Riociguat - Generic Drug Details

What are the generic sources for riociguat and what is the scope of freedom to operate?

Riociguat is the generic ingredient in two branded drugs marketed by Bayer Hlthcare and MSN, and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are two drug master file entries for riociguat. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for riociguat

International Patents:	69
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	49
Patent Applications:	1,009
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for riociguat
What excipients (inactive ingredients) are in riociguat?	riociguat excipients list
DailyMed Link:	riociguat at DailyMed

Recent Clinical Trials for riociguat

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 riociguat clinical trials

Generic filers with tentative approvals for RIOCIGUAT

Applicant	Application No.	Strength	Dosage Form
		2.5MG	TABLET;ORAL
		2MG	TABLET;ORAL
		1.5MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for riociguat

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

Anatomical Therapeutic Chemical (ATC) Classes for riociguat

C02KX	Antihypertensives for pulmonary arterial hypertension
C02K	OTHER ANTIHYPERTENSIVES
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

Paragraph IV (Patent) Challenges for RIOCIGUAT

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 riociguat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msn	RIOCIGUAT	riociguat	TABLET;ORAL	211135-004	Sep 1, 2022	AB	RX	No	No
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	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
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013	AB	RX	Yes	Yes	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
Msn	RIOCIGUAT	riociguat	TABLET;ORAL	211135-001	Sep 1, 2022	AB	RX	No	No

Expired US Patents for riociguat

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
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-005	Oct 8, 2013	6,743,798
Bayer Hlthcare	ADEMPAS	riociguat	TABLET;ORAL	204819-002	Oct 8, 2013	6,743,798

EU/EMA Drug Approvals for riociguat

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 riociguat

Country	Patent Number	Title	Estimated Expiration
Ukraine	78314	КАРБАМАТ-ЗАМЕЩЕННЫЕ ПИРАЗОЛОПИРИДИНЫ;КАРБАМАТЗАМІЩЕНІ ПІРАЗОЛОПІРИДИНИ (CARBAMATE-SUBSTITUTED PYRAZOLOPYRIDINES)
Israel	164958	CARBAMATE-SUBSTITUTED PYRAZOLOPYRIDINES
Canada	2485143	PYRAZOLOPYRIDINES A SUBSTITUTION CARBAMATE (CARBAMATE-SUBSTITUTED PYRAZOLOPYRIDINES)
Argentina	039789	PIRAZOLOPIRIDINAS SUSTITUIDAS CON CARBAMATO
Germany	50303960
Poland	373336	Pirazolopirydyny podstawione karbaminianem (CARBAMATE-SUBSTITUTED PYRAZOLOPYRIDINES)

Supplementary Protection Certificates for riociguat

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
1506193	C 2014 026	Romania		PRODUCT NAME: RIOCIGUAT4,6-DIAMINO-2-[1-(-FLUORBENZIL)-1H-PIRAZOLO[3,4-B]PIRIDIN-3-IL]-5-PIRIMIDINIL 20140327; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/907; DATE OF FIRST AUTHORISATION IN EEA: 20140327 (METIL)CARBAMAT DEMETIL; NATIONAL AUTHORISATION NUMBER: EU/1/13/907; DATE OF NATIONAL AUTHORISATION:
1506193	PA2014018,C1506193	Lithuania		PRODUCT NAME: RIOCIGUATUM; REGISTRATION NO/DATE: EU/1/13/907/001 - EU/1/13/907/015 20140327
1506193	C20140015 00109	Estonia		PRODUCT NAME: RIOTSIGUAAT; REG NO/DATE: K(2014)2152 (LOPLIK) 31.03.2014

Riociguat Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Riociguat

Introduction

Riociguat, marketed under the brand name Adempas, is a groundbreaking drug developed by Bayer for the treatment of two severe and life-threatening conditions: Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH). This article delves into the market dynamics and financial trajectory of riociguat, highlighting its impact, growth prospects, and economic implications.

Market Growth and Expansion

The riociguat market has experienced rapid and substantial growth in recent years. Projections indicate that this expansion will continue from 2023 to 2031, driven by positive market dynamics and sustained demand for effective treatments for PAH and CTEPH[1].

Market Segmentation

The market for riociguat is segmented based on the drug's dosage (0.5mg, 1mg, 1.5mg, 2mg, 2.5mg) and its applications (PAH and CTEPH). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This segmentation helps in understanding the diverse market needs and opportunities across different regions and patient groups[1].

Clinical Efficacy and Impact

Riociguat is the first drug to provide statistically significant clinical improvements in patients with inoperable CTEPH or persistent/recurrent PH disease. Clinical trials have shown that riociguat improves exercise capacity, reduces resistance to blood flow in the lungs, and enhances markers of disease severity. This efficacy has been a key driver of its adoption and market growth[2].

Patient Needs and Treatment Gaps

Before the approval of riociguat, patients with inoperable CTEPH or those who did not respond to surgery had limited treatment options. Riociguat fills this critical gap by offering a proven drug treatment with good tolerability and significant clinical benefits. This addresses the urgent need for effective treatments in these patient populations[2].

Economic Impact on Health Plans

The addition of riociguat to health plan formularies has been evaluated for its budgetary impact. Studies have shown that the financial impact is minimal, with estimated costs as low as $0.02 per member per month (PMPM) and $0.27 per member per year (PMPY) for both Medicare and non-Medicare plans. This suggests that riociguat offers a cost-effective treatment option for managing PAH and CTEPH[3][4].

