metformin hydrochloride; sitagliptin phosphate · Msd Sub Merck · NDA 202270
Janumet Xr
Earliest generic entry, as listed · earliest of 3 marketed strengths
24 May 2027
Blocked by patent: US 7326708 (pediatric extension).
Listed patents · 1 unexpired
2 Orange Book listing rows for 1 patent, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 7326708 | drug substance, drug product, use U-1227 | 24 May 2027 |
| US 7326708 listing row | drug substance, drug product, use U-1227 | 24 Nov 2026 |
| US 7326708 listing row | pediatric extension · sets the listed date | 24 May 2027 |
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
- Enters 12-month window basis: patent · 202270-001Listed date 24 May 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 202270-003Listed date 24 May 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 202270-002Listed date 24 May 2027Detected 24 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202270 · 001 · RLD | tablet, extended release, oral | 500MG;EQ 50MG BASE | 24 May 2027 |
| 202270 · 002 · RLD | tablet, extended release, oral | 1GM;EQ 50MG BASE | 24 May 2027 |
| 202270 · 003 · RLD | tablet, extended release, oral | 1GM;EQ 100MG BASE | 24 May 2027 |