Afamelanotide Patent Expiration
Afamelanotide is Used for managing phototoxic reactions in adult patients with Erythropoietic Protoporphyria (EPP) to increase pain-free light exposure. It was first introduced by Clinuvel Inc
Afamelanotide Patents
Given below is the list of patents protecting Afamelanotide, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Scenesse | US8334265 | Method of treatment of photodermatoses | Jan 20, 2033 | Clivunel Inc |
| Scenesse | US10076555 | Methods of inducing melanogenesis in a subject |
Feb 11, 2025
(Expired) | Clivunel Inc |
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 Afamelanotide's patents.
Latest Legal Activities on Afamelanotide's Patents
Given below is the list recent legal activities going on the following patents of Afamelanotide.
| 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 |
Afamelanotide's Family Patents
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Clinical Trials
Recent Clinical Trials on Afamelanotide:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients | Clinuvel Europe Limited | NA |
COMPLETED
(Jul 1, 2026)
| PHASE1, PHASE2 |