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:	1,015
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 Newcastle Upon-Tyne	Phase 4
Sheffield Teaching Hospitals NHS Foundation Trust	Phase 4
University of Glasgow	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

Expired US Patents for ADEMPAS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-003	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-001	Oct 8, 2013
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	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
Australia	2014220801
Brazil	112015019571
Canada	2807859

Supplementary Protection Certificates for ADEMPAS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506193	C01506193/01	Switzerland		PRODUCT NAME: RIOCIGUAT; REGISTRATION NO/DATE: SWISSMEDIC 62903 21.11.2013
1506193	PA2014018,C1506193	Lithuania		PRODUCT NAME: RIOCIGUATUM; REGISTRATION NO/DATE: EU/1/13/907/001 - EU/1/13/907/015 20140327
1506193	C300659	Netherlands		PRODUCT NAME: RIOCIGUAT, DESGEW ENST IN DE; REGISTRATION NO/DATE: EU/1/13/907 20140327

ADEMPAS (riociguat) market dynamics and financial trajectory: exclusivity, competition, and revenue exposure

Last updated: July 30, 2026

Executive summary: ADEMPAS (riociguat) is a niche pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (CTEPH) franchise with pricing power constrained by limited eligible populations and payer pressure in specialty pharmacy. The key market dynamic is patent- and exclusivity-driven generic/biosimilar entry risk concentrated in the US for oral small-molecule competitors, with settlement structures that can delay or reshape launch timing. Financial trajectory has historically tracked targeted uptake in PAH-CTEPH while facing ongoing headwinds from formulary access, cohort size, and competing PAH mechanisms; near-term value depends on whether future labeling expansion and sustained guideline positioning offset erosion from alternative therapies and potential eventual genericization.

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What are the current market drivers for ADEMPAS (riociguat) in pulmonary arterial hypertension and CTEPH?

Core use cases

• Pulmonary arterial hypertension (PAH), WHO Group 1: ADEMPAS is used in adults for PAH to improve exercise capacity and delay clinical worsening.
• CTEPH: ADEMPAS is used for inoperable CTEPH or persistent/recurrent CTEPH after pulmonary endarterectomy.

Primary commercial drivers

1. Eligible population size is structurally limited
   • PAH and CTEPH are rare diseases, so global revenue scaling depends on penetration, not broad dosing expansion.
2. Therapy sequencing and combination tolerance
   • Riociguat’s positioning is influenced by how clinicians sequence it against PDE5 inhibitors, endothelin receptor antagonists, and prostacyclin pathway agents.
3. Payer and reimbursement dynamics
   • Access is driven by specialty coverage policies and prior authorization norms.
   • Oral administration can help relative to parenteral prostacyclin agents, but co-pay programs and patient assistance requirements shift net pricing.
4. Site-of-care and specialty distribution
   • Most revenue accrues through specialty pharmacy and institutional specialty procurement.
5. Guideline reinforcement
   • Clinical guideline consistency affects durability more than short-term marketing.

How do PAH and CTEPH populations impact ADEMPAS adoption curves?

• Uptake in PAH depends on diagnostic certainty and classification into WHO Group 1, and on clinician willingness to use an sGC stimulator after or alongside other PAH agents.
• Uptake in CTEPH is affected by imaging referral patterns, operability decisions, and post-endarterectomy recurrence identification.

Which competitor classes most affect ADEMPAS pricing and volume?

• PDE5 inhibitors (eg, sildenafil, tadalafil) are the most common oral comparator class in PAH workflows.
• Endothelin pathway therapies compete for baseline control.
• Prostacyclin pathway agents compete for escalation lines.
• In CTEPH, mechanisms-based comparators compete for the “inoperable” and “post-endarterectomy persistent” mindshare.

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How strong is the patent and exclusivity runway for ADEMPAS (riociguat) against generics in the US?

Featured snippet answer: ADEMPAS’ generic entry risk is driven by US small-molecule patent expirations and any listed Orange Book exclusivity tied to the branded approvals for PAH and CTEPH indications.

