Is Adempas still available?

Yes. Adempas (NDA 204819) is listed with marketing status Prescription in the FDA Orange Book.

Does Adempas have a generic?

Yes. The Orange Book lists 1 approved generic (ANDA) application sharing Adempas's active ingredient (Riociguat). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What does Adempas's TE code AB mean?

AB is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Adempas substitutable for its reference brand with no expected difference in clinical effect.

When do Adempas's patents expire?

The FDA Orange Book lists 7 patents against Adempas, with the last listed patent expiring Feb 18, 2034. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Adempas's FDA application number?

Adempas is approved under NDA 204819, held by Bayer Hlthcare.

Orange Book product · Brand (NDA)

Adempas

Riociguat

Brand (NDA)NDA 204819TE ABRLD Bayer Hlthcare

Approved

Oct 08, 2013

Application

Brand (NDA)

TE code

Listed patents

Adempas (Riociguat) is Bayer Hlthcare's brand-name drug, approved by the FDA under NDA 204819 in 2013. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand. 1 approved generic share this drug's active ingredient. The FDA Orange Book lists 7 patents against it, the last expiring 2034.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Oct 08, 2013
12 yr 11 mo ago
Today
Patent 7173037 expires
Listed drug substance patent expiration.
Dec 04, 2026
in 5 mo
Patent 10662188 expires
Listed drug substance patent expiration.
Feb 18, 2034
in 7 yr 9 mo
Patent 10662188 expires
Listed drug substance patent expiration.
Feb 18, 2034
in 7 yr 9 mo
Patent 11203593 expires
Listed drug substance patent expiration.
Feb 18, 2034
in 7 yr 9 mo
Patent 11203593 expires
Listed drug substance patent expiration.
Feb 18, 2034
in 7 yr 9 mo
Patent 12503469 expires
Listed drug product patent expiration.
Feb 18, 2034
in 7 yr 9 mo
Patent 12503469 expires
Listed drug product patent expiration.
Feb 18, 2034
in 7 yr 9 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

RIOCIGUAT

Strength

1MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 204819

Product number

002

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Same application

Other strengths in NDA 204819

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

RiociguatGeneric (ANDA)
ANDA 211135 · Msn
2022

View full Riociguat family

Orange Book patent file

Listed patents

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7173037	Dec 04, 2026	in 5 mo	SubstanceProduct
10662188	Feb 18, 2034	in 7 yr 9 mo	SubstanceProductU-2834
10662188	Feb 18, 2034	in 7 yr 9 mo	SubstanceProductU-2835
11203593	Feb 18, 2034	in 7 yr 9 mo	SubstanceProductU-2834
11203593	Feb 18, 2034	in 7 yr 9 mo	SubstanceProductU-2835
12503469	Feb 18, 2034	in 7 yr 9 mo	ProductU-2834
12503469	Feb 18, 2034	in 7 yr 9 mo	ProductU-2835

Adempas — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Riociguat active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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