The Australian pharmaceutical company Mayne Pharma, on Thursday, 25 July, announced that it has initiated legal action against Sun Pharma, alleging infringement of patents tied to a menopause-related vaginal pain treatment. 

The lawsuit, filed in the United States District Court for New Jersey, claims Sun Pharma violated all 20 Orange Book-listed patents for IMVEXXY, a vaginal insert designed to alleviate post-menopausal sexual pain. 

The Orange Book contains a list of patents that the US Food and Drug Administration (FDA) has approved and deemed safe for use.

The Australian pharmaceutical company said that it filed the lawsuit after learning that Sun Pharma has applied to the FDA for approval to market a generic version of IMVEXXY through an abbreviated new drug application (ANDA).

The ANDA is a request that is made to the health regulation in order to approve a medication that is already authorised for manufacture in the United States. Using these application methods does not obligate the applicant to take part in a clinical investigation.

Sun Pharma allegedly submitted a Paragraph IV certification, according to Mayne Pharma’s complaint, asserting that the patent’s (IMVEXXY) Orange Book listing was null and void or inapplicable.

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 said in a statement.

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