Sunshine Biopharma Announces Canadian Approval for Rivaroxaban, a Generic Form of Xarelto(R)

Sunshine Biopharma (NASDAQ:SBFM) announced Canadian approval of its generic Rivaroxaban tablets in 2.5mg, 10mg, 15mg and 20mg strengths, a generic equivalent of Xarelto®.

Rhea-AI Summary

Sunshine Biopharma (NASDAQ:SBFM) announced Canadian approval of its generic Rivaroxaban tablets in 2.5mg, 10mg, 15mg and 20mg strengths, a generic equivalent of Xarelto®.

The drug will be distributed through Nora Pharma in Canada, expands the company’s anticoagulant portfolio alongside Apixaban, and is anticipated to ship in October 2026.

Positive

• Canadian approval for generic Rivaroxaban tablets in four dosage strengths
• Expansion of anticoagulant portfolio alongside Apixaban (Eliquis® generic)
• Utilization of established Canadian distribution network via Nora Pharma subsidiary
• Anticipated Canadian pharmacy shipments of Rivaroxaban starting October 2026
• Entry into global Rivaroxaban market projected at $12.7B in 2026

Negative

• None.

Argus Jun 1 session

-5.94% close to close 0.1x rel. volume Open Argus

Details

News Market Reaction – SBFM

On Jun 1, the day this news came out, SBFM closed 5.94% below the previous close.

Data tracked by StockTitan Argus for the Jun 1 session.

Key Figures

Rivaroxaban dosage strengths: 2.5mg, 10mg, 15mg, 20mg Global Rivaroxaban market 2026: $12.7 Billion Global Rivaroxaban market 2035: $30.5 Billion +4 more

Rivaroxaban dosage strengths

2.5mg, 10mg, 15mg, 20mg

Approved generic Rivaroxaban tablets for Canada

Global Rivaroxaban market 2026

$12.7 Billion

Estimated global market size in 2026

Global Rivaroxaban market 2035

$30.5 Billion

Projected global market size by 2035

Rivaroxaban CAGR

10.19%

Forecast CAGR from 2026 to 2035

Canada pharma share

2.1%

Canada’s share of global pharmaceutical market

Apixaban time on market

Over 3 years

Company’s first generic anticoagulant in Canada

Rivaroxaban launch timing

October 2026

Anticipated shipping to Canadian pharmacies

Historical Context

5 past events · Latest: May 29

5 events

1. May 29

   Patent issuance

   24h Move

   -19.8%

   U.S. patent granted for coronavirus PLpro inhibitor compounds.

2. May 28

   Reverse stock split

   24h Move

   -25.3%

   1-for-10 reverse split to address Nasdaq minimum bid requirement.

3. May 21

   Drug approval

   24h Move

   +40.6%

   Canadian approval for generic Amoxicillin with August 2026 launch plan.

4. May 19

   Offering closing

   24h Move

   -8.2%

   Closing of public offering raising about $6.0M via units and warrants.

5. May 18

   Offering pricing

   24h Move

   +79.5%

   Pricing of $6.0M public unit offering at $0.50 per Common Unit.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

rivaroxaban, anticoagulant, deep vein thrombosis, pulmonary embolism, +3 more

7 terms

rivaroxaban medical

"approval of its generic Rivaroxaban tablets of 2.5mg, 10mg, 15mg and 20mg"

Rivaroxaban is an oral anticoagulant (blood thinner) that helps prevent and treat dangerous blood clots by blocking a key protein in the clotting process, similar to turning down a valve that would otherwise let a pipe clog. It matters to investors because its clinical use, regulatory approvals, safety warnings, patent status and competition directly affect sales, liability risk and future revenue for companies that manufacture or market the drug.

anticoagulant medical

"the brand name anticoagulant, Xarelto®."

An anticoagulant is a medicine that helps prevent blood from clotting or slows the formation of clots, used to reduce the risk of strokes, heart attacks, and other clot-related problems. For investors it matters because anticoagulants are widely prescribed, carry safety and regulatory risks, and drive sales and competition in drug markets—like a key product line whose approval, label changes, or safety concerns can materially affect a healthcare company’s revenue and stock outlook.

deep vein thrombosis medical

"prescribed to treat and prevent deep vein thrombosis and pulmonary embolism"

Deep vein thrombosis is a blood clot that forms in a deep vein, most often in the leg, which can block blood flow and cause pain, swelling or more serious complications if the clot travels to the lungs. Investors care because DVT influences demand for diagnostics, drugs and devices, affects healthcare costs and liability risks, and can change the commercial prospects of companies developing prevention or treatment—like a highway blockage that disrupts traffic and downstream businesses.

pulmonary embolism medical

"treat and prevent deep vein thrombosis and pulmonary embolism"

A pulmonary embolism is a sudden blockage in a lung blood vessel, usually caused by a blood clot that traveled from elsewhere in the body; think of it like a kink in a hose that prevents water from reaching its destination. It matters to investors because it can create urgent medical costs, affect workforce availability, trigger safety concerns in clinical trials or products, and prompt regulatory scrutiny or liability claims that may influence a company’s finances and stock price.

systemic embolism medical

"reduce the risk of stroke and systemic embolism in patients"

A systemic embolism happens when a blood clot or other debris breaks loose, travels through the bloodstream and lodges in an artery supplying an organ (such as the brain, kidney or limb), blocking blood flow and causing sudden organ damage. Investors care because the frequency and severity of these events affect demand for treatments and devices, shape clinical trial results and regulatory decisions, and influence healthcare costs, liability and insurer reimbursement risks.

non-valvular atrial fibrillation medical

"in patients with non-valvular atrial fibrillation."

