acetylcysteine · Apotex · NDA 021539
Acetadote
Earliest generic entry, as listed
6 Apr 2032
Blocked by patent: US 8722738. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8722738 | use U-1373 | 6 Apr 2032 |
| US 9327028 | use U-1839 | 21 Jul 2031 |
Exclusivities · 1 unexpired
| D-196 | new dosing schedule | 26 Nov 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021539 · 001 · RLD | injectable, intravenous | 6GM/30ML (200MG/ML) | 6 Apr 2032 |
Expired or delisted (1)
- US 8148356 · product · 21 May 2026