RIOMET ER Drug Patent Profile

When do Riomet Er patents expire, and what generic alternatives are available?

Riomet Er is a drug marketed by Sun Pharm and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-nine patent family members in eight countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Riomet Er

A generic version of RIOMET ER was approved as metformin hydrochloride by ANDA REPOSITORY on January 24^th, 2002.

Summary for RIOMET ER

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	41
Patent Applications:	38
DailyMed Link:	RIOMET ER at DailyMed

Recent Clinical Trials for RIOMET ER

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 ER clinical trials

US Patents and Regulatory Information for RIOMET ER

RIOMET ER 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
Sun Pharm	RIOMET ER	metformin hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	212595-001	Aug 29, 2019		DISCN	Yes	No			Y

International Patents for RIOMET ER

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

Country	Patent Number	Title	Estimated Expiration
Japan	2018517460	徐放性懸濁組成物用のデュアルチャンバーパック
Japan	2017524471	二重室の包装体
Japan	2017514903	徐放性懸濁組成物
European Patent Office	3445350
World Intellectual Property Organization (WIPO)	2016178132
Canada	3021475
World Intellectual Property Organization (WIPO)	2017182852

Supplementary Protection Certificates for RIOMET ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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:
1506211	SPC/GB14/050	United Kingdom		PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
1506211	179 5017-2014	Slovakia		PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
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
1506211	122014000071	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: RIOMET ER

Last updated: August 2, 2025

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Introduction

RIOMET ER (metformin hydrochloride extended-release), developed by Dr. Reddy’s Laboratories, stands as a strategic entrant in the diabetic management segment. As an extended-release formulation of metformin, it targets a broad patient base suffering from type 2 diabetes mellitus (T2DM), fitting into evolving market preferences for sustained-release medications that optimize glycemic control and improve patient adherence. This analysis dissects market dynamics, competitive landscape, regulatory influences, and the financial outlook shaping RIOMET ER's trajectory.

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Market Overview: Diabetes and Therapeutic Segment

The global diabetes market, valued at approximately USD 77 billion in 2022, is projected to surpass USD 140 billion by 2030, growing at a compound annual growth rate (CAGR) of 6-7% [1]. Type 2 diabetes accounts for 90-95% of cases; thus, treatment innovations directly influence market share and profitability. Metformin remains the first-line therapy for T2DM, accounting for over 70% of prescribed oral antidiabetic drugs (OADs) owing to its efficacy, safety profile, and cost-effectiveness [2].

The shift toward extended-release formulations like RIOMET ER responds to patient-centric demands for better tolerability, fewer gastrointestinal side effects, and improved compliance. Extended-release metformin reduces peak plasma concentrations, decreasing adverse events, and facilitates once-daily dosing—factors critical in long-term disease management.

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Market Dynamics Influencing RIOMET ER

1. Competitive Landscape and Differentiation

The market for metformin ER formulations is crowded, with established products such as Glucophage XR (Merck), Glumetza (Eli Lilly), and Fortamet (Janssen). Dr. Reddy's introduces RIOMET ER to penetrate this segment with a competitive price point and formulation-specific benefits, emphasizing ease of use and tolerability.

Differentiation hinges on:

• Formulation Absorption: Enhanced bioavailability and consistent plasma levels due to proprietary extended-release technology.
• Pricing Strategy: Cost competitiveness in emerging markets and price-sensitive regions.
• Regulatory Approvals: Achieving broad approval across key markets (US, Europe, India), affecting market access.

2. Regulatory Environment

Regulatory agencies like the FDA and EMA govern approval pathways, emphasizing bioequivalence, safety, and efficacy. The approval timeline impacts market entry; delays or stringent requirements may impede financial gains. Dr. Reddy’s strategy hinges on leveraging patents and regulatory data to secure fast-track approvals, leveraging the existing safety profile of metformin.

3. Market Access and Reimbursement Landscape

Reimbursement policies significantly influence prescription volumes. In the US, inclusion in formularies and favorable reimbursement policies for generic and branded ERs can drive uptake. Emerging markets, such as India and Brazil, favor lower-cost formulations, creating growth opportunities for RIOMET ER.

