Sunshine Biopharma Inc. (NASDAQ: SBFM) announced it has received Canadian regulatory approval for its generic Dienogest 2mg tablets, the generic equivalent of the branded drug Visanne, used as a first-line therapy for pelvic pain associated with endometriosis.

The company said it expects the product to be ready to ship to Canadian pharmacies by the end of 2026. Distribution will be handled through its wholly owned Canadian subsidiary, Nora Pharma Inc.

According to market research firm Dataintelo, the global Dienogest market was valued at $2.8 billion in 2025 and is projected to reach $5.2 billion by 2034, at a compound annual growth rate of 7.8%.

Dienogest works by binding to progesterone receptors and reducing endometriosis-related tissue growth through local anti-inflammatory actions and mild hormone suppression.

"We are pleased to introduce Dienogest oral tablets as the newest addition to our expanding portfolio of high-quality generic medicines," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "With Dienogest widely used for the management of pelvic pain associated with endometriosis, this approval strengthens our position in the women's health market."

Sunshine Biopharma currently markets 60 generic prescription drugs in Canada and has approximately 12 additional drugs scheduled for launch in the remainder of 2026. The company also maintains a proprietary drug development program that includes an mRNA-lipid nanoparticle candidate targeting liver cancer and a small molecule inhibitor targeting SARS coronavirus infections.