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Amondys 45 patents expiration

AMONDYS 45's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9416361 SAREPTA THERAPS INC Splice-region antisense composition and method
May, 2021

(2 years ago)

USRE48960 SAREPTA THERAPS INC Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(1 year, 2 months from now)

US9447415 SAREPTA THERAPS INC Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(1 year, 2 months from now)

US8524880 SAREPTA THERAPS INC Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Apr, 2026

(1 year, 11 months from now)

US10287586 SAREPTA THERAPS INC Antisense molecules and methods for treating pathologies
Nov, 2030

(6 years from now)

US9228187 SAREPTA THERAPS INC Antisense molecules and methods for treating pathologies
Nov, 2030

(6 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10533174 SAREPTA THERAPS INC Splice-region antisense composition and method
May, 2021

(2 years ago)

US9758783 SAREPTA THERAPS INC Antisense molecules and methods for treating pathologies
Nov, 2030

(6 years from now)

US10781450 SAREPTA THERAPS INC Antisense molecules and methods for treating pathologies
Nov, 2030

(6 years from now)

Amondys 45 is owned by Sarepta Theraps Inc.

Amondys 45 contains Casimersen.

Amondys 45 has a total of 9 drug patents out of which 2 drug patents have expired.

Expired drug patents of Amondys 45 are:

  • US10533174
  • US9416361

Amondys 45 was authorised for market use on 25 February, 2021.

Amondys 45 is available in solution;intravenous dosage forms.

Amondys 45 can be used as treatment of duchenne muscular dystrophy (dmd) in patients who have a mutation of the dmd gene that is amenable to exon 45 skipping, treatment of duchenne muscular dystrophy (dmd) in patients who have a mutation of the dmd gene that is amenable to exon 45 skipping by inducing exon-skipping of exon 45, treatment of duchenne muscular dystrophy (dmd) in patients who have a mutation of the dmd gene that is amenable to exon 45 skipping by restoring an mrna reading frame to induce dystrophin protein production.

Drug patent challenges can be filed against Amondys 45 from 25 February, 2025.

The generics of Amondys 45 are possible to be released after 12 November, 2030.

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-347) Feb 25, 2028
New Chemical Entity Exclusivity(NCE) Feb 25, 2026

Drugs and Companies using CASIMERSEN ingredient

NCE-1 date: 25 February, 2025

Market Authorisation Date: 25 February, 2021

Treatment: Treatment of duchenne muscular dystrophy (dmd) in patients who have a mutation of the dmd gene that is amenable to exon 45 skipping by restoring an mrna reading frame to induce dystrophin protein prod...

Dosage: SOLUTION;INTRAVENOUS

More Information on Dosage

AMONDYS 45 family patents

Family Patents