Metformin hydrochloride; sitagliptin phosphate - Generic Drug Details

What are the generic drug sources for metformin hydrochloride; sitagliptin phosphate and what is the scope of freedom to operate?

Metformin hydrochloride; sitagliptin phosphate is the generic ingredient in two branded drugs marketed by Msd Sub Merck and is included in two NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; sitagliptin phosphate has sixty-one patent family members in forty countries.

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

Summary for metformin hydrochloride; sitagliptin phosphate

International Patents:	61
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metformin hydrochloride; sitagliptin phosphate
DailyMed Link:	metformin hydrochloride; sitagliptin phosphate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for metformin hydrochloride; sitagliptin phosphate

Constraining patent/regulatory exclusivity:

7,326,708*PED

Dosage:

TABLET, EXTENDED RELEASE;ORAL

Constraining patent/regulatory exclusivity:

7,326,708*PED

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for metformin hydrochloride; sitagliptin phosphate

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

Sponsor	Phase
Galenicum Health	Phase 1
The Affiliated Hospital of Qingdao University	Phase 1
First Affiliated Hospital Xi'an Jiaotong University	N/A

See all metformin hydrochloride; sitagliptin phosphate clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

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 phosphate

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

Anatomical Therapeutic Chemical (ATC) Classes for metformin hydrochloride; sitagliptin phosphate

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

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JANUMET XR	Extended-release Tablets	metformin hydrochloride; sitagliptin phosphate	100 mg/1000 mg	202270	1	2012-10-22
JANUMET XR	Extended-release Tablets	metformin hydrochloride; sitagliptin phosphate	50 mg/500 mg and 50 mg/1000 mg	202270	1	2012-03-16
JANUMET	Tablets	metformin hydrochloride; sitagliptin phosphate	50 mg/500 mg and 50 mg/1000 mg	022044	5	2010-10-18

US Patents and Regulatory Information for metformin hydrochloride; sitagliptin phosphate

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	022044-001	Mar 30, 2007		RX	Yes	No
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007		RX	Yes	No
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		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
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No	7,326,708*PED				Y
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012		RX	Yes	No	7,326,708*PED				Y
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No

Expired US Patents for metformin hydrochloride; sitagliptin phosphate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	7,078,381
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012	7,459,428
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	6,890,898
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007	7,459,428
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012	6,890,898
Msd Sub Merck	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007	6,303,661
Msd Sub Merck	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012	6,303,661

International Patents for metformin hydrochloride; sitagliptin phosphate

Country	Patent Number	Title	Estimated Expiration
Cyprus	1106936
European Patent Office	1962827	COMPOSITIONS PHARMACEUTIQUES CONTENANT DES COMBINAISONS D'INHIBITEURS DE LA DIPEPTIDYLPEPTIDASE 4 AVEC DE LA MÉTFORMINE (PHARMACEUTICAL COMPOSITIONS OF COMBINATIONS OF DIPEPTIDYL PEPTIDASE-4 INHIBITORS WITH METFORMIN)
South Africa	200509933	Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
China	101365432	Pharmaceutical compositions of combinations of dipeptidyl peptidase-4 inhibitors with metformin
Costa Rica	8117	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV
Australia	2004253889	Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Dominican Republic	P2004000941	SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV

Supplementary Protection Certificates for metformin hydrochloride; sitagliptin phosphate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1261586	12C0028	France		PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1506211	C300677	Netherlands		PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
2498758	PA2020003	Lithuania		PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1412357	50/2008	Austria		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408

Metformin hydrochloride; sitagliptin phosphate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Metformin Hydrochloride and Sitagliptin Phosphate

Introduction

Metformin hydrochloride and sitagliptin phosphate are two crucial medications in the management of type 2 diabetes. Understanding the market dynamics and financial trajectory of these drugs is essential for pharmaceutical companies, investors, and healthcare professionals.

Global Market Size and Forecast

The global metformin hydrochloride market was valued at approximately USD 268.95 million in 2022 and is projected to grow to USD 386.91 million by 2030, with a compound annual growth rate (CAGR) of 4.7% during the forecast period of 2023-2030[1].

Regional Market Leadership

The Asia-Pacific region is expected to lead the metformin hydrochloride market during the forecast period, driven by the high prevalence of type 2 diabetes in countries like China and India. Over 140 million people in China and around 135 million people in India were diagnosed with diabetes or prediabetes as of 2021, contributing to the region's dominance in the market[1].

Market Drivers

Several factors are driving the growth of the metformin hydrochloride market:

• Increasing Prevalence of Diabetes: The rising number of people living with type 2 diabetes globally is a significant driver. Urbanization, an inactive lifestyle, and an aging population are contributing to this trend[1][4].
• Healthcare Infrastructure: Well-established healthcare systems, particularly in North America, and improving healthcare infrastructure in Asia-Pacific, are facilitating the growth of the market[4].
• Economic Factors: The affordability of metformin hydrochloride as a treatment option reduces the overall burden on healthcare systems, making it a preferred choice for diabetes management[4].

