Metformin Large Pack — Competitive Intelligence Brief

Metformin Large Pack (Metformin Large Pack) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Biguanide. Area: Diabetes.

marketed Biguanide AMP-activated protein kinase (AMPK); mitochondrial complex I Diabetes Small molecule

Target snapshot

Metformin Large Pack (Metformin Large Pack) — GlaxoSmithKline. Metformin reduces hepatic glucose production and improves insulin sensitivity, thereby lowering blood glucose levels in type 2 diabetes.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Metformin Large Pack TARGET	Metformin Large Pack	GlaxoSmithKline	marketed	Biguanide	AMP-activated protein kinase (AMPK); mitochondrial complex I
medical nutrition therapy + metformin	medical nutrition therapy + metformin	Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes	marketed	Combination therapy: dietary intervention + biguanide antidiabetic	AMP-activated protein kinase (AMPK) and hepatic glucose metabolism (metformin component)
metformin\pioglitazone\exenatide	metformin\pioglitazone\exenatide	The University of Texas Health Science Center at San Antonio	marketed	Combination antidiabetic agent (biguanide + thiazolidinedione + GLP-1 receptor agonist)	Multiple: AMPK pathway (metformin), PPAR-γ (pioglitazone), GLP-1 receptor (exenatide)
Sitagliptin combined with metformin	Sitagliptin combined with metformin	Sun Yat-sen University	marketed	DPP-4 inhibitor combined with biguanide	DPP-4 enzyme; metformin acts on multiple targets including mitochondrial complex I
Pioglitazone vs Metformin	Pioglitazone vs Metformin	Post Graduate Institute of Medical Education and Research, Chandigarh	marketed	Antidiabetic agents (thiazolidinedione vs. biguanide)	Pioglitazone: PPAR-γ; Metformin: AMPK
Glimepiride/metformin fixed combination	Glimepiride/metformin fixed combination	Handok Inc.	marketed	Sulfonylurea/biguanide combination	ATP-sensitive potassium channel (glimepiride); mitochondrial complex I / AMPK pathway (metformin)
metformin or sulfonylurea	metformin or sulfonylurea	Dr. Milan Gupta	marketed	Antidiabetic agents (biguanide and sulfonylurea)	Metformin: AMP-activated protein kinase (AMPK) pathway; Sulfonylureas: ATP-sensitive potassium channel (KATP)

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 (Biguanide class)

1. AstraZeneca · 4 drugs in this class
2. Merck Sharp & Dohme LLC · 3 drugs in this class
3. University of Texas Southwestern Medical Center · 2 drugs in this class
4. Mount Sinai Hospital, Canada · 2 drugs in this class
5. GlaxoSmithKline · 2 drugs in this class
6. Eli Lilly and Company · 2 drugs in this class
7. University Magna Graecia · 2 drugs in this class
8. First Affiliated Hospital of Wenzhou Medical University · 1 drug in this class
9. Ente Ospedaliero Ospedali Galliera · 1 drug in this class
10. Daewoong Pharmaceutical Co. LTD. · 1 drug in this class