ertugliflozin; sitagliptin phosphate · Msd Sub Merck · NDA 209805
Steglujan
Earliest generic entry, as listed · earliest of 2 marketed strengths
19 Dec 2031
Blocked by patent: US 8080580.
Listed patents · 4 unexpired
5 Orange Book listing rows for 4 patents, 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 8080580 | drug substance, drug product, use U-2214 · sets the listed date | 19 Dec 2031 |
| US 9308204 | drug product | 21 Oct 2030 |
| US 9439901 | use U-2214 | 21 Oct 2030 |
| US 7326708 | drug substance, drug product, use U-2214 | 24 May 2027 |
| US 7326708 listing row | drug substance, drug product, use U-2214 | 24 Nov 2026 |
| US 7326708 listing row | pediatric extension | 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
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 |
|---|---|---|---|
| 209805 · 001 · RLD | tablet, oral | 5MG;EQ 100MG BASE | 19 Dec 2031 |
| 209805 · 002 · RLD | tablet, oral | 15MG;EQ 100MG BASE | 19 Dec 2031 |