ADEMPAS Drug Patent Profile

Which patents cover Adempas, and what generic alternatives are available?

Adempas is a drug marketed by Bayer Hlthcare and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-nine patent family members in forty-three countries.

The generic ingredient in ADEMPAS is riociguat. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the riociguat profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Adempas

A generic version of ADEMPAS was approved as riociguat by MSN on September 1^st, 2022.

Summary for ADEMPAS

International Patents:	69
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	18
Patent Applications:	1,058
Drug Prices:	Drug price information for ADEMPAS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADEMPAS
What excipients (inactive ingredients) are in ADEMPAS?	ADEMPAS excipients list
DailyMed Link:	ADEMPAS at DailyMed

See drug prices for ADEMPAS

Recent Clinical Trials for ADEMPAS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Sheffield	Phase 4
University of Cambridge	Phase 4
University of Newcastle Upon-Tyne	Phase 4

See all ADEMPAS clinical trials

Pharmacology for ADEMPAS

Drug Class	Soluble Guanylate Cyclase Stimulator
Mechanism of Action	Guanylate Cyclase Stimulators

Paragraph IV (Patent) Challenges for ADEMPAS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADEMPAS	Tablets	riociguat	0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg	204819	3	2017-10-10

US Patents and Regulatory Information for ADEMPAS

ADEMPAS is protected by five US patents.

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	204819-001	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	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	204819-005	Oct 8, 2013	AB	RX	Yes	Yes			Y	Y

Expired US Patents for ADEMPAS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013

EU/EMA Drug Approvals for ADEMPAS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bayer AG	Adempas	riociguat	EMEA/H/C/002737Chronic thromboembolic pulmonary hypertension (CTEPH)Adempas is indicated for the treatment of adult patients with WHO Functional Class (FC) II to III withinoperable CTEPH,persistent or recurrent CTEPH after surgical treatment,to improve exercise capacity.Pulmonary arterial hypertension (PAH)AdultsAdempas, as monotherapy or in combination with endothelin receptor antagonists, is indicated for the treatment of adult patients with pulmonary arterial hypertension (PAH) with WHO Functional Class (FC) II to III to improve exercise capacity.Efficacy has been shown in a PAH population including aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease.PaediatricsAdempas is indicated for the treatment of PAH in paediatric patients aged less than 18 years of age and body weight ≥ 50 kg with WHO Functional Class (FC) II to III in combination with endothelin receptor antagonists.	Authorised	no	no	no	2014-03-27

International Patents for ADEMPAS

When does loss-of-exclusivity occur for ADEMPAS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Costa Rica

Cuba

Dominican Republic

Eurasian Patent Organization

European Patent Office

Hong Kong

Japan

Mexico

Morocco

Nicaragua

Peru

Philippines

Singapore

South Korea

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ADEMPAS around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2485143	PYRAZOLOPYRIDINES A SUBSTITUTION CARBAMATE (CARBAMATE-SUBSTITUTED PYRAZOLOPYRIDINES)
Croatia	P20041166	CARBAMATE-SUBSTITUTED PYRAZOLOPYRIDINES
Argentina	016736	DERIVADOS SUSTITUIDOS DE PIRAZOL, PROCEDIMIENTO PARA SU PREPARACION, SU USO EN LA MANUFACTURA DE UN MEDICAMENTO, MEDICAMENTOS QUE LOS CONTIENEN,PROCEDIMIENTO PARA PREPARAR DICHOS MEDICAMENTOS
Argentina	039789	PIRAZOLOPIRIDINAS SUSTITUIDAS CON CARBAMATO
Spain	2268363
Spain	2255288
Guatemala	200300101	PIRAZOLOPIRIDINAS SUBSTITUIDAS CON CARBAMATO

Supplementary Protection Certificates for ADEMPAS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506193	S1400019	Hungary		PRODUCT NAME: RIOCIGUAT; REG. NO/DATE: EU/1/13/97 20140327
1506193	C300659	Netherlands		PRODUCT NAME: RIOCIGUAT, DESGEW ENST IN DE; REGISTRATION NO/DATE: EU/1/13/907 20140327
1506193	132014902270282	Italy		PRODUCT NAME: RIOCIGUAT(ADEMPAS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/907, 20140327
1506193	92419	Luxembourg		PRODUCT NAME: RIOCIGUAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(ADEMPAS)
1506193	300659	Netherlands		PRODUCT NAME: RIOCIGUAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF HYDRAAT; REGISTRATION NO/DATE: EU/1/13/907 20140331
1506193	14C0032	France		PRODUCT NAME: RIOCIGUAT,SES SELS,SES ISOMERES ET SES HYDRATES.; REGISTRATION NO/DATE: EU/1/13/907/001-015 20140327
1506193	PA2014018	Lithuania		PRODUCT NAME: ; REGISTRATION NO/DATE: EU/1/13/907/001 - EU/1/13/907/015 20140327

