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EXONDYS 51 Drug Profile

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Exondys 51 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug.

This drug has ninety-two patent family members in fourteen 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:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: EXONDYS 51

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sarepta Theraps Inc
EXONDYS 51
eteplirsen
SOLUTION;IV (INFUSION)206488-001Sep 19, 2016RXYes8,486,907► subscribe ► subscribe
Sarepta Theraps Inc
EXONDYS 51
eteplirsen
SOLUTION;IV (INFUSION)206488-002Sep 19, 2016RXYes9,416,361► subscribeY ► subscribe
Sarepta Theraps Inc
EXONDYS 51
eteplirsen
SOLUTION;IV (INFUSION)206488-001Sep 19, 2016RXYes► 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
7,888,012Antisense composition and method for treating muscle atrophy► subscribe
9,035,040Antisense oligonucleotides for inducing exon skipping and methods of use thereof► subscribe
9,441,229Antisense oligonucleotides for inducing exon skipping and methods of use thereof► 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
Japan2010505741► subscribe
Japan2008513012► subscribe
Canada2742281► 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.

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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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