metformin hydrochloride; saxagliptin hydrochloride · Astrazeneca Ab · NDA 200678
Kombiglyze Xr
Earliest generic entry, as listed · earliest of 3 marketed strengths
11 Oct 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by exclusivity: M-14.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| M-14 | miscellaneous (3 years) | 11 Oct 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 · 200678-001Listed date 11 Oct 2027Detected 24 Oct 2026
- Enters 12-month window basis: exclusivity · 200678-002Listed date 11 Oct 2027Detected 24 Oct 2026
- Enters 12-month window basis: exclusivity · 200678-003Listed date 11 Oct 2027Detected 24 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 200678 · 001 · RLD · discontinued | tablet, extended release, oral | 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 11 Oct 2027 |
| 200678 · 002 · RLD · discontinued | tablet, extended release, oral | 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 11 Oct 2027 |
| 200678 · 003 · RLD · discontinued | tablet, extended release, oral | 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 11 Oct 2027 |