Metformin hydrochloride - Generic Drug Details

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

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-two 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-two 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:	132
Drug Master File Entries:	43
Finished Product Suppliers / Packagers:	82
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	2,850
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
Aspargo Labs, Inc	PHASE1
Duke University	PHASE1

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
Sun Pharm	SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	206081-002	Jul 31, 2023		DISCN	No	No
Mylan	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	075973-001	Jan 25, 2002	AB	RX	No	No
Granules India	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	090564-002	Apr 22, 2010	AB	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	021748-002	Jun 3, 2005	8,323,692
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-001	Oct 13, 2000	6,475,521
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004	6,866,866

International Patents for metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Portugal	1476138
Russian Federation	2016147009
European Patent Office	3445350

Supplementary Protection Certificates for metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	C01506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1412357	C300357	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1261586	C300524	Netherlands		PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:

Market Dynamics and Financial Trajectory for Metformin Hydrochloride

Last updated: January 13, 2026

Executive Summary

Metformin Hydrochloride, a cornerstone in type 2 diabetes management, has exhibited sustained demand driven by global diabetes prevalence, evolving treatment protocols, and generic market expansion. Its market dynamics are characterized by robust growth prospects and competitive pressures, prompting shifts in pricing, regulatory landscapes, and R&D investments. Financial trajectories indicate consistent revenue streams, yet margins face compression amid increasing generic competition and regulatory scrutiny.

This analysis delineates the current market landscape, delineates key growth drivers and challenges, compares notable competitors, and forecasts future financial trajectories based on market trends, policy influences, and demographic shifts.

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What Is the Current Market Size and Global Demand?

Global Prevalence of Diabetes

• Estimated global population with diabetes (2022): 537 million, projected to reach 643 million by 2030 [1].
• Type 2 diabetes accounts for 90-95% of cases.
• Key markets: North America, Europe, Asia-Pacific.

Market Valuation and Revenue

Parameter	Data	Source
Global metformin market size (2022)	~$8 billion	[2]
CAGR (2022-2028)	4.2%	[2]
Revenue contribution (by region)	North America (40%), Europe (25%), Asia-Pacific (25%), Rest of World (10%)	[3]

Market Segments and Formulations

• Forms: Immediate-release (IR) and extended-release (XR).
• Routes: Oral tablets dominate (~98% of sales).
• Top brands: Glucophage (original brand by Bristol-Myers Squibb), generics accounting for 70%+ of sales.

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What Are the Key Drivers of Market Growth?

Rising Global Diabetes Incidence

• Increasing prevalence directly correlates with need for affordable, effective interventions.
• Urbanization, sedentary lifestyles, obesity escalate demand.

Cost-Effectiveness and Generic Availability

• Metformin's low cost (~$0.05 per tablet for generics) sustains demand in price-sensitive markets.
• WHO recommends metformin as first-line therapy [4].

Expanding Indications and Combination Therapies

• Research on metformin’s potential beyond diabetes, including oncology, aging, and cardiovascular health, broadens market prospects.
• Rise in fixed-dose combination pills enhances compliance and revenue streams.

Regulatory Policies and Health Initiatives

• National health frameworks emphasizing metabolic syndrome management bolster adoption.
• Policies favor generics to reduce costs, increasing market penetration.

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What Challenges and Risks Impact Market Dynamics?

Generic Competition and Price Erosion

• Saturation of the market with multiple manufacturers reduces margins.
• Patent expirations (e.g., US patent expired in 2002) facilitate entry of low-cost generics.

Regulatory Scrutiny and Safety Concerns

• Rare risk of lactic acidosis, especially in patients with renal impairment, attracts regulatory oversight.
• Quality control issues, especially in emerging markets, threaten brand reputation.

Emergence of Newer Therapies

• SGLT2 inhibitors, GLP-1 receptor agonists, and DPP-4 inhibitors gaining popularity due to favorable efficacy profiles, with some approved for substantial weight loss and cardiovascular benefits.
• Competition may restrict future growth potential of metformin, especially in combination regimens.

Supply Chain Risks

• Raw material shortages (notably of active pharmaceutical ingredients [APIs]) can disrupt production.
• Regulatory restrictions on manufacturing practices.

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How Do Competitors and Patent Strategies Shape the Market?

