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ADEMPAS

NDA

RIOCIGUAT | N204819 | BAYER HEALTHCARE PHARMACEUTICALS INC

5 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Expiring < 1yr (1)Active (3)Today

2027

2028

2029

2030

2031

2032

2033

2034

Today

Dec. 4, 2026

Feb. 18, 2034

Feb. 18, 2034

Feb. 18, 2034

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

6 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Adverio Pharma GmbH et al v. Sandoz Inc. 1:2026cv00321 1 patentANDA 219225riociguat	D. Del.	2026-03-23	Active	—
Adverio Pharma GmbH et al v. MSN Laboratories Private Limited et al 1:2020cv01617	D. Del.	2020-11-25	Terminated 2020-12-21	—
Adverio Pharma GmbH et al v. Teva Pharmaceuticals USA, Inc. et al 1:2018cv00112	D. Del.	2018-01-19	Terminated 2018-10-19	—
Adverio Pharma GmbH et al v. MSN Laboratories Private Limited et al 1:2018cv00111	D. Del.	2018-01-19	Terminated 2020-12-21	—
Adverio Pharma GmbH et al v. MSN Laboratories Private Limited et al 1:2018cv00073 1 patentANDA 211127riociguat	D. Del.	2018-01-09	Terminated 2020-12-21	—
Gilead Sciences, Inc. v. Mylan Pharmaceuticals Inc. 1:2017cv00217 1 patentANDA 207453atazanavir and cobicistat	N.D. W. Va.	2017-12-15	Terminated 2018-07-23	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

41 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 31 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Riociguat in Children With Pulmonary Arterial Hypertension (PAH)NCT02562235	Phase 3	Active	Bayer	24	2015-10-29 → 2027-08-03
Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH NCT04062565	Phase 3	Recruiting	University of Arizona	20	2019-03-25 → 2025-12-31
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction NCT01065454	Phase 2	Completed	Bayer	202	2010-04-14 → 2025-07-23
Efficacy Study of Riociguat and Its Effects on Exercise Performance and Pulmonary Artery Pressure at High Altitude NCT02024386	Phase 4	Completed	Richard Moon	28	2014-01 → 2015-12
Relative Bioavailability Study NCT02159313	Phase 1	Completed	Bayer	48	2014-06 → 2015-01
Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics NCT03389321	Phase 1	Completed	Actelion	20	2018-01-09 → 2018-02-06
BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension NCT00910429	Phase 3	Completed	Bayer	237	2009-07-01 → 2019-08-19
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)NCT00810693	Phase 3	Completed	Bayer	445	2008-12-17 → 2012-05-14
BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension NCT00863681	Phase 3	Completed	Bayer	396	2009-03-12 → 2019-08-19
Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy NCT02891850	Phase 4	Completed	Bayer	225	2017-01-11 → 2020-03-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 20 NDCs (10 FSS, 10 Big4)

Lowest Price

$1051.49

Highest Price

$12396.11

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50419-0252-01ADEMPAS 1.5MG TAB	$12396.11	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0252-01ADEMPAS 1.5MG TAB	$9979.80	Big4	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0250-01ADEMPAS 0.5MG TAB	$12396.11	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0250-01ADEMPAS 0.5MG TAB	$10531.73	Big4	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0250-91ADEMPAS 0.5MG TAB	$1239.61	FSS	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026
50419-0250-91ADEMPAS 0.5MG TAB	$1053.15	Big4	Bayer HealthCare Pharmaceuticals, Inc.	09/30/2026

Showing 6 of 20 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Adempas (2024)

Total Spending

$694.2M

Total Claims

50,847

Beneficiaries

5,553

Avg Cost/Unit

$154.23

Spending Trend

$316.9M(2019)→$463.2M(2020)→$566.5M(2021)→$577.0M(2022)→$598.2M(2023)→$694.2M(2024)

YoY Change:+1.3%

5yr CAGR:+5.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

MSN LIFE SCIENCES PRIVATE LTDRIOCIGUAT USP

DMF 310922016

ALEMBIC PHARMACEUTICALS LTDRIOCIGUAT USP

DMF 316652017

MSN LIFE SCIENCES PRIVATE LTDRIOCIGUAT USP [ROUTE CODE UJ]

DMF 383722023

HONOUR LAB LTDRIOCIGUAT

DMF 422402025

BIOPHORE INDIA PHARMACEUTICALS PVT LTDRIOCIGUAT

DMF 423492025

ZHEJIANG KINGLAND PHARMACEUTICAL CO LTDRIOCIGUAT

DMF 433202025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
May 11, 2026	SUPPL -20	View Letter (PDF)
Sep 14, 2021	SUPPL -15	View Letter (PDF)
Dec 2, 2020	SUPPL -13	View Letter (PDF)
Feb 12, 2020	SUPPL -14	View Letter (PDF)
Dec 10, 2018	SUPPL -9	View Letter (PDF)
Jan 17, 2018	SUPPL -11	View Letter (PDF)
Mar 2, 2017	SUPPL -8	View Letter (PDF)
Jan 19, 2017	SUPPL -6	View Letter (PDF)
Oct 6, 2016	SUPPL -7	View Letter (PDF)
Dec 7, 2015	SUPPL -4	View Letter (PDF)
Jun 12, 2014	SUPPL -1	View Letter (PDF)
May 8, 2014	SUPPL -2	View Letter (PDF)
Oct 10, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 0.5MG

RLDAB

4 patents0 exclusivities▴