Amondys 45 is a drug owned by Sarepta Therapeutics Inc. It is protected by 9 US drug patents filed from 2021 to 2022. Out of these, 7 drug patents are active and 2 have expired. Amondys 45's patents have been open to challenges since 25 February, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 12, 2030. Details of Amondys 45'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. | |||
| US9228187 | Antisense molecules and methods for treating pathologies |
Nov, 2030
(5 years from now) | Active |
| US10287586 | Antisense molecules and methods for treating pathologies |
Nov, 2030
(5 years from now) | Active |
| US8524880 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Apr, 2026
(11 months from now) | Active |
| US9447415 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(2 months from now) | Active |
| USRE48960 | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
Jun, 2025
(2 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). | |||
| US9758783 | Antisense molecules and methods for treating pathologies |
Nov, 2030
(5 years from now) | Active |
| US10781450 | Antisense molecules and methods for treating pathologies |
Nov, 2030
(5 years 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 Amondys 45's patents.
Latest Legal Activities on Amondys 45's Patents
Given below is the list of recent legal activities going on the following patents of Amondys 45.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Mar, 2024 | US10781450 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Mar, 2024 | US9447415 |
| Expire Patent Critical | 19 Feb, 2024 | US10533174 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US9447415 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US10287586 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US10781450 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US9228187 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US8524880 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US9758783 |
| Maintenance Fee Reminder Mailed Critical | 04 Sep, 2023 | US10533174 |
FDA has granted several exclusivities to Amondys 45. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Amondys 45, 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 Amondys 45.
Exclusivity Information
Amondys 45 holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Amondys 45's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 25, 2026 |
| Orphan Drug Exclusivity(ODE-347) | Feb 25, 2028 |
Several oppositions have been filed on Amondys 45'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 Amondys 45's generic, the next section provides detailed information on ongoing and past EP oppositions related to Amondys 45 patents.
Amondys 45's Oppositions Filed in EPO
Amondys 45 has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 25, 2016, by Nippon Shinyaku Co., Ltd.. This opposition was filed on patent number EP10004274A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10004274A | Aug, 2016 | Nippon Shinyaku Co., Ltd. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Amondys 45 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 Amondys 45's family patents as well as insights into ongoing legal events on those patents.
Amondys 45's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Amondys 45's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 12, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Amondys 45 Generics:
There are no approved generic versions for Amondys 45 as of now.
About Amondys 45
Amondys 45 is a drug owned by Sarepta Therapeutics Inc. It is used for treating Duchenne Muscular Dystrophy (DMD) in patients with a mutation of the DMD gene amenable to exon 45 skipping. Amondys 45 uses Casimersen as an active ingredient. Amondys 45 was launched by Sarepta Theraps Inc in 2021.
Approval Date:
Amondys 45 was approved by FDA for market use on 25 February, 2021.
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 Amondys 45 is 25 February, 2021, its NCE-1 date is estimated to be 25 February, 2025.
Active Ingredient:
Amondys 45 uses Casimersen as the active ingredient. Check out other Drugs and Companies using Casimersen ingredient
Treatment:
Amondys 45 is used for treating Duchenne Muscular Dystrophy (DMD) in patients with a mutation of the DMD gene amenable to exon 45 skipping.
Dosage:
Amondys 45 is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/2ML (50MG/ML) | SOLUTION | Prescription | INTRAVENOUS |