Pharsight

Exondys 51 patents expiration

EXONDYS 51'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)

US9018368 SAREPTA THERAPS INC Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(1 year, 2 months from now)

US10781451 SAREPTA THERAPS INC Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(1 year, 2 months from now)

US9243245 SAREPTA THERAPS INC Means and methods for counteracting muscle disorders
Oct, 2028

(4 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)

USRE47751 SAREPTA THERAPS INC Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(1 year, 2 months from now)

US8486907 SAREPTA THERAPS INC Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Jun, 2025

(1 year, 2 months from now)

USRE48468 SAREPTA THERAPS INC Means and methods for counteracting muscle disorders
Oct, 2028

(4 years from now)

USRE47769 SAREPTA THERAPS INC Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Feb, 2029

(4 years from now)

US9506058 SAREPTA THERAPS INC Compositions for treating muscular dystrophy
Mar, 2034

(9 years from now)

US10364431 SAREPTA THERAPS INC Compositions for treating muscular dystrophy
Mar, 2034

(9 years from now)

US10337003 SAREPTA THERAPS INC Compositions for treating muscular dystrophy
Mar, 2034

(9 years from now)

Exondys 51 is owned by Sarepta Theraps Inc.

Exondys 51 contains Eteplirsen.

Exondys 51 has a total of 12 drug patents out of which 2 drug patents have expired.

Expired drug patents of Exondys 51 are:

  • US10533174
  • US9416361

Exondys 51 was authorised for market use on 19 September, 2016.

Exondys 51 is available in solution;intravenous dosage forms.

Exondys 51 can be used as treatment of duchenne muscular dystrophy in patients having a mutation of the dmd gene that is amenable to exon 51 skipping, 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, 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, treatment of dmd in patients having a mutation of the dmd gene that is amenable to exon 51 skipping, (i)treatment of duchenne muscular dystrophy; (ii)restoring/increasing functional dystrophin protein; or (iii) inducing skipping; each of (i)-(iii) in patients having a confirmed mutation of the dmd gene that is amenable to exon 51 skipping, increasing production of functional dystrophin protein in dmd patients having a mutation of the dmd gene that is amenable to exon 51 skipping.

Drug patent challenges can be filed against Exondys 51 from 19 September, 2020.

The generics of Exondys 51 are possible to be released after 14 March, 2034.

Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE) Sep 19, 2023
New Chemical Entity Exclusivity(NCE) Sep 19, 2021
Orphan Drug Exclusivity(ODE-122) Sep 19, 2023

Drugs and Companies using ETEPLIRSEN ingredient

NCE-1 date: 19 September, 2020

Market Authorisation Date: 19 September, 2016

Treatment: 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; (i)treatment of duchenne muscular dys...

Dosage: SOLUTION;INTRAVENOUS

More Information on Dosage

EXONDYS 51 family patents

Family Patents