lamivudine; raltegravir potassium · Merck Sharp Dohme · NDA 206510
Dutrebis
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7754731 (pediatric extension).
Listed patents · 1 unexpired
2 Orange Book listing rows for 1 patent, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 7754731 | drug substance, drug product, use U-1663 | 11 Sep 2029 |
| US 7754731 listing row | drug substance, drug product, use U-1663 | 11 Mar 2029 |
| US 7754731 listing row | pediatric extension · sets the listed date | 11 Sep 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 |
|---|---|---|---|
| 206510 · 001 · discontinued | tablet, oral | 150MG;EQ 300MG BASE | 11 Sep 2029 |