Eteplirsen - Generic Drug Details

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What are the generic drug sources for eteplirsen and what is the scope of patent protection?

Eteplirsen is the generic ingredient in one branded drug marketed by Sarepta Theraps Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eteplirsen has one hundred and twenty-seven patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for eteplirsen

International Patents:	127
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for eteplirsen
What excipients (inactive ingredients) are in eteplirsen?	eteplirsen excipients list
DailyMed Link:	eteplirsen at DailyMed

Recent Clinical Trials for eteplirsen

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Kevin Flanigan	Phase 2
Catabasis Pharmaceuticals	Phase 1/Phase 2
Sarepta Therapeutics, Inc.	Phase 3

See all eteplirsen clinical trials

Pharmacology for eteplirsen

Drug Class	Antisense Oligonucleotide

Anatomical Therapeutic Chemical (ATC) Classes for eteplirsen

M09AX	Other drugs for disorders of the musculo-skeletal system
M09A	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M09	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M	Musculo-skeletal system

US Patents and Regulatory Information for eteplirsen

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-002	Sep 19, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-002	Sep 19, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-002	Sep 19, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for eteplirsen

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016	⤷ Sign Up	⤷ Sign Up
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-002	Sep 19, 2016	⤷ Sign Up	⤷ Sign Up
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016	⤷ Sign Up	⤷ Sign Up
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-002	Sep 19, 2016	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for eteplirsen

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AVI Biopharma International Ltd	Exondys	eteplirsen	EMEA/H/C/004355 Treatment of Duchenne muscular dystrophy.	Refused	no	no	yes		2018-12-06
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for eteplirsen

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Country	Patent Number	Title	Estimated Expiration
Denmark	2203173		⤷ Sign Up
Spain	2692886		⤷ Sign Up
Israel	205322	שילוב של אוליגונוקלאוטיד משלים ל, pre-mrna- של אקסון 51 דיסטרופין וסטרואיד, לשימוש כתרופה ותכשירים רפואיים המכילים אותו (Combination of an oligonucleotide complementary to pre-mrna of dystrophin exon 51 and a steroid, for use as a medicament and pharmaceutical preparations thereof)	⤷ Sign Up
Japan	2012506698		⤷ Sign Up
European Patent Office	2968991	COMPOSITIONS AMÉLIORÉES POUR LE TRAITEMENT DE LA DYSTROPHIE MUSCULAIRE (IMPROVED COMPOSITIONS FOR TREATING MUSCULAR DYSTROPHY)	⤷ Sign Up
European Patent Office	4272748	OLIGONUCLÉOTIDES ANTISENS POUR INDUIRE L'OMISSION DE L'EXON ET LEURS PROCÉDÉS D'UTILISATION (ANTISENSE OLIGONUCLEOTIDES FOR INDUCING EXON SKIPPING AND METHODS OF USE THEREOF)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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