cobicistat; darunavir ethanolate · Janssen Prods · NDA 205395
Prezcobix
Earliest generic entry, as listed · earliest of 2 marketed strengths
6 Oct 2032
Blocked by patent: US 10039718.
Listed patents · 3 unexpired
6 Orange Book listing rows for 3 patents, 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 10039718 | drug product · sets the listed date | 6 Oct 2032 |
| US 8148374 | drug substance, drug product, use U-1279, U-2939, U-4162 | 3 Sep 2029 |
| US 8148374 listing row | drug substance, drug product, use U-1279 | 3 Sep 2029 |
| US 8148374 listing row | drug substance, drug product, use U-2939 | 3 Sep 2029 |
| US 8148374 listing row | drug substance, drug product, use U-4162 | 3 Sep 2029 |
| US 7700645 | drug substance, drug product | 26 Jun 2027 |
| US 7700645 listing row | drug substance, drug product | 26 Dec 2026 |
| US 7700645 listing row | pediatric extension | 26 Jun 2027 |
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 |
|---|---|---|---|
| 205395 · 001 · RLD | tablet, oral | 150MG;EQ 800MG BASE | 6 Oct 2032 |
| 205395 · 002 · RLD | tablet, oral | 150MG;EQ 675MG BASE | 6 Oct 2032 |