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Last Updated: April 15, 2021

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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 eleven patents protecting this drug.

This drug has two hundred and thirteen 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.

DrugPatentWatch® Generic Entry Outlook for Exondys 51

Exondys 51 was eligible for patent challenges on September 19, 2020.

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
International Patents:213
US Patents:11
Suppliers / Packagers: 1
Clinical Trials: 1
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for EXONDYS 51
What excipients (inactive ingredients) are in EXONDYS 51?EXONDYS 51 excipients list
DailyMed Link:EXONDYS 51 at DailyMed
Drug patent expirations by year for EXONDYS 51
DrugPatentWatch® Estimated Generic Entry Opportunity Date for EXONDYS 51
Generic Entry Date for EXONDYS 51*:
Constraining patent/regulatory exclusivity:

*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

Sarepta TherapeuticsPhase 3

See all EXONDYS 51 clinical trials

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 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
>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 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.