Dayvigo is a drug owned by Eisai Inc. It is protected by 4 US drug patents filed from 2020 to 2024 out of which none have expired yet. Dayvigo's patents have been open to challenges since 07 April, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 21, 2035. Details of Dayvigo'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. | |||
| US8268848 | Cyclopropane compound |
Sep, 2031
(6 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). | |||
| US10702529 | Compositions and methods for treating insomnia |
Oct, 2035
(10 years from now) | Active |
| US10188652 | Compositions and methods for treating insomnia |
Oct, 2035
(10 years from now) | Active |
| US11026944 | Compositions and methods for treating insomnia |
Oct, 2035
(10 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 Dayvigo's patents.
Latest Legal Activities on Dayvigo's Patents
Given below is the list of recent legal activities going on the following patents of Dayvigo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Mar, 2024 | US8268848 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 28 Dec, 2023 | US10702529 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jul, 2022 | US10188652 |
| Initial letter Re: PTE Application to regulating agency | 12 Jul, 2021 | US8268848 |
| Patent Issue Date Used in PTA Calculation Critical | 08 Jun, 2021 | US11026944 |
| Recordation of Patent Grant Mailed Critical | 08 Jun, 2021 | US11026944 |
| Email Notification Critical | 20 May, 2021 | US11026944 |
| Issue Notification Mailed Critical | 19 May, 2021 | US11026944 |
| Application Is Considered Ready for Issue Critical | 07 May, 2021 | US11026944 |
| Dispatch to FDC | 06 May, 2021 | US11026944 |
FDA has granted several exclusivities to Dayvigo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Dayvigo, 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 Dayvigo.
Exclusivity Information
Dayvigo holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Dayvigo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 07, 2025 |
| M(M-293) | Apr 20, 2026 |
US patents provide insights into the exclusivity only within the United States, but Dayvigo 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 Dayvigo's family patents as well as insights into ongoing legal events on those patents.
Dayvigo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Dayvigo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 21, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Dayvigo Generics:
There are no approved generic versions for Dayvigo as of now.
About Dayvigo
Dayvigo is a drug owned by Eisai Inc. It is used for treating insomnia in adults with difficulties in sleep onset and/or sleep maintenance. Dayvigo uses Lemborexant as an active ingredient. Dayvigo was launched by Eisai Inc in 2020.
Approval Date:
Dayvigo was approved by FDA for market use on 07 April, 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 Dayvigo is 07 April, 2020, its NCE-1 date is estimated to be 07 April, 2024.
Active Ingredient:
Dayvigo uses Lemborexant as the active ingredient. Check out other Drugs and Companies using Lemborexant ingredient
Treatment:
Dayvigo is used for treating insomnia in adults with difficulties in sleep onset and/or sleep maintenance.
Dosage:
Dayvigo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |