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Sitagliptin phosphate/metformin hydrochloride FDC — Competitive Intelligence Brief

Sitagliptin phosphate/metformin hydrochloride FDC (Sitagliptin phosphate/metformin hydrochloride FDC) competitive landscape: 2 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: DPP-4 inhibitor / biguanide combination. Area: Diabetes.

marketed DPP-4 inhibitor / biguanide combination DPP-4 enzyme / metformin (AMPK pathway) Diabetes Small molecule Live · refreshed every 30 min

Target snapshot

Sitagliptin phosphate/metformin hydrochloride FDC (Sitagliptin phosphate/metformin hydrochloride FDC) — Merck Sharp & Dohme LLC. This combination drug inhibits dipeptidyl peptidase-4 (DPP-4) to increase incretin levels while metformin reduces hepatic glucose production and improves insulin sensitivity.

Comparator set (2 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Sitagliptin phosphate/metformin hydrochloride FDC TARGET Sitagliptin phosphate/metformin hydrochloride FDC Merck Sharp & Dohme LLC marketed DPP-4 inhibitor / biguanide combination DPP-4 enzyme / metformin (AMPK pathway)
Linagliptin / Metformin Oral Tablet Linagliptin / Metformin Oral Tablet Universidad de Guanajuato marketed DPP-4 inhibitor / Biguanide combination DPP-4 (dipeptidyl peptidase-4) / AMPK pathway
Saxagliptin-Metformin XR Saxagliptin-Metformin XR Woman's phase 3 DPP-4 inhibitor / Biguanide combination DPP-4 enzyme; metformin targets mitochondrial glycerophosphate dehydrogenase and AMPK

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (DPP-4 inhibitor / biguanide combination class)

  1. Merck Sharp & Dohme LLC · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Sitagliptin phosphate/metformin hydrochloride FDC — Competitive Intelligence Brief. https://druglandscape.com/ci/sitagliptin-phosphate-metformin-hydrochloride-fdc. Accessed 2026-05-17.

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