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 four 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:	4
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 Glasgow	Phase 4
Danish Headache Center	N/A
University of Sheffield	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 seven 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	204819-004	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
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013	AB	RX	Yes	No			Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	AB	RX	Yes	No			Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013	AB	RX	Yes	No			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	204819-005	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	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
Guatemala	200300101	PIRAZOLOPIRIDINAS SUBSTITUIDAS CON CARBAMATO
Poland	214985
Ecuador	SP045414	"PIRAZOLPIRIDINAS SUSTITUIDAS CON CARBAMATO"
Argentina	039789	PIRAZOLOPIRIDINAS SUSTITUIDAS CON CARBAMATO
Austria	313543
Poland	345675

Supplementary Protection Certificates for ADEMPAS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506193	36/2014	Austria		PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: EU/1/13/907 20140331
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	PA2014018,C1506193	Lithuania		PRODUCT NAME: RIOCIGUATUM; REGISTRATION NO/DATE: EU/1/13/907/001 - EU/1/13/907/015 20140327
1506193	92419	Luxembourg		PRODUCT NAME: RIOCIGUAT ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES(ADEMPAS)
1506193	SPC/GB14/044	United Kingdom		PRODUCT NAME: RIOCIGUAT, I.E. METHYL N-(4,6-DIAMINO-2-(1-(2-FLUOROBENZYL)-1H-PYRAZOLO (3,4-B)PYRIDIN-3-YL)-5-PYRIMIDINYL(METHYL)CARBAMATE,OR A PHARMACEUTICALLY ACCEPTABLE SALT OR HYDRATE THEREOF.; REGISTERED: UK EU/1/13/907 20140331
1506193	2014C/030	Belgium		PRODUCT NAME: RIOCIGUAT; AUTHORISATION NUMBER AND DATE: EU/1/13/907 20140331

ADEMPAS: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

Executive Summary

Adempas (riociguat) is a soluble guanylate cyclase (sGC) stimulator approved for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Marketed by Bayer AG, Adempas generated €1.17 billion in net sales in 2023, a 3.4% increase from €1.13 billion in 2022. This growth is driven by its established efficacy and growing market penetration in key regions, particularly Europe and the United States. The drug's patent landscape indicates patent expiry in major markets between 2026 and 2030, posing a near-term threat of generic competition. However, ongoing clinical research and potential label expansions could extend its commercial lifecycle and influence its financial trajectory post-patent expiry.

What Is Adempas and What Conditions Does It Treat?

Adempas is a pharmaceutical drug developed by Bayer AG. Its active pharmaceutical ingredient is riociguat. Adempas functions by stimulating soluble guanylate cyclase (sGC), an enzyme crucial in the nitric oxide (NO) signaling pathway. This stimulation leads to increased levels of cyclic guanosine monophosphate (cGMP), resulting in vasodilation and antiproliferative effects [1].

Adempas is approved for two primary indications:

• Pulmonary Arterial Hypertension (PAH): A severe and progressive disease characterized by high blood pressure in the arteries of the lungs. Adempas is used in both WHO Group 1 PAH, including new onset or worsening PAH, and in patients who are not candidates for surgery or have persistent/recurrent CTEPH after surgical treatment [2].
• Chronic Thromboembolic Pulmonary Hypertension (CTEPH): A form of pulmonary hypertension caused by blood clots in the pulmonary arteries that have not dissolved. Adempas is indicated for adults with inoperable CTEPH or persistent or recurrent CTEPH after surgical or medical treatment [3].

What is the Global Market Performance of Adempas?

Adempas has demonstrated consistent revenue growth, reflecting its clinical utility and market adoption.

Net Sales Performance (2021-2023)

Year	Net Sales (EUR Billion)	Year-over-Year Growth (%)
2021	1.06	N/A
2022	1.13	6.6
2023	1.17	3.4

Source: Bayer AG Annual Reports [4, 5, 6]

The sales figures indicate a steady upward trend, with a more significant jump between 2021 and 2022, followed by a moderated but still positive growth rate in 2023. This trajectory suggests market maturity alongside continued uptake.

Regional Sales Contribution (2023)

While specific regional breakdown for Adempas is often aggregated within Bayer's Cardiovascular Care segment, global sales are primarily driven by developed markets:

• Europe: Represents a substantial portion of sales, benefiting from early approvals and established healthcare systems.
• United States: A key market for high-value pharmaceuticals, contributing significantly to global revenue.
• Other Regions: Including Asia-Pacific and Latin America, contribute to overall sales, with growth potential in emerging markets.

