doravirine · Msd Merck Co · NDA 210806
Pifeltro
Earliest generic entry, as listed
30 Aug 2032
Blocked by patent: US 8486975.
Listed patents · 1 unexpired
3 Orange Book listing rows for 1 patent. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8486975 | drug substance, drug product, use U-2394, U-2630, U-3308 | 30 Aug 2032 |
| US 8486975 listing row | drug substance, drug product, use U-2394 · sets the listed date | 30 Aug 2032 |
| US 8486975 listing row | drug substance, drug product, use U-2630 · sets the listed date | 30 Aug 2032 |
| US 8486975 listing row | drug substance, drug product, use U-3308 · sets the listed date | 30 Aug 2032 |
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 |
|---|---|---|---|
| 210806 · 001 · RLD | tablet, oral | 100MG | 30 Aug 2032 |