  ✓
  Drug substance
- October 27, 2028
  ✓
  Patent use: INCREASING PRODUCTION OF FUNCTIONAL DYSTROPHIN PROTEIN IN DMD PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
  ✓
  Drug substance
Compositions for treating muscular dystrophy
Patent 9,506,058
Issued: November 29, 2016
Inventor(s): Kaye Edward M.
Assignee(s): Sarepta Therapeutics, Inc.
Improved compositions and methods for treating muscular dystrophy by administering antisense molecules capable of binding to a selected target site in the human dystrophin gene to induce exon skipping are described.
Patent expiration dates:
- March 14, 2034
  ✓
  Patent use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
- March 14, 2034
  ✓
  Patent use: RESTORING AN MRNA READING FRAME TO INDUCE DYSTROPHIN PROTEIN PRODUCTION IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent RE47751
Issued: December 3, 2019
Inventor(s): Wilton Stephen Donald & Fletcher Sue & McClorey Graham
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
  ✓
  Patent use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
- June 28, 2025
  ✓
  Patent use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY INDUCING SKIPPING OF EXON 51
- June 28, 2025
  ✓
  Patent use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY CORRECTING A DEFECTIVE GENE FOR DYSTROPHIN
- June 28, 2025
  ✓
  Patent use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY RESTORING OR INCREASING FUNCTIONAL DYSTROPHIN PROTEIN PRODUCTION
Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent RE47769
Issued: December 17, 2019
Inventor(s): Wilton Stephen Donald & Fletcher Sue & McClorey Graham
Assignee(s): The University of Western Australia
Antisense molecules capable of binding to a selected target site in the dystrophin gene to induce exon skipping are described.
Patent expiration dates:
- February 2, 2029
  ✓
  Drug product
Means and methods for counteracting muscle disorders
Patent RE48468
Issued: March 16, 2021
Inventor(s): De Kimpe Josephus Johannes & Platenburg Gerard Johannes & Van Deutekom Judith Christina Theodora & Aartsma-Rus Annemieke & Van Ommen Garrit-Jan Boudewijn
The invention provides means and methods for alleviating one or more symptom(s) of Duchenne Muscular Dystrophy and/or Becker Muscular Dystrophy. Therapies using compounds for providing patients with functional muscle proteins are combined with at least one adjunct compound for reducing inflammation, preferably for reducing muscle tissue inflammation, and/or at least one adjunct compound for improving muscle fiber function, integrity and/or survival.
Patent expiration dates:
- October 27, 2028
  ✓
  Patent use: TREATMENT OF DMD IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

More about Exondys 51 (eteplirsen)

Patient resources

Professional resources

Related treatment guides

Duchenne Muscular Dystrophy

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

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

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