Question 1

Is there a generic for Riociguat?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Riociguat, referencing the brand ADEMPAS. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Riociguat?

Accepted Answer

ADEMPAS (NDA 204819, BAYER HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Riociguat?

Accepted Answer

The Orange Book lists 4 patents against Riociguat products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Riociguat are approved?

Accepted Answer

Riociguat is approved in the following dosage form: tablet.

Patent	Expires	In	Type
7173037	Dec 04, 2026	in 6 mo	SubstanceProduct
12503469	Feb 18, 2034	in 7 yr 9 mo	ProductU-2834
10662188	Feb 18, 2034	in 7 yr 9 mo	SubstanceProductU-2834
11203593	Feb 18, 2034	in 7 yr 9 mo	SubstanceProductU-2834

Riociguat

Brand (NDA) products · tablet

Generic (ANDA) products (1)

Listed patents (4)

Riociguat — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.