mechlorethamine hydrochloride · Helsinn · NDA 202317
Valchlor
Earliest generic entry, as listed
8 Jul 2029
Blocked by patent: US 7872050. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7872050 | use U-1427 | 8 Jul 2029 |
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 |
|---|---|---|---|
| 202317 · 001 · RLD | gel, topical | EQ 0.016% BASE | 8 Jul 2029 |
Expired or delisted (5)
- US 7838564 · product · 7 Mar 2026
- US 8450375 · product · 7 Mar 2026
- US 8501818 · product · 7 Mar 2026
- US 8501819 · use U-1427 · 7 Mar 2026
- US 9382191 · product · 7 Mar 2026