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-five 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 ATLAS PHARMS LLC 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:	164
Clinical Trials:	51
Patent Applications:	4,053
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			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	021748-002	Jun 3, 2005
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005

International Patents for GLUMETZA

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

Country	Patent Number	Title	Estimated Expiration
Austria	536863
Japan	2009040787	TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM
Japan	5133495
Denmark	1294363
Germany	60101581
South Korea	20030023876
Japan	2013224324	TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM

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
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
1506211	CR 2014 00037	Denmark		PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1412357	50/2008	Austria		PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
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
1261586	132012902044560	Italy		PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
1506211	PA2014026,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116

Market Dynamics and Financial Trajectory for Glumetza (Metformin Hydrochloride Extended-Release Tablets)

Introduction to Glumetza

Glumetza, a brand name for metformin hydrochloride extended-release tablets, is a medication used to treat type 2 diabetes. It belongs to the class of biguanides and works by decreasing glucose production in the liver and increasing insulin sensitivity.

Market Drivers

Increasing Prevalence of Diabetes

The global rise in the prevalence of type 2 diabetes is a significant driver for the Glumetza market. As the number of people diagnosed with diabetes increases, so does the demand for effective diabetes medications like metformin[4].

Growing Geriatric Population

The risk of developing type 2 diabetes increases with age. The growing geriatric population worldwide contributes to the increased demand for Glumetza and other metformin formulations[1][4].

Product Launches and Market Expansion

Key players in the pharmaceutical industry continue to launch new products and expand their market presence, which boosts the growth of the Glumetza market. For example, Teva Pharmaceutical Industries Ltd. launched generic Glumetza in the U.S. in 2017[1].

Market Restraints

Side Effects Associated with the Drug

Despite its effectiveness, Glumetza is associated with various side effects, which can hamper market growth. Common side effects include gastrointestinal issues, which may deter some patients from using the medication[1][4].

Alternative Treatment Options

The availability of alternative treatments for type 2 diabetes, such as other oral medications or insulin therapies, can also impact the market for Glumetza. Patients and healthcare providers may opt for these alternatives based on individual patient needs and preferences[4].

Geographical Market Segmentation

North America

North America is expected to dominate the Glumetza market due to the high prevalence of type 2 diabetes and a growing geriatric population in the region. The U.S., in particular, has seen significant demand for diabetes medications, driven by factors such as obesity and an aging population[1][4].

Europe

Europe holds the second-largest market share for Glumetza. The region's market growth is driven by an increasing geriatric population and various product launches by key market players[1].

Asia Pacific

The Asia Pacific region is projected to register the highest Compound Annual Growth Rate (CAGR) for Glumetza. This growth is attributed to increasing awareness about diabetes, rising chronic disease prevalence, and expanding healthcare infrastructure in countries like India and China[1][4].

Financial Trajectory

Revenue and Market Size

Glumetza, as a product, contributes significantly to the revenue of pharmaceutical companies. For instance, Valeant Pharmaceuticals International (now Bausch Health) reported Glumetza as its 18th top product based on revenue of $26 million. However, if the entire Product Acquisition Cost (PAC) had been recorded as Glumetza revenue, it would have been the company's second-highest revenue-generating product with $136 million in revenue[2].

Impact on Company Financials

The financial performance of companies like Valeant (Bausch Health) is influenced by the revenue generated from Glumetza. The allocation of the PAC for Glumetza affected various financial metrics, including Cash EPS and same-store organic growth. For example, in Q2 2015, the inclusion of Glumetza PAC in the revenue calculation resulted in a reported 19% same-store organic growth, which would have been 14% without the PAC allocation[2].

Competitive Landscape

The diabetes drug market, including Glumetza, is highly competitive with major players such as Novo Nordisk, Sanofi, Merck & Co, Eli Lilly and Company, and AstraZeneca. These companies invest heavily in research and development, marketing, and strategic initiatives to maintain and expand their market share[3].

Future Prospects

Technological Advancements

Future prospects for the Glumetza market are enhanced by technological advancements in diabetes treatment. Innovations in drug delivery systems, monitoring devices, and personalized medicine are expected to drive market growth[3].

Government Funding and Regulatory Framework

Government funding for diabetes research and a supportive regulatory framework also act as opportunities for market growth. However, strict regulatory requirements can sometimes hamper the launch of new products or formulations[4].

Key Takeaways

• The Glumetza market is driven by the increasing prevalence of type 2 diabetes and a growing geriatric population.
• North America dominates the market, followed by Europe and the Asia Pacific region.
• Side effects associated with the drug and alternative treatment options are significant restraints.
• The financial performance of pharmaceutical companies is significantly influenced by the revenue generated from Glumetza.
• Technological advancements and government funding are key opportunities for future market growth.

Frequently Asked Questions (FAQs)

Q: What is Glumetza used for? A: Glumetza is used to treat type 2 diabetes by decreasing glucose production in the liver and increasing insulin sensitivity.

Q: Who are the major players in the Glumetza market? A: Major players include pharmaceutical companies like Novo Nordisk, Sanofi, Merck & Co, Eli Lilly and Company, and AstraZeneca.

Q: What are the key drivers of the Glumetza market? A: The key drivers include the increasing prevalence of type 2 diabetes and a growing geriatric population.

Q: Which region dominates the Glumetza market? A: North America dominates the Glumetza market due to the high prevalence of type 2 diabetes and an aging population.

Q: What are the potential restraints for the Glumetza market? A: Potential restraints include side effects associated with the drug and the availability of alternative treatment options.

Cited Sources:

1. Fortune Business Insights - Metformin Hydrochloride Tablets Market Size, Industry Share ...
2. SEC - Valeant Pharmaceuticals International, Inc. and n/k/a Bausch Health ...
3. SNS Insider - Diabetes Drug Market Size, Share & Trends Outlook 2024-2032
4. Data Bridge Market Research - Global Metformin Market Size, Share, Statistics & Industry Forecast By 2030

Last updated: 2024-12-18