Acrux (ASX:ACR) has announced the US Food and Drug Administration has accepted for review its Paragraph IV Abbreviated New Drug Application (ANDA) dossier for its generic version of Jublia (efinaconazole) topical solution, 10%.
The company said its ANDA contains the required data that allows it to demonstrate to the FDA its generic product is bioequivalent to Jublia.
Once approved by the FDA, and subject to the litigation process typical for first generic products, Acrux said it will be able to commence marketing and sales of Efinaconazole Topical Solution 10% in the US.
In the US, a 180-day period of exclusivity is granted on final approval to the applicant that is first-to-file a substantially complete ANDA for a generic.
Jublia is indicated for the topical treatment of onychomycosis, also known as tinea unguium. Onychomycosis is a fungal infection of the nail that can result in thickening and yellowing of the nail and can result in separation from the nail bed. Annual US sales for Jublia for the 12 months ended March 2018 were US$283 million.
According to Acrux CEO Michael Kotsanis, “We are pleased that the first product in our current pipeline of 13 generic topical products is now being reviewed by the FDA for approval.
"This first-to-file Paragraph IV ANDA is the first example of our investment in our topical generic strategy and is the result of the great work by our R&D team. We look forward to updating the market on the outcomes of this application, and continued progress across our topical generic product portfolio.”