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	10,662,188		Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	AB	RX	Yes	No	11,203,593		Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	AB	RX	Yes	No	7,173,037		Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013	AB	RX	Yes	No	11,203,593		Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	AB	RX	Yes	No	10,662,188		Y	Y
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013	AB	RX	Yes	Yes	11,203,593		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	6,743,798
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013	6,743,798
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013	6,743,798
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	6,743,798
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013	6,743,798

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
Germany	59912966
China	1317005
Netherlands	300659
Japan	4455321
European Patent Office	3760629	FORMES DU {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDIN-3-YL]PYRIMIDIN-5-YL}MÉTHYLCARBAMATE DE MÉTHYLE (FORMS OF METHYL {4,6-DIAMINO-2-[1-(2-FLUOROBENZYL)-1H-PYRAZOLO[3,4-B]PYRIDINO-3-YL]PYRIMIDINO-5-YL}METHYL CARBAMATE)
Brazil	9912562

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	515	Finland
1506193	2014/028	Ireland		PRODUCT NAME: RIOCIGUAT OR A SALT, ISOMER OR HYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/13/907/001-015 20140327
1506193	C20140015 00109	Estonia		PRODUCT NAME: RIOTSIGUAAT; REG NO/DATE: K(2014)2152 (LOPLIK) 31.03.2014
1506193	C01506193/01	Switzerland		PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: SWISSMEDIC 62903 21.11.2013
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ADEMPAS (Riociguat)

Last updated: July 27, 2025

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Introduction

ADEMPAS (riociguat) is a prescription medication developed by Bayer Pharmaceuticals for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Since its approval, ADEMPAS has positioned itself within a specialized yet growing segment of the pulmonary hypertension market. Analyzing its market dynamics and financial trajectory provides insights into its commercial potential, competitive landscape, and future growth prospects.

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Market Overview and Therapeutic Landscape

Pulmonary Hypertension (PH) is a complex, progressive disorder characterized by increased pressure in the pulmonary arteries, leading to right heart failure. The World Health Organization classifies PH into five groups, with Group 1 (pulmonary arterial hypertension) and Group 4 (chronic thromboembolic pulmonary hypertension) being the primary indications for ADEMPAS.

The global PAH market was valued at approximately USD 3.5 billion in 2021 and is projected to grow at a CAGR of around 7-8% through 2030, driven by increased diagnosis rates, expanding therapeutic indications, and ongoing drug development efforts (Source: Persistence Market Research). CTEPH, a subgroup of PH, remains an area of unmet medical need, with limited treatment options primarily focusing on surgical interventions and medical therapy.

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Mechanism of Action and Clinical Positioning

Riociguat, ADEMPAS's active ingredient, functions as a soluble guanylate cyclase (sGC) stimulator, enhancing the nitric oxide pathway and leading to vasodilation of pulmonary arteries. This unique mechanism differentiates ADEMPAS from traditional endothelin receptor antagonists and phosphodiesterase-5 inhibitors, offering a novel therapeutic approach for patients unresponsive to existing treatments.

Clinically, ADEMPAS demonstrated significant improvements in pulmonary hemodynamics, exercise capacity (measured by 6-minute walk distance), and disease progression markers, establishing it as a first-line treatment for inoperable or persistent/recurrent CTEPH and PAH (source: CHEST 2013, CHEST 2018 guidelines).

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Market Adoption and Sales Trajectory

Since its initial approval in 2013 for PAH and subsequent approval for inoperable or persistent/recurrent CTEPH in 2014, ADEMPAS has experienced a steady but modest growth trajectory. Key factors influencing its market adoption include:

• Global Reach: Approved in over 70 countries, with primary markets in the U.S., Europe, and select Asia-Pacific nations.

• Physician Awareness and Prescriber Confidence: The drug's novel mechanism and clinical trial data have fostered prescriber confidence, though the relatively niche market limits widespread adoption.

• Pricing and Reimbursement: High treatment costs (~USD 50,000–USD 70,000 annually) influence patient access, with reimbursement policies varying by country, affecting overall sales volume.

• Patient Population Growth: Increasing diagnosis rates, attributed to heightened clinical awareness and improved diagnostic technologies, have expanded the eligible patient cohort.

In 2022, Bayer reported global sales of approximately EUR 400 million, reflecting a gradual increase from EUR 300 million in 2019, indicating a compound annual growth rate (CAGR) of roughly 8-10%. Notably, European markets accounted for the majority share, with emerging markets showing initial uptake.

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Competitive Landscape

The pulmonary hypertension space features several key players and treatment options, including:

• Endothelin receptor antagonists: Ambrisentan, Bosentan
• Phosphodiesterase-5 inhibitors: Sildenafil, Tadalafil
• Prostacyclin analogs: Epoprostenol, Treprostinil
• Other sGC stimulators: Focused research ongoing, but riociguat remains the only approved sGC stimulator for PAH and CTEPH.

