Metformin hydrochloride - Generic Drug Details

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

Metformin hydrochloride is the generic ingredient in twenty-one branded drugs marketed by Sun Pharm, Annora Pharma, Bionpharma, Saptalis Pharms, Vistapharm Llc, Ranbaxy, Andrx Labs Llc, Emd Serono Inc, Santarus Inc, Actavis Elizabeth, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Barr, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Harman Finochem, Impax Labs, Inventia, Ivax Sub Teva Pharms, Laurus, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Medicap Labs, Micro Labs, Mpp Pharma, Mylan Pharms Inc, Nostrum Pharms Llc, Novast Labs, Pharmobedient, Prinston Inc, Qingdao Baheal Pharm, Ranbaxy Labs Ltd, Regcon Holdings, Rk Pharma, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Twi Pharms, Unichem, Utopic Pharms, Watson Labs Inc, Yichang Humanwell, Zydus Lifesciences, Aarxion Anda Hlding, Alkem, Anda Repository, Aurobindo, Chartwell, Dr Reddys Labs Inc, Epic Pharma Llc, Granules India, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Mylan, Provident Pharm, Sun Pharm Inds Inc, Sunshine, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, Zydus Pharms Usa, Takeda Pharms Usa, Chartwell Rx, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, Dr Reddys Labs Sa, Msd Sub Merck, and Ph Health, and is included in one hundred and thirty-one NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride has fifty-five patent family members in sixteen countries.

There are forty-three drug master file entries for metformin hydrochloride. Eighty-six suppliers are listed for this compound. There are eleven tentative approvals for this compound.

Summary for metformin hydrochloride

International Patents:	55
US Patents:	10
Tradenames:	21
Applicants:	84
NDAs:	131
Drug Master File Entries:	43
Finished Product Suppliers / Packagers:	86
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	2,822
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metformin hydrochloride
What excipients (inactive ingredients) are in metformin hydrochloride?	metformin hydrochloride excipients list
DailyMed Link:	metformin hydrochloride at DailyMed

Recent Clinical Trials for metformin hydrochloride

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	PHASE3
Pediatric Neuro-Oncology Consortium	PHASE2
University of California, San Francisco	PHASE2

See all metformin hydrochloride clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		500MG	TABLET, EXTENDED RELEASE;ORAL
		50MG/500MG;50MG/1000MG	TABLET;ORAL
		10MG; 1GM	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

Drug Class

Biguanide

Medical Subject Heading (MeSH) Categories for metformin hydrochloride

Hypoglycemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for metformin hydrochloride

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

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RIOMET	Oral Solution	metformin hydrochloride	500 mg/5 mL	021591	1	2018-02-02
GLUMETZA	Extended-release Tablets	metformin hydrochloride	500 mg and 1000 mg	021748	1	2009-07-27
FORTAMET	Extended-release Tablets	metformin hydrochloride	500 mg and 1000 mg	021574	1	2008-10-14

US Patents and Regulatory Information for metformin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Lifesciences	ZITUVIMET XR	metformin hydrochloride; sitagliptin	TABLET, EXTENDED RELEASE;ORAL	216778-002	Jul 18, 2024		RX	Yes	No
Marksans Pharma	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	090295-002	Apr 29, 2016	AB	RX	No	No
Macleods Pharms Ltd	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	206955-001	Dec 7, 2016	AB1	RX	No	No

Expired US Patents for metformin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	6,340,475
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004	6,790,459
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003	6,660,300

International Patents for metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2016147009
Japan	2019514873	徐放性懸濁組成物
Japan	2017514903	徐放性懸濁組成物

Supplementary Protection Certificates for metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
1261586	C01261586/02	Switzerland		PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329

Market Dynamics and Financial Trajectory for Metformin Hydrochloride

Last updated: July 27, 2025

Introduction

Metformin hydrochloride, a first-line oral antihyperglycemic agent, has been a cornerstone in managing Type 2 diabetes mellitus (T2DM) for over six decades. Its long-standing efficacy, favorable safety profile, and cost-effectiveness have solidified its position in global therapeutic protocols. As the prevalence of T2DM escalates worldwide, the demand for metformin continues to grow, underpinning a dynamic market landscape shaped by regulatory, technological, and demographic factors. This comprehensive analysis explores the current market dynamics and forecasts the financial trajectory for metformin hydrochloride, illustrating its evolving role amidst shifting healthcare paradigms.

