GLUCOPHAGE XR Drug Patent Profile

Which patents cover Glucophage Xr, and when can generic versions of Glucophage Xr launch?

Glucophage Xr is a drug marketed by Emd Serono Inc and is included in one NDA.

The generic ingredient in GLUCOPHAGE XR 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 Glucophage Xr

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

Summary for GLUCOPHAGE XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	352
Patent Applications:	4,095
Drug Prices:	Drug price information for GLUCOPHAGE XR
DailyMed Link:	GLUCOPHAGE XR at DailyMed

See drug prices for GLUCOPHAGE XR

Recent Clinical Trials for GLUCOPHAGE XR

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

Sponsor	Phase
China National Center for Cardiovascular Diseases	PHASE4
James Wang	Phase 1
United States Department of Defense	Phase 1

See all GLUCOPHAGE XR clinical trials

US Patents and Regulatory Information for GLUCOPHAGE XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-001	Oct 13, 2000		DISCN	Yes	No
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003		DISCN	Yes	No

Expired US Patents for GLUCOPHAGE XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-001	Oct 13, 2000	6,475,521
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003	6,660,300
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003	6,475,521

International Patents for GLUCOPHAGE XR

See the table below for patents covering GLUCOPHAGE XR around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2332522
Eurasian Patent Organization	200000968
China	1203846

Supplementary Protection Certificates for GLUCOPHAGE XR

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 Glucophage XR

Last updated: July 28, 2025

Introduction

Glucophage XR (extended-release metformin) remains a cornerstone in managing type 2 diabetes mellitus (T2DM), a chronic condition with rising global prevalence. Its unique pharmacokinetics, efficacy, safety profile, and economic implications have cemented its role in diabetes treatment algorithms. Understanding the market dynamics and financial trajectory continues to be essential for stakeholders—including pharmaceutical companies, healthcare providers, and investors—given the evolving landscape marked by innovation, regulatory shifts, and demographic trends.

Market Overview and Demand Drivers

Increasing Global Prevalence of T2DM

The global diabetes epidemic is accelerating, with the International Diabetes Federation estimating over 537 million adults affected worldwide as of 2021, projected to reach 700 million by 2045 [1]. This surge is driven by lifestyle changes, urbanization, and aging populations. As the frontline therapy, metformin, including its XR formulations like Glucophage XR, benefits from a broad patient base needing long-term management, underpinning stable and growing demand.

Biopharmaceutical Position and Prescribing Practices

Glucophage XR distinguishes itself through improved gastrointestinal tolerability and convenience due to once-daily dosing compared to immediate-release variants. Clinical guidelines from organizations such as the American Diabetes Association (ADA) recommend metformin as first-line therapy [2], solidifying its market dominance. The drug’s price stability, proven efficacy, and safety profile continue to support prescriptions despite emerging therapies.

Competitive Landscape

While newer classes of medications—SGLT2 inhibitors and GLP-1 receptor agonists—offer additional benefits (cardiovascular protection, weight loss), metformin remains foundational for most patients, especially due to its low cost and extensive clinical data. Patent expirations for various formulation components have increased generic availability, driving down prices and increasing accessibility, especially in emerging markets.

Market Dynamics

Price and Reimbursement Trends

The accessibility of Glucophage XR is heavily influenced by pricing policies, reimbursement frameworks, and healthcare budgets, especially across developed and emerging economies. Generic versions have pressurized brand prices, making extensive use of cost-effective prescribing strategies. In the U.S., Medicare and Medicaid coverage bolster utilization, while developing markets benefit from lower retail costs [3].

Regulatory Factors and Approvals

Regulatory decisions concerning bioequivalence, naming, and quality standards impact the market. Approvals for new formulations or combination therapies including metformin extend its therapeutic markets. The FDA's continued approval and post-marketing surveillance support confidence, whereas regulatory hurdles in certain jurisdictions may restrain growth.

Technological and Formulation Innovations

Efforts to enhance patient adherence include novel extended-release formulations and fixed-dose combinations. These innovations aim to reduce pill burden and improve metabolic control. The introduction of next-generation XR formulations with improved pharmacokinetics could sustain or expand market share.

