Assyro AI

Orange Book product · Brand (NDA)

ADEMPAS

RIOCIGUAT

Brand (NDA)NDA 204819TE ABRX BAYER HLTHCARE

At a glance

Oct 08, 2013

Approved

Brand (NDA)

Application

AB

TE code

7

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 08, 2013

    12 yr 11 mo ago

  2. Today

  3. Patent 7173037 expires

    Listed drug substance patent expiration.

    Dec 04, 2026

    in 6 mo

  4. Patent 10662188 expires

    Listed drug substance patent expiration.

    Feb 18, 2034

    in 7 yr 9 mo

  5. Patent 10662188 expires

    Listed drug substance patent expiration.

    Feb 18, 2034

    in 7 yr 9 mo

  6. Patent 11203593 expires

    Listed drug substance patent expiration.

    Feb 18, 2034

    in 7 yr 9 mo

  7. Patent 11203593 expires

    Listed drug substance patent expiration.

    Feb 18, 2034

    in 7 yr 9 mo

  8. Patent 12503469 expires

    Listed drug product patent expiration.

    Feb 18, 2034

    in 7 yr 9 mo

  9. Patent 12503469 expires

    Listed drug product patent expiration.

    Feb 18, 2034

    in 7 yr 9 mo

Pharmaceutical detail

Active ingredient

RIOCIGUAT

Strength

0.5MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

NDA 204819

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

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

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7173037Dec 04, 2026in 6 mo
SubstanceProduct
10662188Feb 18, 2034in 7 yr 9 mo
SubstanceProductU-2834
10662188Feb 18, 2034in 7 yr 9 mo
SubstanceProductU-2835
11203593Feb 18, 2034in 7 yr 9 mo
SubstanceProductU-2834
11203593Feb 18, 2034in 7 yr 9 mo
SubstanceProductU-2835
12503469Feb 18, 2034in 7 yr 9 mo
ProductU-2834
12503469Feb 18, 2034in 7 yr 9 mo
ProductU-2835
Agent CTA Background

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