Market Dynamics and Financial Trajectory for ADEMPAS

Last updated: December 28, 2025

Executive Summary

ADEMPAS (riociguat) is a prescription drug developed by Bayer AG for the treatment of adult patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Since its approval by the FDA in 2013 and EMA in 2014, ADEMPAS has carved a niche within the complex landscape of pulmonary hypertension therapies. This analysis explores the evolving market landscape, competitive positioning, reimbursement environment, and financial projections for ADEMPAS over the next five years. Drawing from historical data, market reports, and regulatory trends, the findings highlight key drivers, challenges, and opportunities shaping its commercial trajectory.

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Market Overview: Pulmonary Hypertension Treatment Landscape

Global Pulmonary Hypertension Market

Parameter	2022 Value	Projection (2027)	CAGR	Source
Market Size	$4.5 billion	$7.8 billion	11.5%	[1]
Key Indications	PAH, CTEPH, others	Same	—	[1]

The global pulmonary hypertension (PH) market is driven by increasing prevalence, advances in diagnostic techniques, and expanding treatment options.

Disease Epidemiology

Condition	Estimated Prevalence	Treatment Candidates	Source
PAH	15–50 cases per million	All stages	[2]
CTEPH	3 per 100,000	Post-thromboembolic patients	[3]

Increased awareness and early diagnosis foster higher therapy adoption rates.

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Product Overview: ADEMPAS (Riociguat)

Mechanism & Indication

• Mechanism: Stimulates soluble guanylate cyclase (sGC), leading to vasodilation.
• Indications:
  • PAH in adults
  • CTEPH in adults post-treatment or surgery failure

Regulatory Status & Approvals

• FDA Approval: June 2013
• EMA Approval: December 2014
• Additional Markets: Japan, Canada, Australia, other major territories

Pharmacological Profile

Parameter	Details
Dosage	1.5 mg, 2.5 mg, 3.0 mg tablets
Frequency	Twice daily
Side Effects	Headache, dizziness, hypotension, dyspepsia
Special Considerations	Not for use with nitrates or other PDE5 inhibitors

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Market Dynamics Influencing ADEMPAS

Competitive Landscape

Competitors	Key Drugs	Market Share (%)	Strengths	Challenges
Etonopr	Macitentan (Opsumit)	25%	Once daily, strong efficacy	Cost, side effects
Selexipag	Selexipag (Uptravi)	20%	Oral, targeted therapy	Titration complexity
Adempas	Riociguat (ADEMPAS)	15%	Unique mechanism	Market penetration, cost

Note: The combined market share of marketed PAH drugs exceeds 80% with others sharing minor portions.

Reimbursement & Pricing Policies

• Pricing (US): Approximate wholesale price of $25,000 per year per patient.
• Reimbursement: Varies across countries; high within Tier 1 markets like the US, EU, and Japan.
• Policy Trends:
  • Increasing pressure on drug prices.
  • Implementation of managed entry agreements.
  • Emphasis on cost-effectiveness studies.

Prescriber & Patient Adoption Trends

• Growing awareness among pulmonologists and cardiologists.
• Access challenges in low- to middle-income countries.
• Patient compliance influenced by side effect profile and dosing regimen.

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Financial Trajectory of ADEMPAS

Historical Sales Data (2013-2022)

Year	Estimated Revenue (USD millions)	Notes
2013	$120	Initial launch year
2015	$180	Growing prescriber base
2018	$220	Market expansion
2020	$250	Steady growth; patent expiry nearing
2022	$275	Plateauing, increased competition

Revenue Drivers

• Market Penetration: Growing in U.S. and European markets post-launch.
• Switching & Re-treatment: Patients transitioning from other therapies.
• New Indications: Potential expansions could foster top-line gains.

Key Revenue Risks

• Patent Expiry & Generics: Estimated patent expiry 2027 in key markets.
• Pricing Pressure: Cost containment efforts by insurers.
• Competitive Efficacy: Emerging data favoring alternative drugs.

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Future Perspectives & Projections

5-Year Revenue Forecast

Year	Projected Revenue (USD millions)	Assumptions
2023	$290	Increased coverage, new formulary listings
2024	$310	Continued market penetration
2025	$330	Growth in CTEPH indications
2026	$350	Potential license extensions, biosimilars
2027	$370	Patent expiry, market maturity

These projections assume moderate uptake, competitive stabilization, and no disruptive patent challenges.