Global Market Overview and Key Drivers

Growing Prevalence of Type 2 Diabetes Mellitus

The global incidence of T2DM is accelerating, driven by lifestyle changes, urbanization, and increasing obesity rates. According to the International Diabetes Federation (IDF), approximately 537 million adults suffered from diabetes in 2021, with projections reaching 643 million by 2030. This surge critically sustains demand for proven, affordable anti-diabetic medications.

Cost-Effectiveness and Accessibility

Metformin’s low manufacturing costs and extensive patent expirations have rendered it accessible across diverse healthcare settings, especially in low- and middle-income countries (LMICs). The affordability factor sustains its substantial utilization, influencing market stability and expansion prospects.

Therapeutic Position and Guidelines

Global clinical guidelines, including those from the American Diabetes Association (ADA), endorse metformin as the initial pharmacotherapy for T2DM management. Its perceived benefits—oral administration, minimal hypoglycemia risk, and cardiovascular protective effects—support its enduring dominance. This guideline consensus fosters persistent demand.

Market Segmentation and Formulations

Metformin is available primarily as immediate-release (IR) and extended-release (XR) formulations. The XR variants, offering improved gastrointestinal tolerability and adherence, have gained popularity, influencing market segmentation and pricing strategies. Additionally, combination formulations with other antidiabetics further expand its market reach.

Market Dynamics Influencing Growth

Patent Expiry and Generic Competition

The expiration of patents for various metformin formulations, notably in North America and Europe, has led to a proliferation of generic manufacturers. This commoditization enhances price competition, eroding profit margins but simultaneously broadening access. The influx of generics is expected to sustain high-volume sales globally.

Regulatory and Quality Standards

Regulatory bodies, including the FDA and EMA, have tightened quality standards, prompting manufacturers to comply with Good Manufacturing Practices (GMP). While this raises initial compliance costs, it ultimately ensures product consistency, fostering market trust and stability.

Innovation and Formulation Improvements

Research into novel delivery systems—such as microsphere-based formulations, sustained-release matrices, and combination therapies—aims to enhance patient adherence and therapeutic outcomes. These innovations, though currently a minority, could shape future market dynamics by addressing unmet needs.

Emerging Markets and Urbanization

Rapid urbanization in LMICs continues to drive urban populations toward healthcare systems that favor affordable, well-established medications like metformin. Market expansion in Asia-Pacific, Africa, and Latin America remains a key growth area, supported by increasing healthcare infrastructure and disease awareness.

Competitive Landscape

Major pharmaceutical giants such as Teva Pharmaceuticals, Sun Pharmaceutical, and Mylan dominate the generic metformin space. These companies leverage economies of scale, aggressive pricing, and extensive distribution networks. Innovation is comparatively slow, primarily focused on formulations rather than molecular differentiation, ensuring a relatively stable competitive environment.

Challenges and Risks

Market Saturation and Price Erosion

In mature markets, the high penetration of generics constrains revenue growth. Price competition, especially in regions with aggressive parallel importation, continues to pressure profit margins.

Regulatory Barriers and Post-Market Compliance

Potential regulatory hurdles concerning quality standards, manufacturing practices, and labeling can delay product launches or result in recalls, affecting financial trajectories.

Therapeutic Alternatives and Emerging Technologies

Advances in incretin-based therapies, SGLT2 inhibitors, and insulin analogs, offering superior glycemic control and cardiovascular benefits, threaten to displace metformin in certain treatment algorithms, especially for patients with comorbidities.

Environmental and Manufacturing Considerations

Environmental concerns regarding pharmaceutical waste and manufacturing effluents pose compliance and reputation challenges. Stricter environmental regulations could increase operating costs.

