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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

3 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 1:2018cv00073 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	WVND	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

1 trial from ClinicalTrials.gov, 1 active

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

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

Medicare Part D Spending

CMS annual spending data for Adempas (2023)

Total Spending

$598.2M

Total Claims

44,483

Beneficiaries

4,980

Avg Cost/Unit

$152.26

Spending Trend

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

YoY Change:+6.2%

5yr CAGR:+6.5%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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#001 — 0.5MG

RLDAB

4 patents0 exclusivities▴