Sun Pharma sued by Mayne Pharma for patent infringement
Mayne Pharma has initiated legal action against Sun Pharma of India, alleging patents infringement related to a certain product designed to alleviate menopause-related vaginal pain, the Australian pharmaceutical company announced on Thursday.
The lawsuit was filed in the United States District Court for New Jersey, where Mayne Pharma claims that Sun Pharma has violated all 20 Orange Book-listed patents associated with IMVEXXY. IMVEXXY is a vaginal insert specifically intended to reduce pain during sexual intercourse following menopause.
Orange Book-listed patents are those approved by the US Food and Drug Administration (FDA) and deemed safe to use.
The Australian drugmaker said it filed the lawsuit after a notification indicated Sun Pharma's submission of an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of IMVEXXY.
The ANDA is a request filed to the health regulator for approval of an already licensed drug to manufacture the medication in the United States. These application processes do not warrant the applicant to go through a clinical trial.
Sun Pharma did not immediately respond to a Reuters' request for comment.
Mayne Pharma's complaint also indicated that Sun Pharma filed a Paragraph IV certification, suggesting the latter challenged the patent's (IMVEXXY) listing in the Orange Book as invalid 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.
IMVEXXY is distributed by TherapeuticsMD and had sealed the FDA's approval in 2018.
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