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EXONDYS 51 Drug Profile

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

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

This drug has one hundred and three patent family members in nineteen 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 Tradename: EXONDYS 51

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list1
Drug Prices:see details
DailyMed Link:EXONDYS 51 at DailyMed

Pharmacology for Tradename: EXONDYS 51

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sarepta Theraps Inc
EXONDYS 51
eteplirsen
SOLUTION;IV (INFUSION)206488-001Sep 19, 2016RXYesYes8,486,907► Subscribe ► Subscribe
Sarepta Theraps Inc
EXONDYS 51
eteplirsen
SOLUTION;IV (INFUSION)206488-001Sep 19, 2016RXYesYes► Subscribe► Subscribe
Sarepta Theraps Inc
EXONDYS 51
eteplirsen
SOLUTION;IV (INFUSION)206488-001Sep 19, 2016RXYesYes9,018,368► SubscribeYY ► Subscribe
Sarepta Theraps Inc
EXONDYS 51
eteplirsen
SOLUTION;IV (INFUSION)206488-002Sep 19, 2016RXYesYes9,018,368► SubscribeYY ► Subscribe
Sarepta Theraps Inc
EXONDYS 51
eteplirsen
SOLUTION;IV (INFUSION)206488-002Sep 19, 2016RXYesYes8,486,907► Subscribe ► Subscribe
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Non-Orange Book Patents for Tradename: EXONDYS 51

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,507,196Antisense antiviral compounds and methods for treating a filovirus infection► Subscribe
8,030,291Antisense antiviral compounds and methods for treating a filovirus infection► Subscribe
8,476,423Antisense oligonucleotides for inducing exon skipping and methods of use thereof► Subscribe
7,582,615Antisense antiviral compound and method for treating arenavirus infection► Subscribe
8,933,216Immunosuppression compound and treatment method► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: EXONDYS 51

Country Document Number Estimated Expiration
Canada2584873► Subscribe
Hong Kong1216545► Subscribe
Australia2004311826► Subscribe
Germany602007006457► Subscribe
Australia2007223776► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

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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.

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