Evrysdi is a drug owned by Genentech Inc. It is protected by 5 US drug patents filed from 2020 to 2024 out of which none have expired yet. Evrysdi's patents have been open to challenges since 07 August, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 04, 2038. Details of Evrysdi'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. | |||
| US9969754 | Compounds for treating spinal muscular atrophy |
May, 2035
(10 years from now) | Active |
| US9586955 | Compounds for treating spinal muscular atrophy |
Feb, 2033
(8 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11534444 | Treatment of SMA |
Oct, 2038
(13 years from now) | Active |
| US11938136 | Compositions for treating spinal muscular atrophy |
Nov, 2036
(11 years from now) | Active |
| US11827646 | Compounds for treating spinal muscular atrophy |
Jan, 2036
(11 years from now) | Active |
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 Evrysdi's patents.
Latest Legal Activities on Evrysdi's Patents
Given below is the list of recent legal activities going on the following patents of Evrysdi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eGrant Notification | 26 Mar, 2024 | US11938136 |
| Recordation of Patent eGrant | 26 Mar, 2024 | US11938136 |
| Recordation of Patent Grant Mailed Critical | 26 Mar, 2024 | US11938136 |
| Sequence Moved to Public Database | 26 Mar, 2024 | US11938136 |
| Email Notification Critical | 26 Mar, 2024 | US11938136 |
| Mail Patent eGrant Notification | 26 Mar, 2024 | US11938136 |
| Patent Issue Date Used in PTA Calculation Critical | 26 Mar, 2024 | US11938136 |
| Email Notification Critical | 07 Mar, 2024 | US11938136 |
| Issue Notification Mailed Critical | 06 Mar, 2024 | US11938136 |
| Dispatch to FDC | 21 Feb, 2024 | US11938136 |
FDA has granted several exclusivities to Evrysdi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Evrysdi, 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 Evrysdi.
Exclusivity Information
Evrysdi holds 5 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Evrysdi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | May 27, 2025 |
| New Chemical Entity Exclusivity(NCE) | Aug 07, 2025 |
| M(M-270) | Oct 03, 2026 |
| Orphan Drug Exclusivity(ODE-334) | Aug 07, 2027 |
| Orphan Drug Exclusivity(ODE-400) | May 27, 2029 |
US patents provide insights into the exclusivity only within the United States, but Evrysdi 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 Evrysdi's family patents as well as insights into ongoing legal events on those patents.
Evrysdi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Evrysdi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 04, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Evrysdi Generics:
There are no approved generic versions for Evrysdi as of now.
Alternative Brands for Evrysdi
Evrysdi which is used for treating spinal muscular atrophy., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Biogen Idec |
| |||
About Evrysdi
Evrysdi is a drug owned by Genentech Inc. It is used for treating spinal muscular atrophy. Evrysdi uses Risdiplam as an active ingredient. Evrysdi was launched by Genentech Inc in 2020.
Approval Date:
Evrysdi was approved by FDA for market use on 07 August, 2020.
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 Evrysdi is 07 August, 2020, its NCE-1 date is estimated to be 07 August, 2024.
Active Ingredient:
Evrysdi uses Risdiplam as the active ingredient. Check out other Drugs and Companies using Risdiplam ingredient
Treatment:
Evrysdi is used for treating spinal muscular atrophy.
Dosage:
Evrysdi is available in for solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.75MG/ML | FOR SOLUTION | Prescription | ORAL |