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-six 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
Summary for EXONDYS 51
| International Patents: | 126 |
| 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 |
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
| Sponsor | Phase |
|---|---|
| Sarepta Therapeutics, Inc. | Phase 3 |
| Sarepta Therapeutics | Phase 3 |
| Catabasis Pharmaceuticals | Phase 1/Phase 2 |
Pharmacology for EXONDYS 51
| Drug Class | Antisense Oligonucleotide |
Anatomical Therapeutic Chemical (ATC) Classes 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 ⤷ 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
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: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||
| 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 | ||||
| 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 | 206488-001 | Sep 19, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | Sep 19, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | 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 | 206488-002 | 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 |
| Sarepta Theraps Inc | EXONDYS 51 | eteplirsen | SOLUTION;INTRAVENOUS | 206488-001 | 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 |
|---|---|---|---|
| Canada | 2550642 | COMPOSE OLIGONUCLEOTIDIQUE ET METHODE DE TRAITEMENT D'INFECTIONS PAR NIDOVIRUS (OLIGONUCLEOTIDE COMPOUND AND METHOD FOR TREATING NIDOVIRUS INFECTIONS) | ⤷ Try a Trial |
| European Patent Office | 1954836 | Composé destiné à l'immunodépression et procédé de traitement (Immunosuppression compound and treatment method) | ⤷ Try a Trial |
| Israel | 278912 | תכשירים משופרים לטיפול דיסטרופיה של השרירים (Improved compositions for treating muscular dystrophy) | ⤷ Try a Trial |
| Cyprus | 1117475 | ⤷ Try a Trial | |
| China | 101896186 | Means and methods for counteracting muscle disorders | ⤷ Try a Trial |
| Canada | 2584873 | COMPOSES ANTIVIRAUX ANTISENS ET METHODES DE TRAITEMENT D'INFECTION PAR UN FILOVIRUS (ANTISENSE ANTIVIRAL COMPOUNDS AND METHODS FOR TREATING A FILOVIRUS INFECTION) | ⤷ 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.
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