Exondys 51 is a drug owned by Sarepta Therapeutics Inc. It is protected by 12 US drug patents filed from 2016 to 2021. Out of these, 10 drug patents are active and 2 have expired. Exondys 51's patents have been open to challenges since 19 September, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 14, 2034. Details of Exondys 51's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9243245 | Means and methods for counteracting muscle disorders |
Oct, 2028
(3 years from now) | Active |
| US9018368 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(6 months from now) | Active |
| US10781451 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(6 months from now) | Active |
| US9416361 | Splice-region antisense composition and method |
May, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10364431 | Compositions for treating muscular dystrophy |
Mar, 2034
(9 years from now) | Active |
| US10337003 | Compositions for treating muscular dystrophy |
Mar, 2034
(9 years from now) | Active |
| US9506058 | Compositions for treating muscular dystrophy |
Mar, 2034
(9 years from now) | Active |
| USRE47769 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Feb, 2029
(4 years from now) | Active |
| USRE48468 | Means and methods for counteracting muscle disorders |
Oct, 2028
(3 years from now) | Active |
| US8486907 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(6 months from now) | Active |
| USRE47751 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(6 months from now) | Active |
| US10533174 | Splice-region antisense composition and method |
May, 2021
(3 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Exondys 51's patents.
Latest Legal Activities on Exondys 51's Patents
Given below is the list of recent legal activities going on the following patents of Exondys 51.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 May, 2024 | US9506058 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Mar, 2024 | US10781451 |
| Expire Patent Critical | 19 Feb, 2024 | US10533174 |
| Maintenance Fee Reminder Mailed Critical | 04 Sep, 2023 | US10533174 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Jan, 2023 | US10364431 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Dec, 2022 | US10337003 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Oct, 2022 | US9018368 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 30 Mar, 2021 | US9018368 |
| Withdrawal of Application for PTE Critical | 29 Jan, 2021 | US9018368 |
| Notice of Final Determination -Election Required | 08 Dec, 2020 | US9018368 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Exondys 51 and ongoing litigations to help you estimate the early arrival of Exondys 51 generic.
Exondys 51's Litigations
Exondys 51 been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Sep 29, 2015, against patent number US8486907. The petitioner , challenged the validity of this patent, with Stephen Donald Wilton et al as the respondent. Click below to track the latest information on how companies are challenging Exondys 51's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8486907 | September, 2015 |
Decision
(29 Sep, 2015) | Stephen Donald Wilton et al | |
FDA has granted some exclusivities to Exondys 51. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Exondys 51, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Exondys 51.
Exclusivity Information
Exondys 51 holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Exondys 51's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 19, 2021 |
| Orphan Drug Exclusivity(ODE) | Sep 19, 2023 |
| Orphan Drug Exclusivity(ODE-122) | Sep 19, 2023 |
Several oppositions have been filed on Exondys 51's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Exondys 51's generic, the next section provides detailed information on ongoing and past EP oppositions related to Exondys 51 patents.
Exondys 51's Oppositions Filed in EPO
Exondys 51 has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 24, 2015, by Howard Wright/ Nicholas Wallin/ Withers & Rogers Llp. This opposition was filed on patent number EP09788160A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP17171389A | Jan, 2023 | Maiwald GmbH | Granted and Under Opposition |
| EP17171389A | Jan, 2023 | Bosch Jehle Patentanwaltsgesellschaft mbH | Granted and Under Opposition |
| EP13160338A | Oct, 2016 | Withers & Rogers LLP/Wright Howard/Wallin Nicholas | Revoked |
| EP08842559A | Sep, 2016 | Withers & Rogers LLP | Revoked |
| EP10004274A | Aug, 2016 | Nippon Shinyaku Co., Ltd. | Revoked |
| EP09788160A | Sep, 2015 | Howard Wright/ Nicholas Wallin/ Withers & Rogers LLP | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Exondys 51 is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Exondys 51's family patents as well as insights into ongoing legal events on those patents.
Exondys 51's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Exondys 51's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 14, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Exondys 51 Generics:
There are no approved generic versions for Exondys 51 as of now.
About Exondys 51
Exondys 51 is a drug owned by Sarepta Therapeutics Inc. It is used for treating Duchenne Muscular Dystrophy by increasing the production of functional dystrophin protein in patients with a specific gene mutation amenable to exon 51 skipping. Exondys 51 uses Eteplirsen as an active ingredient. Exondys 51 was launched by Sarepta Theraps Inc in 2016.
Approval Date:
Exondys 51 was approved by FDA for market use on 19 September, 2016.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Exondys 51 is 19 September, 2016, its NCE-1 date is estimated to be 19 September, 2020.
Active Ingredient:
Exondys 51 uses Eteplirsen as the active ingredient. Check out other Drugs and Companies using Eteplirsen ingredient
Treatment:
Exondys 51 is used for treating Duchenne Muscular Dystrophy by increasing the production of functional dystrophin protein in patients with a specific gene mutation amenable to exon 51 skipping.
Dosage:
Exondys 51 is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG/10ML (50MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 100MG/2ML (50MG/ML) | SOLUTION | Prescription | INTRAVENOUS |