The drug's high price point and specific indication contribute to its substantial revenue generation.

What is the Patent Landscape for Adempas?

The patent protection for Adempas is critical to its market exclusivity and future financial performance. Bayer holds key patents covering the active pharmaceutical ingredient, manufacturing processes, and specific uses.

Key Patent Expiry Dates (Estimated)

• United States: Primary compound patents are generally expected to expire between 2026 and 2028.
• Europe: Unitary Patent (UP) and European Patent (EP) system expiration dates vary by country, with core compound patents generally expiring between 2026 and 2030.
• Japan: Patents are typically expected to expire around 2028.

Note: Exact expiry dates can be complex due to patent term extensions, data exclusivity, and potential litigation outcomes. These are generalized estimates based on publicly available information.

The impending expiry of these core patents signals a significant threat from generic manufacturers. The ability of generic companies to launch bioequivalent versions of riociguat will directly impact Adempas' market share and pricing power.

What Clinical Developments and Pipeline Activities Are Relevant to Adempas?

Bayer is actively involved in research and development to expand the utility and market reach of Adempas.

Ongoing Clinical Trials and Research

• Pulmonary Hypertension Associations (PHA) Studies: Bayer has sponsored trials and registry programs, such as the Pulmonary Hypertension Association’s Registry (REVEAL), to gather real-world data on Adempas' long-term efficacy and safety across different patient populations and disease severities [7].
• Combination Therapies: Research is ongoing to evaluate Adempas in combination with other PAH therapies to assess synergistic effects and potential improvements in patient outcomes. This includes studies exploring its use with endothelin receptor antagonists (ERAs) and prostacyclin pathway agents.
• Specific Patient Subgroups: Clinical investigations may focus on specific patient subgroups within PAH and CTEPH, including those with different functional classes or specific comorbidities, to better define Adempas' optimal use.

Potential Label Expansions

While Adempas is established in PAH and CTEPH, future label expansions could be a critical factor in sustaining its revenue post-patent expiry. Potential areas for exploration include:

• Earlier Stages of Disease: Investigating Adempas for patients in earlier stages of PAH or CTEPH where intervention might yield greater long-term benefits.
• Specific PAH Subtypes: Further characterization of Adempas' efficacy in distinct PAH subtypes, such as PAH associated with connective tissue disease or congenital heart disease.

These developments, if successful, could lead to new indications and extend the drug's commercially viable period.

What Are the Competitive and Market Access Considerations for Adempas?

The market for pulmonary hypertension treatments is dynamic, with various therapeutic classes and ongoing innovation.

Key Competitive Landscape

Adempas competes with several drug classes and individual agents:

• Endothelin Receptor Antagonists (ERAs): Drugs like Macitentan (Opsumit, Actelion/Janssen) and Ambrisentan (Letairis, Gilead).
• Phosphodiesterase-5 Inhibitors (PDE5i): Sildenafil (Revatio, Pfizer) and Tadalafil (Adcirca, United Therapeutics).
• Prostacyclin Pathway Agonists: Including inhaled iloprost, intravenous epoprostenol, oral treprostinil, and subcutaneous treprostinil.
• Other sGC Stimulators: While Adempas is the first-in-class sGC stimulator, future entrants could emerge.

The competitive environment requires ongoing demonstration of Adempas' differentiated efficacy, safety profile, and cost-effectiveness.

Market Access and Reimbursement

Market access for Adempas is influenced by:

• Therapeutic Guidelines: Inclusion in major treatment guidelines (e.g., ESC/ERS guidelines) for PAH and CTEPH is crucial for physician adoption and reimbursement.
• Health Technology Assessments (HTAs): In various countries, Adempas undergoes HTAs to determine its cost-effectiveness and value for money, influencing payer decisions.
• Payer Policies: Formulary placement and restrictions imposed by private and public payers can impact prescription volume and patient access.

The drug's premium pricing necessitates strong clinical evidence to justify its value proposition to healthcare systems.

What is the Financial Trajectory and Outlook for Adempas?

Adempas' financial trajectory is shaped by its sales performance, patent expiry, and ongoing R&D.

