Allergan Faces Battle Over Generic Restasis
Allergan plc (the corporate name for the recently combined Allergan and Actavis) has received a notice letter dated July 10, 2015 from Akorn Pharmaceuticals stating that the US Food and Drug Administration (FDA) has received Akorn’s abbreviated new drug application (ANDA) containing a Paragraph IV patent certification seeking approval to market a generic version of Allergan’s Restasis (cyclosporine ophthalmic emulsion) 0.05% product. In addition, Allergan has received communication suggesting that additional ANDAs for generic versions of Restasis may have been received by the FDA.
A Paragraph IV filing refers to when a generic company files an ANDA and certifies against patents listed in the Orange Book that its generic product does not infringe on the listed patents or that those patents are not enforceable. The notice letter received from Akorn states that the Paragraph IV patent certification was made with respect to certain US patents covering the formulation and method of use of the Restasis product, which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Allergan has five Orange Book-listed patents covering Restasis that are scheduled to expire in August 2024.
In a statement, Allergan said that it ” is highly confident in its intellectual property rights relating to Restasis and intends to vigorously enforce such rights in all applicable venues. ”
Restasis, which is indicated for treating dry eye, is Allergan’s top-selling drug in its eye-care franchise with the overall franchise posting 2014 sales of $3.26 billion. According to Allergan’s 2014 annual filing, it is the largest eye drop by value worldwide, the largest prescription ophthalmic pharmaceutical by sales value in the United States. Restasis was launched in the United States in 2003 and is currently approved in approximately 35 countries.