FORTAMET Drug Patent Profile

Which patents cover Fortamet, and when can generic versions of Fortamet launch?

Fortamet is a drug marketed by Andrx Labs Llc and is included in one NDA.

The generic ingredient in FORTAMET 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 Fortamet

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

Summary for FORTAMET

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	43
Patent Applications:	4,090
Drug Prices:	Drug price information for FORTAMET
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FORTAMET
What excipients (inactive ingredients) are in FORTAMET?	FORTAMET excipients list
DailyMed Link:	FORTAMET at DailyMed

See drug prices for FORTAMET

Recent Clinical Trials for FORTAMET

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

Sponsor	Phase
Arthritis Foundation	Phase 2
Brigham and Women's Hospital	Phase 2
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1

See all FORTAMET clinical trials

Paragraph IV (Patent) Challenges for FORTAMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FORTAMET	Extended-release Tablets	metformin hydrochloride	500 mg and 1000 mg	021574	1	2008-10-14

US Patents and Regulatory Information for FORTAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004		DISCN	Yes	No
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004		DISCN	Yes	No

Expired US Patents for FORTAMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004

International Patents for FORTAMET

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	0236100
South Korea	20030061392
Spain	2540972
European Patent Office	2087889	Comprimé oral à libération contrôlée doté d'un coeur unitaire (Controlled release oral tablet having a unitary core)
European Patent Office	1063971	COMPRIMES ORAUX A NOYAU MONOLITHIQUE A LIBERATION CONTROLEE (CONTROLLED RELEASE ORAL TABLET HAVING A UNITARY CORE)
Japan	2007535557
Australia	3101999

Supplementary Protection Certificates for FORTAMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
1261586	C01261586/02	Switzerland		PRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
1532149	92128	Luxembourg		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
2498758	CR 2020 00017	Denmark		PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
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
2498758	CA 2020 00017	Denmark		PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113

Market Dynamics and Financial Trajectory for FORTAMET

Last updated: July 27, 2025

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Introduction

FORTAMET, the branded formulation of metformin hydrochloride, is a cornerstone in the management of Type 2 Diabetes Mellitus (T2DM). Its long-standing presence in the global pharmaceutical market, coupled with evolving patient demographics and healthcare policies, orchestrates a complex landscape of market dynamics and financial trajectories. This analysis explores the current market environment, growth drivers, challenges, and future perspectives shaping FORTAMET's financial outlook.

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Pharmacological Profile and Market Position

FORTAMET (generic metformin) is recognized for its efficacy, safety profile, and affordability, positioning it as a first-line treatment for T2DM globally. Its mechanism involves decreasing hepatic glucose production and enhancing insulin sensitivity. As per recent statistical data, metformin remains the most prescribed oral hypoglycemic agent, with an estimated global market share exceeding 70% in the oral diabetes drug segment [1].

The expansive adoption of FORTAMET is grounded in its clinical benefits and cost-effectiveness, making it accessible in both developed and emerging markets. Nevertheless, patent expirations and rising competition demand strategic re-evaluation of its market positioning.

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Market Dynamics

1. Market Drivers

• Growing Prevalence of T2DM: The International Diabetes Federation reports approximately 463 million adults living with diabetes in 2019, projected to reach 700 million by 2045 [2]. This surge amplifies demand for effective management therapies like FORTAMET.

• Cost-effectiveness and Accessibility: As healthcare expenditures escalate, governments and insurers favor affordable treatments. FORTAMET's low cost reinforces its downstream demand, especially in low- and middle-income countries.

• Clinical Acceptance and Guidelines: Endorsements by leading health associations (e.g., ADA, EASD) position metformin as the therapy of choice, indirectly fueling its market traction.

• Combination Therapies: Integration of FORTAMET with newer antihyperglycemics fosters growth, although it also introduces revenue diversification for pharmaceutical players.

2. Market Challenges

• Patent Expirations and Generic Competition: Multiple patents on branded formulations have expired or are nearing expiry, prompting generic manufacturers to enter the market. This intensifies price competition, pressuring profit margins for branded FORTAMET products [3].

• Side Effect Profile and Patient Preferences: Gastrointestinal adverse effects, although generally mild, lead some patients to seek alternatives, influencing prescription patterns.

• Regulatory and Patent Strategies: Patent litigations and subsidiary regulations in various regions create barriers and uncertainties.

• Emerging Therapies: New drug classes, such as SGLT2 inhibitors and GLP-1 receptor agonists, offer additional benefits but are often cost-prohibitive; however, their increasing popularity could limit long-term reliance on metformin in certain populations.

3. Market Trends

• Formulation Innovations: Extended-release versions of FORTAMET have improved tolerability, expanding vapor capacity among patients.