While ADEMPAS occupies a unique position, competition persists primarily from endothelin receptor antagonists and PDE-5 inhibitors, often used in combination therapies. The arrival of combination therapy regimens may influence future market share for ADEMPAS.

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Pricing, Reimbursement, and Market Access

High-cost therapies like ADEMPAS depend heavily on reimbursement frameworks. In the U.S., Medicare and private insurers generally cover the drug, but prior authorization is customary. In Europe, national health authorities’ approval influences market access, with some countries implementing price negotiations and managed entry agreements to contain costs.

Pricing strategies have maintained high per-treatment costs, vital for pharmaceutical profitability but potentially limiting patient uptake in price-sensitive markets.

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Regulatory and Developmental Dynamics

Ongoing clinical trials aim to extend ADEMPAS's indications:

• REPLACE trial (for inoperable/recurrent CTEPH post-balloon pulmonary angioplasty) aims to expand its therapeutic role.
• UPGRADE trial and other phase IV studies assess long-term safety and efficacy.

Regulatory agencies’ evolving frameworks emphasizing accelerated approval and real-world evidence collection could influence adoption rates.

Financial Trajectory and Future Outlook

With sales demonstrating a steady increase and emerging markets gaining momentum, Bayer projects an incremental compound annual growth rate of approximately 8-10% over the next five years. Several factors will influence this trajectory:

• Pipeline Developments: Positive outcomes from ongoing trials could lead to expanded indications, adding revenue streams.
• Market Penetration: Increased awareness and improved healthcare infrastructure in Asia and Latin America could accelerate adoption.
• Pricing Dynamics: Competitive pricing or negotiated discounts in key markets might impact margins.
• Competitive Introductions: The emergence of biosimilars or novel therapies targeting PAH could challenge ADEMPAS’s market dominance.

Overall, with a focus on clinical excellence and expanding indications, ADEMPAS is poised to maintain a stable and gradually expanding financial trajectory.

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Risks and Challenges

• Market Saturation: Limited patient pool due to disease rarity may constrain growth.
• Price Pressure: Regulatory and payer measures to reduce healthcare costs could impact margins.
• Competitive Innovation: Development of alternative therapies, including gene therapy or combination regimens, could threaten market share.
• Regulatory Delays: Unanticipated delays in clinical trials or approvals might hamper expansion efforts.

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Conclusion

ADEMPAS stands as a key therapeutic agent within the niche but evolving realm of pulmonary hypertension. Its innovative mechanism, expanding indications, and growing global adoption underpin a positive financial trajectory. While challenges remain, particularly from competitive therapies and pricing pressures, strategic clinical development and market expansion efforts are well-positioned to sustain its growth.

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Key Takeaways

• ADEMPAS (riociguat) benefits from a pioneering mechanism targeting a critical pathway in PAH and CTEPH treatment.
• The drug’s global sales are increasing at an estimated CAGR of 8-10%, driven by expanding indications and markets.
• Main growth drivers include regulatory approvals, increased diagnosis, and improved reimbursement frameworks.
• Competitive pressures from existing therapies and emerging treatments require Bayer to maintain clinical differentiation and market access strategies.
• Future growth hinges on clinical trial success, indication expansion, and broader market penetration, especially in emerging economies.

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FAQs

1. What are the primary indications for ADEMPAS?
ADEMPAS is approved for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH), particularly in inoperable or persistent cases post-surgery.

2. How does riociguat differentiate from other pulmonary hypertension therapies?
Its unique mechanism as a soluble guanylate cyclase stimulator offers a novel approach, enhancing the nitric oxide pathway, unlike endothelin receptor antagonists or PDE-5 inhibitors.

3. What factors could influence ADEMPAS’s sales growth in coming years?
Key factors include clinical trial outcomes, regulatory approvals for new indications, market access strategies, competitive drug launches, and reimbursement policies.

4. Which regions are the most significant markets for ADEMPAS?
Europe remains the largest market, followed by North America, with emerging markets in Asia-Pacific and Latin America showing increasing uptake.

5. What are the main challenges facing ADEMPAS’s market expansion?
Challenges include limited patient populations due to the rarity of PH, high treatment costs, pricing pressures, and competition from other therapies and future innovations.

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References

[1] Persistence Market Research. Pulmonary Arterial Hypertension Market Report, 2022.
[2] Bayer Pharmaceuticals. ADEMPAS product monograph, 2022.
[3] CHEST Society guidelines, 2018.
[4] Bayer Annual Financial Reports, 2019-2022.
[5] ClinicalTrials.gov. Ongoing studies on riociguat, 2023.