FDA Orange Book · active-ingredient family
Simvastatin; sitagliptin phosphate
Simvastatin; sitagliptin phosphate: 1 brand, 0 generics; first approved Oct 07, 2011; on patent until Apr 11, 2026.
On patentHas discontinued products
Generic status & protection
Protected until Apr 11, 2026 (earliest listed patent expiry).
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
2
Next patent expiry
Apr 11, 2026
4 mo ago
Brand (NDA) products
Originator applications
- JUVISYNCRLDMERCK SHARP DOHMENDA 20234320126 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG;EQ 100MG BASE TABLET ORAL Discontinued — 20MG;EQ 100MG BASE TABLET ORAL Discontinued — 40MG;EQ 100MG BASE TABLET ORAL Discontinued — 10MG;EQ 50MG BASE TABLET ORAL Discontinued — 20MG;EQ 50MG BASE TABLET ORAL Discontinued — 40MG;EQ 50MG BASE TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7326708 | 4 mo ago | SubstanceProductU-1188 | |
| 7326708*PED | in 2 mo |
Approval history
FDA approval span
First approval
15 yr 1 mo ago
Most recent approval
14 yr 2 mo ago
Approvals span 2011–2012 across 1 FDA application.
Brand (NDA) 1100%
Generic (ANDA) 00%
Simvastatin; sitagliptin phosphate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
