guaifenesin; hydrocodone bitartrate · Sovereign Pharms · NDA 205474
Obredon
Earliest generic entry, as listed
13 Nov 2035
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10105324, US 9549907, US 9808431.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10105324 | drug substance, drug product, use U-2023 · sets the listed date | 13 Nov 2035 |
| US 9549907 | drug substance, drug product, use U-2023 · sets the listed date | 13 Nov 2035 |
| US 9808431 | drug substance, drug product, use U-2023 · sets the listed date | 13 Nov 2035 |
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 |
|---|---|---|---|
| 205474 · 001 · RLD · discontinued | solution, oral | 200MG/5ML;2.5MG/5ML | 13 Nov 2035 |