• Bi-Layer and Fixed-Dose Combinations: Co-formulation with other antidiabetic agents enhances therapeutic adherence and captures incremental market share.

• Digital Integration & Personalized Therapy: Digital monitoring and personalized medicine influence treatment plans, potentially affecting the demand for traditional formulations.

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Financial Trajectory

1. Revenue Outlook

The global FORTAMET market is projected to maintain a moderate CAGR of approximately 4-6% over the next five years, driven primarily by rising diabetes prevalence and generic competition aligning with regional dynamics. In developed markets like the U.S., the rapid shift toward generics has compressed price points, but volume growth steadyifies profits. In emerging markets—such as India, China, and Brazil—substitution effects, economic growth, and favorable regulatory policies support sustained demand expansion.

2. Pricing and Profit Margins

In mature markets, especially those with established generic commoditization, price erosion remains a primary concern. Companies leveraging economies of scale and efficient supply chains mitigate margin erosion. In contrast, patent-protected or innovative formulations command premium pricing, safeguarding margins temporarily.

3. R&D and Patent Strategy

R&D investments focus on extended-release and combination formulations that offer differentiation. Patent protections for these derivatives may provide residual exclusivity, but generics are likely to entering the market within 3-5 years post patent expiry, pressuring revenue streams further [4].

4. Market Entry and Competition

The proliferation of quality generics in emerging markets reduces prices but also widens access, boosting overall volume and revenue. Strategic alliances with local manufacturers, licensing agreements, and differentiation through formulation improvements are common tactics to maintain financial stability.

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Future Perspectives

The financial trajectory for FORTAMET hinges on a confluence of factors:

• Regulatory Environment: Policies favoring affordable generics support steady revenues, especially in price-sensitive regions.

• Innovation and Formulation Development: Success in launching sustained-release and fixed-dose combinations may unlock premium pricing opportunities.

• Global Diabetes Trends: Continued rise in T2DM prevalence sustains demand. However, shifts towards personalized therapy and new drug classes could partially displace traditional metformin formulations in specific patient cohorts.

• Market Penetration in Emerging Economies: Expanding access and adoption, driven by healthcare reforms, could offset revenue pressures from mature markets.

• Patent Litigation and Intellectual Property Rights: Protecting advances related to formulations and combination therapies may extend profitability windows.

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Conclusion

FORTAMET's market dynamics are characterized by its foundational role in diabetes management, tempered by competitive pressures from patents, generics, and evolving healthcare landscapes. Its financial trajectory remains cautiously optimistic, supported by rising diabetes prevalence and strategic product development. Companies that innovate in formulations, expand access in emerging markets, and adapt to regulatory shifts will optimize profitability and sustain growth.

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Key Takeaways

• Demand steadfastness: The global increase in T2DM prevalence ensures ongoing demand for metformin-based therapies.

• Competitive landscape: Patent expiries and global generic proliferation exert downward pressure on prices but open markets for volume-driven growth.

• Innovation focus: Developing extended-release, combination, and fixed-dose formulations offers avenues for premium pricing and market differentiation.

• Regional strategies: Expansion into emerging markets remains vital, leveraging their growing healthcare infrastructure and rising affluence.

• Regulatory agility: Navigating diverse regulatory environments and patent landscapes is crucial for maintaining profitability and market share.

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FAQs

1. What is the current market share of FORTAMET globally?
Metformin, including FORTAMET, dominates the oral antidiabetic market with over 70% share, owing to its efficacy, safety, and affordability [1].

2. How do patent expirations impact FORTAMET’s revenue?
Patent expirations open the market to generic competitors, leading to price erosion and reduced margins for branded formulations, although they may also accelerate volume growth.

3. What are the recent innovations in FORTAMET formulations?
Extended-release formulations and fixed-dose combinations with drugs like sitagliptin or rosiglitazone have been developed to improve tolerability and adherence.

4. Which regions present the best growth prospects for FORTAMET?
Emerging markets such as China, India, and Brazil offer substantial growth potential driven by increasing diabetes prevalence and healthcare reforms facilitating generic drug access.

5. What future challenges could affect FORTAMET’s market position?
Emerging drug classes, regulatory hurdles, patent litigations, and shifts toward personalized medicine may influence its market stability.

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References

[1] International Diabetes Federation. (2019). IDF Diabetes Atlas, 9th Edition.

[2] American Diabetes Association. (2022). Standards of Medical Care in Diabetes.

[3] MarketWatch. (2021). "Global Generic Pharmaceutical Market Trends."

[4] FDA. (2022). Patent and Exclusivity Data for Metformin Products.