Metformin hydrochloride - Generic Drug Details

What are the generic sources for metformin hydrochloride and what is the scope of freedom to operate?

Metformin hydrochloride is the generic ingredient in twenty branded drugs marketed by Sun Pharm, Saptalis Pharms, Vistapharm Llc, Ranbaxy, Andrx Labs Llc, Emd Serono Inc, Santarus Inc, Actavis Elizabeth, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Alignscience Pharma, Alkem Labs Ltd, Amneal Pharms Ny, Apotex, Aurobindo Pharma, Aurobindo Pharma Ltd, Barr, Beximco Pharms Usa, Cspc Ouyi, Glenmark Pharms Ltd, Granules, Harman Finochem, Impax Labs, Intellipharmaceutics, Inventia, Ivax Sub Teva Pharms, Laurus, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Micro Labs, Mylan Pharms Inc, Norvium Bioscience, Nostrum Labs Inc, Nostrum Pharms Llc, Novast Labs, Prinston Inc, Qingdao Baheal Pharm, Ranbaxy Labs Ltd, Rk Pharma, Sandoz, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Industries, Teva, Torrent, Torrent Pharms Ltd, Twi Pharms, Unichem, Utopic Pharms, Watson Labs Inc, Yichang Humanwell, Zydus Lifesciences, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell, Dr Reddys Labs Inc, Epic Pharma Llc, Granules India, Heritage Pharma, Indicus Pharma, Ipca Labs Ltd, Mylan, Provident Pharm, Sun Pharm Inds Inc, Sunshine, Torrent Pharms, Watson Labs, Watson Labs Florida, Zydus Hlthcare, Zydus Pharms Usa, Takeda Pharms Usa, Chartwell Rx, Teva Pharms Usa, Novo Nordisk Inc, Sb Pharmco, Astrazeneca Ab, Dr Reddys Labs Sa, and Msd Sub Merck, and is included in one hundred and twenty-eight NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride has fifty-five patent family members in sixteen countries.

There are forty-three drug master file entries for metformin hydrochloride. Eighty-three suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for metformin hydrochloride

International Patents:	55
US Patents:	10
Tradenames:	20
Applicants:	80
NDAs:	128
Drug Master File Entries:	43
Finished Product Suppliers / Packagers:	83
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	2,583
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metformin hydrochloride
What excipients (inactive ingredients) are in metformin hydrochloride?	metformin hydrochloride excipients list
DailyMed Link:	metformin hydrochloride at DailyMed

Recent Clinical Trials for metformin hydrochloride

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

Sponsor	Phase
Arthritis Foundation	Phase 2
James Wang	Phase 1
United States Department of Defense	Phase 1

See all metformin hydrochloride clinical trials

Generic filers with tentative approvals for METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		500MG	TABLET, EXTENDED RELEASE;ORAL
		1GM; EQ 100MG BASE	TABLET, EXTENDED RELEASE;ORAL
		1GM; EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for metformin hydrochloride

Drug Class

Biguanide

Medical Subject Heading (MeSH) Categories for metformin hydrochloride

Hypoglycemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for metformin hydrochloride

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RIOMET	Oral Solution	metformin hydrochloride	500 mg/5 mL	021591	1	2018-02-02
GLUMETZA	Extended-release Tablets	metformin hydrochloride	500 mg and 1000 mg	021748	1	2009-07-27
FORTAMET	Extended-release Tablets	metformin hydrochloride	500 mg and 1000 mg	021574	1	2008-10-14

US Patents and Regulatory Information for metformin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Inc	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	077787-002	Aug 23, 2006	AB	RX	No	No
Sun Pharm Inds (in)	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077336-001	Feb 9, 2006	AB1	RX	No	No
Glenmark Pharms Ltd	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212969-001	Nov 25, 2019	AB3	RX	No	No
Aurobindo Pharma Ltd	PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	200823-001	Feb 13, 2013	AB	RX	No	No
Laurus	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	217631-002	Oct 5, 2023	AB	RX	No	No
Sun Pharm Inds Inc	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET;ORAL	075967-002	Jan 29, 2002		DISCN	No	No
Sciegen Pharms Inc	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	214629-002	Feb 22, 2022	AB2	RX	No	No

Expired US Patents for metformin hydrochloride

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
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004
Ranbaxy	RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591-001	Sep 11, 2003
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004

International Patents for metformin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Australia	2018250470
European Patent Office	3445350
World Intellectual Property Organization (WIPO)	2017182852
Brazil	112017001968
Mexico	PA04008100	FORMULACIONES DE LIBERACION MODIFICADA DE AL MENOS UNA FORMA DE TRAMADOL. (MODIFIED RELEASE FORMULATIONS OF AT LEAST ONE FORM OF TRAMADOL.)
Japan	2017524471	二重室の包装体
World Intellectual Property Organization (WIPO)	03072089

Supplementary Protection Certificates for metformin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2498758	LUC00152	Luxembourg		PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
2498758	PA2020003	Lithuania		PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
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
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
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
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	C300524	Netherlands		PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:

Market Dynamics and Financial Trajectory for Metformin Hydrochloride

Market Overview

Metformin hydrochloride, a widely used medication for managing type 2 diabetes, is experiencing significant growth in the global market. Here are the key dynamics and financial projections for this drug.

Market Size and Forecast

As of 2022, the global metformin hydrochloride market was valued at approximately USD 268.95 million. It is projected to grow to USD 386.91 million by 2030, with a compound annual growth rate (CAGR) of 4.7% during the forecast period of 2023-2030[1].

