LIPOFEN Drug Patent Profile

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

Lipofen is a drug marketed by Cipher Pharms Inc and is included in one NDA.

The generic ingredient in LIPOFEN 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 Lipofen

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

Summary for LIPOFEN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	3
Patent Applications:	4,129
Drug Prices:	Drug price information for LIPOFEN
What excipients (inactive ingredients) are in LIPOFEN?	LIPOFEN excipients list
DailyMed Link:	LIPOFEN at DailyMed

See drug prices for LIPOFEN

See drug sales revenues for LIPOFEN

Recent Clinical Trials for LIPOFEN

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 LIPOFEN clinical trials

Pharmacology for LIPOFEN

Drug Class

Peroxisome Proliferator Receptor alpha Agonist

US Patents and Regulatory Information for LIPOFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-001	Jan 11, 2006		RX	Yes	No
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-002	Jan 11, 2006		DISCN	No	No
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-003	Jan 11, 2006		RX	Yes	Yes

Expired US Patents for LIPOFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-001	Jan 11, 2006
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-003	Jan 11, 2006
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-002	Jan 11, 2006

International Patents for LIPOFEN

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9621439
Germany	69627817
Japan	H10511959
Australia	4380896
European Patent Office	0801562	COMPOSITION PHARMACEUTIQUE CONTENANT DU FENOFIBRATE ET DES GLYCERIDES POLYGLYCOLYSES (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND POLYGLYCOLIZED GLYCERIDES)

LIPOFEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lipofen

Overview of Lipofen

Lipofen, a fibrate drug, is used to manage high cholesterol and triglyceride levels in the blood. It is part of the broader class of lipid-lowering drugs that are crucial in preventing and managing cardiovascular diseases.

Market Position and Segmentation

Global Lipid-Lowering Drugs Market

The global lipid-lowering drugs market, which includes fibrates like Lipofen, 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[3].

Fibrate Drugs Market

Within the fibrate drugs segment, the global market size was USD 3.25 billion in 2023 and is expected to grow to USD 5.41 billion by 2033, with a CAGR of 5.22% from 2024 to 2033. North America dominates this market, driven by a well-established healthcare infrastructure and a high prevalence of cardiovascular diseases[1].

Distribution Channels and Product Types

Distribution Channels

Lipofen is distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. The retail pharmacy segment is significant due to its widespread accessibility and patient preference[1][3].

Product Types

The market for fibrate drugs, including Lipofen, is segmented into branded and generic products. Branded medications, like Lipofen, dominated the market in 2023 due to their innovator status and patent protections. However, generic versions are gaining traction as they offer the same benefits at a lower cost[1].

Financial Performance

Revenue and Market Share

Lipofen, as part of Cipher Pharmaceuticals' portfolio, has been a steady source of revenue. In 2016, prescriptions for Lipofen and its authorized generic version were down 21% compared to the previous year, reflecting reduced commercial efforts by Kowa. However, the product still generated approximately $1.0 million in net revenue per quarter[2].

In 2019, licensing revenue from Lipofen and its authorized generic version was $2.3 million for the year ended December 31, 2019. This indicates a stable cash flow from this product despite fluctuations in prescription rates[5].

Impact of Market Trends

The increasing prevalence of cardiovascular diseases and hyperlipidemia is driving the demand for lipid-lowering drugs like Lipofen. However, the market is also influenced by the availability of other lipid-lowering treatments such as statins and PCSK9 inhibitors, which can impact the market share of fibrates[3].

Competitive Landscape

Market Competition

The fibrate drugs market, including Lipofen, faces competition from other lipid-lowering drugs. The branded segment, while dominant, is under pressure from generic versions that offer similar efficacy at lower prices. Regulatory approvals for generic versions have increased market competition, driving down prices and affecting the revenue of branded products like Lipofen[1].

Strategic Partnerships

Cipher Pharmaceuticals, the company behind Lipofen, has strategic partnerships that help in maintaining and expanding its market presence. For example, the partnership with Sun Pharmaceutical Industries for Absorica has provided additional revenue streams and extended the company's agreement, which indirectly supports the financial stability of other products like Lipofen[5].

Regional Dynamics

North America

North America, particularly the U.S., is a significant market for Lipofen. The region's well-established healthcare infrastructure and high prevalence of cardiovascular diseases drive the demand for lipid-lowering treatments. The U.S. fibrate drugs market is projected to grow from USD 890 million in 2023 to USD 1,510 million by 2033, at a CAGR of 5.42% from 2024 to 2033[1].

Other Regions

While North America is the largest market, other regions such as Europe and Asia-Pacific are also crucial. Europe is expected to show the fastest growth in the fibrate drugs market due to increasing incidence of cardiovascular and metabolic disorders. Asia-Pacific, driven by a rising geriatric population and sedentary lifestyles, is also a growing market for lipid-lowering drugs[1][3].

Regulatory and Healthcare Trends

Regulatory Support

Supportive regulatory policies and increasing healthcare spending are key drivers for the fibrate drugs market. European countries' emphasis on preventive healthcare has increased the demand for lipid-lowering medications, benefiting products like Lipofen[1].

Awareness and Prevention

Awareness campaigns about cardiovascular health and the importance of lipid management are further boosting the demand for fibrate drugs. As healthcare systems focus more on preventive care, the market for these drugs is expected to grow[1].

Key Takeaways

• Market Growth: The global fibrate drugs market, including Lipofen, is expected to grow significantly, driven by the increasing prevalence of cardiovascular diseases.
• Distribution Channels: Retail pharmacies remain a key distribution channel, but online pharmacies are gaining traction.
• Competition: The market faces competition from generic versions and other lipid-lowering drugs, impacting the revenue of branded products.
• Regional Dynamics: North America is the largest market, but Europe and Asia-Pacific are growing rapidly.
• Regulatory Support: Supportive regulatory policies and increasing healthcare spending are driving the market growth.

FAQs

What is the current market size of the global fibrate drugs market?

The global fibrate drugs market size was USD 3.25 billion in 2023 and is expected to reach around USD 5.41 billion by 2033[1].

Which region dominates the fibrate drugs market?

North America dominates the global fibrate drugs market, driven by a well-established healthcare infrastructure and a high prevalence of cardiovascular diseases[1].

What are the main drivers of the fibrate drugs market?

The main drivers include the increasing prevalence of cardiovascular diseases, supportive regulatory policies, rising healthcare spending, and awareness campaigns about preventive healthcare[1].

How does the competition from generic versions affect Lipofen?

The competition from generic versions increases market competition, driving down prices and affecting the revenue of branded products like Lipofen[1].

What is the projected growth rate of the fibrate drugs market from 2024 to 2033?

The fibrate drugs market is expected to grow at a CAGR of 5.22% from 2024 to 2033[1].

Sources

1. Precedence Research: "Fibrate Drugs Market Size to Worth USD 5.41 Billion by 2033"
2. Cipher Pharmaceuticals: "2016 Second Quarter Report"
3. Precedence Research: "Lipid-lowering Drugs Market Size to Hit USD 46.58 Bn by 2033"
4. Maximize Market Research: "Fibrate Drugs Market: Global Industry Analysis and Forecast (2023 - 2029)"
5. Cipher Pharmaceuticals: "2019 Annual Report"