Patents listed in the Orange Book are patents that have been approved by the U.S. Food and Drug Administration (FDA) and are considered safe for use.
Mayne Pharma has filed a lawsuit against India’s Sun Pharma alleging patent infringements related to a certain product used for vaginal pain during menopause, the Australian drugmaker said on Thursday.
In the lawsuit filed in the U.S. District Court for New Jersey, Mayne Pharma accuses its competitor of infringing all 20 Orange Book patents related to IMVEXXY, a vaginal insert intended to reduce pain during intercourse after menopause.
Patents listed in the Orange Book are patents that have been approved by the U.S. Food and Drug Administration (FDA) and are considered safe for use.
The Australian drugmaker said it filed the lawsuit after a report emerged that Sun Pharma had submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to market a generic version of IMVEXXY.
The ANDA is a request submitted to the health regulator for approval of an already licensed drug to manufacture the drug in the United States. These application procedures do not guarantee that the applicant will undergo a clinical trial.
Sun Pharma did not immediately respond to a Reuters request for comment.
Mayne Pharma’s complaint also revealed that Sun Pharma had filed a Paragraph IV certification, which showed that Sun Pharma had challenged the listing of the patent (IMVEXXY) in the Orange Book as invalid or inapplicable.
“This formally initiates the legal process under the Hatch-Waxman Act and initiates a 30-month suspension of potential FDA approval for Sun Pharma’s ANDA,” Mayne Pharma said in a statement.
IMVEXXY is distributed by TherapeuticsMD and received FDA approval in 2018.
(Only the headline and image of this report may have been edited by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
First print: Jul 25, 2024 | 08:38 AM IST