nevirapine · Boehringer Ingelheim · NDA 201152
Viramune Xr
Earliest generic entry, as listed · earliest of 2 marketed strengths
12 Mar 2029
1 of 2 marketed strengths has no unexpired patent or exclusivity listed; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8460704. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8460704 | use U-1409 | 12 Mar 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 201152 · 001 · RLD · discontinued | tablet, extended release, oral | 400MG | 12 Mar 2029 |
| 201152 · 002 · RLD · discontinued | tablet, extended release, oral | 100MG | open |