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Last Updated: June 4, 2020

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EXONDYS 51 Drug Profile


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Which patents cover Exondys 51, and what generic alternatives are available?

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

This drug has two hundred and six 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.

US ANDA Litigation and Generic Entry Outlook for Exondys 51

Exondys 51 will be eligible for patent challenges on September 19, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 27, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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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;INTRAVENOUS

*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 206488-002 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 206488-002 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 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:

Mallinckrodt
Merck
AstraZeneca
Dow
Medtronic
Colorcon

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 verification 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.