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-three 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 ATLAS PHARMS LLC on January 24^th, 2002.

Summary for GLUCOPHAGE XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	350
Patent Applications:	579
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
James Wang	Phase 1
United States Department of Defense	Phase 1
Aga Khan University	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	021202-004	Apr 11, 2003
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-004	Apr 11, 2003
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-001	Oct 13, 2000
Emd Serono Inc	GLUCOPHAGE XR	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021202-001	Oct 13, 2000

International Patents for GLUCOPHAGE XR

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

Country	Patent Number	Title	Estimated Expiration
China	1295467
New Zealand	506202	Biphasic controlled release delivery system for high solubility pharmaceuticals and method
World Intellectual Property Organization (WIPO)	9947128
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)

Supplementary Protection Certificates for GLUCOPHAGE XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	300677	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
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
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
1532149	C300569	Netherlands		PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720

Market Dynamics and Financial Trajectory for GLUCOPHAGE XR

Introduction

GLUCOPHAGE XR, an extended-release formulation of metformin hydrochloride, is a pivotal medication in the management of type 2 diabetes. This article delves into the market dynamics and financial trajectory of GLUCOPHAGE XR, highlighting its performance, drivers, and challenges.

Market Size and Growth

The global metformin market, which includes GLUCOPHAGE XR, has been experiencing significant growth. As of 2022, the global metformin market was valued at USD 4.028 billion and is projected to reach USD 6.420 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.0% during the forecast period of 2023 to 2030[4].

Drivers of Market Growth

Several factors are driving the growth of the metformin market, including GLUCOPHAGE XR:

Increasing Prevalence of Diabetes

The global increase in type 2 diabetes cases is a major driver. The rising incidence of diabetes, particularly in developing countries, has led to an increased demand for effective and affordable treatments like metformin[4].

Rising Obesity and Lifestyle Changes

The global rise in obesity and the adoption of sedentary lifestyles have contributed to the increasing prevalence of type 2 diabetes, thereby boosting the demand for metformin-based medications[4].

Government Funding and Research Activities

Increased government funding and research activities in the healthcare sector have also supported the growth of the metformin market. These initiatives often focus on developing more effective and safer treatments, which can include extended-release formulations like GLUCOPHAGE XR[4].

Financial Performance

While specific financial data for GLUCOPHAGE XR alone is not readily available, the performance of its parent company and the broader metformin market provide valuable insights.

Revenue Trends

Metformin, including its extended-release formulations, has consistently generated significant revenue. For instance, the global metformin market's valuation and growth projections indicate a robust financial trajectory. The market's expected growth to USD 6.420 billion by 2030 underscores the financial potential of medications like GLUCOPHAGE XR[4].

Clinical Efficacy and Market Acceptance

GLUCOPHAGE XR has demonstrated strong clinical efficacy in managing type 2 diabetes. Studies have shown that GLUCOPHAGE XR maintains glycemic control, reduces fasting plasma glucose levels, and can lead to weight reduction when combined with diet and exercise. These benefits have contributed to its market acceptance and financial success[3].

Competitive Landscape

The diabetes management market is highly competitive, with several key players:

Major Competitors

• Eli Lilly and Company: Known for its insulin products and other diabetes medications like Trulicity.
• Novo Nordisk: Dominant in the GLP-1 agonist market with products like Victoza and Ozempic.
• AstraZeneca: Successful with SGLT2 inhibitors like Farxiga.
• Bristol Myers Squibb: The manufacturer of GLUCOPHAGE XR, which competes in the metformin segment[1][2].

Regulatory and Market Challenges

Despite its growth, the metformin market, including GLUCOPHAGE XR, faces several challenges:

Regulatory Framework

A strict regulatory framework can hamper market growth. Regulatory approvals and compliance with safety standards are crucial for the continued success of GLUCOPHAGE XR[4].

Side Effects and Alternative Treatments

High side effects associated with metformin, such as gastrointestinal issues, and the availability of alternative treatments can impact market growth. However, the extended-release formulation of GLUCOPHAGE XR is designed to mitigate some of these side effects[3][4].

Pricing and Access

Pricing strategies and access to healthcare can also influence the financial trajectory of GLUCOPHAGE XR. Affordable pricing and widespread availability are key to maintaining market share[4].

Clinical Trials and Efficacy

GLUCOPHAGE XR has undergone extensive clinical trials to establish its efficacy:

Glycemic Control

Studies have shown that GLUCOPHAGE XR effectively reduces HbA1c levels and fasting plasma glucose in patients with type 2 diabetes. For example, a 24-week study demonstrated a decrease in mean HbA1c of 0.6% compared to a 0.2% increase in the placebo group[3].

Body Weight Reduction

In addition to glycemic control, GLUCOPHAGE XR has been associated with body weight reduction. A study showed a mean weight reduction of 3.11 pounds when combined with insulin, compared to an increase of 1.30 pounds in the placebo group[3].

Market Segmentation

The metformin market, including GLUCOPHAGE XR, is segmented based on several factors:

Product Type

• Standard-release tablets
• Slow-release tablets (like GLUCOPHAGE XR)

Dosage Type

• Various dosages such as 500mg, 750mg, 850mg, and 1g

End-Users

• Clinics
• Hospitals
• Homecare
• Others

Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy
• Others[4].

Conclusion

GLUCOPHAGE XR is a significant player in the metformin market, driven by its clinical efficacy, increasing prevalence of type 2 diabetes, and favorable market dynamics. Despite challenges such as regulatory hurdles and side effects, the financial trajectory of GLUCOPHAGE XR remains strong, supported by its market acceptance and the growing demand for effective diabetes management solutions.

Key Takeaways

• The global metformin market, including GLUCOPHAGE XR, is projected to grow significantly by 2030.
• Increasing prevalence of type 2 diabetes and lifestyle changes are key drivers.
• GLUCOPHAGE XR has demonstrated strong clinical efficacy in managing glycemic control and reducing body weight.
• The market faces challenges such as regulatory frameworks and side effects.
• Market segmentation includes various product types, dosages, end-users, and distribution channels.

FAQs

What is GLUCOPHAGE XR?

GLUCOPHAGE XR is an extended-release formulation of metformin hydrochloride used for the treatment of type 2 diabetes.

How effective is GLUCOPHAGE XR in managing type 2 diabetes?

GLUCOPHAGE XR has been shown to effectively reduce HbA1c levels and fasting plasma glucose in clinical trials, and it also aids in body weight reduction when combined with diet and exercise.

What are the key drivers of the metformin market growth?

The key drivers include the increasing prevalence of type 2 diabetes, rising obesity, and lifestyle changes, as well as increased government funding and research activities.

What challenges does the metformin market face?

The market faces challenges such as a strict regulatory framework, high side effects associated with metformin, and the availability of alternative treatments.

How is the metformin market segmented?

The market is segmented based on product type, dosage type, end-users, and distribution channels.

Sources

1. Xtalks: Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics
2. Eli Lilly: Lilly Reports Solid Fourth-Quarter and Full-Year 2021 Financial
3. Bristol Myers Squibb: GLUCOPHAGE XR (metformin hydrochloride) Extended-Release Tablets
4. Data Bridge Market Research: Global Metformin Market Size, Share, Statistics & Industry Forecast By 2030