bictegravir sodium, lenacapavir sodium; lenacapavir sodium · Gilead Sciences Inc · NDA 221443
Bixlenvo Sunlenca Starter Pack (Copackaged)
Earliest generic entry, as listed
16 Aug 2038
Blocked by patent: US 11267799.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11267799 | drug substance · sets the listed date | 16 Aug 2038 |
| US 10071985 | drug substance, drug product | 17 Aug 2037 |
| US 10654827 | use U-4602 | 17 Aug 2037 |
| US 10385067 | use U-4602 | 19 Jun 2035 |
| US 9708342 | drug substance, drug product | 19 Jun 2035 |
| US 9951043 | drug substance, drug product, use U-4602 | 28 Feb 2034 |
| US 9216996 | drug substance, drug product | 19 Dec 2033 |
| US 9732092 | drug substance, drug product | 19 Dec 2033 |
Exclusivities · 2 unexpired
| NP | new product | 27 Aug 2029 |
| NCE | new chemical entity (5 years) | 22 Dec 2027 |
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 |
|---|---|---|---|
| 221443 · 001 · RLD | tablet, oral | EQ 75MG BASE, EQ 50MG BASE; EQ 300MG BASE | 16 Aug 2038 |