acetylcysteine lysine · Galephar · NDA 215040
Legubeti
Earliest generic entry, as listed · earliest of 2 marketed strengths
13 Feb 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by exclusivity: NP.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| NP | new product | 13 Feb 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
- Enters 12-month window basis: exclusivity · 215040-001Listed date 13 Feb 2027Detected 24 Oct 2026
- Enters 12-month window basis: exclusivity · 215040-002Listed date 13 Feb 2027Detected 24 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215040 · 001 · RLD · discontinued | for solution, oral | EQ 500MG BASE/PACKET | 13 Feb 2027 |
| 215040 · 002 · RLD · discontinued | for solution, oral | EQ 2.5GM BASE/PACKET | 13 Feb 2027 |