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Last Updated: March 29, 2024

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EXONDYS 51 Drug Patent 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 nine patents protecting this drug.

This drug has one hundred and twenty-seven 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:127
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 Loss of Exclusivity (LOE) 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EXONDYS 51 is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Means and methods for counteracting muscle disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 206488-001 Sep 19, 2016 ⤷  Try a Trial ⤷  Try a Trial
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-001 Sep 19, 2016 ⤷  Try a Trial ⤷  Try a Trial
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 ⤷  Try a Trial ⤷  Try a Trial
Sarepta Theraps Inc EXONDYS 51 eteplirsen SOLUTION;INTRAVENOUS 206488-002 Sep 19, 2016 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for EXONDYS 51

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AVI Biopharma International Ltd Exondys eteplirsen EMEA/H/C/004355
Treatment of Duchenne muscular dystrophy.
Refused no no yes 2018-12-06
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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: ⤷  Try a Trial

Patent: 09310557
Estimated Expiration: ⤷  Try a Trial

Patent: 09310558
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 04049
Estimated Expiration: ⤷  Try a Trial

Patent: 41629
Estimated Expiration: ⤷  Try a Trial

Patent: 41793
Estimated Expiration: ⤷  Try a Trial

Patent: 17539
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1896186
Estimated Expiration: ⤷  Try a Trial

Patent: 2256606
Estimated Expiration: ⤷  Try a Trial

Patent: 2264903
Estimated Expiration: ⤷  Try a Trial

Patent: 5641700
Estimated Expiration: ⤷  Try a Trial

Patent: 5647921
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0160025
Estimated Expiration: ⤷  Try a Trial

Patent: 0160078
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 16305
Estimated Expiration: ⤷  Try a Trial

Patent: 17286
Estimated Expiration: ⤷  Try a Trial

Patent: 17454
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 03173
Estimated Expiration: ⤷  Try a Trial

Patent: 44637
Estimated Expiration: ⤷  Try a Trial

Patent: 07484
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 03173
Estimated Expiration: ⤷  Try a Trial

Patent: 44637
Estimated Expiration: ⤷  Try a Trial

Patent: 49287
Estimated Expiration: ⤷  Try a Trial

Patent: 07484
Estimated Expiration: ⤷  Try a Trial

Patent: 14827
Estimated Expiration: ⤷  Try a Trial

Patent: 38737
Estimated Expiration: ⤷  Try a Trial

Patent: 00948
Estimated Expiration: ⤷  Try a Trial

Patent: 83399
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 60169
Estimated Expiration: ⤷  Try a Trial

Patent: 85098
Estimated Expiration: ⤷  Try a Trial

Patent: 45670
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 27124
Estimated Expiration: ⤷  Try a Trial

Patent: 28662
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 5322
Estimated Expiration: ⤷  Try a Trial

Patent: 2508
Estimated Expiration: ⤷  Try a Trial

Patent: 2509
Estimated Expiration: ⤷  Try a Trial

Patent: 1928
Estimated Expiration: ⤷  Try a Trial

Patent: 1127
Estimated Expiration: ⤷  Try a Trial

Patent: 5424
Estimated Expiration: ⤷  Try a Trial

Patent: 4321
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 00064
Estimated Expiration: ⤷  Try a Trial

Patent: 86109
Estimated Expiration: ⤷  Try a Trial

Patent: 79374
Estimated Expiration: ⤷  Try a Trial

Patent: 05260
Estimated Expiration: ⤷  Try a Trial

Patent: 79629
Estimated Expiration: ⤷  Try a Trial

Patent: 85620
Estimated Expiration: ⤷  Try a Trial

Patent: 07622
Estimated Expiration: ⤷  Try a Trial

Patent: 11502118
Estimated Expiration: ⤷  Try a Trial

Patent: 12506697
Estimated Expiration: ⤷  Try a Trial

Patent: 12506698
Estimated Expiration: ⤷  Try a Trial

Patent: 14111638
Estimated Expiration: ⤷  Try a Trial

Patent: 16033140
Estimated Expiration: ⤷  Try a Trial

Patent: 17141296
Estimated Expiration: ⤷  Try a Trial

Patent: 19142942
Estimated Expiration: ⤷  Try a Trial

Patent: 21113229
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4793
Estimated Expiration: ⤷  Try a Trial

Patent: 2446
Estimated Expiration: ⤷  Try a Trial

Patent: 2498
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 03173
Estimated Expiration: ⤷  Try a Trial

Patent: 07484
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 03173
Estimated Expiration: ⤷  Try a Trial

Patent: 44637
Estimated Expiration: ⤷  Try a Trial

Patent: 07484
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 07484
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 32634
Estimated Expiration: ⤷  Try a Trial

Patent: 62658
Estimated Expiration: ⤷  Try a Trial

Patent: 64563
Estimated Expiration: ⤷  Try a Trial

Patent: 39852
Estimated Expiration: ⤷  Try a Trial

Patent: 92886
Estimated Expiration: ⤷  Try a Trial

Patent: 14775
Estimated Expiration: ⤷  Try a Trial

Patent: 36464
Estimated Expiration: ⤷  Try a Trial

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 101896186 Means and methods for counteracting muscle disorders ⤷  Try a Trial
Israel 269845 תכשירים משופרים לטיפול דיסטרופיה של השרירים (Improved compositions for treating muscular dystrophy) ⤷  Try a Trial
Canada 2741629 PROCEDES ET MOYENS D'INDUCTION DU SAUT DE L'EXON 45 DANS L'ARN PRE-MESSAGER DU GENE DE LA DYSTROPHIE MUSCULAIRE DE DUCHENNE (METHODS AND MEANS FOR EFFICIENT SKIPPING OF EXON 45 IN DUCHENNE MUSCULAR DYSTROPHY PRE-MRNA) ⤷  Try a Trial
South Korea 20200139271 근육 이영양증의 치료를 위한 개선된 조성물 (IMPROVED COMPOSITIONS FOR TREATING MUSCULAR DYSTROPHY) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated 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.