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Last Updated: March 30, 2020

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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 nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Eteplirsen has two hundred and five patent family members in twenty-four countries.

Summary for eteplirsen
International Patents:205
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 10
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for eteplirsen
DailyMed Link:eteplirsen at DailyMed
Recent Clinical Trials for eteplirsen

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SponsorPhase
Sarepta Therapeutics, Inc.Phase 2
Kevin FlaniganPhase 2
Sarepta TherapeuticsPhase 3

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Recent Litigation for eteplirsen

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

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

International Patents for eteplirsen

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Moodys
Harvard Business School
Merck
Baxter

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