Healthcare Policy and Market Penetration

Policy initiatives targeting non-communicable disease control support increased utilization of affordable drugs like Glucophage XR. Implementation of screening programs, especially in low- and middle-income countries, broadens access. The rising prevalence of metabolic syndrome fuels ongoing demand.

Financial Trajectory Trends

Revenue Stability and Growth

Globally, Glucophage XR generates substantial revenue owing to its market penetration and extensive clinical validation. In the United States, the drug constitutes a significant component of diabetes-related pharmaceutical expenditure, with generated revenues supported by high volume sales and extended patient adherence attributable to improved formulations.

Impact of Patent Expiry and Generic Competition

Patents for the brand-name Glucophage XR have largely expired or are nearing expiration in many regions, prompting a transition toward generics. This shift typically leads to significant price erosion but sustains volume. The launch of generic equivalents often increases overall market size as pricing barriers decrease, especially in emerging markets.

Emerging Markets and Market Expansion

Countries such as India, China, and Brazil witness burgeoning demand due to increasing diabetes prevalence and cost-sensitive healthcare systems. Local manufacturing of generics ensures improved supply chains, fostering market expansion and steady financial growth.

Future Growth Opportunities

Potential growth avenues include:

• Combination Therapies: Fixed-dose combinations combining metformin XR with SGLT2 inhibitors or DPP-4 inhibitors are gaining traction, offering simplified regimens with enhanced efficacy.
• Personalized Medicine: Biomarker-driven treatments could optimize patient selection, expanding targeted use.
• Digital Health Integration: Using health apps to improve adherence could increase long-term market retention.

Challenges and Risks

Key challenges include:

• Market Saturation: Mature markets face saturation; growth relies on new formulations and expanding indications.
• Competitive Innovations: Emergence of newer drugs with superior efficacy or safety profiles may erode market share.
• Pricing Pressures: Governments and payers increasingly mandate price reductions, affecting profit margins.

Strategic Outlook

The financial trajectory of Glucophage XR will continue along a trajectory marked by moderate growth driven by generic proliferation, regional expansion, and formulation innovations. Companies should strategically focus on differentiation through combination products and digital health integration aligned with healthcare policies emphasizing affordability and access.

Key Takeaways

• Global demand for Glucophage XR remains robust, buoyed by the rising prevalence of T2DM and its positioning as first-line therapy.
• Patent expirations and generic competition drive market volume increases but exert downward pressure on prices.
• Emerging markets present significant growth opportunities due to demographic shifts, affordability factors, and expanding healthcare infrastructure.
• Innovation in formulations and fixed-dose combination therapies offer avenues to sustain competitive advantage and revenue streams.
• Regulatory, payer, and policy landscapes significantly influence the financial trajectory; adaptive strategies are critical for long-term success.

FAQs

1. How does Glucophage XR differ from immediate-release metformin formulations?
Glucophage XR offers extended-release properties, releasing metformin gradually over time, resulting in fewer gastrointestinal side effects and once-daily dosing, which enhances patient adherence.

2. What is the impact of patent expiry on Glucophage XR’s market?
Patent expiry facilitates the entry of generics, leading to price reductions and increased accessibility. While this may reduce brand revenue, overall volume growth can offset margins, especially in markets with high diabetes prevalence.

3. Are there upcoming formulations or combinations of Glucophage XR in development?
Yes, fixed-dose combinations with agents like SGLT2 inhibitors are gaining regulatory approval, offering simplified regimens with added clinical benefits, thus expanding the therapeutic market.

4. How do regulatory differences across regions affect Glucophage XR’s market prospects?
Regions with stringent bioequivalence standards and robust regulatory frameworks support consistent quality and acceptance. Delays or restrictions can hinder market penetration, emphasizing the need for tailored compliance strategies.

5. What are the primary factors influencing the future financial performance of Glucophage XR?
Key factors include patent status, competitive innovations, regional market expansion, healthcare policies, pricing strategies, and patient adherence influenced by formulation convenience.

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Sources:

[1] International Diabetes Federation. "IDF Diabetes Atlas," 10th Edition, 2021.
[2] American Diabetes Association. "Standards of Medical Care in Diabetes—2022," Diabetes Care.
[3] IQVIA. "Global Medicine Spending and Usage Trends," 2022.