sitagliptin · Zydus Lifesciences · NDA 211566
Zituvio
Earliest generic entry, as listed · earliest of 3 marketed strengths
25 Feb 2035
Blocked by patent: US 10925871.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10925871 | drug product · sets the listed date | 25 Feb 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
- Generic tentatively approved · ANDA 218441, Biocon Pharma Ltd · 211566-001Tentative approval 1 May 2026Detected 25 Oct 2026Historical import
- Generic tentatively approved · ANDA 217979, Umedica Laboratories Private Limited · 211566-001Tentative approval 20 Jul 2026Detected 25 Oct 2026Historical import
- Generic tentatively approved · ANDA 216057, Laurus Labs Ltd · 211566-001Tentative approval 12 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211566 · 001 · RLD | tablet, oral | 25MG | 25 Feb 2035 |
| 211566 · 002 · RLD | tablet, oral | 50MG | 25 Feb 2035 |
| 211566 · 003 · RLD | tablet, oral | 100MG | 25 Feb 2035 |