Pharsight

1. Amondys 45 patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP10004274A	2016-08-25	Nippon Shinyaku Co., Ltd.	Revoked

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
USRE48960	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
US9447415	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
US9228187	SAREPTA THERAPS INC	Antisense molecules and methods for treating pathologies	Nov, 2030 (7 years from now)
US10287586	SAREPTA THERAPS INC	Antisense molecules and methods for treating pathologies	Nov, 2030 (7 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).
US9758783	SAREPTA THERAPS INC	Antisense molecules and methods for treating pathologies	Nov, 2030 (7 years from now)
US10781450	SAREPTA THERAPS INC	Antisense molecules and methods for treating pathologies	Nov, 2030 (7 years from now)

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

Drugs and Companies using CASIMERSEN ingredient

NCE-1 date: 2025-02-25

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; Treatment of duchenne muscular dystrophy (dmd) in patients who have...

Dosage: SOLUTION;INTRAVENOUS

Strength	Dosage	Availability
100MG/2ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription

AMONDYS 45 family patents

2. Exondys 51 patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP17171389A	2023-01-09	Maiwald GmbH	Granted and Under Opposition
EP17171389A	2023-01-09	Bosch Jehle Patentanwaltsgesellschaft mbH	Granted and Under Opposition
EP13160338A	2016-10-06	Withers & Rogers LLP/Wright Howard/Wallin Nicholas	Revoked
EP08842559A	2016-09-22	Withers & Rogers LLP	Revoked
EP10004274A	2016-08-25	Nippon Shinyaku Co., Ltd.	Revoked
EP09788160A	2015-09-24	Howard Wright/ Nicholas Wallin/ Withers & Rogers LLP	Patent maintained as amended

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9018368	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
US10781451	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
US9243245	SAREPTA THERAPS INC	Means and methods for counteracting muscle disorders	Oct, 2028 (5 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).
USRE47751	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
USRE48468	SAREPTA THERAPS INC	Means and methods for counteracting muscle disorders	Oct, 2028 (5 years from now)
USRE47769	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Feb, 2029 (5 years from now)
US10337003	SAREPTA THERAPS INC	Compositions for treating muscular dystrophy	Mar, 2034 (10 years from now)
US10364431	SAREPTA THERAPS INC	Compositions for treating muscular dystrophy	Mar, 2034 (10 years from now)
US9506058	SAREPTA THERAPS INC	Compositions for treating muscular dystrophy	Mar, 2034 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Sep 19, 2023

Drugs and Companies using ETEPLIRSEN ingredient

Market Authorisation Date: 19 September, 2016

Treatment: 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 mutatio...

Dosage: SOLUTION;INTRAVENOUS

Strength	Dosage	Availability
100MG/2ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription
500MG/10ML (50MG/ML)	SOLUTION;INTRAVENOUS	Prescription

EXONDYS 51 family patents

3. Vyondys 53 patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP10004274A	2016-08-25	Nippon Shinyaku Co., Ltd.	Revoked

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10968450	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
US10227590	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
US9024007	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
US9994851	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
US10421966	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10995337	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
US10266827	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)
USRE47691	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 8 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Dec 12, 2026
New Chemical Entity Exclusivity (NCE)	Dec 12, 2024

Drugs and Companies using GOLODIRSEN ingredient

NCE-1 date: 2023-12-13

Market Authorisation Date: 12 December, 2019

Treatment: Treatment of duchenne muscular dystrophy (dmd) in patients having a confirmed mutation of the dmd gene that is amenable to exon 53 skipping

Dosage: SOLUTION;INTRAVENOUS