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Harvard Business School
Johnson and Johnson

Last Updated: December 12, 2019

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ETEPLIRSEN - Generic Drug Details

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What are the generic drug sources for eteplirsen and what is the scope of freedom to operate?

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

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

One supplier is listed for this compound.

Summary for ETEPLIRSEN
International Patents:197
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 9
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for ETEPLIRSEN
DailyMed Link:ETEPLIRSEN at DailyMed
Recent Clinical Trials for ETEPLIRSEN

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

SponsorPhase
Sarepta TherapeuticsPhase 3
Sarepta TherapeuticsPhase 2
British Medical Research CouncilPhase 1/Phase 2

See all ETEPLIRSEN clinical trials

Recent Litigation for ETEPLIRSEN

Identify potential future generic entrants

District Court Litigation
Case NameDate
University of Western Australia v. Academisch Ziekenhuis Leiden2016-02-25

See all ETEPLIRSEN litigation

Pharmacology for ETEPLIRSEN

US Patents and Regulatory Information for ETEPLIRSEN

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

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
AstraZeneca
McKesson
Baxter
Express Scripts

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