Glucophage — Competitive Intelligence Brief

Glucophage (metformin) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Dipeptidyl Peptidase 4 Inhibitor [EPC]. Area: Metabolic.

marketed Dipeptidyl Peptidase 4 Inhibitor [EPC] 5'-AMP-activated protein kinase subunit beta-1, Solute carrier family 22 member 1, Solute carrier family 22 member 2 Metabolic Small molecule

Target snapshot

Glucophage (metformin) — Generic (originally Merck Serono/Lipha). Activates AMP-activated protein kinase (AMPK) to reduce hepatic glucose production and improve insulin sensitivity without causing hypoglycemia.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Glucophage TARGET	metformin	Generic (originally Merck Serono/Lipha)	marketed	Dipeptidyl Peptidase 4 Inhibitor [EPC]	5'-AMP-activated protein kinase subunit beta-1, Solute carrier family 22 member 1, Solute carrier family 22 member 2	1995-03-03
Glucophage	Glucophage	Dr. Reddy's Laboratories Limited	marketed		5'-AMP-activated protein kinase subunit beta-1, Solute carrier family 22 member 1, Solute carrier family 22 member 2
Nesina	ALOGLIPTIN	Takeda	marketed	Dipeptidyl Peptidase 4 Inhibitor	Dipeptidyl peptidase 4	2013-01-01
Tradjenta	BI 1356	Boehringer Ingelheim	marketed	Dipeptidyl Peptidase 4 Inhibitor [EPC]	Dipeptidyl peptidase 4	2011-01-01
Tradjenta	LINAGLIPTIN	Boehringer Ingelheim	marketed	Dipeptidyl Peptidase 4 Inhibitor [EPC]	Dipeptidyl peptidase 4	2011-01-01
Januvia	SITAGLIPTIN	Zydus Lifesciences	marketed	Dipeptidyl Peptidase 4 Inhibitor [EPC]	Dipeptidyl peptidase 4	2006-01-01
METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE		marketed	Dipeptidyl Peptidase 4 Inhibitor [EPC]		1995-01-01

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)

• 2026-05-26 — Tradjenta · 8883805*PED · US
• 2027-04-15 — Tradjenta · 7713938 · US
• 2027-05-04 — Tradjenta · 8673927 · US
• 2027-05-04 — Tradjenta · 9173859 · US
• 2027-05-04 — Tradjenta · 11033552 · US
• 2027-10-15 — Tradjenta · 7713938*PED · US
• 2027-11-04 — Tradjenta · 11033552*PED · US
• 2027-11-04 — Tradjenta · 9173859*PED · US
• 2027-11-04 — Tradjenta · 8673927*PED · US
• 2028-08-01 — Tradjenta · 7579449 · US
• 2029-02-01 — Tradjenta · 7579449*PED · US
• 2029-04-02 — Tradjenta · 9415016 · US
• 2029-04-02 — Tradjenta · 10973827 · US
• 2029-04-02 — Tradjenta · 10022379 · US
• 2029-08-05 — Tradjenta · 9486526 · US
• 2029-08-05 — Tradjenta · 10034877 · US
• 2029-10-02 — Tradjenta · 9415016*PED · US
• 2029-10-02 — Tradjenta · 10022379*PED · US
• 2029-10-02 — Tradjenta · 10973827*PED · US
• 2029-10-14 — Tradjenta · 8551957 · US
• 2030-02-05 — Tradjenta · 9486526*PED · US
• 2030-02-05 — Tradjenta · 10034877*PED · US
• 2030-04-14 — Tradjenta · 8551957*PED · US
• 2030-05-21 — Tradjenta · 9155705 · US
• 2030-06-04 — Tradjenta · 8846695 · US
• 2030-06-15 — Tradjenta · 10406172 · US
• 2030-11-21 — Tradjenta · 9155705*PED · US
• 2030-12-04 — Tradjenta · 8846695*PED · US
• 2031-03-05 — Tradjenta · 8853156 · US
• 2031-09-05 — Tradjenta · 8853156*PED · US

Sponsor landscape (Dipeptidyl Peptidase 4 Inhibitor [EPC] class)

1. · 2 drugs in this class
2. Boehringer Ingelheim · 2 drugs in this class
3. Generic (originally Merck Serono/Lipha) · 1 drug in this class
4. Institut für Pharmakologie und Präventive Medizin · 1 drug in this class
5. University Medical Centre Ljubljana · 1 drug in this class
6. Zhujiang Hospital · 1 drug in this class
7. Zydus Lifesciences · 1 drug in this class