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:	108
Clinical Trials:	18
Patent Applications:	530
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
Sheffield Teaching Hospitals NHS Foundation Trust	Phase 4
University of Glasgow	Phase 4
Danish Headache Center	N/A

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

Expired US Patents for ADEMPAS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-004	Oct 8, 2013	6,743,798
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

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/002737 Chronic 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	10220570	Carbamat-substituierte Pyrazolopyridine
China	1165536
Luxembourg	92419

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	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	CR 2014 00028	Denmark		PRODUCT NAME: RIOCIGUAT OG SALTE, ISOMERER OG HYDRATER HERAF; REG. NO/DATE: EU/1/13/907 20140327

ADEMPAS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Adempas

Introduction

Adempas, developed by Bayer, is a soluble guanylate cyclase (sGC) stimulator, a novel class of drugs specifically designed to treat pulmonary hypertension. Here, we delve into the market dynamics and financial trajectory of Adempas, examining its performance, challenges, and future outlook.

Approval and Indications

Adempas is approved for the treatment of two distinct forms of pulmonary hypertension:

• Chronic Thromboembolic Pulmonary Hypertension (CTEPH): For patients who have undergone surgery but still have high pulmonary blood pressure, or for those who cannot undergo surgery due to inoperable conditions[5].
• Pulmonary Arterial Hypertension (PAH): For patients classified under WHO Group 1, primarily those with WHO functional class II-III symptoms[5].

Initial Growth Expectations

Initially, Adempas was hailed as one of Bayer's key growth products, expected to generate significant revenue. Analysts had predicted sales of $870 million by 2018, positioning it alongside other high-growth products like Xarelto and Eylea[1].

Challenges and Setbacks

However, Adempas faced several challenges that impacted its financial trajectory:

• Canceled Trial: A trial for Adempas in PAH patients with idiopathic interstitial pneumonias was halted due to increased risk of death or serious adverse events. This halted hopes for label expansion, which could have boosted sales[1].
• Competition: The PAH market is highly competitive, with rivals like Actelion's Opsumit and Uptravi gaining significant market share. Opsumit, for instance, netted CHF 516 million ($525 million) in 2015, posing a direct challenge to Adempas[1].
• Safety Concerns: Adempas has been associated with several safety issues, including hypotension, bleeding, and pulmonary veno-occlusive disease, which can affect patient compliance and prescribing rates[2].

Revised Sales Projections

Following these setbacks, sales projections for Adempas were significantly revised downward. By 2022, EvaluatePharma predicted sales of only $459 million, far below initial expectations[1].

Current Market Performance

Despite the challenges, Adempas has shown some resilience:

• Revenue Growth: Bayer reported a significant increase in revenue from Adempas, driven by higher volume sales in the U.S. during 2020 and 2021. This indicates that the drug still maintains a market presence[4].
• Market Share: Adempas operates in a market dominated by oral formulations, with the oral segment holding over 55% of the market share. Adempas, being an oral drug, benefits from this patient preference[4].

Global PAH Market Outlook

The global pulmonary arterial hypertension market is expected to grow significantly:

• Market Size: The market is predicted to reach USD 10.9 billion by 2030, growing at a CAGR of 5.1% from 2022 to 2030[4].
• Key Drivers: Increasing prevalence of PAH, drug development, technological advancements, and reimbursement availability are key drivers of this market growth[4].

Regional Performance

• North America: This region dominates the PAH market, with a large share due to the developed healthcare infrastructure in the U.S. and Canada. Adempas benefits from this favorable environment[4].
• Asia Pacific: This region is expected to witness the fastest CAGR due to growing consumption of generics, presence of key pharmaceutical companies, and developing healthcare infrastructure[4].

Patent Expiry and Generic Competition

A significant challenge for Adempas in the future is the expiry of its active ingredient patent in several key markets. This could lead to the entry of generics, potentially dampening sales[4].

Patient Support and Access Programs

To mitigate some of the financial and access challenges, Bayer offers several support programs:

• Aim Patient Support Program: This program provides benefit verification, financial assistance, and education about CTEPH and PAH, helping patients navigate the treatment journey[2].
• Hospital Programs: Patients initiating treatment in hospitals can continue Adempas at no cost while awaiting insurance confirmation, ensuring uninterrupted therapy[2].

Key Takeaways

• Adempas, despite initial high expectations, has faced significant challenges including a canceled trial and competitive market pressures.
• The drug has shown some resilience with increased revenue from higher volume sales.
• The global PAH market is growing, driven by increasing prevalence and technological advancements.
• Patent expiry and generic competition pose future challenges.
• Patient support programs are crucial in maintaining patient compliance and access.

FAQs

1. What are the approved indications for Adempas? Adempas is approved for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH)[5].

2. Why was the Adempas trial in PAH patients with idiopathic interstitial pneumonias halted? The trial was halted due to an increased risk of death or serious adverse events in patients receiving Adempas[1].

3. How has the competition affected Adempas sales? Competition from drugs like Opsumit and Uptravi has significantly impacted Adempas sales, reducing its market share and sales projections[1].

4. What is the current market size and growth rate of the PAH market? The PAH market is expected to reach USD 10.9 billion by 2030, growing at a CAGR of 5.1% from 2022 to 2030[4].

5. What support programs are available for Adempas patients? Bayer offers the Aim Patient Support Program, which includes benefit verification, financial assistance, and education about CTEPH and PAH, as well as hospital programs for uninterrupted therapy[2].

Sources

1. FiercePharma - Can Adempas meet Bayer's growth expectations after a canceled trial?
2. Bayer - The Adempas Enrollment Journey
3. Resmed Journal - The role of riociguat in combination therapies for pulmonary arterial hypertension
4. Vision Research Reports - Pulmonary Arterial Hypertension Market Size Worth Around USD 10.9 billion by 2030
5. Bayer - About Adempas® a sGC Stimulator in PH