Sunshine Biopharma Launches Generic Lurasidone for Schizophrenia in the Canadian Sector of the Global $1.2 Billion Market

Rhea-AI Summary

Sunshine Biopharma (NASDAQ:SBFM) has announced the launch of generic Lurasidone through its Canadian subsidiary Nora Pharma. The drug, a generic version of Latuda®, is designed for treating schizophrenia and bipolar depression. Available in 20mg, 40mg, 60mg, and 80mg strengths, the medication comes in 30-tablet bottles. The global Lurasidone market, valued at $1.2 billion in 2024, is projected to reach $2.5 billion by 2033, growing at an 8.01% CAGR. While Canada represents 2.2% of the global pharmaceutical market, it ranks as the eighth-largest pharmaceutical market globally. The Canadian generic drugs market, currently at $9.4 billion, is expected to reach $19.2 billion by 2032.

Positive

• Entry into the growing global Lurasidone market valued at $1.2 billion
• Multiple dosage strengths (20mg, 40mg, 60mg, 80mg) offering treatment flexibility
• Targeting Canada's expanding generic drugs market projected to reach $19.2 billion by 2032
• Positioning in a market with 8.01% CAGR potential through 2033

Negative

• Limited initial market reach as launch is only in Canada (2.2% of global pharmaceutical market)
• Competition in an established generic drug market
• Dependence on market adoption and prescription patterns

Insights

Pharmaceutical Industry Analyst

Sunshine Biopharma enters $26.4M Canadian Lurasidone market with multi-dosage generic, strategically expanding their mental health portfolio.

Sunshine Biopharma's launch of generic Lurasidone through its Canadian subsidiary Nora Pharma represents a calculated expansion into the antipsychotic medication market. The timing is strategic, with the global Lurasidone market currently valued at $1.2 billion and projected to reach $2.5 billion by 2033, growing at a 8.01% CAGR.

The Canadian pharmaceutical landscape, while representing just 2.2% of the global market, still ranks as the eighth-largest worldwide. This positions the Lurasidone launch to potentially capture a portion of approximately $26.4 million in annual opportunity based on Canada's share of the global Lurasidone market.

The company's approach of offering multiple dosage strengths (20mg, 40mg, 60mg, and 80mg) demonstrates sound pharmaceutical strategy to maximize prescriber flexibility and patient coverage. This comprehensive dosing range allows for personalized treatment approaches for both schizophrenia and bipolar depression indications.

This product introduction aligns with broader pharmaceutical industry trends toward addressing mental health conditions, a therapeutic area experiencing increased awareness and demand. The launch appears to be part of a deliberate portfolio expansion strategy, as indicated by CEO Dr. Steve Slilaty's statement about launching "additional, much needed products in 2025" to strengthen their position in Canada's $9.4 billion generic drugs market, which is projected to reach $19.2 billion by 2032.

Healthcare Economics Expert

Generic Lurasidone launch increases affordable mental health treatment access in Canada, potentially improving patient outcomes and healthcare system efficiency.

The introduction of generic Lurasidone in Canada represents a meaningful development for mental healthcare accessibility. By providing a generic alternative to Latuda®, Sunshine Biopharma addresses treatment needs for two serious mental health conditions: schizophrenia and bipolar depression.

Generic medications typically provide substantial cost advantages compared to branded counterparts. For chronic conditions requiring long-term medication management, these savings compound over time, benefiting both individual patients and the broader healthcare system. The availability of multiple dosage strengths (20mg, 40mg, 60mg, and 80mg) in 30-tablet bottles supports appropriate clinical customization, which is particularly important for psychiatric medications where optimal dosing is crucial for treatment effectiveness.

The timing aligns with increasing focus on mental health treatment availability. As noted in the press release, the growth in market size for Lurasidone is "driven by increasing awareness of mental health disorders and the demand for effective treatments." The Canadian generic pharmaceutical market, currently valued at $9.4 billion and projected to reach $19.2 billion by 2032, reflects the growing importance of affordable medication options in healthcare delivery.

From a healthcare economics perspective, improving access to effective treatments for serious mental health conditions can yield significant benefits beyond direct medication costs, potentially reducing hospitalizations, emergency care utilization, and other high-cost interventions while improving quality of life for affected individuals.

FORT LAUDERDALE, F / ACCESS Newswire / May 6, 2025 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a pharmaceutical company offering and researching life-saving medicines in a variety of therapeutic areas including oncology and antivirals today announced that its wholly owned Canadian subsidiary, Nora Pharma Inc., has launched Lurasidone, a new generic prescription drug in the therapeutic class of antipsychotics.

Lurasidone is a generic version of Latuda^®. Lurasidone is indicated for the management of schizophrenia and bipolar depression. Nora Pharma's Lurasidone is available in strengths of 20 mg, 40 mg, 60 mg, and 80 mg and comes in bottles of 30 tablets.

According to Verified Market Reports, the global market size of Lurasidone was valued at approximately $1.2 billion in 2024 and is projected to grow to $2.5 billion by 2033, with a compound annual growth rate (CAGR) of approximately 8.01%. The growth in market size for Lurasidone is driven by increasing awareness of mental health disorders and the demand for effective treatments.

Canada represents approximately 2.2% of the global pharmaceutical market (Made in CA). Despite its relatively small share, Canada is ranked as the eighth-largest pharmaceutical market in the world (Statista). Factors contributing to Canada's prominence in this sector include innovative pharmaceutical sector, aging population, and increasing healthcare expenditures.

"We are committed to strengthening our position in Canada's $9.4 billion generic drugs market, which is projected to reach $19.2 billion by 2032," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "As we launch additional, much needed products in 2025, we aim to enhance accessibility to affordable, high-quality medications, improving the lives of patients nationwide."

About Sunshine Biopharma Inc.

Sunshine Biopharma currently has 70 generic prescription drugs on the market in Canada and more than 15 additional drugs scheduled to be launched in the remainder of 2025. Among the new drugs to be launched is NIOPEG®, a biosimilar of NEULASTA®. Like NEULASTA®, NIOPEG® is a long-acting form of recombinant human granulocyte colony-stimulating factor (filgrastim). It is indicated to decrease the incidence of infection in patients with non-myeloid malignancies receiving anti-neoplastic therapy. 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
camille.sebaaly@sunshinebiopharma.com

SOURCE: Sunshine Biopharma Inc.

View the original press release on ACCESS Newswire

FAQ

What is the market size for Lurasidone that SBFM is entering?

The global Lurasidone market was valued at $1.2 billion in 2024 and is projected to grow to $2.5 billion by 2033, with an 8.01% CAGR.

What dosage strengths is Sunshine Biopharma's generic Lurasidone available in?

Nora Pharma's Lurasidone is available in strengths of 20 mg, 40 mg, 60 mg, and 80 mg, packaged in bottles of 30 tablets.

What conditions does SBFM's generic Lurasidone treat?

Lurasidone is indicated for the management of schizophrenia and bipolar depression.

What is the size of the Canadian generic drugs market that SBFM is targeting?

The Canadian generic drugs market is currently $9.4 billion and is projected to reach $19.2 billion by 2032.

Which company is manufacturing the generic Lurasidone for SBFM?

The generic Lurasidone is being launched through Nora Pharma Inc., Sunshine Biopharma's wholly owned Canadian subsidiary.