Generic Amondys 45 Availability
Last updated on Nov 6, 2024.
Amondys 45 is a brand name of casimersen, approved by the FDA in the following formulation(s):
AMONDYS 45 (casimersen - solution;intravenous)
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Manufacturer: SAREPTA THERAPS INC
Approval date: February 25, 2021
Strength(s): 100MG/2ML (50MG/ML) [RLD]
Has a generic version of Amondys 45 been approved?
No. There is currently no therapeutically equivalent version of Amondys 45 available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Amondys 45. 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.
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Antisense molecules and methods for treating pathologies
Patent 10,287,586
Issued: May 14, 2019
Inventor(s): Wilson Stephen Donald & Fletcher Sue & Adams Abbie & Meloni Penny
Assignee(s): The University of Western AustraliaAn 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 59.
Patent expiration dates:
- November 12, 2030✓✓
- November 12, 2030
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Antisense molecules and methods for treating pathologies
Patent 10,781,450
Issued: September 22, 2020
Inventor(s): Wilton Stephen Donald & Fletcher Sue & Adams Abbie & Meloni Penny
Assignee(s): Sarepta Therapeutics, Inc.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 59.
Patent expiration dates:
- November 12, 2030✓
- November 12, 2030
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Antisense molecules and methods for treating pathologies
Patent 9,228,187
Issued: January 5, 2016
Inventor(s): Wilton Stephen Donald & Fletcher Sue & Adams Abbie & Meloni Penny
Assignee(s): The University of Western AustraliaAn 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 59.
Patent expiration dates:
- November 12, 2030✓✓
- November 12, 2030
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Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent 9,447,415
Issued: September 20, 2016
Inventor(s): Wilton Stephen Donald & Fletcher Sue & McClorey Graham
Assignee(s): The University of Western AustraliaAn 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✓✓
- June 28, 2025
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Antisense molecules and methods for treating pathologies
Patent 9,758,783
Issued: September 12, 2017
Inventor(s): Wilton Stephen Donald & Fletcher Sue & Adams Abbie & Meloni Penny
Assignee(s): The University of Western AustraliaAn 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 59.
Patent expiration dates:
- November 12, 2030✓
- November 12, 2030✓
- November 12, 2030
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Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent RE48960
Issued: March 8, 2022
Inventor(s): Wilton Stephen Donald & Fletcher Sue & McClorey Graham
Assignee(s): The University of Western AustraliaAn 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✓✓✓
- June 28, 2025✓✓✓
- June 28, 2025
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:
- February 25, 2026 - NEW CHEMICAL ENTITY
- February 25, 2028 - TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING
More about Amondys 45 (casimersen)
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- Drug class: miscellaneous uncategorized agents
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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.