4. Patient and Physician Acceptance

Physician preference for established brands may slow adoption unless RIOMET ER demonstrates clear superior tolerability or distinct advantages. Patient adherence benefits due to extended-release benefits strengthen growth prospects.

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Financial Trajectory and Revenue Forecasts

1. Revenue Drivers

• Market Penetration and Prescription Volume: Growth depends on successful adoption in primary markets—US, India, and Europe.
• Pricing Strategy: Competitive setting aligned with local economic contexts.
• Regulatory Approvals & Launch Timeline: Faster approvals expedite revenue inflow; delayed launches compress forecast windows.
• Payer and Physician Acceptance: Key to volume growth.

2. Market Entry and Projected Growth

Based on competitor sales data and Dr. Reddy’s existing portfolio, conservative estimates project initial annual sales at USD 50-100 million within the first 2-3 years post-launch, with potential growth to USD 250-300 million annually over five years, assuming sustained market share expansion [3].

The growth trajectory is bolstered by:

• Expansion into emerging markets, where demand for low-cost, effective T2DM therapies escalates.
• Brand loyalty and patient adherence from extended-release benefits.
• Potential pipeline enhancements, such as combination therapies or new formulations.

3. Cost Considerations and Profit Margins

R&D and regulatory compliance costs are relatively modest, given the established safety profile of metformin. Manufacturing efficiencies and economies of scale further enhance profit margins, projected to stabilize around 20-30% after initial launch phases.

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Impact of Industry Trends and External Factors

• Generic Competition: As patent exclusivity expires, price competition intensifies, pressuring margins.
• Biopharmaceutical Innovations: Emerging digital health tools and personalized medicine could influence treatment adherence and market share.
• Regulatory and Policy Changes: Focus on affordability and access in healthcare reforms may favor low-cost formulations like RIOMET ER.
• Supply Chain Dynamics: Raw material prices, especially for active pharmaceutical ingredients (API), significantly affect profitability.

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Strategic Outlook

Dr. Reddy’s execution of targeted marketing, proactive regulatory engagement, and strategic collaborations will shape RIOMET ER’s financial trajectory. A focus on novel formulations, expanded indications, and global market penetration will amplify long-term growth potential. Moreover, integrating digital tools to monitor adherence may offer competitive advantages amid evolving healthcare landscapes.

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Key Takeaways

• Strong Demand for ER Antidiabetic Therapies: Driven by patient compliance and tolerability preferences, supporting steady demand for RIOMET ER.
• Competitive Environment: Success depends on differentiation, pricing, and regulatory approval timelines.
• Global Market Expansion: Emerging markets represent significant growth opportunities due to cost sensitivities and increasing diabetes prevalence.
• Revenue Potential: Market entry likely forecasts first-year sales of USD 50-100 million, with potential to reach USD 250-300 million over five years under optimal conditions.
• External Risks: Patent expiries, generic competition, and regulatory hurdles pose ongoing challenges but also opportunities for strategic positioning.

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FAQs

1. How does RIOMET ER compare to other extended-release metformin formulations?
RIOMET ER leverages proprietary extended-release technology designed to improve bioavailability and patient tolerability, aiming to differentiate by offering consistent plasma levels and potentially fewer GI side effects compared to competitors.

2. What are the primary markets for RIOMET ER?
Key markets include the US, India, China, and European countries, where diabetes prevalence is high. Emerging markets like Brazil and Southeast Asia also present growth opportunities.

3. How do regulatory pathways impact RIOMET ER's financial prospects?
Fast-track approvals and streamlined regulatory processes can accelerate market entry, boosting early sales. Conversely, delays hinder revenue realization and affect projected growth.

4. What external factors could influence RIOMET ER’s success?
Market competition, patent expirations, pricing pressures, healthcare policy shifts, and supply chain stability are pivotal external determinants.

5. What is the long-term outlook for RIOMET ER's revenue?
With strategic market expansion, competitive positioning, and effective adoption, RIOMET ER could generate substantial revenues, potentially exceeding USD 250 million annually within five years, contingent on favorable external conditions.

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References

[1] Mordor Intelligence. Global Diabetes Market Analysis. 2022.

[2] American Diabetes Association. Standards of Medical Care in Diabetes—2022. Diabetes Care, 2022.

[3] EvaluatePharma. 2023 World Preview: Outlook to 2028.

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