RIOMET Drug Patent Profile

Which patents cover Riomet, and what generic alternatives are available?

Riomet is a drug marketed by Ranbaxy and Sun Pharm and is included in two NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in RIOMET is metformin hydrochloride. There are forty-nine drug master file entries for this compound. Eighty-eight suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Riomet

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

Summary for RIOMET

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	41
Patent Applications:	579
Drug Prices:	Drug price information for RIOMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RIOMET
What excipients (inactive ingredients) are in RIOMET?	RIOMET excipients list
DailyMed Link:	RIOMET at DailyMed

See drug prices for RIOMET

See drug sales revenues for RIOMET

Recent Clinical Trials for RIOMET

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

Sponsor	Phase
National Institutes of Health (NIH)	Early Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Early Phase 1
Washington State University	Early Phase 1

See all RIOMET clinical trials

Pharmacology for RIOMET

Drug Class

Biguanide

Paragraph IV (Patent) Challenges for RIOMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RIOMET	Oral Solution	metformin hydrochloride	500 mg/5 mL	021591	1	2018-02-02

US Patents and Regulatory Information for RIOMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ranbaxy	RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591-001	Sep 11, 2003		DISCN	Yes	No
Sun Pharm	RIOMET ER	metformin hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	212595-001	Aug 29, 2019		DISCN	Yes	No			Y

Expired US Patents for RIOMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ranbaxy	RIOMET	metformin hydrochloride	SOLUTION;ORAL	021591-001	Sep 11, 2003

International Patents for RIOMET

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2003104808
Poland	365135
China	1635881
New Zealand	524519	Liquid formulation of metformin
European Patent Office	1387675
Australia	7659801

Supplementary Protection Certificates for RIOMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
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
1261586	12C0028	France		PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1506211	C300677	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
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

RIOMET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RIOMET (Metformin Hydrochloride)

Introduction to RIOMET

RIOMET, a brand name for metformin hydrochloride, is a biguanide used as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients with type 2 diabetes. Understanding the market dynamics and financial trajectory of RIOMET is crucial for stakeholders in the pharmaceutical industry.

Global Metformin Hydrochloride Market Overview

The global metformin hydrochloride market, which includes RIOMET, was valued at approximately USD 268.95 million in 2022. This market is projected to grow to around USD 386.91 million by 2030, with a compound annual growth rate (CAGR) of about 4.7% during the forecast period from 2023 to 2030[1].

Market Drivers

Growing Prevalence of Type 2 Diabetes

The increasing number of people living with type 2 diabetes is a significant driver for the metformin hydrochloride market. According to the International Diabetes Federation, the number of adults with diabetes in the IDF South-East Asia and Western Pacific regions is expected to rise substantially by 2030, contributing to the demand for oral anti-diabetic drugs like RIOMET[4].

Regulatory Approvals and Product Innovations

Recent approvals and launches of new formulations, such as extended-release tablets and oral suspensions, have boosted the market. For instance, India-based Glenmark Pharmaceuticals received approval for its new metformin hydrochloride extended-release tablet, and Sun Pharma launched RIOMET ER oral suspension in the American market after FDA approval[1].

Market Segments

By Application

The metformin hydrochloride market is primarily driven by its application in managing type 2 diabetes. The drug is used as an adjunct to diet and exercise to improve glycemic control in patients.

By Distribution Channel

The distribution channels for RIOMET include pharmacies, hospitals, and online platforms. The availability of generic versions and discount programs, such as the Drugs.com Discount Card, also play a significant role in market dynamics[2].

By Region

The Asia-Pacific region is expected to lead the metformin hydrochloride market during the forecast period due to the large and growing diabetic population in countries like India and China. This region is home to several dominant pharmaceutical companies that contribute significantly to the market[1].

Competitive Landscape

The global metformin hydrochloride market is highly competitive, with several key players. Some of the major companies include Shouguang Fukang Pharmaceutical, CR Double-Crane, Wanbury, Keyuan Pharmaceutical, Aarti Drugs, and Farmhispania Group. These companies compete based on product innovation, pricing, and market reach[1].

Pricing and Cost Considerations

The cost of RIOMET can vary depending on the pharmacy and the form of the medication. For example, the cost for RIOMET (500 mg/5 mL) oral solution is around $184 for a supply of 118 milliliters. Generic versions of metformin are also available, which can be more affordable, starting from $144.87 for 118 milliliters[2].

Generic Drug Dynamics

The generic drug industry, including metformin hydrochloride, is characterized by decreasing prices with increasing competition. Studies have shown that generic drug prices fall as the number of competitors increases, approaching long-run marginal costs when there are eight or more competitors. This dynamic affects the profitability and market share of generic metformin products like RIOMET[3].

Financial Projections

The financial trajectory of RIOMET is closely tied to the overall growth of the metformin hydrochloride market. With a projected CAGR of 4.7% from 2023 to 2030, the market is expected to see steady growth. Here are some key financial projections:

• Market Size in 2022: USD 268.95 million
• Market Forecast in 2030: USD 386.91 million
• CAGR: 4.7%[1].

Regional Market Analysis

Asia-Pacific Region

The Asia-Pacific region is expected to witness the highest CAGR in the oral anti-diabetic drugs market, including metformin hydrochloride. Countries like China and Japan are significant markets due to their large and growing diabetic populations. The region's market growth is driven by new-generation oral drugs that reduce cardiovascular risks in diabetes patients[4].

Challenges and Opportunities

Regulatory Scrutiny

The FDA's increased scrutiny of generic drug applications can raise the cost of obtaining approval, potentially affecting the entry of new generic metformin products into the market. However, this also ensures higher quality standards for approved drugs[3].

Growing Demand for Generic Drugs

The increasing demand for affordable healthcare solutions, particularly in emerging markets, presents an opportunity for generic metformin products like RIOMET. As more firms enter the market, competition will drive prices down, making the drug more accessible to a wider population[3].

Key Takeaways

• The global metformin hydrochloride market, including RIOMET, is projected to grow from USD 268.95 million in 2022 to USD 386.91 million by 2030.
• The Asia-Pacific region is expected to lead the market due to its large and growing diabetic population.
• Generic versions of metformin are available and can significantly reduce costs for patients.
• The market is driven by the increasing prevalence of type 2 diabetes and regulatory approvals of new formulations.
• Competition in the generic drug market will continue to drive prices down and increase accessibility.

FAQs

What is the current market size of the metformin hydrochloride market?

The global metformin hydrochloride market size was approximately USD 268.95 million in 2022[1].

What is the projected growth rate of the metformin hydrochloride market?

The market is expected to grow at a CAGR of about 4.7% from 2023 to 2030[1].

Which region is expected to lead the metformin hydrochloride market?

The Asia-Pacific region is expected to lead the market during the forecast period[1].

How does the availability of generic versions affect the market?

Generic versions of metformin, like RIOMET, reduce costs and increase accessibility, driving market growth and competition[2][3].

What are the key drivers for the metformin hydrochloride market?

The key drivers include the growing prevalence of type 2 diabetes, regulatory approvals, and product innovations[1][4].

Sources

1. Zion Market Research: Metformin Hydrochloride Market Size, Share and Forecast 2030.
2. Drugs.com: Riomet Prices, Coupons, Copay Cards & Patient Assistance.
3. Federal Trade Commission: Generic Drug Industry Dynamics.
4. Mordor Intelligence: Oral Anti Diabetic Drugs Market - Size, Share & Industry Analysis.