Generic Dry Eye Drug Seeks FDA Approval

The FDA has received Akorn’s Paragraph IV filing seeking approval for its generic version of Allergan’s Restasis.

Allergan has received a notice letter from Akorn concerning the regulatory filing, as well as communication suggesting that the FDA may have received other Abbreviated New Drug Applications (ANDAs) for generic cyclosporine ophthalmic emulsion 0.05%.

Akorn’s Paragraph IV filing concerns Allergan’s Orange Book-listed patents that cover the formulation and method of use of Restasis, which is indicated to treat chronic dry eye disease.

Allergan has 5 such patents covering Restasis that are scheduled to expire in August 2024.

The company said it is “highly confident” in its intellectual property rights related to Restatis and intends “vigorously enforce” them.

Under the Hatch-Waxman Act, Allergan has 45 days from the date it received Akorn’s notice letter to file a patent infringement action against the generic company. If a suit is filed, the FDA cannot approve the ANDA until Akorn successfully defends the suit or until 30 months, whichever comes first.