GLUCOPHAGE XR Drug Patent Profile

Which patents cover Glucophage Xr, and what generic alternatives are available?

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-one 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 CHARTWELL on January 24^th, 2002.

Summary for GLUCOPHAGE XR

US Patents:	0
Applicants:	1
NDAs:	1

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

International Patents for GLUCOPHAGE XR

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

Country	Patent Number	Title	Estimated Expiration
Australia	736951
African Regional IP Organization (ARIPO)	1224	Biphasic controlled release delivery system for high solubility pharmaceuticals and method.
Indonesia	26082
Canada	2320900	SYSTEME D'APPORT A LIBERATION LENTE BIPHASIQUE DESTINE A DESMEDICAMENTS A SOLUBILITE ELEVEE ET PROCEDE ASSOCIE (BIPHASIC CONTROLLED RELEASE DELIVERY SYSTEM FOR HIGH SOLUBILITY PHARMACEUTICALS AND METHOD)
Japan	4523153
Japan	2002506812
Brazil	9908911

Supplementary Protection Certificates for GLUCOPHAGE XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	42/2014	Austria		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
2498758	16/2020	Austria		PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 (MITTEILUNG) 20191113
1261586	15/2012	Austria		PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
2498758	132020000000034	Italy		PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
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
1412357	PA2008013	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
1532149	132013902118390	Italy		PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720

Investment Scenario and Fundamentals Analysis for GLUCOPHAGE XR

Last updated: February 20, 2026

What is GLUCOPHAGE XR?

GLUCOPHAGE XR (extended-release metformin) is an oral antidiabetic medication used primarily to manage type 2 diabetes mellitus. It is developed and marketed by Merck & Co. (known as MSD outside the United States and Canada). The drug is formulated as an extended-release tablet to improve gastrointestinal tolerability and adherence.

Market Overview

Market Size and Growth

• The global diabetes drugs market was valued at approximately $86 billion in 2022.
• Expected compound annual growth rate (CAGR): 7% through 2028 (source: Grand View Research).
• Metformin accounts for roughly 50% of prescriptions for type 2 diabetes, making it a foundational treatment.

Key Players

• Merck & Co. (marketed as Glucophage XR in the U.S., generics available globally)
• Novo Nordisk, Eli Lilly (innovator and biosimilar competitors, but focus on insulins and newer agents)
• Teva, Sun Pharmaceuticals (generic manufacturers)

Competitive Landscape

• Immediate-release metformin (IR) is cost-effective, widely prescribed.
• Extended-release formulations like GLUCOPHAGE XR are prescribed for patients with gastrointestinal side effects or adherence issues.
• Generics: multiple generic versions of XR are available, pressuring pricing.

Patent and Regulatory Status

• The original patent for Glucophage (immediate-release) expired in 2002.
• Extended-release formulations like GLUCOPHAGE XR have had patent protections extending into the 2010s; patents on specific formulations have expired.
• No current patents cover GLUCOPHAGE XR or active formulations; regulatory exclusivity mainly relates to data protection, which may vary by region.

Financial Fundamentals

Revenue and Market Capture

• Merck’s U.S. sales of GLUCOPHAGE XR were approximately $200 million in 2022, with declining trend due to patent expiration and generic competition.
• Global sales are larger but diluted by generic competition outside the U.S.

Cost Dynamics

• Development costs for formulations are moderate; commercial manufacturing costs are low due to high generic competition.
• Price erosion in the U.S.: branded GLUCOPHAGE XR sells at approximately $150–$200 for a 30-day supply, down from peak premium pricing of over $300 pre-generic.

Regulatory considerations

• As a generic drug, GLUCOPHAGE XR faces minimal regulatory hurdles unless a new formulation or indication claims are pursued.
• Off-label use is common but does not impact regulatory approval.

Investment Risks and Opportunities

Risks

• Patent expiry reduces market exclusivity, pressuring margins.
• Increased generic competition, especially in emerging markets, reduces profitability.
• Emerging diabetes therapies (SGLT2 inhibitors, GLP-1 receptor agonists) gain market share, impacting metformin sales.
• Pricing pressures due to healthcare reforms and payer negotiations.

Opportunities

• Growing type 2 diabetes prevalence in emerging markets.
• Potential formulations with improved bioavailability or adherence profiles.
• Expansion into combination therapies (metformin + SGLT2 inhibitors).

Strategic Outlook for Investment

• Short-term: revenues decline owing to patent expiration and generic erosion.
• mid-to-long-term: growth depends on market penetration, regulatory approvals for new uses or formulations, and pipeline developments.
• Patent expirations are primarily behind, making GLUCOPHAGE XR a declining asset unless supplemented by new formulations or indications.

Key Data points summary

Aspect	Details
Market value (2022)	$86 billion (global diabetes drugs market)
CAGR (2023-2028)	7%
U.S. sales (2022)	$200 million
Price (per 30-day supply)	$150–$200 (generic price range: lower)
Patent expiry	Patents expired for formulations since early 2010s
Competition landscape	Generics dominate outside the U.S.; branded sales declining
Regulatory exclusivity	Limited; mainly data protection, varies by country

Key Takeaways

• GLUCOPHAGE XR's market share is shrinking due to patent expiration and rising generics.
• The global diabetes market's growth offers expansion possibilities in developing markets.
• Competitive pressures and new therapies threaten future revenue.
• Investment in new formulations, indications, or combination therapies could offset decline.
• Profitability hinges on brand loyalty, pricing strategies, and regulatory pathway advancements.

FAQs

1. How does GLUCOPHAGE XR compare to immediate-release metformin?
Extended-release formulations like GLUCOPHAGE XR are better tolerated gastrointestinally and promote adherence, but generally cost more and have less market share compared to IR formulations.

2. What are the patent expiry dates for GLUCOPHAGE XR?
Patents for the formulation and method of use expired or are close to expiry in most major markets, leading to increased generic competition since the early 2010s.

3. Can GLUCOPHAGE XR's sales recover?
Recovery is unlikely without new formulations, indications, or combination products, given the saturation of the market and the dominance of generics.

4. What are the market growth opportunities?
Emerging markets with rising diabetes prevalence, potential combination therapies, and pipeline innovations provide growth avenues.

5. What is the impact of new diabetes medications on GLUCOPHAGE XR?
Newer drugs like SGLT2 inhibitors and GLP-1 receptor agonists are capturing market share but are typically more expensive, limiting their impact on metformin's core market, especially in cost-sensitive regions.

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References

1. Grand View Research. (2022). Diabetes Drugs Market Size, Share & Trends Analysis Report.
2. U.S. Food and Drug Administration. (2012). Patent status of metformin formulations.
3. IQVIA. (2022). Prescription drug sales data.
4. Merck & Co. Annual Reports (2022).
5. MarketWatch. (2023). Trends in global diabetes treatments.