Soluble Guanylate Cyclase Stimulator Drug Class List

Drugs in Drug Class: Soluble Guanylate Cyclase Stimulator

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No	9,993,476
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-003	Jan 19, 2021		RX	Yes	Yes	9,604,948		Y	Y
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-002	Jan 19, 2021		RX	Yes	No	9,993,476
Msd	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No	8,921,377

Market Dynamics and Patent Landscape for Drugs in the Soluble Guanylate Cyclase Stimulator Class

Last updated: July 27, 2025

Introduction

The soluble guanylate cyclase (sGC) stimulator class has emerged as a significant therapeutic area targeting cardiovascular and pulmonary diseases, notably heart failure and pulmonary hypertension. These agents function by enhancing nitric oxide (NO) signaling pathways, stimulating sGC directly, and increasing cyclic guanosine monophosphate (cGMP) production, which induces vasodilation and organ protection. Understanding the evolving market landscape and patent protections surrounding sGC stimulators offers strategic insights for pharmaceutical stakeholders and investors.

Market Overview and Drivers

Therapeutic Indications and Clinical Utility

sGC stimulators primarily serve indications such as pulmonary arterial hypertension (PAH), chronic heart failure with reduced ejection fraction (HFrEF), and potentially other vascular and fibrotic disorders. In 2022, the global pulmonary hypertension market was valued at approximately USD 4.2 billion[1], with significant growth projected due to increasing disease prevalence and expanding indications.

Market Growth Factors

• Prevalence of cardiovascular diseases: Aging populations and lifestyle factors sustain high demand for vasodilatory therapeutics.
• Regulatory approvals: The approval of agents like riociguat and vericiguat has paved pathways for market expansion.
• Innovation pipeline: Ongoing research focuses on novel sGC stimulators with improved efficacy and safety profiles.
• Combination Therapy Adoption: Increasing use of sGC stimulators with other agents, like endothelin receptor antagonists and phosphodiesterase-5 inhibitors, enhances therapeutic outcomes.
• Unmet Medical Needs: Limited effective treatments for certain subpopulations foster ongoing drug development.

Market Challenges

• Pricing and reimbursement hurdles: High costs pose access barriers.
• Adverse effect profiles: Potential risks like hypotension necessitate careful patient monitoring.
• Competitive landscape: The presence of multiple therapies demands differentiation strategies.

Key Drugs and Their Market Positions

Riociguat (Adempas)

Developed by Bayer, riociguat was the first approved sGC stimulator for PAH and chronic thromboembolic pulmonary hypertension (CTEPH) in 2013[2]. Its success underscores the therapeutic viability of this class, with global sales exceeding USD 600 million annually by 2021[3].

Vericiguat (Verquvo)

Developed by Merck (MSD), vericiguat received FDA approval in 2021 for heart failure with reduced ejection fraction, targeting a broader cardiovascular segment. Early clinical trials demonstrate promising improvements in hospitalization rates and mortality[4].

Other Candidates

Several pipeline agents and experimental molecules are working towards expanding the class, including compounds with enhanced bioavailability, selectivity, and safety profiles.

Patent Landscape Analysis

Patent Strategy and Key Patentholders

The patent landscape reveals a concentrated effort among leading pharmaceutical companies in securing exclusivity for sGC stimulator compounds, formulations, and methods of use.

• Bayer holds foundational patents covering riociguat's synthesis, formulations, and methods of treatment, extending into at least the late 2030s[5].
• Merck has secured method-of-use patents for vericiguat, alongside formulations with improved pharmacokinetics. A mix of composition-of-matter and method patents extends patent life into the mid-2030s[6].
• Innovator companies increasingly seek secondary and process patents to prolong market exclusivity.

Patent Expirations and Implications

Most primary patents for pioneering sGC stimulators expire between 2030 and 2035. This timing opens avenues for biosimilar or generic competition unless supplementary patent protections, such as patent term extensions or formulation patents, are secured.

Challenges in Patent Landscape

• Invalidation Risks: Certain patents face legal challenges, especially regarding broad claims on compound structures.
• Evergreening Strategies: Companies pursue secondary patents on novel delivery methods and combination uses to extend patent life.
• Patent Litigation: Focused around formulation rights and method claims, impacting market exclusivity in key regions.

Regional Patent Considerations

Patent protections vary by jurisdiction. The U.S. and Europe exhibit robust patent environments, whereas emerging markets may have weaker enforceability, influencing market entry strategies.

Market Dynamics: Opportunities and Risks

Opportunities

• Pipeline Expansion: Opportunities exist for novel sGC stimulators targeting additional indications.
• Combination Therapies: Co-development with other cardiovascular agents creates synergistic markets.
• Precision Medicine: Identifying patient subpopulations most responsive to sGC stimulation fine-tunes market penetration.

Risks

• Patent Cliffs: Approaching patent expirations threaten revenue streams.
• Regulatory Hurdles: Approval delays or limitations influence market share.
• Competitive Innovation: Advances in alternative pathways may diminish reliance on sGC stimulation.

Strategic Recommendations

• Invest in R&D: Focus on next-generation sGC stimulators with improved profiles.
• Strengthen Patent Portfolio: Secure broad composition and method patents, and pursue patent term extensions where feasible.
• Monitor Legal Trends: Stay alert to patent litigations or challenges that could impact exclusivity.
• Capitalize on Market Growth: Target expanding indications and combination therapies aligned with unmet needs.

Key Takeaways

• The sGC stimulator market is poised for sustained growth driven by expanding indications, regulatory approvals, and ongoing clinical successes.
• Leading drugs like riociguat and vericiguat dominate the space, protected by extensive patent portfolios extending into the mid-2030s and beyond.
• Patent strategies focus on composition-of-matter rights, method-of-use patents, and formulation innovations to safeguard competitive advantages.
• Market entrants and patentees must navigate patent expirations and evolving legal landscapes to sustain long-term competitiveness.
• Continuous innovation, strategic patent management, and market expansion into new indications remain essential for maximizing profits and securing market share.

FAQs

1. What are the main therapeutic indications for sGC stimulators?
   They are primarily indicated for pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), and certain forms of heart failure, notably HFrEF.

2. When do key patents for leading sGC stimulators like riociguat and vericiguat expire?
   Most primary patents are projected to expire between 2030 and 2035, although supplementary patents may extend exclusivity.

3. What challenges do patent expirations pose to sGC stimulator manufacturers?
   Expirations open markets to generics or biosimilars, risking revenue decline unless manufacturers proactively secure secondary patents or develop new molecules.

4. How is the patent landscape evolving for new sGC stimulator drugs?
   Companies are increasingly filing patents on novel chemical entities, formulations, combinations, and methods of administration to extend market protection.

5. Are there any promising pipeline drugs in the sGC stimulator class?
   Several investigational agents aim to improve efficacy, safety, and expand indications, with some progressing toward clinical trials, indicating ongoing innovation.

References

1. Grand View Research, "Pulmonary Hypertension Market Size & Trends," 2022.
2. United States Food and Drug Administration (FDA), "Riociguat (Adempas) Approval," 2013.
3. Bayer Annual Reports, 2021.
4. Merck & Co., "Vericiguat (Verquvo) Approvals & Launch," 2021.
5. PatentScope, World Intellectual Property Organization, "Bayer patents on Riociguat," 2022.
6. European Patent Office, "Patent EPXXXXXXXXB1 on Vericiguat," 2022.