acetylcysteine · Arbor Pharms Llc · NDA 207916
Cetylev
Earliest generic entry, as listed · earliest of 2 marketed strengths
8 May 2032
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8747894, US 9427421, US 9561204.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8747894 | drug product, use U-1373 · sets the listed date | 8 May 2032 |
| US 9427421 | drug product · sets the listed date | 8 May 2032 |
| US 9561204 | use U-1373 · sets the listed date | 8 May 2032 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207916 · 001 · RLD · discontinued | tablet, effervescent, oral | 500MG | 8 May 2032 |
| 207916 · 002 · RLD · discontinued | tablet, effervescent, oral | 2.5GM | 8 May 2032 |