CHADDS FORD, Pa. — Mylan has announced its intention to market a version of a painkiller made by Endo Pharmaceuticals and partner company Teikoku Seiyaku ahead of patent expiration.
Endo said Monday that Teikoku Seiyaku and U.S. subsidiary Teikoku Pharma USA had received a Paragraph IV certification from Mylan stating the latter’s intention to market a generic lidocaine topical patch. The drug is a generic version of Endo’s and Teikoku’s Lidoderm.
Under the Hatch-Waxman Act of 1984, a Paragraph IV certification is an assertion included with a regulatory approval application that the patents covering a drug are invalid, unenforceable or won’t be infringed by a generic version. In this case, the certification refers to patents that expire in March 2014 and October 2015.
Endo said it would “vigorously defend” its intellectual property rights. Under Hatch-Waxman, the drug maker is allowed to sue Mylan for patent infringement, which would put an automatic stay of final Food and Drug Administration approval on Mylan’s generic version that would expire after 30 months or when the companies reach a settlement.