VYONDYS 53 Drug Patent Profile
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When do Vyondys 53 patents expire, and when can generic versions of Vyondys 53 launch?
Vyondys 53 is a drug marketed by Sarepta Theraps Inc and is included in one NDA. There are eight patents protecting this drug.
This drug has thirty patent family members in thirteen countries.
The generic ingredient in VYONDYS 53 is golodirsen. One supplier is listed for this compound. Additional details are available on the golodirsen profile page.
DrugPatentWatch® Generic Entry Outlook for Vyondys 53
Vyondys 53 was eligible for patent challenges on December 12, 2023.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 12, 2026. This may change due to patent challenges or generic licensing.
There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for VYONDYS 53
| International Patents: | 30 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VYONDYS 53 |
| What excipients (inactive ingredients) are in VYONDYS 53? | VYONDYS 53 excipients list |
| DailyMed Link: | VYONDYS 53 at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VYONDYS 53
Generic Entry Date for VYONDYS 53*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING 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.
Anatomical Therapeutic Chemical (ATC) Classes for VYONDYS 53
US Patents and Regulatory Information for VYONDYS 53
VYONDYS 53 is protected by eight US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYONDYS 53 is ⤷ Try a Trial.
This potential generic entry date is based on INDICATED FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING.
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 VYONDYS 53
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
Patented Use: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 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
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 CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 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
Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting VYONDYS 53
INDICATED FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING
Exclusivity Expiration: ⤷ Try a Trial
NEW CHEMICAL ENTITY
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 | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 VYONDYS 53
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sarepta Theraps Inc | VYONDYS 53 | golodirsen | SOLUTION;INTRAVENOUS | 211970-001 | Dec 12, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VYONDYS 53
When does loss-of-exclusivity occur for VYONDYS 53?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Austria
Patent: 98685
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0110352
Estimated Expiration: ⤷ Try a Trial
Patent: 0160225
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 11447
Estimated Expiration: ⤷ Try a Trial
Patent: 17475
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 66010
Estimated Expiration: ⤷ Try a Trial
Patent: 06781
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 66010
Estimated Expiration: ⤷ Try a Trial
Patent: 06781
Estimated Expiration: ⤷ Try a Trial
Patent: 05200
Estimated Expiration: ⤷ Try a Trial
Patent: 00430
Estimated Expiration: ⤷ Try a Trial
Patent: 33332
Estimated Expiration: ⤷ Try a Trial
Patent: 29142
Estimated Expiration: ⤷ Try a Trial
Patent: 28711
Estimated Expiration: ⤷ Try a Trial
Patent: 08845
Estimated Expiration: ⤷ Try a Trial
Patent: 47096
Estimated Expiration: ⤷ Try a Trial
Patent: 72748
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2005026386
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 16545
Estimated Expiration: ⤷ Try a Trial
Patent: 45325
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 28632
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 66010
Estimated Expiration: ⤷ Try a Trial
Patent: 06781
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 66010
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 66010
Estimated Expiration: ⤷ Try a Trial
Patent: 06781
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 61325
Estimated Expiration: ⤷ Try a Trial
Patent: 64185
Estimated Expiration: ⤷ Try a Trial
Patent: 27917
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 VYONDYS 53 around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Lithuania | 2735568 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2007056466 | ⤷ Try a Trial | |
| Canada | 2542875 | ⤷ Try a Trial | |
| Canada | 2628093 | ⤷ Try a Trial | |
| Croatia | P20160225 | ⤷ Try a Trial | |
| Spain | 2657400 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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