ACRUX TIMELINE
Acrux incorporated
First US patent granted
Veterinary licensed to Elanco globally (including Recuvyra®)
Acrux listed on ASX (ACR:ASX)
Evamist® licensed to KV Pharmaceutical in US
Evamist® launched by KV Pharmaceutical
Acrux initiates Axiron® Phase III clinical trial
Acrux submits Axiron® NDA to FDA
Axiron® licensed to Eli Lilly globally
Axiron® launched by Eli Lilly
Evamist® licensed to Perrigo in US
Initiated generic programs
Lenzetto® launched in Europe
Active pipeline of 10 generic products.
Axiron® was withdrawn from the US market on 5th of September 2017 due to the launch of generic versions.
Submitted first two ANDA (generic) products to the FDA for review
Submitted third ANDA (generic) product to the FDA for review.
Active pipeline of 14 generic products.
Development agreement with Amring Pharmaceuticals and marketing and distribution agreements with DASH Pharmaceuticals and TruPharma LLC .
3 ANDAs approved by the FDA
• Jan 2021 - Testosterone Topical Solution 30mg/1.5ml
• June 2021 - Efinaconazole Topical Solution 10%
• July 2021 - Lidocaine and Prilocaine Cream USP, 2.5%/2.5%
2 additional ANDAs submitted to FDA for review.