FENOGLIDE Drug Patent Profile

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

Fenoglide is a drug marketed by Salix and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in FENOGLIDE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fenoglide

A generic version of FENOGLIDE was approved as fenofibrate by RHODES PHARMS on May 13^th, 2005.

Summary for FENOGLIDE

International Patents:	29
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	2
Patent Applications:	4,066
Drug Prices:	Drug price information for FENOGLIDE
What excipients (inactive ingredients) are in FENOGLIDE?	FENOGLIDE excipients list
DailyMed Link:	FENOGLIDE at DailyMed

See drug prices for FENOGLIDE

See drug sales revenues for FENOGLIDE

Recent Clinical Trials for FENOGLIDE

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

Sponsor	Phase
Lindsay Ferguson, MD	Phase 1
The Scripps Research Institute	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2

See all FENOGLIDE clinical trials

Paragraph IV (Patent) Challenges for FENOGLIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FENOGLIDE	Tablets	fenofibrate	40 mg and 120 mg	022118	1	2010-03-17

US Patents and Regulatory Information for FENOGLIDE

FENOGLIDE is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007		DISCN	Yes	No	8,124,125		Y
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007		DISCN	Yes	No	7,658,944		Y
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007		DISCN	Yes	No	9,173,847		Y
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007		DISCN	Yes	No	9,173,847		Y
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007		DISCN	Yes	No	8,481,078		Y

Expired US Patents for FENOGLIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	7,658,944
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-001	Aug 10, 2007	7,658,944
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	8,481,078
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	8,124,125
Salix	FENOGLIDE	fenofibrate	TABLET;ORAL	022118-002	Aug 10, 2007	9,173,847

International Patents for FENOGLIDE

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1804768	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU FENOFIBRATE ET DE L'ATORVASTATINE (PHARMACEUTICAL COMPOSITIONS COMPRISING FENOFIBRATE AND ATORVASTATIN)
Canada	2540984	FORME DE DOSE SOLIDE COMPRENANT UN FIBRATE (A SOLID DOSAGE FORM COMPRISING A FIBRATE)
Japan	2007508249
European Patent Office	1680091	FORME DE DOSE SOLIDE COMPRENANT UN FIBRATE (A SOLID DOSAGE FORM COMPRISING A FIBRATE)
Mexico	PA06003813	FORMA SOLIDA DE DOSIFICACION QUE COMPRENDE UN FIBRATO Y UNA ESTATINA. (A SOLID DOSAGE FORM COMPRISING A FIBRATE AND A STATIN.)

FENOGLIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FENOGLIDE

Introduction to FENOGLIDE

FENOGLIDE, a brand name for fenofibrate, is a medication used to reduce cholesterol and triglyceride levels in the blood, thereby decreasing the risk of heart disease. Here, we will delve into the market dynamics and financial trajectory of FENOGLIDE, highlighting key factors influencing its market performance.

Market Growth Drivers

Increasing Prevalence of Cardiovascular Diseases

The global market for fibrate drugs, including FENOGLIDE, is driven significantly by the rising incidence of cardiovascular diseases. The COVID-19 pandemic exacerbated this trend, as physical inactivity and other lifestyle changes increased the risk of developing cardiovascular conditions. This has led to a higher demand for treatments like fenofibrate[1].

Product Launches and Approvals

The market for FENOGLIDE is also boosted by the launch of new and generic versions of fenofibrate. For instance, in November 2021, Lupin launched generic fenofibrate capsules in the United States, which is expected to contribute to market growth[1].

Market Segmentation

Fenofibrate Segment Dominance

The fenofibrate segment, which includes FENOGLIDE, is expected to hold a significant market share due to its high efficacy in reducing cholesterol and triglyceride levels. The worldwide prevalence of peripheral arterial disease (PAD) and other cardiovascular conditions further fuels the demand for fenofibrate[1].

Regional Market Performance

North America

North America is anticipated to hold a major market share in the global fibrate drugs market, including FENOGLIDE. This is attributed to the high prevalence of cardiovascular diseases in the region, the aging population, and the presence of key market players. For example, in the United States, approximately 6.5 million people aged 40 and older have peripheral arterial disease, driving the demand for fenofibrate[1].

Financial Performance

Historical Sales Data

Historical sales data for FENOGLIDE provide insights into its financial trajectory. Prior to being acquired by Santarus, FENOGLIDE achieved peak U.S. sales of approximately $23 million for the 12 months ended August 31, 2010, when it was promoted by Shionogi Pharma, Inc. After the acquisition, Santarus assumed distribution and expected to increase sales through active promotion[4].

Post-Acquisition Performance

Under Santarus, the sales of FENOGLIDE continued, although at a lower scale initially. For the 12 months ended October 31, 2011, sales were $8.7 million. Santarus planned to increase promotional activities, which was expected to boost sales further[4].

Challenges and Opportunities

Regulatory Framework

The market for FENOGLIDE faces challenges from a stringent regulatory framework. Frequent product recalls and discontinuations can hinder market growth. However, regulatory approvals, such as the one received by Aurobindo Pharma Limited for its fenofibrate capsules, can also present opportunities for growth[1].

Competitive Landscape

The competitive landscape for fibrate drugs is dynamic, with multiple players launching generic and branded versions. This competition can drive innovation and reduce prices, making the medication more accessible to a broader population.

Financial Metrics and Projections

Revenue and Growth Rate

The global fibrate drugs market, which includes FENOGLIDE, is projected to grow at a CAGR of 5.2% by 2028. This growth is driven by the increasing prevalence of cardiovascular diseases and the launch of effective fibrate drugs[1].

Non-GAAP Financial Measures

Companies involved in the production and distribution of FENOGLIDE often report non-GAAP financial measures to provide a clearer picture of their operational performance. For example, non-GAAP net income can exclude one-time costs and amortization, giving a more stable view of the company's financial health[2].

Key Takeaways

• The market for FENOGLIDE is driven by the increasing prevalence of cardiovascular diseases.
• Product launches and regulatory approvals are crucial for market growth.
• North America is a significant market due to the high prevalence of cardiovascular diseases.
• The market faces challenges from a stringent regulatory framework but benefits from competitive innovation.
• Financial performance is expected to grow, with a projected CAGR of 5.2% by 2028.

FAQs

Q: What is FENOGLIDE used for?

FENOGLIDE, a brand name for fenofibrate, is used to reduce cholesterol and triglyceride levels in the blood, thereby decreasing the risk of heart disease.

Q: How has the COVID-19 pandemic affected the market for FENOGLIDE?

The COVID-19 pandemic increased the risk of developing cardiovascular diseases due to physical inactivity and other lifestyle changes, thereby increasing the demand for FENOGLIDE.

Q: Which region is expected to hold a significant market share for FENOGLIDE?

North America is expected to hold a significant market share due to the high prevalence of cardiovascular diseases and the presence of key market players.

Q: What are the challenges faced by the market for FENOGLIDE?

The market faces challenges from frequent product recalls/discontinuations and a stringent regulatory framework.

Q: What is the projected growth rate for the global fibrate drugs market?

The global fibrate drugs market, which includes FENOGLIDE, is projected to grow at a CAGR of 5.2% by 2028.

Sources:

1. Mordor Intelligence: Fibrate Drugs Market - Size, Share & Statistics.
2. Business Wire: Salix Pharmaceuticals Reports 1Q2014 Results.
3. Market Research Intellect: Global Fenofibrate Market Size And Forcast.
4. Business Wire: Santarus Adds FENOGLIDE to Marketed Products Portfolio.