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
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013	AB	RX	Yes	Yes			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013	AB	RX	Yes	No			Y	Y

Soluble Guanylate Cyclase Stimulator Market Analysis and Financial Projection

The market for soluble guanylate cyclase (sGC) stimulators is experiencing significant growth driven by cardiovascular disease prevalence and novel therapeutic applications, while the patent landscape reveals strategic positioning by key pharmaceutical players. Here's a detailed analysis:

Market Dynamics

1. Growth Projections
   The global sGC stimulators market is projected to reach $2.5 billion by 2033, growing at a 9.2% CAGR from 2026[11][16]. Key drivers include:

   • Rising cardiovascular disease burden (17.9 million annual deaths globally)[11]
   • Aging populations prone to pulmonary hypertension and heart failure[6][15]
   • Expansion into new indications like chronic kidney disease and diabetic retinopathy[5]

2. Key Therapeutic Areas

   • Pulmonary arterial hypertension (PAH): Dominates with riociguat (Adempas®) as the first FDA-approved sGC stimulator[3][8]
   • Heart failure: Vericiguat (Verquvo®) shows promise in phase 3 trials for chronic heart failure[1][15]
   • Emerging applications in diabetic retinopathy and CKD via runcaciguat[5]

3. Regional Analysis	Region	Market Share	Growth Driver
   North America	40%	Strong clinical trial activity, FDA approvals[11][16]
   Europe	25%	Robust healthcare spending[16]
   Asia-Pacific	Fastest CAGR (6%)	Generic adoption and expanding pharma infrastructure[10][15]

4. Competitive Landscape
   Major players include Bayer (riociguat), Merck (vericiguat), and Cyclerion Therapeutics, with strategic partnerships accelerating development[9][17]. The SGC stimulators segment is growing at 5.9% CAGR, outpacing other PAH therapies[10][15].

Patent Landscape

1. Key Patents and Exclusivity

   • Vericiguat (Verquvo®): Protected by 6 US patents until 2032, with NCE exclusivity until 2026[4]
   • Riociguat: Facing impending patent cliffs, with generics expected post-2031[3][6]
   • Novel compounds like runcaciguat and praliciguat in active development[5][17]

2. Innovation Trends
   Recent patents focus on:

   • Extended-release formulations to enable once-daily dosing[1]
   • Tissue-selective sGC activation mechanisms[2][13]
   • Stabilized crystalline forms for improved bioavailability[9]

3. Strategic Moves

   • Bayer/MSD collaboration: Co-developing vericiguat with revenue-sharing[4]
   • Cyclerion Therapeutics: Licensing praliciguat to Akebia while retaining $560M milestone potential[17]
   • Patent challenges: First generic entries expected in pulmonary hypertension by 2032[4][6]

Future Outlook

The market faces a dual trajectory: branded therapies will dominate through 2026 due to exclusivity protections[4], while generics are projected to capture 30-40% market share by 2035[6][10]. Pipeline candidates targeting new indications could expand the addressable market by $3.8 billion by 2030[5][12]. Emerging markets like China and India are becoming battlegrounds for generic manufacturers as regional patent protections weaken[10][16].

"sGC stimulators represent a paradigm shift in targeting vascular dysfunction through direct NO-independent pathways, offering multi-indication potential beyond current cardiovascular applications."[7]

References

1. https://pubs.acs.org/doi/10.1021/acs.jmedchem.7b00449
2. https://pubmed.ncbi.nlm.nih.gov/33395323/
3. https://www.qyresearch.com/reports/4661097/riociguat
4. https://pharsight.greyb.com/drug/verquvo-patent-expiration
5. https://pubs.acs.org/doi/10.1021/acs.jmedchem.0c02154
6. https://www.globenewswire.com/news-release/2019/08/01/1895674/0/en/Pulmonary-Arterial-Hypertension-PAH-Market-Projected-to-Reach-8-7-Billion-by-2025-Key-Players-are-Actelion-Pharmaceuticals-Gilead-Sciences-United-Therapeutics-Corp-GlaxoSmithKline-.html
7. https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.963255/full
8. https://pmc.ncbi.nlm.nih.gov/articles/PMC4220430/
9. https://patents.justia.com/assignee/cyclerion-therapeutics-inc
10. https://www.visionresearchreports.com/pulmonary-arterial-hypertension-market/39125
11. https://www.verifiedmarketreports.com/product/soluble-guanylate-cyclase-market/
12. https://www.360iresearch.com/library/intelligence/soluble-guanylate-cyclase-stimulators
13. https://patents.google.com/patent/US10428076B2/en
14. https://reports.valuates.com/market-reports/QYRE-Auto-32D18294/global-soluble-guanylate-cyclase-sgc-stimulators
15. https://www.precedenceresearch.com/pulmonary-arterial-hypertension-market
16. https://www.qyresearch.com/reports/4666264/soluble-guanylate-cyclase--sgc--stimulators
17. https://www.globenewswire.com/news-release/2024/12/17/2998240/0/en/Cyclerion-s-sGC-Stimulator-Portfolio-Generates-Revenues-to-Enable-Company-Growth.html
18. https://patents.google.com/patent/WO2013025425A1/en