Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 17, 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-six patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for eteplirsen
International Patents:196
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

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SponsorPhase
Sarepta TherapeuticsPhase 3
Sarepta TherapeuticsPhase 2
Sarepta TherapeuticsPhase 1/Phase 2

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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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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 206488-002 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   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
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.