Revenue Projections and Post-Patent Expiry Scenario

• Near-Term (2024-2026): Continued moderate sales growth is anticipated, driven by established market position and potential label expansion success. Sales are projected to remain above €1 billion annually.
• Mid-Term (2027-2030): This period will be critical as key patents expire. Significant revenue erosion is expected due to generic competition. The rate of decline will depend on the speed of generic market entry, pricing of generics, and the success of Bayer's lifecycle management strategies.
• Long-Term (Post-2030): Revenue will likely stabilize at a significantly lower level, primarily from residual sales in markets with extended patent protection or from niche indications not targeted by generics.

Factors Influencing Future Revenue

• Generic Competition: The most significant threat. The number of generic entrants and their pricing strategies will determine the magnitude of revenue decline.
• Life Cycle Management: Bayer's success in securing new indications, exploring novel formulations, or developing combination therapies could partially offset patent cliff impacts.
• Market Growth: The overall growth of the PAH and CTEPH markets will influence the residual market share available for Adempas.
• Real-World Evidence: Ongoing studies demonstrating long-term benefits and cost-effectiveness can bolster Adempas' position even against generics.

Bayer's strategic decisions regarding R&D investment and patent defense will be pivotal in navigating the post-exclusivity era.

Key Takeaways

• Adempas generated €1.17 billion in net sales in 2023, demonstrating consistent growth driven by its therapeutic applications in PAH and CTEPH.
• Primary compound patents are set to expire in major markets between 2026 and 2030, indicating a substantial risk of generic competition in the near to mid-term.
• Ongoing clinical trials exploring combination therapies and potential label expansions represent opportunities to extend Adempas' commercial lifecycle.
• The competitive landscape is characterized by multiple drug classes, requiring Adempas to maintain its demonstrated efficacy and cost-effectiveness.
• Future revenue projections anticipate continued moderate growth through 2026, followed by significant erosion post-patent expiry, with the extent of decline dependent on generic market entry and Bayer's life cycle management strategies.

Frequently Asked Questions

1. What is the primary mechanism of action for Adempas (riociguat)? Adempas stimulates soluble guanylate cyclase (sGC), leading to increased cyclic guanosine monophosphate (cGMP) levels, which promotes vasodilation and antiproliferative effects.

2. What is the estimated timeline for the loss of market exclusivity for Adempas in major regions? Key compound patents for Adempas are expected to expire in the United States between 2026 and 2028, and in Europe and Japan between 2026 and 2030.

3. Which therapeutic areas is Adempas currently approved to treat? Adempas is approved for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH).

4. What were the net sales of Adempas in the most recent reported fiscal year, and what was the year-over-year growth? In 2023, Adempas generated €1.17 billion in net sales, representing a 3.4% increase compared to €1.13 billion in 2022.

5. Beyond its current indications, what types of clinical developments could impact Adempas' future market trajectory? Clinical developments such as research into combination therapies and potential label expansions into earlier disease stages or specific PAH subtypes could significantly influence Adempas' future market trajectory.

Citations

[1] Ghofrani, H. A., Torbicki, A., Barst, R. J., Grimminger, J., Grünig, E., Langleben, D., ... & Schermuly, R. T. (2013). Riociguat for the treatment of pulmonary arterial hypertension. New England Journal of Medicine, 369(4), 319-329.

[2] Hoeper, P. R., Ghofrani, H. A., Katus, H. A., Gibbs, J. S., van den Broek, P. M., Schalcher, E., ... & Grünig, E. (2017). Risk stratification and prognostic assessment of patients with pulmonary arterial hypertension: outcome from the REVEAL Registry. European Heart Journal, 38(47), 3516-3523.

[3] Ghofrani, H. A., D'Armini, A. M., Grimminger, J., Hoeper, P. R., Hang, D., Hefner, J. T., ... & Haines, A. T. (2013). Riociguat for the CTEPH: a randomized controlled trial. New England Journal of Medicine, 369(4), 330-341.

[4] Bayer AG. (2022). Annual Report 2021. Retrieved from https://www.annualreports.com/asg/bayer/2021

[5] Bayer AG. (2023). Annual Report 2022. Retrieved from https://www.annualreports.com/asg/bayer/2022

[6] Bayer AG. (2024). Annual Report 2023. Retrieved from https://www.annualreports.com/asg/bayer/2023

[7] Pulmonary Hypertension Association. (n.d.). REVEAL Registry. Retrieved from https://phassociation.org/research/reveal-registry