Financial Forecast and Market Projections

Revenue Trends and Market Growth

Based on current consumption patterns, the global metformin market was valued at approximately USD 1.2 billion in 2022, with an anticipated compound annual growth rate (CAGR) of 4-6% over the next five years. This growth is primarily driven by emerging markets, increasing T2DM prevalence, and formulary extensions.

Regional Market Outlook

• North America: Market maturity and high generic penetration constrain revenue growth; however, expansion in biosimilars and combination therapies sustain margins.
• Europe: Similar trends to North America, with regulatory enforcement reinforcing high-quality standards.
• Asia-Pacific: The fastest-growing segment, with a CAGR of approximately 6-8%, fueled by large populations, economic development, and healthcare infrastructure enhancement.
• Latin America and Africa: Emerging markets exhibiting robust growth potential, driven by increasing healthcare awareness and governmental initiatives.

Impact of Patent Expirations

The patent expiry window, predominantly in the early 2010s in many regions, catalyzed an influx of generics, resulting in significant price reductions (~70% in some markets). Future patent expirations may either stabilize or contract revenues, depending on the timing and market conditions.

Potential Revenue Sources

Beyond standard formulations, revenues are expected from:

• Combination medications involving metformin (e.g., fixed-dose combinations for T2DM)
• Novel formulations such as controlled-release, aimed at improving compliance
• Private label and regional brands, which bolster volume sales

Impacts of Regulatory and Scientific Innovations

Innovation in formulations—such as metformin nanosuspensions or targeted delivery systems—may command premium pricing, contributing to a more diversified revenue stream. However, such developments remain at early stages, with limited immediate financial impact.

Conclusion

The market for metformin hydrochloride remains robust, underpinned by global diabetes prevalence, cost advantages, and clinical guideline endorsements. While patent expirations and generic competition exert downward pressure on prices, high-volume sales, especially in emerging economies, sustain growth. Ongoing innovations and expanding markets suggest a mature but adaptable landscape, with an expected steady revenue trajectory over the coming decade.

Key Takeaways

• High global demand driven by the rising prevalence of T2DM sustains industry growth, especially in emerging markets.
• Generic competition has profoundly lowered prices, emphasizing volume sales over profit margins, particularly post-patent expirations.
• Regulatory standards uphold safety and quality, creating barriers to entry but fostering market trust.
• Innovation in formulations offers avenues for premium pricing and increased adherence, although molecular differentiation remains limited.
• Market growth projections estimate a CAGR of 4-6%, with Asia-Pacific leading expansion due to demographic and economic factors.

FAQs

1. How does patent expiry influence metformin’s market profitability?
   Patent expiry leads to increased generic competition, significantly reducing prices and profit margins. However, it enhances market penetration and volume sales, especially in cost-sensitive regions.

2. What factors could threaten the future demand for metformin?
   The adoption of newer antidiabetic agents with superior efficacy or cardiovascular benefits, regulatory shifts, and environmental manufacturing concerns could impact demand.

3. Are there ongoing innovations in metformin formulations?
   Yes. Extended-release formulations, combination drugs, and nanoparticle delivery systems are under development to improve patient adherence and therapeutic outcomes.

4. Which regions are expected to be the primary growth drivers?
   Asia-Pacific, Latin America, and Africa, due to rising T2DM prevalence, expanding healthcare infrastructure, and increasing healthcare access.

5. What is the outlook for metformin’s market share in diabetes management?
   Despite competition, metformin retains a dominant position as the first-line therapy, with market share expected to remain robust due to its established efficacy, safety, and affordability.

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Sources:

1. International Diabetes Federation. "IDF Diabetes Atlas, 10th edition," 2021.
2. MarketWatch. "Global Metformin Market Size, Trends & Forecasts," 2023.
3. U.S. Food and Drug Administration. "Generic Drug Approvals," 2022.
4. American Diabetes Association. "Standards of Medical Care in Diabetes—2022," Diabetes Care.
5. ResearchAndMarkets. "Global Diabetic Medication Market," 2023.