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
Jiangsu Province Geriatric Institute	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 50MG BASE	TABLET, EXTENDED RELEASE;ORAL
		500MG; EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL
		1GM; EQ 100MG 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	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007		RX	Yes	Yes
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007		RX	Yes	Yes	8,414,921*PED				Y
Zydus Lifesciences	ZITUVIMET	metformin hydrochloride; sitagliptin	TABLET;ORAL	216743-002	Nov 3, 2023		RX	Yes	Yes
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007		RX	Yes	Yes	7,326,708*PED				Y
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No	8,414,921*PED				Y
Zydus Lifesciences	ZITUVIMET	metformin hydrochloride; sitagliptin	TABLET;ORAL	216743-001	Nov 3, 2023		RX	Yes	No
Zydus Lifesciences	ZITUVIMET XR	metformin hydrochloride; sitagliptin	TABLET, EXTENDED RELEASE;ORAL	216778-002	Jul 18, 2024		RX	Yes	No

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

METFORMIN HYDROCHLORIDE; SITAGLIPTIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Metformin Hydrochloride and Sitagliptin

Introduction to Metformin Hydrochloride and Sitagliptin

Metformin hydrochloride and sitagliptin are two prominent medications used in the management of type 2 diabetes. Understanding their market dynamics and financial trajectories is crucial for stakeholders in the pharmaceutical industry.

Market Size and Growth of Metformin Hydrochloride

Current Market Size

The global metformin hydrochloride market was valued at approximately USD 268.95 million in 2022[1].

Forecasted Growth

This market is projected to grow to around USD 386.91 million by 2030, with a compound annual growth rate (CAGR) of roughly 4.7% between 2023 and 2030[1].

Regional Dominance of Metformin Hydrochloride Market

Asia-Pacific Region

The Asia-Pacific region is expected to lead the metformin hydrochloride market during the forecast period. This is largely due to the high prevalence of type 2 diabetes in countries like China and India, where over 140 million people in China and 135 million people in India were diagnosed with diabetes or prediabetes as of 2021[1].

North America

While the Asia-Pacific region is growing rapidly, North America also plays a significant role in the metformin hydrochloride market, driven by the high incidence of diabetes and a well-established healthcare infrastructure[4].

Drivers of Metformin Hydrochloride Market Growth

Increasing Prevalence of Type 2 Diabetes

The rising global prevalence of type 2 diabetes is a major driver for the metformin hydrochloride market. As more people develop diabetes, the demand for effective and affordable antidiabetic medications like metformin increases[1][4].

Healthcare Infrastructure and Awareness

Improving healthcare infrastructure and growing awareness about diabetes management in emerging economies further boost the demand for metformin hydrochloride[4].

Challenges Facing the Metformin Hydrochloride Market

Supply Constraints

Supply constraints, particularly in regions like Germany, are anticipated to propel metformin HCL prices. Factors such as logistical challenges, currency fluctuations, and inadequate local supply contribute to these constraints[2].

Economic and Logistical Disruptions

Global events like the Lunar New Year celebrations in China and conflicts in the Red Sea can lead to factory closures, reduced production, and transportation delays, exacerbating supply shortages and price hikes[2].

Market Size and Growth of Sitagliptin

Current Market Size

The global sitagliptin market was valued at USD 6.66 billion in 2024[3].

Forecasted Growth

This market is projected to reach USD 60.09 billion by 2031, growing at a CAGR of 34.90% from 2024 to 2031[3].

Regional Dominance of Sitagliptin Market

Asia-Pacific Region

Similar to the metformin hydrochloride market, the Asia-Pacific region, particularly countries like China, India, and Japan, leads the sitagliptin market due to the growing prevalence of type 2 diabetes and expanding healthcare infrastructure[3].

Drivers of Sitagliptin Market Growth

Rising Prevalence of Type 2 Diabetes

The increasing global prevalence of type 2 diabetes significantly drives the sitagliptin market. The need for effective and well-tolerated antidiabetic medications like sitagliptin is on the rise as more individuals develop diabetes[3].

Focus on Diabetes Management

A heightened focus on diabetes management from both healthcare providers and patients drives the demand for medications like sitagliptin to achieve and maintain target blood glucose levels[3].

Challenges Facing the Sitagliptin Market

Competition from Other Antidiabetic Drugs

The sitagliptin market faces competition from other classes of antidiabetic drugs such as metformin, sulfonylureas, and sodium-glucose cotransporter-2 (SGLT-2) inhibitors. This competition can impact the market share and growth potential of sitagliptin[3].

Safety Profile Concerns

Concerns regarding the safety profile of sitagliptin, including rare cases of pancreatitis and hypersensitivity reactions, may also impact its adoption and utilization in specific patient populations[3].

Economic Impact and Job Creation

Contribution to the Global Economy

The metformin hydrochloride market plays a vital role in the global economy by providing affordable diabetes treatment options. It reduces the overall burden on healthcare systems and potentially lowers costs associated with diabetes-related complications. Additionally, the production and distribution of metformin create jobs within the pharmaceutical sector, contributing to economic stability[4].

Key Players in the Metformin Hydrochloride Market

Major Companies

Key companies in the metformin hydrochloride market include Shouguang Fukang Pharmaceutical, CR Double-Crane, Wanbury, Keyuan Pharmaceutical, Aarti Drugs, Farmhispania Group, Harman Finochem, Exemed Pharmaceuticals, Vistin Pharma, Shijiazhuang Polee Pharmaceutical, and USV among others[1].

Key Takeaways

• Growth Projections: The metformin hydrochloride market is expected to grow from USD 268.95 million in 2022 to USD 386.91 million by 2030, while the sitagliptin market is projected to grow from USD 6.66 billion in 2024 to USD 60.09 billion by 2031.
• Regional Dominance: The Asia-Pacific region is a key driver for both markets due to the high prevalence of type 2 diabetes.
• Drivers: Increasing prevalence of type 2 diabetes, improving healthcare infrastructure, and a focus on diabetes management are major drivers for both markets.
• Challenges: Supply constraints, logistical disruptions, and competition from other antidiabetic drugs are significant challenges facing these markets.

FAQs

What is the current market size of the metformin hydrochloride market?

The global metformin hydrochloride market was valued at approximately USD 268.95 million in 2022[1].

What is the forecasted growth rate for the metformin hydrochloride market?

The metformin hydrochloride market is projected to grow at a CAGR of roughly 4.7% between 2023 and 2030[1].

Which region is expected to lead the sitagliptin market?

The Asia-Pacific region, particularly countries like China, India, and Japan, is expected to lead the sitagliptin market[3].

What are the major drivers for the sitagliptin market?

The rising global prevalence of type 2 diabetes and a heightened focus on diabetes management are major drivers for the sitagliptin market[3].

How does the metformin hydrochloride market contribute to the global economy?

The metformin hydrochloride market contributes to the global economy by providing affordable diabetes treatment options, reducing healthcare costs, and creating jobs within the pharmaceutical sector[4].

Sources

1. Zion Market Research: Metformin Hydrochloride Market Size, Share and Forecast 2030
2. ChemAnalyst: Supply Constraints Anticipated to Propel Metformin HCL Prices in Germany
3. Verified Market Research: Sitagliptin Market Size, Share, Scope, Trends, Analysis & Forecast
4. Market Research Intellect: Metformin Hydrochloride Tablet Market - Market Research Intellect
5. Biospace: Metformin Hydrochloride Market Analysis, Industry Size, Share, Leaders, Current Status by Major Key Vendors and Trends by Forecast to 2027