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: December 7, 2019

DrugPatentWatch Database Preview

EXONDYS 51 Drug Profile

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Which patents cover Exondys 51, and when can generic versions of Exondys 51 launch?

Exondys 51 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. There are seven patents protecting this drug.

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

The generic ingredient in EXONDYS 51 is eteplirsen. One supplier is listed for this compound. Additional details are available on the eteplirsen profile page.

Summary for EXONDYS 51
Drug patent expirations by year for EXONDYS 51
Generic Entry Opportunity Date for EXONDYS 51
Generic Entry Date for EXONDYS 51*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;IV (INFUSION)

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EXONDYS 51

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

SponsorPhase
Sarepta TherapeuticsPhase 3

See all EXONDYS 51 clinical trials

Recent Litigation for EXONDYS 51

Identify potential future generic entrants

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

See all EXONDYS 51 litigation

Pharmacology for EXONDYS 51

US Patents and Regulatory Information for EXONDYS 51

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 206488-002 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   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 206488-001 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

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Serving leading biopharmaceutical companies globally:

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Medtronic

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