The product is the first generic version of Valeant Pharmaceuticals International’s (Valeant’s) Zovirax ointment (aciclovir 5%), which is indicated in the management of initial genital herpes and in limited non-life threatening mucocutaneous herpes simplex virus infections in immunocompromised patients.

Acyclovir ointment 5% had US sales of approximately US$230 million during 2012, according to IMS Health.

Canada-based Valeant responded to the approval by saying that ‘although not unexpected’ they had not included the generic launch in their budget predictions and therefore expected competition from Mylan’s generic to reduce the company’s profits.

Valeant is, however, not taking the news lying down. It announced on 5 April 2013 that it had entered into an agreement with generics giant Actavis, formerly Watson, to be the exclusive marketer and distributor of an authorized generic of Valeant’s Zovirax ointment (acyclovir 5%).

Mylan currently has 178 ANDAs pending FDA approval representing US$78.4 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing US$20.3 billion in annual brand-name sales, for the 12 months ending 30 June 2012, according to IMS Health.

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