Clinuvel Pharmaceuticals has the worldwide rights to the licence of analogues of alpha-MSH invented by scientists at the University of Arizona. In total there are 34 patents in the licence's patent family. The patents contain within their scope the use of numerous analogues of alpha-MSH for the induction of melanogenesis
A period of marketing exclusivity is established in the major marketing jurisdictions globally. This basically affords protection for a period of 7 years in the US and Australia/New Zealand and 6-10 years (plus a further 1 to 3 years for the generic registration process) in Europe.
Clinuvel’s current patent portfolio:
|
Patent Application |
Expiry |
Comment |
|
Composition of matter |
2018 |
|
|
Method of inducing melanogenesis |
2024 |
MC1R Allele variations |
|
Methods of inducing melanogenesis in a subject |
2025 |
Sustained release formulations |
|
Method for reducing incidence or rate of development of skin cancers |
2027 |
Skin cancer in immunocompromised patients |
|
Methods of treatment of photodermatoses |
2028 |
Photodermatoses (eg. EPP, SU) |
|
Method of treatment of photosensitivity and phototoxicity following photosensitising PDT |
2028 |
PDT |
|
Melanogenesis and skin protection |
2024 |
Topical formulations |
|
Method for inducing photoprotection and DNA protection |
2028 |
|
Orphan Drug Designations
Clinuvel has obtained Orphan Drug Designations (ODDs) for afamelanotide for the indications porphyria (EPP) and solar urticaria (SU) in Europe and the USA. ODD status entitles Clinuvel to market exclusivity in the USA and European Union’s 27 member states (plus Lichtenstein and Norway) for seven and ten years respectively.
Together with its extensive data on afamelanotide and clinical trials, Clinuvel is in a strong position to retain the exclusive rights to afamelanotide and its analogues.
