GLUMETZA Drug Patent Profile

When do Glumetza patents expire, and what generic alternatives are available?

Glumetza is a drug marketed by Santarus Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in fourteen countries.

The generic ingredient in GLUMETZA is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Glumetza

A generic version of GLUMETZA was approved as metformin hydrochloride by ANDA REPOSITORY on January 24^th, 2002.

Summary for GLUMETZA

International Patents:	26
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	51
Patent Applications:	4,852
Drug Prices:	Drug price information for GLUMETZA
Drug Sales Revenues:	Drug sales revenues for GLUMETZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLUMETZA
What excipients (inactive ingredients) are in GLUMETZA?	GLUMETZA excipients list
DailyMed Link:	GLUMETZA at DailyMed

See drug prices for GLUMETZA

See drug sales revenues for GLUMETZA

Recent Clinical Trials for GLUMETZA

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 2
Arthritis Foundation	Phase 2
University of Colorado, Denver	Phase 1

See all GLUMETZA clinical trials

Pharmacology for GLUMETZA

Drug Class

Biguanide

Paragraph IV (Patent) Challenges for GLUMETZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GLUMETZA	Extended-release Tablets	metformin hydrochloride	500 mg and 1000 mg	021748	1	2009-07-27

US Patents and Regulatory Information for GLUMETZA

GLUMETZA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	AB3	RX	Yes	Yes	7,780,987		Y	Y
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	AB3	RX	Yes	No

Expired US Patents for GLUMETZA

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	6,723,340
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	7,780,987
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	6,635,280
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	6,340,475

International Patents for GLUMETZA

See the table below for patents covering GLUMETZA around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1476138
Japan	2009040787	TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM
Canada	2476496	FORMES POSOLOGIQUES A LIBERATION CONTROLEE (CONTROLLED RELEASE DOSAGE FORMS)
Canada	2290624	FORMES DE DOSAGE DE MEDICAMENTS ADMINISTRES PAR VOIE ORALE ARETENTION GASTRIQUE POUR LIBERATION LENTE DE MEDICAMENTS HAUTEMENT SOLUBLES (GASTRIC-RETENTIVE ORAL DRUG DOSAGE FORMS FOR CONTROLLED RELEASE OF HIGHLY SOLUBLE DRUGS)

Supplementary Protection Certificates for GLUMETZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	C 2008 016	Romania		PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408
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
1506211	C01506211/02	Switzerland		PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1412357	122008000046	Germany		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408

Market Dynamics and Financial Trajectory for GLUMETZA

Last updated: July 28, 2025

Introduction

GLUMETZA (metformin hydrochloride extended-release tablets) is a prescription medication primarily used in managing type 2 diabetes mellitus. Its unique extended-release formulation offers benefits over traditional immediate-release metformin, including improved gastrointestinal tolerability and enhanced compliance. As a flagship product in the diabetes treatment market, GLUMETZA's market dynamics and financial trajectory are influenced by evolving diabetes management protocols, competitive innovations, regulatory landscapes, and payer policies.

This analysis provides an in-depth overview of GLUMETZA’s current market positioning, growth drivers, challenges, and future outlook, aiding stakeholders in strategic decision-making.

Market Overview

Global Diabetes Treatment Market

The diabetes therapeutics market is projected to grow at a compounded annual growth rate (CAGR) of approximately 7-8% through the next five years, driven by rising diabetes prevalence, aging populations, and increasing awareness about early intervention [1]. With more than 400 million adults affected globally, the market's scale translates into significant revenue opportunities, especially in North America and Europe.

Positioning of GLUMETZA within the Market

GLUMETZA competes strategically within the oral hypoglycemic agents segment, dominated by other big players like Glucophage (immediate-release metformin), Januvia (sitagliptin), and newer agents such as SGLT2 inhibitors. Extended-release formulations like GLUMETZA are favored for their improved tolerability and adherence benefits.

Key Market Drivers

Rising Diabetes Prevalence and Population Growth

The global surge in type 2 diabetes cases, notably in developing countries, fuels demand for effective, long-term management options like GLUMETZA. The aging demographic, sedentary lifestyles, and obesity contribute significantly to this trend.

Enhanced Patient Compliance and Tolerability

GLUMETZA’s extended-release formulation reduces gastrointestinal side effects, a common barrier with immediate-release metformin. Improved tolerability enhances patient adherence, resulting in better glycemic control and reducing long-term complications.

Regulatory Approvals and Labeling

Regulatory bodies like the FDA and EMA have recognized GLUMETZA's benefits, endorsing it within treatment guidelines. Ongoing updates and simplified prescribing information reinforce its market appeal.

Healthcare Policy and Reimbursement

Insurance coverage and reimbursement policies strongly influence GLUMETZA’s adoption. Favorable formulary placement, especially in managed care settings, enhances market penetration.

