Arizona Tribune - Sunshine Biopharma Enters the $2.8 Billion Global Dienogest Market with Canadian Regulatory Approval

FORT LAUDERDALE, FL / ACCESS Newswire / August 4, 2026 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a leading pharmaceutical company specializing in generic and specialty prescription medications, is pleased to announce the approval of its generic Dienogest tablets of 2mg for the Canadian market. Dienogest is the generic equivalent of the brand name, Visanne^®.

Dienogest works through progesterone receptor binding, local anti-inflammatory actions, and mild hormone suppression. It reduces endometriosis pain by shrinking abnormal tissue growth.

According to Dataintelo, the global Dienogest market was valued at $2.8 billion in 2025 and is projected to reach $5.2 billion by 2034, expanding at a compound annual growth rate (CAGR) of 7.8%. According to IQVIA Pharmafocus 2028, the Canadian pharmaceutical market accounts for approximately 2.1% of the global pharmaceutical market and ranks as the sixth largest worldwide.

Sunshine Biopharma has established a robust distribution network across Canada through its wholly owned Canadian subsidiary, Nora Pharma Inc. The addition of Dienogest represents a strategic expansion for the Company into the area of women's health with first-line therapy for pelvic pain associated with endometriosis. The Company anticipates that its Dienogest will be ready to ship to pharmacies by the end of 2026.

"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 and underscores our commitment to delivering reliable therapies that meet critical patient needs."

About Sunshine Biopharma Inc.

Sunshine Biopharma currently has 60 generic prescription drugs on the market in Canada and approximately 12 additional drugs scheduled to be launched in the remainder of 2026. In addition, Sunshine Biopharma is conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA, an mRNA-Lipid Nanoparticle targeted for liver cancer, and (ii) PLpro protease inhibitor, a small molecule for treatment of SARS Coronavirus infections. For more information, please visit: www.sunshinebiopharma.com.

All registered trademarks are the property of their respective owners.

Safe Harbor Forward-Looking Statements

This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma Inc. (the "Company") that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company's drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company's filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company's most recent SEC filings.

For more information, please contact:

Camille Sebaaly, CFO
Direct Line: 514-814-0464
[email protected]

SOURCE: Sunshine Biopharma Inc.

View the original press release on ACCESS Newswire

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