METFORMIN HYDROCHLORIDE Drug Patent Profile

When do Metformin Hydrochloride patents expire, and when can generic versions of Metformin Hydrochloride launch?

Metformin Hydrochloride is a drug marketed by Annora Pharma, Saptalis Pharms, Vistapharm Llc, 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, Inventia, Ivax Sub Teva Pharms, Laurus, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, Medicap Labs, 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, 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, and Zydus Pharms Usa. and is included in one hundred and three NDAs.

The generic ingredient in METFORMIN HYDROCHLORIDE 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 Metformin Hydrochloride

A generic version of METFORMIN HYDROCHLORIDE was approved as metformin hydrochloride by ATLAS PHARMS LLC on January 24^th, 2002.

Summary for METFORMIN HYDROCHLORIDE

US Patents:	0
Applicants:	69
NDAs:	103
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

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
Prinston Inc	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	212681-001	Jun 9, 2022	AB3	RX	No	No
Watson Labs Inc	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076818-001	Dec 14, 2004		DISCN	No	No
Impax Labs	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	076249-001	Jul 30, 2004		DISCN	No	No
Cspc Ouyi	METFORMIN HYDROCHLORIDE	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	078321-002	Apr 17, 2008	AB	RX	No	No

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.

Last updated: 2024-12-16