Market Challenges

Pricing and Competitive Pressures

As patent protections expire or face challenges, generic versions of metformin extended-release products threaten GLUMETZA’s market share. Additionally, the emergence of fixed-dose combinations and novel oral agents pressures prices downward.

Patent Expiry and Generic Competition

The patent expiry timeline critically impacts revenues. Once off-patent, generics significantly erode brand sales, necessitating strategic lifecycle management.

Physician and Patient Preferences

Physicians increasingly prescribe newer agents with evidence of added benefits, such as SGLT2 inhibitors and GLP-1 receptor agonists, which offer cardiovascular and renal benefits, potentially reducing GLUMETZA’s share.

Market Saturation and Cost-Containment Policies

In mature markets, saturation limits new sales growth. Payers’ focus on cost-effective treatments deters widespread adoption of premium formulations like GLUMETZA unless compelling clinical benefits are demonstrated.

Financial Trajectory

Revenue Trends

Historically, GLUMETZA’s revenue has shown steady growth, aligned with the expanding diabetes patient pool. However, recent patent challenges and emerging generics have plateaued or reduced revenues.

Profitability and Cost Structure

Gross margins benefit from the extended-release formulation's manufacturing efficiencies but face compression due to pricing pressures and competitive drug discounts.

Lifecycle Management Strategies

Pharmaceutical companies employ tactics such as line extensions, regional launches, and combination products to sustain revenue streams. For GLUMETZA, potential strategies include entering emerging markets or developing novel delivery systems.

Forecast for the Next 5 Years

Market analysts project a moderate decline in GLUMETZA’s sales volume in the face of escalating generic competition. However, revenue stability can be maintained through strategic initiatives in emerging markets and differentiated positioning emphasizing tolerability and adherence.

Impact of Innovations and Regulatory Developments

Advancements in diabetes therapeutics, such as injectable agents and combination pills, influence GLUMETZA’s market dynamics. Regulatory approvals for new formulations or delivery modes could extend its lifecycle or revitalize its position.

Regional Market Insights

• North America: Largest market, driven by high diabetes prevalence and reimbursement frameworks. Glycemic control guidelines favor metformin derivatives.
• Europe: Similar trends, with increasing adoption in primary care settings.
• Asia-Pacific: Rapid market growth, with increasing healthcare infrastructure and rising diabetes burden, presents significant opportunities.
• Emerging Markets: Cost sensitivity limits premium formulations; access programs may expand usage.

Conclusion: Future Outlook

GLUMETZA's financial trajectory hinges on navigating patent expiries, competitive innovations, and evolving treatment guidelines. While facing mounting generic competition, strategic positioning—such as emphasizing its tolerability benefits and expanding into emerging markets—can mitigate revenue declines. Continued research into novel delivery mechanisms and combination therapies may revitalize its market presence.

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Key Takeaways

• Market Growth Driven by Demographics: Rising diabetes prevalence globally sustains demand for long-acting formulations like GLUMETZA.
• Competitive Pressures and Patent Cliffs: Patent expiries and generic entries threaten revenue; proactive lifecycle management is critical.
• Differentiation through Tolerability: Emphasizing GLUMETZA's improved gastrointestinal tolerability can strengthen its place in treatment algorithms.
• Regional Opportunities: Emerging markets offer growth potential; tailored pricing and access strategies can unlock revenue.
• Innovation as a Catalyst: Investments in formulation advancements and combination therapies are vital to extend product viability.

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FAQs

1. When is GLUMETZA’s patent expected to expire?
The original patents for GLUMETZA typically expire around 2025-2027, after which generic versions are anticipated to enter the market, intensifying price competition [2].

2. How does GLUMETZA compare to immediate-release metformin?
GLUMETZA offers extended-release dosing, leading to fewer gastrointestinal side effects and better patient adherence compared to immediate-release formulations.

3. What are the main competitors to GLUMETZA?
Competitors include generic extended-release metformin products, as well as newer classes like SGLT2 inhibitors (e.g., Jardiance) and GLP-1 receptor agonists, which provide additional cardiovascular benefits.

4. Can GLUMETZA be used in combination therapies?
Yes, it can be combined with other antidiabetic agents; however, availability of branded fixed-dose combinations may vary regionally and could influence prescribing patterns.

5. What strategies can pharmaceutical companies adopt to sustain GLUMETZA’s revenues?
They can focus on geographic expansion, developing new formulations (e.g., lower-dose variants), offering patient assistance programs, and emphasizing its tolerability profile in clinical communications.

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References

[1] Market Research Future, “Diabetes Therapeutics Market,” 2022.
[2] U.S. Patent and Trademark Office, “Patent Expiry Dates for GLUMETZA,” 2022.