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-eight 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 ATLAS PHARMS LLC on January 24^th, 2002.

Summary for FORTAMET

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	43
Patent Applications:	579
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
Brigham and Women's Hospital	Phase 2
Arthritis Foundation	Phase 2
University of Colorado, Denver	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	AB2	RX	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	6,866,866
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-002	Apr 27, 2004	7,919,116
Andrx Labs Llc	FORTAMET	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021574-001	Apr 27, 2004	6,790,459

International Patents for FORTAMET

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

Country	Patent Number	Title	Estimated Expiration
Spain	2540972
Spain	2328308
Japan	5427677

Supplementary Protection Certificates for FORTAMET

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

FORTAMET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FORTAMET

Introduction to FORTAMET

FORTAMET is a brand name for the extended-release formulation of metformin, a medication primarily used to treat type 2 diabetes. Understanding the market dynamics and financial trajectory of FORTAMET involves analyzing the broader metformin market, as well as specific factors influencing this particular formulation.

Global Metformin Market Overview

The global metformin market is experiencing significant growth driven by several key factors:

• Increasing Prevalence of Diabetes: The rising number of people diagnosed with type 2 diabetes globally is a major driver. According to the International Diabetes Federation, approximately 537 million adults had diabetes in 2021, with projections indicating an increase to 643 million by 2030 and 783 million by 2045[3].
• Growing Awareness and Adoption: Increased awareness of the benefits of metformin among healthcare professionals and patients has contributed to its widespread adoption[1].
• Aging Population: The risk of developing type 2 diabetes increases with age, and as the world's population ages, the demand for metformin is expected to rise[1].

Market Size and Growth

The global metformin market was valued at USD 4,028 million in 2022 and is expected to reach USD 6,420.02 billion by 2030, growing at a CAGR of 6.0% during the forecast period of 2023 to 2030[1].

Segmentation and Distribution

The metformin market is segmented by product type, dosage type, end-users, and distribution channels. For FORTAMET, which is an extended-release formulation, the market segmentation is crucial:

• Product Type: Extended-release tablets like FORTAMET are gaining traction due to their convenience and better patient compliance[1][3].
• Dosage Type: FORTAMET is available in various dosages, such as 500mg, 750mg, 850mg, and 1g, catering to different patient needs[1].
• Distribution Channels: Hospital pharmacies, retail pharmacies, and online pharmacies are key distribution channels for FORTAMET[1].

Financial Performance of FORTAMET

While specific financial data for FORTAMET is not provided in the sources, we can infer its performance from the broader context of metformin and pharmaceutical company reports:

• Revenue Growth: The revenue from FORTAMET, as part of the extended-release metformin segment, is expected to grow in line with the overall metformin market. For instance, Shionogi's financial reports indicate significant revenue growth from their pharmaceutical products, including those related to diabetes management[2].
• Impact of Generic Competition: The expiry of patents and the rise of generic competition can affect the revenue of branded products like FORTAMET. However, the introduction of new formulations and combination therapies can help maintain market share[1][3].

Drivers and Opportunities

Drivers

• Increasing Prevalence of Diabetes: The growing number of diabetes cases drives the demand for effective diabetes medications like FORTAMET[1][3].
• Aging Population: The aging population increases the demand for diabetes management drugs, including extended-release formulations[1].
• Government Funding and Research: Increased government funding and research activities in diabetes care contribute to the growth of the metformin market, including FORTAMET[1].

Opportunities

• Expansion in Emerging Markets: There is significant potential for growth in emerging markets where diabetes is rising rapidly. Pharmaceutical companies can expand their presence in these markets to increase sales of FORTAMET[1][3].
• Technological Advancements: Advancements in drug delivery systems and formulations can create opportunities for improved metformin products, enhancing patient compliance and convenience[1].

Challenges and Restraints

Side Effects and Safety Concerns

• Although metformin is generally well tolerated, it can cause side effects such as gastrointestinal disturbances and rare but severe conditions like lactic acidosis. These safety concerns may limit the widespread use of FORTAMET[1].

Generic Competition and Patent Expiry

• The expiry of patents and the rise of generic competition can reduce the market share and revenue of branded products like FORTAMET. However, this also drives innovation and the development of new formulations[1][3].

Regional Market Performance

• North America: This region accounts for a significant market share due to a high prevalence of diabetes and obesity, as well as robust research and development activities and government funding[1].
• Asia-Pacific: Emerging countries in this region, such as India and China, are expected to drive growth due to increasing awareness about diabetes and rising chronic disease prevalence[1].

Key Takeaways

• The global metformin market, including FORTAMET, is driven by the increasing prevalence of diabetes, aging population, and growing awareness of the drug's benefits.
• The market is expected to grow significantly, with a CAGR of 6.0% from 2023 to 2030.
• FORTAMET benefits from its extended-release formulation, which enhances patient compliance.
• Challenges include side effects, safety concerns, and generic competition, but opportunities exist in emerging markets and technological advancements.

FAQs

1. What is FORTAMET, and how is it used?

FORTAMET is an extended-release formulation of metformin, used to treat type 2 diabetes by lowering blood sugar levels and improving insulin sensitivity.

2. What drives the growth of the metformin market, including FORTAMET?

The growth is driven by the increasing prevalence of diabetes, an aging population, and growing awareness of the drug's benefits.

3. How does generic competition affect FORTAMET?

Generic competition can reduce the market share and revenue of FORTAMET, but it also drives innovation and the development of new formulations.

4. What are the key distribution channels for FORTAMET?

Hospital pharmacies, retail pharmacies, and online pharmacies are the primary distribution channels for FORTAMET.

5. What are the potential side effects of FORTAMET?

FORTAMET can cause gastrointestinal disturbances and, rarely, severe conditions like lactic acidosis.

Cited Sources:

1. Data Bridge Market Research: Global Metformin Market Size, Share, Statistics & Industry Forecast By 2030.
2. SHIONOGI & CO., LTD.: 2021 Financial Presentation.
3. Research and Markets: Metformin Global Market Size, Competitors, Trends & Forecast.
4. The American Journal of Managed Care: Safety vs Price in the Generic Drug Market: Metformin.