riociguat · Bayer Hlthcare · NDA 204819
Adempas
Earliest generic entry, as listed · earliest of 5 marketed strengths
18 Feb 2034
Blocked by patent: US 10662188, US 11203593, US 12503469.
Listed patents · 4 unexpired
7 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10662188 | drug substance, drug product, use U-2834, U-2835 | 18 Feb 2034 |
| US 10662188 listing row | drug substance, drug product, use U-2834 · sets the listed date | 18 Feb 2034 |
| US 10662188 listing row | drug substance, drug product, use U-2835 · sets the listed date | 18 Feb 2034 |
| US 11203593 | drug substance, drug product, use U-2834, U-2835 | 18 Feb 2034 |
| US 11203593 listing row | drug substance, drug product, use U-2834 · sets the listed date | 18 Feb 2034 |
| US 11203593 listing row | drug substance, drug product, use U-2835 · sets the listed date | 18 Feb 2034 |
| US 12503469 | drug product, use U-2834, U-2835 | 18 Feb 2034 |
| US 12503469 listing row | drug product, use U-2834 · sets the listed date | 18 Feb 2034 |
| US 12503469 listing row | drug product, use U-2835 · sets the listed date | 18 Feb 2034 |
| US 7173037 | drug substance, drug product | 4 Dec 2026 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 204819 · 001 · RLD | tablet, oral | 0.5MG | 18 Feb 2034 |
| 204819 · 002 · RLD | tablet, oral | 1MG | 18 Feb 2034 |
| 204819 · 003 · RLD | tablet, oral | 1.5MG | 18 Feb 2034 |
| 204819 · 004 · RLD | tablet, oral | 2MG | 18 Feb 2034 |
| 204819 · 005 · RLD | tablet, oral | 2.5MG | 18 Feb 2034 |