vardenafil hydrochloride · Bayer Hlthcare · NDA 200179
Staxyn
Earliest generic entry, as listed
23 Dec 2028
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8613950.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8613950 | product | 23 Dec 2028 |
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 |
|---|---|---|---|
| 200179 · 001 · RLD · discontinued | tablet, orally disintegrating, oral | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 23 Dec 2028 |