lenacapavir sodium · Gilead Sciences Inc · NDA 220018, 220020
Yeztugo
Earliest generic entry, as listed · earliest of 2 marketed strengths
16 Aug 2038
Other strengths are listed to 25 Nov 2040.
Blocked by patent: US 11267799.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11807625 | use U-4190 | 25 Nov 2040 |
| US 12594267 | drug product | 15 Jul 2039 |
| US 11267799 | drug substance · sets the listed date | 16 Aug 2038 |
| US 10071985 | drug substance, drug product | 17 Aug 2037 |
| US 9951043 | drug substance, drug product, use U-4190 | 28 Feb 2034 |
Exclusivities · 2 unexpired
| NP | new product | 18 Jun 2028 |
| 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 220018 · 001 · RLD | solution, subcutaneous | EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) | 25 Nov 2040 |
| 220020 · 001 · RLD | tablet, oral | EQ 300MG BASE | 16 Aug 2038 |