oxybutynin chloride · Abbvie · NDA 022204
Gelnique
Earliest generic entry, as listed
26 Mar 2031
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8920392. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8920392 | use U-1644 · sets the listed date | 26 Mar 2031 |
| US 10449173 | drug product, use U-2637 | 6 Nov 2029 |
| US 9259388 | use U-1644 | 6 Nov 2029 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022204 · 001 · RLD · discontinued | gel, transdermal | 10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 26 Mar 2031 |