Scenesse is a drug owned by Clinuvel Inc. It is protected by 2 US drug patents filed in 2019 out of which none have expired yet. Scenesse's patents have been open to challenges since 09 October, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 11, 2029. Details of Scenesse's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8334265 | Method of treatment of photodermatoses |
Mar, 2029
(4 years from now) | Active |
| US10076555 | Methods of inducing melanogenesis in a subject |
Feb, 2025
(2 months 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 Scenesse's patents.
Latest Legal Activities on Scenesse's Patents
Given below is the list of recent legal activities going on the following patents of Scenesse.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Yr, Small Entity | 10 Jun, 2024 | US8334265 |
| Patent Term Extension Certificate Critical | 25 May, 2023 | US8334265 |
| Notice of Final Determination -Eligible | 17 Apr, 2023 | US8334265 |
| FDA Final Eligibility Letter Critical | 01 Aug, 2022 | US8334265 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 14 Mar, 2022 | US10076555 |
| transaction for FDA Determination of Regulatory Review Period | 04 Nov, 2021 | US8334265 |
| transaction for FDA Determination of Regulatory Review Period | 22 Oct, 2021 | US8334265 |
| Second letter to regulating agency to determine regulatory review period | 31 Mar, 2021 | US8334265 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 10 Jun, 2020 | US8334265 |
| Letter from FDA or Dept of Agriculture re PTE application | 26 May, 2020 | US8334265 |
FDA has granted several exclusivities to Scenesse. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Scenesse, 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 Scenesse.
Exclusivity Information
Scenesse holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Scenesse's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 08, 2024 |
| Orphan Drug Exclusivity(ODE-270) | Oct 08, 2026 |
US patents provide insights into the exclusivity only within the United States, but Scenesse 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 Scenesse's family patents as well as insights into ongoing legal events on those patents.
Scenesse's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Scenesse's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 11, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Scenesse Generics:
There are no approved generic versions for Scenesse as of now.
About Scenesse
Scenesse is a drug owned by Clinuvel Inc. It is used for managing phototoxic reactions in adult patients with Erythropoietic Protoporphyria (EPP) to increase pain-free light exposure. Scenesse uses Afamelanotide as an active ingredient. Scenesse was launched by Clivunel Inc in 2019.
Approval Date:
Scenesse was approved by FDA for market use on 08 October, 2019.
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 Scenesse is 08 October, 2019, its NCE-1 date is estimated to be 09 October, 2023.
Active Ingredient:
Scenesse uses Afamelanotide as the active ingredient. Check out other Drugs and Companies using Afamelanotide ingredient
Treatment:
Scenesse is used for managing phototoxic reactions in adult patients with Erythropoietic Protoporphyria (EPP) to increase pain-free light exposure.
Dosage:
Scenesse is available in implant form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 16MG | IMPLANT | Prescription | SUBCUTANEOUS |