lorlatinib · Pfizer · NDA 210868
Lorbrena
Earliest generic entry, as listed · earliest of 2 marketed strengths
4 Oct 2038
Blocked by patent: US 11299500.
Listed patents · 4 unexpired
5 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11299500 | drug substance · sets the listed date | 4 Oct 2038 |
| US 10420749 | drug substance, drug product, use U-2633, U-3096 | 27 Jul 2036 |
| US 10420749 listing row | drug substance, drug product, use U-2633 | 27 Jul 2036 |
| US 10420749 listing row | drug substance, drug product, use U-3096 | 27 Jul 2036 |
| US 11020376 | drug product | 27 Jul 2036 |
| US 8680111 | drug substance, drug product | 5 Mar 2033 |
Exclusivities · 1 unexpired
| ODE-349 | orphan drug (7 years) | 3 Mar 2028 |
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 |
|---|---|---|---|
| 210868 · 001 · RLD | tablet, oral | 25MG | 4 Oct 2038 |
| 210868 · 002 · RLD | tablet, oral | 100MG | 4 Oct 2038 |