An irregular, often rapid heartbeat originating in the heart’s upper chambers (atria) that is not caused by a mechanical heart valve or significant narrowing of the mitral valve. It matters because this specific label changes which drugs and devices are considered safe and approved, and therefore the size of the eligible patient market and rejection or acceptance by regulators; untreated, it raises stroke and hospitalization risk, so treatment choice influences sales and liability.

cagr financial

"growing at a CAGR of 10.19% during the forecast"

Compound Annual Growth Rate (CAGR) measures the average yearly growth of an investment, revenue, or other metric over a multi-year period as if it had grown at a steady rate each year. Think of it like the constant speed that would take you from the starting value to the ending value over the same time—useful because it smooths out ups and downs and lets investors compare different assets or performance periods on an even footing.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FORT LAUDERDALE, FL / ACCESS Newswire / June 1, 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 Rivaroxaban tablets of 2.5mg, 10mg, 15mg and 20mg for the Canadian market. Rivaroxaban is the generic equivalent of the brand name anticoagulant, Xarelto^®.

Rivaroxaban is a direct oral anticoagulant prescribed to treat and prevent deep vein thrombosis and pulmonary embolism. It is also widely utilized to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

The global market for Rivaroxaban is estimated to reach $12.7 Billion in 2026 and is set to expand to approximately $30.5 Billion by 2035, growing at a CAGR of 10.19% during the forecast from 2026 to 2035, (Business Research Insights). According to IQVIA Pharmafocus 2028, the Canadian pharmaceutical market accounts for approximately 2.1% of the global pharmaceutical market and ranks as the 6th largest worldwide.

Sunshine Biopharma has established a robust distribution network across Canada through its wholly owned Canadian subsidiary, Nora Pharma Inc. The addition of Rivaroxaban to our portfolio of drugs represents a strategic expansion for the Company in the area of anticoagulants. The Company's first generic anticoagulant, Apixaban (brand name Eliquis^®) has been on the market for over three years. It is anticipated that Sunshine Biopharma's Rivaroxaban will be ready to ship to pharmacies in October 2026.

"We are pleased to introduce Rivaroxaban oral tablets as the newest addition to our expanding portfolio of high-quality generic drugs," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "This approval strengthens our position in the generics market and reflects our ongoing commitment to delivering affordable medicines that patients and healthcare providers can rely on."

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
camille.sebaaly@sunshinebiopharma.com

SOURCE: Sunshine Biopharma Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Sunshine Biopharma (NASDAQ:SBFM) announce about Rivaroxaban approval in Canada on June 1, 2026?

Sunshine Biopharma announced Canadian approval of its generic Rivaroxaban tablets in four strengths. According to Sunshine Biopharma, this generic equivalent of Xarelto® expands its prescription portfolio and targets the Canadian anticoagulant market through its Nora Pharma distribution network.

When will Sunshine Biopharma's generic Rivaroxaban be available in Canadian pharmacies?

Sunshine Biopharma anticipates its generic Rivaroxaban will be ready to ship to Canadian pharmacies in October 2026. According to Sunshine Biopharma, distribution will occur through its wholly owned Canadian subsidiary, Nora Pharma, which already operates a nationwide network.

What strengths of Rivaroxaban tablets did Sunshine Biopharma receive approval for in Canada?

Sunshine Biopharma received Canadian approval for Rivaroxaban tablets in 2.5mg, 10mg, 15mg and 20mg strengths. According to Sunshine Biopharma, these strengths match common clinical dosing needs and position the product as a generic equivalent to the branded anticoagulant Xarelto®.

How large is the global Rivaroxaban market Sunshine Biopharma is targeting with SBFM stock?

The global Rivaroxaban market is estimated at $12.7 billion in 2026 and about $30.5 billion by 2035. According to Business Research Insights, this implies a 10.19% CAGR from 2026 to 2035, offering a sizable space for generic competitors.

How does Rivaroxaban fit into Sunshine Biopharma's anticoagulant portfolio for SBFM investors?

Rivaroxaban becomes Sunshine Biopharma’s second generic anticoagulant, alongside Apixaban (Eliquis®). According to Sunshine Biopharma, this approval strengthens its presence in cardiovascular therapies and broadens its offering of high-quality, affordable oral anticoagulants for patients and healthcare providers in Canada.

What medical conditions is Sunshine Biopharma's generic Rivaroxaban intended to treat?

Sunshine Biopharma’s generic Rivaroxaban is prescribed to treat and prevent deep vein thrombosis and pulmonary embolism. It is also used to reduce stroke and systemic embolism risk in patients with non‑valvular atrial fibrillation, according to Sunshine Biopharma.