Company	Market Share (%)	Key Strategies	Notes
Mylan (now Viatris)	~20%	Extensive generic portfolio, price competition	Leading generics manufacturer in US and EU
Teva Pharmaceuticals	~15%	Cost leadership, broad global reach	Major supplier for emerging markets
Lupin and Sun Pharma	~10-12%	Focus on APAC markets, cost-effective manufacturing	Rapid expansion in India and Africa
Original brands (e.g., Glucophage)	~5-8%	Brand loyalty, quality assurance	Limited in markets where generics dominate

Patent Strategies

• Since 2002, no patent restrictions in key markets (US, EU), facilitating generic entry.
• Some companies develop extended-release formulations (e.g., Glumetza), with residual patents until around 2027-2028, offering limited protection.

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What Is the Future Financial Trajectory?

Projected Revenue Trends

Year	Estimated Global Revenue (USD billion)	Growth Rate	Key Assumptions
2023	~$8.2	2.5-3%	Continued growth due to increasing prevalence and generic dominance
2025	~$9.0	3.0-3.5%	Market expansion in emerging markets
2028	~$10.2	4.2% CAGR	New formulations, expanded indications

Profitability Outlook

• Margins: Historically high (~20-35% gross margins), but compressing to ~15-20% due to pricing pressures.
• R&D Spend: Focused on formulations, combination therapies, and new indications, with investments estimated at 3-5% of revenues annually.

Revenue Streams

Source	Share	Details
Generic sales	70-80%	Dominant in mature markets
Brand (original formulations)	10-15%	Maintained through patent protections in some regions until mid-2020s
New formulations & combos	5-10%	Extended-release and fixed-dose combos, growing niche

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Comparison of Regulatory Environments and Market Access

Region	Regulatory Bodies	Key Policies	Impact on Market
US	FDA	Generic approval via ANDA applications	Rapid entry post-patent expiry, price-entry barriers till generics flood market
Europe	EMA, MHRA	Stringent bioequivalence requirements	Higher compliance costs, shorter patent lifespans
Asia-Pacific	NMPA (China), PMDA (Japan), TGA (Australia)	Increasing regulatory harmonization	Growing manufacturing hubs, price-sensitive markets
Latin America & Africa	Local regulatory agencies	Limited regulatory stringency	Market opportunities for low-cost generics

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What Are the Key Policy & Market Trends?

• Global emphasis on affordable diabetes management propels generic distribution.
• Policies such as the US’s Medicaid drug rebates and EU’s price negotiations pressure margins.
• Pending reforms for aging populations and digital health integration could drive demand.
• Continued research may unveil additional therapeutic roles for metformin, expanding its market scope.

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Conclusion and Strategic Implications

Metformin Hydrochloride remains a pillar of diabetes care with a stable and resilient market trajectory. Its dominance, driven by cost-effectiveness and global prevalence, supports consistent financial performance. However, increasing generic competition, regulatory pressures, and emerging therapeutic alternatives pose challenges that necessitate innovation and strategic diversification.

Pharmaceutical companies focusing on expanding formulations, exploring new indications, and optimizing supply chains are positioned to leverage growth opportunities in both mature and emerging markets. International policy developments emphasizing affordability will further sustain demand but may compress profit margins.

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Key Takeaways

• The global metformin market is around $8 billion with a compound annual growth rate (CAGR) of over 4% projected into 2028.
• Generic competition is the primary market driver, with 70%+ of sales attributable to generics.
• Cost-effectiveness and clinician preference sustain its status as first-line therapy worldwide.
• Emerging formulations (extended-release, fixed-dose combinations) are poised to capture incremental revenues.
• Regulatory policies in developed and developing regions significantly influence market access and profitability.

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FAQs

1. What are the primary factors driving the growth of metformin hydrochloride?
   The key factors include the rising prevalence of type 2 diabetes globally, cost benefits of generics, expanding indications, and supportive health policies promoting affordable glucose management.

2. How do patent expirations affect the market for metformin?
   Patent expirations since 2002 have led to a proliferation of generics, intensifying price competition and reducing profit margins for brand-name manufacturers.

3. What regulatory challenges could impact the future trajectory of metformin?
   Safety concerns like lactic acidosis, quality control in manufacturing, and global regulatory variability can influence market access and formulation approvals.

4. In what ways are new formulations impacting the market?
   Extended-release formulations, fixed-dose combinations, and novel delivery systems improve patient compliance, open new revenue streams, and support therapeutic innovation.

5. What are the prospects for metformin beyond diabetes treatment?
   Emerging research suggests potential roles in oncology, aging, and cardiovascular conditions, which could diversify and expand the market in the coming decade.

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References

[1] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th Edition.

[2] MarketResearch.com. (2022). Global Metformin Market Report.

[3] IQVIA. (2022). Regional Pharmaceutical Market Reports.

[4] World Health Organization. (2019). Guidelines on the Treatment of Diabetes Mellitus.

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