The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Kerydin Topical Solution, 5%, of Anacor Pharmaceuticals, Inc. (Anacor). Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
Tavaborole Topical Solution, 5% has an estimated market size of US$ 82 million for twelve months ending June 2020 according to IQVIA. Alembic is currently in litigation with Anacor in District Court of Delaware and launch of the product will depend on litigation outcome.
Alembic has a cumulative total of 128 ANDA approvals (112 final approvals and 16 tentative approvals) from USFDA.
Alembic Pharmaceuticals Ltd is currently trading at Rs1,084.75, up by Rs8.55 or 0.79% from its previous closing of Rs1,076.20 on the BSE.