METFORMIN HYDROCHLORIDE; SITAGLIPTIN - Generic Drug Details

What are the generic sources for metformin hydrochloride; sitagliptin and what is the scope of patent protection?

Metformin hydrochloride; sitagliptin is the generic ingredient in four branded drugs marketed by Zydus Lifesciences and Msd Sub Merck, and is included in four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for METFORMIN HYDROCHLORIDE; SITAGLIPTIN

US Patents:	2
Tradenames:	4
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	3
Clinical Trials:	189
DailyMed Link:	METFORMIN HYDROCHLORIDE; SITAGLIPTIN at DailyMed

Recent Clinical Trials for METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Institute of Liver and Biliary Sciences, India	N/A
University Health Network, Toronto	Phase 4
Peking University People's Hospital	Phase 4

See all METFORMIN HYDROCHLORIDE; SITAGLIPTIN clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Applicant	Application No.	Strength	Dosage Form
		1GM; EQ 100MG BASE	TABLET, EXTENDED RELEASE;ORAL
		1GM; EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL
		500MG; EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for METFORMIN HYDROCHLORIDE; SITAGLIPTIN

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No					Y
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No					Y
Zydus Lifesciences	ZITUVIMET	metformin hydrochloride; sitagliptin	TABLET;ORAL	216743-002	Nov 3, 2023		RX	Yes	Yes

EU/EMA Drug Approvals for METFORMIN HYDROCHLORIDE; SITAGLIPTIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Ristfor	sitagliptin, metformin hydrochloride	EMEA/H/C/001235 For patients with type-2 diabetes mellitus:Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Ristfor is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated-receptor-gamma (PPARγ) agonist (i.e. a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.Ristfor is also indicated as add-on to insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.	Authorised	no	no	no	2010-03-15
Accord Healthcare S.L.U.	Sitagliptin / Metformin hydrochloride Accord	sitagliptin, metformin hydrochloride	EMEA/H/C/005850 For adult patients with type 2 diabetes mellitus:It is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.It is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.It is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.It is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.	Authorised	yes	no	no	2022-07-22
Sun Pharmaceutical Industries Europe B.V.	Sitagliptin / Metformin hydrochloride Sun	sitagliptin, metformin hydrochloride	EMEA/H/C/005778 For adult patients with type 2 diabetes mellitus:Sitagliptin/Metformin hydrochloride SUN is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Sitagliptin/Metformin hydrochloride SUN is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Sitagliptin/Metformin hydrochloride SUN is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPARγ) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPARγ agonist.Sitagliptin/Metformin hydrochloride SUN is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.	Authorised	yes	no	no	2023-03-31