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Last Updated: May 20, 2022

EXONDYS 51 Drug Patent 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 nine patents protecting this drug.

This drug has one hundred and twenty patent family members in twenty-three 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:120
US Patents:9
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 2
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:
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 Therapeutics, Inc.Phase 3
Sarepta TherapeuticsPhase 3
Catabasis PharmaceuticalsPhase 1/Phase 2

See all EXONDYS 51 clinical trials

Pharmacology for EXONDYS 51

US Patents and Regulatory Information for EXONDYS 51

EXONDYS 51 is protected by fifteen US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EXONDYS 51 is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting EXONDYS 51

Compositions for treating muscular dystrophy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

Compositions for treating muscular dystrophy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RESTORING AN MRNA READING FRAME TO INDUCE DYSTROPHIN PROTEIN PRODUCTION IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

Compositions for treating muscular dystrophy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Means and methods for counteracting muscle disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DMD IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

Means and methods for counteracting muscle disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: INCREASING PRODUCTION OF FUNCTIONAL DYSTROPHIN PROTEIN IN DMD PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

Compositions for treating muscular dystrophy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

Compositions for treating muscular dystrophy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RESTORING AN MRNA READING FRAME TO INDUCE DYSTROPHIN PROTEIN PRODUCTION IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY INDUCING SKIPPING OF EXON 51

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY CORRECTING A DEFECTIVE GENE FOR DYSTROPHIN

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY RESTORING OR INCREASING FUNCTIONAL DYSTROPHIN PROTEIN PRODUCTION

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Means and methods for counteracting muscle disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF DMD IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

FDA Regulatory Exclusivity protecting EXONDYS 51

TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for EXONDYS 51

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 See Plans and Pricing See Plans and Pricing
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for EXONDYS 51

When does loss-of-exclusivity occur for EXONDYS 51?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 08317566
Estimated Expiration: See Plans and Pricing

Patent: 09310557
Estimated Expiration: See Plans and Pricing

Patent: 09310558
Estimated Expiration: See Plans and Pricing

Canada

Patent: 04049
Estimated Expiration: See Plans and Pricing

Patent: 41629
Estimated Expiration: See Plans and Pricing

Patent: 41793
Estimated Expiration: See Plans and Pricing

Patent: 17539
Estimated Expiration: See Plans and Pricing

China

Patent: 1896186
Estimated Expiration: See Plans and Pricing

Patent: 2256606
Estimated Expiration: See Plans and Pricing

Patent: 2264903
Estimated Expiration: See Plans and Pricing

Patent: 5641700
Estimated Expiration: See Plans and Pricing

Patent: 5647921
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160025
Estimated Expiration: See Plans and Pricing

Patent: 0160078
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16305
Estimated Expiration: See Plans and Pricing

Patent: 17286
Estimated Expiration: See Plans and Pricing

Patent: 17454
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 03173
Estimated Expiration: See Plans and Pricing

Patent: 44637
Estimated Expiration: See Plans and Pricing

Patent: 07484
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 03173
Estimated Expiration: See Plans and Pricing

Patent: 44637
Estimated Expiration: See Plans and Pricing

Patent: 49287
Estimated Expiration: See Plans and Pricing

Patent: 07484
Estimated Expiration: See Plans and Pricing

Patent: 14827
Estimated Expiration: See Plans and Pricing

Patent: 38737
Estimated Expiration: See Plans and Pricing

Patent: 00948
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 60169
Estimated Expiration: See Plans and Pricing

Patent: 85098
Estimated Expiration: See Plans and Pricing

Patent: 45670
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 27124
Estimated Expiration: See Plans and Pricing

Patent: 28662
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5322
Estimated Expiration: See Plans and Pricing

Patent: 2508
Estimated Expiration: See Plans and Pricing

Patent: 2509
Estimated Expiration: See Plans and Pricing

Patent: 1928
Estimated Expiration: See Plans and Pricing

Patent: 1127
Estimated Expiration: See Plans and Pricing

Patent: 5424
Estimated Expiration: See Plans and Pricing

Patent: 4321
Estimated Expiration: See Plans and Pricing

Japan

Patent: 00064
Estimated Expiration: See Plans and Pricing

Patent: 86109
Estimated Expiration: See Plans and Pricing

Patent: 79374
Estimated Expiration: See Plans and Pricing

Patent: 05260
Estimated Expiration: See Plans and Pricing

Patent: 79629
Estimated Expiration: See Plans and Pricing

Patent: 85620
Estimated Expiration: See Plans and Pricing

Patent: 11502118
Estimated Expiration: See Plans and Pricing

Patent: 12506697
Estimated Expiration: See Plans and Pricing

Patent: 12506698
Estimated Expiration: See Plans and Pricing

Patent: 14111638
Estimated Expiration: See Plans and Pricing

Patent: 16033140
Estimated Expiration: See Plans and Pricing

Patent: 17141296
Estimated Expiration: See Plans and Pricing

Patent: 19142942
Estimated Expiration: See Plans and Pricing

Patent: 21113229
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4793
Estimated Expiration: See Plans and Pricing

Patent: 2446
Estimated Expiration: See Plans and Pricing

Patent: 2498
Estimated Expiration: See Plans and Pricing

Poland

Patent: 03173
Estimated Expiration: See Plans and Pricing

Patent: 07484
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 03173
Estimated Expiration: See Plans and Pricing

Patent: 44637
Estimated Expiration: See Plans and Pricing

Patent: 07484
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 07484
Estimated Expiration: See Plans and Pricing

Spain

Patent: 32634
Estimated Expiration: See Plans and Pricing

Patent: 62658
Estimated Expiration: See Plans and Pricing

Patent: 64563
Estimated Expiration: See Plans and Pricing

Patent: 39852
Estimated Expiration: See Plans and Pricing

Patent: 92886
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EXONDYS 51 around the world.

Country Patent Number Title Estimated Expiration
China 105307723 Improved compositions for treating muscular dystrophy See Plans and Pricing
European Patent Office 2203173 MOYENS ET PROCÉDÉ DE COMPENSATION DES TROUBLES MUSCULAIRES (MEANS AND METHODS FOR COUNTERACTING MUSCLE DISORDERS) See Plans and Pricing
Cyprus 1111447 See Plans and Pricing
Cyprus 1120486 See Plans and Pricing
Spain 2361325 See Plans and Pricing
Japan 5786109 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Express Scripts
Moodys
Baxter
Dow

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.