LIPIDIL Drug Patent Profile

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

Lipidil is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in LIPIDIL 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 Lipidil

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

Summary for LIPIDIL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	5
Patent Applications:	4,099
Drug Prices:	Drug price information for LIPIDIL
DailyMed Link:	LIPIDIL at DailyMed

See drug prices for LIPIDIL

Recent Clinical Trials for LIPIDIL

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

Sponsor	Phase
Chong Kun Dang Pharmaceutical	Phase 1
HK inno.N Corporation	Phase 1
CJ HealthCare Corporation	Phase 1

See all LIPIDIL clinical trials

US Patents and Regulatory Information for LIPIDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	LIPIDIL	fenofibrate	CAPSULE;ORAL	019304-001	Dec 31, 1993		DISCN	No	No

Expired US Patents for LIPIDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LIPIDIL	fenofibrate	CAPSULE;ORAL	019304-001	Dec 31, 1993

International Patents for LIPIDIL

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

Country	Patent Number	Title	Estimated Expiration
Germany	2250327
Canada	960670	PHENOXY-ALKYL-CARBOXYLIC ACID DERIVATIVES AND THE PREPARATION THEREOF
United Kingdom	1268321
Japan	H01254624	TREATMENT COMPOSITION CONTAINING PHENOFIBRATE AND PRODUCTION THEREOF
Netherlands	7900613
Australia	2982889
Switzerland	515873	Procédé de préparation de composés dérivés de l'acide phénoxy-alkyl-carboxylique (Phenoxyacetic acid derivs)

LIPIDIL Market Analysis and Financial Projection Experimental

Lipid-Lowering Drugs Market Dynamics and Financial Trajectory: A Focus on Fenofibrate (LIPIDIL)

Market Overview of Lipid-Lowering Drugs

The global lipid-lowering drugs market is experiencing significant growth, driven by the increasing prevalence of cardiovascular diseases and the rising demand for effective cholesterol management. The market was valued at USD 33.12 billion in 2023 and is projected to reach USD 46.58 billion by 2033, growing at a CAGR of 3.47% from 2024 to 2033[1].

Segments of the Lipid-Lowering Drugs Market

The market is segmented by drug type, indication, and distribution channel. Key drug types include statins, PCSK9 inhibitors, bile acid sequestrants, fibrates (such as fenofibrate), and cholesterol absorption inhibitors. The primary indications are hypercholesterolemia, coronary artery disease, and high triglycerides[1].

Fenofibrate (LIPIDIL) Market Dynamics

Fenofibrate, marketed under the brand name LIPIDIL among others, is a fibrate used to lower cholesterol levels and treat conditions such as hypercholesterolemia and high triglycerides.

Market Presence and Competition

Despite the availability of generic fenofibrate since 2002, branded formulations of fenofibrate have maintained a significant market share. Abbott's strategic approach of launching successive branded reformulations and engaging in patent litigation has delayed the approval of generic versions, allowing branded fenofibrate to dominate the market. This strategy has resulted in substantial costs to the healthcare system, with annual savings of approximately $700 million possible if all patients switched to generic fenofibrate[2].

Sales and Revenue

The sales of Abbott's fenofibrate franchise have shown a steady increase, even after the publication of a large outcomes trial in 2005 that showed fenofibrate had little effect on cardiovascular outcomes. By 2006, sales had eclipsed $1 billion and were expected to reach almost $1.4 billion in 2011. The continuous launch of new reformulations, such as Tricor-2, which rapidly replaced Tricor-1, has contributed to this growth[2].

Financial Trajectory

Cost Implications

The use of branded fenofibrate formulations imposes a significant cost burden on the healthcare system. If all patients using branded fenofibrate were to switch to generic versions, the healthcare system could realize annual savings of approximately $700 million. This highlights the financial impact of branded drug strategies on healthcare costs[2].

Revenue Projections

The overall lipid-lowering drugs market, which includes fenofibrate, is expected to grow steadily. With a projected CAGR of 3.03% to 3.47% from 2024 to 2031/2033, the market is anticipated to expand from USD 30.30 billion in 2023 to USD 38.47 billion by 2031 or USD 46.58 billion by 2033[1][4].

Regional Market Performance

North America

North America leads the lipid-lowering drugs market, driven by the high prevalence of cardiovascular diseases and a well-developed healthcare infrastructure. The sedentary lifestyle and higher demand for drugs to treat cardiovascular diseases in this region contribute to the market's growth[1].

Asia-Pacific

The Asia-Pacific region is expected to witness the fastest growth during the forecast period due to the rising geriatric population and increasing adoption of sedentary lifestyles, which contribute to higher cholesterol levels and cardiovascular diseases. Rising investments in pharmaceutical companies in countries like India and China also drive market growth[1].

Distribution Channels

The retail pharmacies segment dominated the market in 2023 due to easy access and availability of drugs. However, the online pharmacies segment is expected to grow significantly, offering convenience and direct delivery of medications, which is particularly beneficial for individuals with mobility issues or busy schedules[1].

Customer Preferences and Health Awareness

Customers, especially in the Americas, are highly conscious of their health and willing to invest in products that help maintain a healthy lifestyle. As the population ages, there is a greater need for products that manage chronic conditions such as high cholesterol levels[3].

Key Takeaways

• The global lipid-lowering drugs market is projected to grow significantly, driven by the rising prevalence of cardiovascular diseases.
• Fenofibrate, despite generic availability, maintains a strong market presence due to strategic branding and patent litigation.
• The use of branded fenofibrate formulations results in substantial healthcare costs that could be mitigated by switching to generics.
• North America and the Asia-Pacific region are key markets, with the latter expected to show the fastest growth.
• Retail and online pharmacies are crucial distribution channels, with online pharmacies expected to grow rapidly.

FAQs

1. What is the projected growth rate of the global lipid-lowering drugs market?

The global lipid-lowering drugs market is projected to grow at a CAGR of 3.03% to 3.47% from 2024 to 2031/2033[1][4].

2. Why do branded formulations of fenofibrate dominate the market despite generic availability?

Branded formulations of fenofibrate dominate due to Abbott's strategic approach of launching successive reformulations and engaging in patent litigation, which delays the approval of generic versions[2].

3. What are the primary indications for lipid-lowering drugs?

The primary indications are hypercholesterolemia, coronary artery disease, and high triglycerides[1].

4. Which region is expected to witness the fastest growth in the lipid-lowering drugs market?

The Asia-Pacific region is expected to witness the fastest growth due to the rising geriatric population and increasing adoption of sedentary lifestyles[1].

5. What are the cost implications of using branded fenofibrate formulations?

The use of branded fenofibrate formulations imposes a significant cost burden, with potential annual savings of approximately $700 million if all patients switched to generic versions[2].

Cited Sources:

1. Precedence Research, "Lipid-lowering Drugs Market Size to Hit USD 46.58 Bn by 2033"
2. PMC, "How Abbott's Fenofibrate Franchise Avoided Generic Competition"
3. Statista, "Lipid-Lowering Agents - Americas | Statista Market Forecast"
4. MarketsandData, "Lipid-lowering Drugs Market Size, Share, Growth, Forecast 2031"