Mayne Pharma Sues Sun Pharma Over IMVEXXY Patent Infringement

The Australian pharmaceutical company Mayne Pharma said on Thursday that it has sued Sun Pharma of India for patent infringements pertaining to a particular medicine used to treat vaginal discomfort associated with menopause.

Mayne Pharma sued its rival, IMVEXXY, a vaginal implant designed to lessen discomfort during sexual activity after menopause, alleging that the competitor had violated all 20 Orange Book-listed patents. The complaint was filed in the United States District Court for New Jersey.Patents that have been authorised by the US Food and Drug Administration (FDA) and determined to be safe for use are recorded in the Orange Book.

The Australian pharmaceutical company stated that it brought the case in response to notice that Sun Pharma had submitted an Abbreviated New Drug Application (ANDA) to the FDA in an attempt to get permission to sell a generic version of IMVEXXY. The ANDA is a request for approval of a medicine that is already licensed to be manufactured in the United States that is submitted to the health regulator. The applicant is not required to participate in a clinical study via these application procedures.

Sun Pharma allegedly submitted a Paragraph IV certification, arguing that the patent's (IMVEXXY) Orange Book listing was invalid or unapplicable, according to Mayne Pharma's lawsuit.This "formally initiates the litigation process under the Hatch-Waxman Act and triggers a 30-month stay of any potential FDA approval for Sun Pharma's ANDA," Mayne Pharma stated in a statement.