Growth Drivers

Increasing Prevalence of Diabetes

The rising prevalence of type 2 diabetes globally is a major driver for the metformin hydrochloride market. Regions like Asia-Pacific, particularly China and India, are seeing a significant increase in diabetes cases, with over 140 million people in China and 135 million people in India diagnosed with diabetes or prediabetes as of 2021[1].

Geriatric Population

The growing geriatric population is another key factor. Older adults are more likely to develop type 2 diabetes, and this demographic shift is expected to drive the demand for metformin hydrochloride[4].

Technological Advancements and Healthcare Infrastructure

Improvements in healthcare infrastructure and the adoption of advanced medical technologies, including rapid testing and point-of-care diagnosis, are also fueling market growth. Increased investments in the pharmaceutical sector and advancements in drug discovery are further boosting the market[2].

Market Segmentation

By Type

The metformin hydrochloride market is segmented into different types, including Metformin HCL, Metformin DC, and others. Each type has its own market dynamics and growth prospects[2].

By Application

The market is also segmented by application, with key segments including Metformin Hydrochloride Tablets and Metformin Hydrochloride Extended-Release Tablets. The extended-release formulation, approved in 2000, has reduced gastrointestinal side effects and is gaining popularity[2][5].

By Distribution Channel

The distribution channels for metformin hydrochloride include various retail and hospital pharmacies, online platforms, and others. The accessibility and availability of the drug through these channels are crucial for market growth[1].

By Region

Geographically, the Asia-Pacific region is expected to lead the market during the forecast period due to the high prevalence of type 2 diabetes in this region. North America and Europe are also significant markets, driven by the increasing demand for the drug and the growing geriatric population[1][4].

Challenges and Restraints

High Healthcare Costs

One of the major challenges facing the metformin hydrochloride market is the surging cost of healthcare. The cost of healthcare has increased significantly over the years, from USD 353 per individual in 1970 to USD 12,900 in 2021, making it inaccessible to many, especially in underdeveloped countries[1].

Side Effects

Side effects associated with metformin hydrochloride, such as gastrointestinal issues and the risk of lactic acidosis in patients with renal impairment, are also a restraint. However, these risks are generally managed through proper prescribing practices and patient monitoring[4][5].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the metformin hydrochloride market. On one hand, there has been an increased focus on healthcare and pharmaceuticals, which has driven some growth. On the other hand, disruptions in supply chains and healthcare services have posed challenges. Interestingly, a study by Lancet suggested a 40% risk reduction of long-term COVID-19 complications in patients taking metformin, which could provide new growth avenues for the market[1].

Key Players

The market is dominated by several key players, including Shouguang Fukang Pharmaceutical, CR Double-Crane, Wanbury, Keyuan Pharmaceutical, Aarti Drugs, Farmhispania Group, Harman Finochem, Exemed Pharmaceuticals, Vistin Pharma, and USV, among others. These companies are investing in research and development and launching new products to capture market share[1].

Financial Projections

The financial trajectory of the metformin hydrochloride market is positive, with a projected growth from USD 268.95 million in 2022 to USD 386.91 million by 2030. This growth is driven by increasing demand, technological advancements, and expanding healthcare infrastructure[1].

Regional Outlook

• Asia-Pacific: Expected to lead the market due to the high prevalence of type 2 diabetes and a large patient pool.
• North America: Expected to dominate the metformin hydrochloride tablets market, driven by the growing number of patients with type 2 diabetes and a rising geriatric population.
• Europe: Anticipated to hold the second-largest market share, driven by an increasing geriatric population and various product launches by key players[1][4].

Key Takeaways

• The global metformin hydrochloride market is expected to grow significantly, driven by the increasing prevalence of type 2 diabetes and a growing geriatric population.
• Asia-Pacific is expected to lead the market, while North America and Europe will also be significant contributors.
• High healthcare costs and side effects associated with the drug are key challenges.
• The COVID-19 pandemic has introduced new potential benefits for metformin hydrochloride, such as reduced risk of long-term COVID-19 complications.

FAQs

Q: What is the projected market size of metformin hydrochloride by 2030?

A: The global metformin hydrochloride market is projected to grow to around USD 386.91 million by 2030[1].

Q: What is the CAGR of the metformin hydrochloride market from 2023 to 2030?

A: The CAGR is expected to be around 4.7% during the forecast period[1].

Q: Which region is expected to lead the metformin hydrochloride market?

A: The Asia-Pacific region is expected to lead the market due to the high prevalence of type 2 diabetes[1].

Q: What are the major drivers of the metformin hydrochloride market?

A: The major drivers include the increasing prevalence of type 2 diabetes, growing geriatric population, and advancements in healthcare infrastructure[1][4].

Q: What are the key challenges facing the metformin hydrochloride market?

A: High healthcare costs and side effects associated with the drug are significant challenges[1][4].

Sources:

1. Zion Market Research, Metformin Hydrochloride Market Size, Share and Forecast 2030.
2. BioSpace, Metformin Hydrochloride Market Analysis, Industry Size, Share Leaders, Current Status by Major Key vendors and Trends by Forecast to 2027.
3. Market Research Intellect, Global Metformin Hydrochloride Consumption Market Size and Forecast.
4. Fortune Business Insights, Metformin Hydrochloride Tablets Market Size, Industry Share.
5. Aston Research Explorer, Metformin: historical overview.