Viewing data from:

SCENESSE

NDA

AFAMELANOTIDE | N210797 | CLINUVEL INC

1 strength1 unique patent1 unique exclusivity

Patent Timeline

1 unique patent, 1 exclusivity by expiration date

Active (1)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

Today

Jan. 20, 2033

ODE-270

Oct. 8, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CLINUVEL INCAFAMELANOTIDE BULK DRUG SUBSTANCE

DMF 174712004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 13, 2024	SUPPL -7	View Letter (PDF)
Oct 10, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 16MG

RLD

1 patent1 exclusivity▴

IMPLANT;SUBCUTANEOUS | Approved: Oct 8, 2019

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8334265	Jan 20, 2033	—	—	—		—

Code	Date	Status
ODE-270	Oct 8, 2026	< 1 year