lenacapavir sodium · Gilead Sciences Inc · NDA 215973, 215974
Sunlenca
Earliest generic entry, as listed · earliest of 2 marketed strengths
28 Aug 2041
Blocked by patent: US 11944611. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
8 Orange Book listing rows for 6 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11944611 | use U-3507 · sets the listed date | 28 Aug 2041 |
| US 12594267 | drug product | 15 Jul 2039 |
| US 11267799 | drug substance | 16 Aug 2038 |
| US 10071985 | drug substance, drug product | 17 Aug 2037 |
| US 10654827 | use U-3507, U-4602 | 17 Aug 2037 |
| US 10654827 listing row | use U-3507 | 17 Aug 2037 |
| US 10654827 listing row | use U-4602 | 17 Aug 2037 |
| US 9951043 | drug substance, drug product, use U-3507, U-4602 | 28 Feb 2034 |
| US 9951043 listing row | drug substance, drug product, use U-3507 | 28 Feb 2034 |
| US 9951043 listing row | drug substance, drug product, use U-4602 | 28 Feb 2034 |
Exclusivities · 2 unexpired
| I-999 | new indication (3 years) | 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215973 · 001 · RLD | solution, subcutaneous | EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML) | 28 Aug 2041 |
| 215974 · 001 · RLD | tablet, oral | EQ 300MG BASE | 28 Aug 2041 |