Metformin immediate release — Competitive Intelligence Brief

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

phase 3 Biguanide AMP-activated protein kinase (AMPK); mitochondrial complex I Diabetes Small molecule

Target snapshot

Metformin immediate release (Metformin immediate release) — Janssen Research & Development, LLC. Metformin reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK) and inhibiting mitochondrial complex I.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Metformin immediate release TARGET	Metformin immediate release	Janssen Research & Development, LLC	phase 3	Biguanide	AMP-activated protein kinase (AMPK); 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
Linagliptin / Metformin Oral Tablet	Linagliptin / Metformin Oral Tablet	Universidad de Guanajuato	marketed	DPP-4 inhibitor / Biguanide combination	DPP-4 (dipeptidyl peptidase-4) / AMPK pathway
Metformin and Saxagliptin	Metformin and Saxagliptin	ikfe-CRO GmbH	marketed	Biguanide + DPP-4 inhibitor combination	Metformin: mitochondrial glycerophosphate dehydrogenase; Saxagliptin: DPP-4 (dipeptidyl peptidase-4)
Glucophage tablets and Victoza	Glucophage tablets and Victoza	University Medical Centre Ljubljana	marketed	Biguanide (metformin) and GLP-1 receptor agonist (liraglutide)	AMP-activated protein kinase (metformin); GLP-1 receptor (liraglutide)
oral hypoglycemic agents	oral hypoglycemic agents	Queen Elizabeth II Health Sciences Centre	marketed	Oral hypoglycemic agents (multiple classes: sulfonylureas, meglitinides, biguanides, thiazolidinediones, DPP-4 inhibitors, GLP-1 agonists, SGLT2 inhibitors)
Janumet, Lantus	Janumet, Lantus	Chinese University of Hong Kong	marketed	DPP-4 inhibitor + biguanide (Janumet); long-acting basal insulin (Lantus)	DPP-4 enzyme, metformin (AMPK pathway), insulin receptor (Lantus)

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