Metformin cloridrate — Competitive Intelligence Brief

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

marketed Biguanide AMP-activated protein kinase (AMPK) Diabetes Small molecule

Target snapshot

Metformin cloridrate (Metformin cloridrate) — University Magna Graecia. Metformin hydrochloride reduces hepatic glucose production and improves insulin sensitivity, thereby lowering blood glucose levels in patients with type 2 diabetes.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Metformin cloridrate TARGET	Metformin cloridrate	University Magna Graecia	marketed	Biguanide	AMP-activated protein kinase (AMPK)
hypoglycemic Agents(metformin)	hypoglycemic Agents(metformin)	First Affiliated Hospital of Wenzhou Medical University	marketed	Biguanide	AMP-activated protein kinase (AMPK); complex I of the mitochondrial electron transport chain
metformin and liraglutide	metformin and liraglutide	University Medical Centre Ljubljana	marketed	Biguanide + GLP-1 receptor agonist combination	AMP-activated protein kinase (metformin); GLP-1 receptor (liraglutide)
alogliptin and actoplus met	alogliptin and actoplus met	The Fourth Affiliated Hospital of Zhejiang University School of Medicine	marketed	DPP-4 inhibitor + biguanide combination	DPP-4 enzyme; metformin acts on multiple targets including mitochondrial glycerophosphate dehydrogenase
Placebo matching with Metformin IR	Placebo matching with Metformin IR	Bristol-Myers Squibb	marketed	Placebo (trial formulation); comparator is biguanide
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
Sitagliptin + Metformin	Sitagliptin + Metformin	Baylor College of Medicine	marketed	DPP-4 inhibitor + biguanide combination	DPP-4 enzyme; metformin acts on multiple targets including mitochondrial complex I

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