pemetrexed · Eagle Pharms · NDA 209472
Pemfexy
Earliest generic entry, as listed
19 Feb 2036
Blocked by patent: US 11793813, US 12115164.
Listed patents · 3 unexpired
5 Orange Book listing rows for 3 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11793813 | drug product · sets the listed date | 19 Feb 2036 |
| US 12115164 | use U-4246, U-4247, U-4248 | 19 Feb 2036 |
| US 12115164 listing row | use U-4246 · sets the listed date | 19 Feb 2036 |
| US 12115164 listing row | use U-4247 · sets the listed date | 19 Feb 2036 |
| US 12115164 listing row | use U-4248 · sets the listed date | 19 Feb 2036 |
| US 9604990 | drug substance | 28 Oct 2035 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209472 · 001 · RLD | solution, intravenous | 500MG/20ML (25MG/ML) | 19 Feb 2036 |