Patent estate logic for riociguat

• Riociguat is an oral small molecule, so generic risk is mostly tied to:
  • Composition of matter patents covering riociguat itself
  • Formulation or solid-state patents (salt, polymorph, particle size, tablets)
  • Method-of-use patents tied to clinical dosing regimens or indication-specific use
• If composition-of-matter protection has already lapsed, remaining risk shifts to formulation or method-of-use claims and to device-like “use” restrictions that can still delay competition by limiting carve-outs.

What patents protect riociguat products like ADEMPAS?

• Look for Orange Book listings for:
  • active ingredient riociguat
  • finished dosage form (tablets)
  • patents covering PAH and CTEPH indication claims
• The commercial relevance is that an ANDA can enter only when it can either:
  • carve out an exclusivity-impacted use (design-around the covered indication), or
  • obtain Paragraph IV alignment that forces litigation and a potential 30-month stay.

When does ADEMPAS lose exclusivity in the US?

• Loss of exclusivity occurs through a mix of:
  • patent expiration
  • regulatory exclusivity expiration (if any relevant statutory exclusivities apply)
  • any regulatory exclusivity tied to specific labeling or line extension approvals

What generic entry risks exist for ADEMPAS?

• If remaining patents focus on method-of-use, launch can occur with narrow labeling carve-outs.
• If remaining patents focus on formulation or solid-state, launch timing depends on whether generics can use a non-infringing crystalline form or alternative formulation path.
• The biggest market-impact risk is a full-label ANDA entry because it triggers pricing compression across both PAH and CTEPH cohorts.

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Which companies have Paragraph IV challenges or litigation exposure for ADEMPAS (riociguat)?

Featured snippet answer: ADEMPAS generic challenge activity is typically concentrated among ANDA filers targeting US oral small-molecule rights listed in the Orange Book for riociguat.

How to assess challenge strength

• Litigation outcomes matter less for “existence” than for:
  • settlement terms (launch date, non-challenge clauses)
  • claim construction outcomes
  • whether settlement covers both PAH and CTEPH labeling or only specific carve-outs
• Even when a company does not win at trial, settlement can still shift commercial reality by pushing launch out.

What patent litigation affects ADEMPAS launch timing?

• For an oral small molecule like riociguat, relevant litigation typically includes:
  • infringement of composition or formulation claims
  • invalidity challenges grounded in prior art or obviousness
  • procedural defenses and timing arguments

How do settlement agreements change ADEMPAS revenue risk?

• Settlements can:
  • establish an agreed “at-risk” entry date
  • include covenants restricting patent challenges
  • segment the market via labeling carve-outs

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What is the Orange Book status of ADEMPAS (riociguat) and how does it map to launch barriers?

Featured snippet answer: Orange Book listings for riociguat map directly to the legal barriers an ANDA must navigate: patent expiry and any relevant exclusivity block. The list also helps identify whether a generic can launch with label carve-outs.

Orange Book mapping to competitive scenarios

• Scenario A: composition-of-matter expired, formulation/method still listed
  • High likelihood of delayed launch for full label, with potential narrow entry.
• Scenario B: method-of-use still active
  • Label carve-outs become the main path; revenue risk concentrates in the protected indication portion.
• Scenario C: formulation patents still strong
  • Generics may delay due to need for non-infringing solid-state or process redesign.

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How does ADEMPAS (riociguat) financial trajectory compare with competing PAH and CTEPH drugs?

Market comparison framework

• Compare by:
  • oral vs parenteral pathway class
  • line position (first-line vs add-on vs escalation)
  • diagnostic funnel (PAH vs CTEPH referral density)
  • payer reimbursement intensity

What commercial outcomes typically differ among PAH oral agents?

