Sun Pharma sued by Australian drug maker for patent infringement; stock trades lower

Mayne Pharma Group filed a lawsuit against Sun Pharma at the United States District Court for New Jersey. The Australian drugmaker has claimed that Sun Pharma violated all 20 Orange Book-listed patents for IMVEXXY. IMVEXXY, distributed by TherapeuticsMD, is a vaginal insert that reduces pain during sexual intercourse after menopause for women. Mayne Pharma Group had received approval from the USFDA for IMVEXXY in 2018.

Orange Book-listed patents are approved by the United States Food and Drug Administration (USFDA) and are classified to be safe for use.

The lawsuit filed by Mayne Pharma Group resulted in a 30-month stay on USFDA approval for Sun Pharma’s Abbreviated New Drug Application (ANDA). Mayne Pharma also stated that Sun Pharma challenged IMVEXXY’s patent listing in the Orange Book as invalid by filing a Paragraph IV certification.

Mayne Pharma is a specialty pharmaceutical company that is listed on the ASX. The company focused on commercialising branded and generic versions of drugs.

Sun Pharma announced on Wednesday that the company was informed by the USFDA to make public, the contents of a warning letter issued by the FDA for the company’s Dadra facility. The company provided further clarification stating that the warning letter issued by USFDA has no impact on the company’s financials, operations, or other activities.

Sun Pharma will be announcing its financial results for the first quarter of FY25 on August 1, 2024.

Shares of the company have risen by nearly 23% since the beginning of the year. The stock has gained over 47% in the past year.