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Serving leading biopharmaceutical companies globally:

Deloitte
Teva
McKesson
UBS
Julphar
Farmers Insurance
Chinese Patent Office
AstraZeneca
Fish and Richardson
Fuji

Generated: January 20, 2018

DrugPatentWatch Database Preview

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 five patents protecting this drug.

This drug has one hundred and seventy-seven patent family members in twenty-two 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
International Patents:177
US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Drug Prices:see details
DailyMed Link:EXONDYS 51 at DailyMed
Drug patent expirations by year for EXONDYS 51
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;IV (INFUSION) 206488-001 Sep 19, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;IV (INFUSION) 206488-002 Sep 19, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;IV (INFUSION) 206488-001 Sep 19, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;IV (INFUSION) 206488-002 Sep 19, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;IV (INFUSION) 206488-001 Sep 19, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;IV (INFUSION) 206488-002 Sep 19, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;IV (INFUSION) 206488-002 Sep 19, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;IV (INFUSION) 206488-001 Sep 19, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;IV (INFUSION) 206488-001 Sep 19, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;IV (INFUSION) 206488-001 Sep 19, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Non-Orange Book US Patents for 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
9,499,818 Methods and means for efficient skipping of at least one of the exons 51-53, 55, 57 and 59 of the human duchenne muscular dystrophy gene ➤ Subscribe
8,455,634 Antisense oligonucleotides for inducing exon skipping and methods of use thereof ➤ Subscribe
9,035,040 Antisense oligonucleotides for inducing exon skipping and methods of use thereof ➤ Subscribe
7,807,816 Antisense oligonucleotides for inducing exon skipping and methods of use thereof ➤ Subscribe
8,129,352 Antisense antiviral compound and method for treating ssRNA viral infection ➤ Subscribe
8,524,676 Method for treating enterovirus or rhinovirus infection using antisense antiviral compounds ➤ Subscribe
8,476,423 Antisense oligonucleotides for inducing exon skipping and methods of use thereof ➤ Subscribe
8,501,704 Immunosuppression compound and treatment method ➤ Subscribe
8,030,291 Antisense antiviral compounds and methods for treating a filovirus infection ➤ Subscribe
8,906,872 Antisense antiviral compound and method for treating ssRNA viral infection ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for EXONDYS 51

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Moodys
Teva
UBS
QuintilesIMS
McKinsey
Cerilliant
Baxter
Citi

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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