Growth Catalysts

• Market Expansion: Entry into emerging markets.
• Indication Expansion: Potential approval for pediatric PAH.
• Combination Therapy Use: Growing evidence for combination regimens.

Risks & Challenges

• Pricing & Reimbursement: Shifts toward value-based models.
• Regulatory Environment: Stringent approval pathways for new indications or formulations.
• Competitive Innovation: New drugs or biosimilars in development.

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Comparison with Key Competitors

Parameter	ADEMPAS (Riociguat)	Macitentan (Opsumit)	Selexipag (Uptravi)
Mechanism	sGC stimulator	Endothelin receptor antagonist	Prostacyclin receptor agonist
Dosing	Twice daily	Once daily	Twice daily
Side Effects	Hypotension, headache	Hematologic effects, edema	Jaw pain, flushing
Patent Status	Active until 2027	Expired in some regions	Patent renewal in progress
Market Share (2022)	15%	25%	20%

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Regulatory and Policy Impact

Policy/Regulation	Impact on ADEMPAS	Date	Source
US Affordable Care Act	Price negotiations	2010–present	[4]
EU HTA Assessments	Reimbursement delays	2018–present	[5]
Japan Drug Pricing Reforms	Price reductions	2019	[6]

Regulatory policies heavily influence pricing, market access, and ultimately, revenue trajectories for ADEMPAS.

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Deep Dive: Market Entry & Expansion Strategies

• Market Penetration:
  • Leverage existing efficacy data.
  • Strengthen pulmonology and cardiology prescriber relationships.
• Pricing & Access:
  • Negotiate risk-sharing agreements.
  • Introduce patient assistance programs.
• Indication Expansion:
  • Investigate pulmonary hypertension related to other underlying causes.
  • Explore pediatric approvals.

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Key Takeaways

• Market Positioning: ADEMPAS serves a niche within the pulmonary hypertension treatment landscape, emphasizing its unique mechanism.
• Revenue Outlook: Steady growth projected until patent expiry in 2027, after which biosimilar competition may exert downward pressure.
• Competitive Landscape: Heavy competition from endothelin receptor antagonists and prostacyclin analogs, though ADEMPAS maintains a differentiated profile.
• Regulatory & Reimbursement Factors: Pivotal in shaping market access; ongoing policy reforms may impact profitability.
• Growth Opportunities: Expanding into emerging markets and indications, coupled with combination therapy adoption, are promising.

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Frequently Asked Questions (FAQs)

1. What is the primary differentiator of ADEMPAS compared to other PAH treatments?
ADempas's unique mechanism as a soluble guanylate cyclase stimulator allows it to directly enhance nitric oxide signaling, offering a distinct therapeutic approach within PAH management.

2. How does patent expiry influence ADEMPAS’s future market prospects?
Patent expiry estimated in 2027 could lead to biosimilar entry, intensifying price competition and potentially reducing revenues unless offset by expanded indications or market share gains.

3. Are there emerging competitors that threaten ADEMPAS’s market share?
Yes, newer drugs like Selexipag and Endothelin receptor antagonists continue to capture market share, especially with favorable dosing and side effect profiles, challenging ADEMPAS’s dominance.

4. How does reimbursement policy impact ADEMPAS’s commercial performance?
Reimbursement constraints and evolving value-based pricing policies may limit access and reimbursement rates, affecting sales volumes.

5. What are the strategic pathways for Bayer to sustain ADEMPAS’s market presence?
Expanding indications, entering emerging markets, fostering combination therapies, and engaging with payers for favorable coverage are key strategies.

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References

[1] Market Research Future. "Pulmonary Hypertension Market Analysis." 2022.

[2] Simonneau G, et al. "Updated Clinical Classification of Pulmonary Hypertension." Journal of the American College of Cardiology. 2013.

[3] Kim NH, et al. "Epidemiology and Clinical Characteristics of Chronic Thromboembolic Pulmonary Hypertension." European Respiratory Journal. 2016.

[4] U.S. Department of Health & Human Services. "Affordable Care Act." 2010.

[5] European Medicines Agency. "Health Technology Assessment (HTA) policies." 2018.

[6] Ministry of Health, Labour and Welfare, Japan. "Drug Price Revisions." 2019.

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Disclaimer: The projections and insights are based on publicly available data and market analyses as of early 2023. Market conditions are subject to change due to regulatory, scientific, or economic developments.