Cost Analysis

The budget impact analysis was conducted using a customizable decision analytic tool, considering factors such as drug costs, administration costs, and monitoring costs. The results indicate that the incremental expenditure for treating patients with PAH or CTEPH is manageable, with a small increase in annual health plan expenditures. Sensitivity analyses further validated the robustness of these findings[4].

Market Drivers and Opportunities

Several factors drive the growth of the riociguat market:

Increasing Prevalence of PAH and CTEPH

The rising prevalence of PAH and CTEPH, coupled with the lack of effective treatments for these conditions, creates a significant demand for riociguat.

Novel Mechanism of Action

Riociguat's unique mechanism as a soluble guanylate cyclase stimulator sets it apart from other treatments, offering improved clinical outcomes and enhancing its market appeal[2].

Regulatory Approvals

The FDA approval of riociguat for both PAH and CTEPH has been a crucial factor in its market success, providing a validated treatment option for healthcare providers and patients[2].

Market Challenges and Restraints

Despite its growth, the riociguat market faces several challenges:

High Development and Production Costs

The development and production of riociguat are costly, which can impact its pricing and accessibility.

Limited Patient Population

PAH and CTEPH are rare conditions, which limits the potential market size compared to more common diseases.

Competition from Other Treatments

While riociguat is a first-in-class treatment, it competes with other established therapies such as prostacyclin analogs, endothelin receptor antagonists, and PDE-5 inhibitors[4].

Competitive Landscape

The riociguat market is dominated by Bayer, with other players like MSD-UK and M Care Exports also involved. The competitive landscape is characterized by a focus on innovation, patient care, and market penetration strategies[1].

Key Players

• Bayer: As the developer and primary marketer of riociguat, Bayer plays a pivotal role in the market.
• MSD-UK: Another significant player, MSD-UK contributes to the market through its distribution and marketing efforts.
• M Care Exports: This company also participates in the market, though its role is less prominent compared to Bayer and MSD-UK[1].

Geographical Market Analysis

The market for riociguat is spread across various geographical regions, each with its own set of opportunities and challenges:

North America

North America is a significant market due to high healthcare spending and advanced healthcare infrastructure.

Europe

Europe also represents a substantial market, driven by a large patient population and strong healthcare systems.

Asia-Pacific

The Asia-Pacific region is expected to grow rapidly due to increasing healthcare expenditure and a large patient base[1].

Future Outlook and Projections

The riociguat market is poised for continued growth, driven by its clinical efficacy, novel mechanism of action, and the increasing prevalence of PAH and CTEPH. Here are some key projections:

Market Size

The market size of riociguat is expected to increase significantly from 2023 to 2031, measured in USD million across various segments[1].

Revenue Growth

Revenue growth is anticipated to be robust, driven by the sustained demand for effective treatments for PAH and CTEPH.

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, are expected to contribute significantly to the market's future growth[1].

Conclusion

Riociguat has revolutionized the treatment landscape for PAH and CTEPH, offering a first-in-class treatment option with significant clinical benefits. The market dynamics are favorable, with sustained growth projected over the next several years. The economic impact on health plans is minimal, making it a cost-effective addition to formularies.

"Riociguat will be welcomed by patients with CTEPH who, up to now, have not had a proven drug treatment option available to them if their disease is inoperable or for those experiencing residual PH following surgery. CTEPH is a devastating diagnosis, and the symptoms of breathlessness, dizziness and fainting can be frightening and have a severe impact on daily activities. To have a treatment that achieves meaningful clinical improvements is a much needed step forward," - Frank Poon, President, Pulmonary Hypertension Association of Canada[2].

Key Takeaways

• Rapid Market Growth: The riociguat market has seen substantial growth and is expected to continue this trend from 2023 to 2031.
• Clinical Efficacy: Riociguat provides statistically significant clinical improvements in patients with PAH and CTEPH.
• Economic Impact: The addition of riociguat to health plan formularies has a minimal financial impact, estimated at $0.02 PMPM and $0.27 PMPY.
• Market Segmentation: The market is segmented by dosage and application, with geographical divisions across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa.
• Competitive Landscape: Bayer is the dominant player, with other companies like MSD-UK and M Care Exports also involved.
• Future Outlook: The market is poised for continued growth, driven by increasing prevalence and demand for effective treatments.

FAQs

Q: What conditions does riociguat treat?

Riociguat is approved for the treatment of Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Q: What is the unique mechanism of action of riociguat?

Riociguat is a soluble guanylate cyclase stimulator, targeting a key molecular mechanism underlying PAH and CTEPH by enhancing the synthesis of cyclic guanosine monophosphate (cGMP).

Q: How does riociguat impact health plan budgets?

The addition of riociguat to health plan formularies results in a minimal financial impact, estimated at $0.02 per member per month (PMPM) and $0.27 per member per year (PMPY).

Q: Who are the key players in the riociguat market?

The key players include Bayer, MSD-UK, and M Care Exports.

Q: What are the projected market growth prospects for riociguat?

The market for riociguat is expected to grow significantly from 2023 to 2031, driven by its clinical efficacy and increasing demand for effective treatments for PAH and CTEPH.

Sources

1. Market Research Intellect - Global Riociguat Tablets Market Size, Scope And Forecast Report.
2. Newswire.ca - Bayer receives approval for Adempas® as first drug to treat rare heart and lung disease.
3. AHDB Online - Budgetary Impact of Adding Riociguat to a US Health Plan for the Treatment of Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension.
4. NCBI - Budgetary Impact of Adding Riociguat to a US Health Plan for the Treatment of Patients with Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension.