fesoterodine fumarate · Pfizer · NDA 022030
Toviaz
Earliest generic entry, as listed · earliest of 2 marketed strengths
7 Dec 2027
Blocked by patent: US 7807715 (pediatric extension), US 8088398 (pediatric extension), US 8501723 (pediatric extension).
Listed patents · 3 unexpired
6 Orange Book listing rows for 3 patents, including 3 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 7807715 | drug product, use U-913 | 7 Dec 2027 |
| US 7807715 listing row | drug product, use U-913 | 7 Jun 2027 |
| US 7807715 listing row | pediatric extension · sets the listed date | 7 Dec 2027 |
| US 8088398 | drug product, use U-913 | 7 Dec 2027 |
| US 8088398 listing row | drug product, use U-913 | 7 Jun 2027 |
| US 8088398 listing row | pediatric extension · sets the listed date | 7 Dec 2027 |
| US 8501723 | drug product | 7 Dec 2027 |
| US 8501723 listing row | drug product | 7 Jun 2027 |
| US 8501723 listing row | pediatric extension · sets the listed date | 7 Dec 2027 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022030 · 001 · RLD | tablet, extended release, oral | 4MG | 7 Dec 2027 |
| 022030 · 002 · RLD | tablet, extended release, oral | 8MG | 7 Dec 2027 |