• Oral agents can share payer structures, driving similar net price pressures.
• Differentials come from:
  • evidence packages and label breadth
  • ability to be used across combination regimens
  • guideline preference and persistence data

Where ADEMPAS tends to under- or out-perform

• Out-performance tends to occur when:
  • clinician adoption aligns with guideline wording and diagnosis trends
  • payer access improves through tier placement
• Under-performance tends to occur when:
  • competing agents receive preferred formulary placement
  • switching patterns move patients to alternative oral mechanisms

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How do payer coverage policies and specialty pharmacy economics shape ADEMPAS net sales?

Mechanisms that affect net price

• Specialty distribution channels drive:
  • wholesaler margins and specialty pharmacy service fees
  • co-pay program participation rates
  • patient assistance offsets

Key net sales sensitivity

• A small change in net price per script can move revenue substantially because the absolute patient population is smaller than for mainstream chronic therapies.

What formularies and contracting dynamics matter most?

• PAH and CTEPH are long duration; contracting changes can lock in pricing durability for a year or more.
• Prior authorization and step edits can reduce volume even without direct clinical substitution.

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What are realistic generic launch scenarios for ADEMPAS (riociguat) and how would they affect revenue?

Featured snippet answer: The most revenue-destructive scenario is a full-label ANDA entry that forces broad substitution. Narrow-label carve-out launches typically produce slower and less complete erosion.

Scenario playbook

• Full-label launch
  • Rapid price compression, fastest revenue erosion across both PAH and CTEPH populations.
• Carve-out launch
  • Erosion concentrates where the protected use remains excluded; remaining ADEMPAS demand persists until carve-out boundaries are lifted.
• Design-around delayed
  • If patents block formulation, delay can keep brand sales resilient; long-tail erosion remains but with longer duration.

At-risk sales and channel stocking

• Oral small molecules can experience pre-launch channel positioning, which can temporarily smooth revenue declines before substitution accelerates post-launch.

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How does ADEMPAS manufacturing and supply chain capacity influence financial stability during competition?

Supply stability factors

• Active ingredient sourcing consistency
• Finished dosage form manufacturing yields
• Batch release timing across geopolitically sensitive supply points

Competition transition

• When generics approach, brand supply planning can reduce risk of inventory shortages that otherwise can cause temporary sales volatility and payer contract renegotiation.

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What regulatory pathway considerations affect ADEMPAS competitive timing?

US regulatory dynamics

• ANDA timelines depend on:
  • Paragraph IV litigation and 30-month stays
  • ability to meet bioequivalence and formulation equivalency requirements
• Label carve-outs require regulatory alignment with legal design-around.

Featured snippet answer: Regulatory timing is usually subordinate to patent status, but it governs how quickly a generic can convert from legal permission into actual market availability.

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Key Takeaways

• ADEMPAS is a rare-disease, specialty-priced franchise where financial trajectory depends on specialty access, guideline-aligned adoption, and payer contracting durability.
• Market competition is typically incremental via oral PAH mechanism rivals and escalates materially once a full-label generic entry becomes legally and operationally feasible.
• The highest revenue risk is a US ANDA that can launch across the same indication set without carve-outs; method-of-use or formulation patents shift risk toward delayed or narrowed competition.
• For business planning, generic launch scenario modeling should split revenue impact into full-label versus carve-out entry and incorporate channel stocking and payer tier dynamics.

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FAQs

1. What labeling carve-outs could allow partial generic entry for ADEMPAS (riociguat)?
2. How do Paragraph IV 30-month stays typically influence generic launch timing for oral small molecules like riociguat?
3. Which PAH competitor mechanisms most frequently substitute for riociguat in real-world treatment sequences?
4. How does specialty pharmacy prior authorization reduce ADEMPAS script volume even when clinical demand is stable?
5. What patent types (composition, formulation, method-of-use) most often delay generic entry for oral drugs like ADEMPAS?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-07-30).
2. FDA. Drug Approval and Database Records for ADEMPAS (riociguat). (Accessed 2026-07-30).
3. FDA. ANDA and Paragraph IV certification guidance materials. (Accessed 2026-07-30).