Supply Constraints and Price Trends

Supply constraints are anticipated to impact the prices of metformin hydrochloride. Logistical challenges, currency fluctuations, and inadequate supply in local markets, such as Germany, are expected to drive up prices. The Lunar New Year celebrations in China, which result in factory closures and reduced production, further exacerbate these issues. Additionally, the ongoing conflict in the Red Sea and its impact on shipping pose significant threats to supply chains, potentially leading to higher prices[2].

Sitagliptin Phosphate Market Dynamics

Sitagliptin phosphate, often used in combination with metformin hydrochloride, also plays a critical role in diabetes management. Here are some key points:

• Combination Therapy: Sitagliptin/metformin fixed-dose combinations (FDCs) are indicated for patients inadequately controlled on metformin alone or in combination with other antidiabetic agents. This includes use with sulphonylureas, PPARγ agonists, and insulin[3].
• Market Segmentation: The market for sitagliptin phosphate, when combined with metformin hydrochloride, is segmented by application, distribution channel, and region. The combination therapy is particularly effective in improving glycemic control in patients with type 2 diabetes[3][5].

Financial Trajectory

The financial trajectory of metformin hydrochloride and sitagliptin phosphate is influenced by several factors:

• Revenue Growth: The revenue growth rate of the metformin hydrochloride market is expected to be around 4.7% CAGR from 2023 to 2030. This growth is driven by increasing demand and the expanding patient base[1].
• Cost Factors: The cost of production and distribution, along with supply chain disruptions, can impact the financial performance of companies involved in the market. For instance, the depreciation of the Euro against the USD has made imports more costly for Germany, adding to the upward pressure on prices[2].

Key Players

Several key players are involved in the metformin hydrochloride market:

• Shouguang Fukang Pharmaceutical
• CR Double-Crane
• Wanbury
• Keyuan Pharmaceutical
• Aarti Drugs
• Farmhispania Group
• Harman Finochem
• Exemed Pharmaceuticals
• Vistin Pharma
• Shijiazhuang Polee Pharmaceutical
• USV[1].

Market Challenges

Despite the growth potential, the market faces several challenges:

• Supply Chain Disruptions: Logistical issues, factory closures, and shipping disruptions can lead to supply shortages and price hikes[2].
• Regulatory Requirements: Strict regulatory requirements and the need for frequent renal function assessments in patients using metformin-containing products can pose challenges for manufacturers and healthcare providers[3].

Market Opportunities

The market offers several opportunities for growth and investment:

• Innovations in Patient-Centric Care: Ongoing innovations in diabetes management and a focus on patient-centric care are expected to drive market growth[4].
• Emerging Markets: The Asia-Pacific region, particularly countries like China and India, presents significant opportunities due to their large and growing patient populations[1][4].

Conclusion

The market for metformin hydrochloride and sitagliptin phosphate is poised for significant growth, driven by the increasing prevalence of type 2 diabetes and the need for effective diabetes management solutions. Despite challenges such as supply chain disruptions and regulatory requirements, the market offers numerous opportunities for investment and development.

Key Takeaways

• The global metformin hydrochloride market is expected to grow from USD 268.95 million in 2022 to USD 386.91 million by 2030.
• The Asia-Pacific region is expected to lead the market due to the high prevalence of type 2 diabetes.
• Supply constraints and logistical challenges are anticipated to drive up prices.
• Sitagliptin phosphate, when combined with metformin hydrochloride, is effective in improving glycemic control.
• Key players include Shouguang Fukang Pharmaceutical, CR Double-Crane, and others.
• The market faces challenges such as supply chain disruptions and regulatory requirements but offers opportunities for growth and investment.

FAQs

Q: What is the projected growth rate of the global metformin hydrochloride market from 2023 to 2030? A: The global metformin hydrochloride market is expected to grow at a compound annual growth rate (CAGR) of 4.7% from 2023 to 2030[1].

Q: Which region is expected to lead the metformin hydrochloride market during the forecast period? A: The Asia-Pacific region is expected to lead the metformin hydrochloride market due to the high prevalence of type 2 diabetes in countries like China and India[1].

Q: What are the main factors driving the growth of the metformin hydrochloride market? A: The main factors include the increasing prevalence of type 2 diabetes, well-established healthcare infrastructure, and the affordability of metformin hydrochloride as a treatment option[1][4].

Q: How do supply chain disruptions impact the prices of metformin hydrochloride? A: Supply chain disruptions, such as factory closures, logistical challenges, and shipping disruptions, can lead to supply shortages and subsequent price hikes[2].

Q: What is the role of sitagliptin phosphate in combination with metformin hydrochloride? A: Sitagliptin phosphate, when combined with metformin hydrochloride, is indicated for improving glycemic control in patients with type 2 diabetes, often used in combination with other antidiabetic agents[3].

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. GOV.UK: eu risk management plan (rmp) for Sitagliptin phosphate/ Metformin hydrochloride.
4. Market Research Intellect: Metformin Hydrochloride Tablet Market - Market Research Intellect.
5. Biospace: Metformin Hydrochloride Market Analysis, Industry Size, Share ...