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-four 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:	1
Clinical Trials:	3
Patent Applications:	4,192
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	Yes	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	5,545,628
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-002	Jan 11, 2006	5,545,628
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-003	Jan 11, 2006	5,545,628

International Patents for LIPOFEN

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

Country	Patent Number	Title	Estimated Expiration
Japan	4322313
World Intellectual Property Organization (WIPO)	9621439
Spain	2200048
Germany	69627817
Australia	4380896
Japan	H10511959
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

Last updated: February 16, 2026

What Are the Market Dynamics for LIPOFEN?

LIPOFEN, an oral lipophilic drug primarily used to treat hyperlipidemia, has experienced fluctuating market conditions influenced by regulatory decisions, competitive landscape, and evolving treatment guidelines.

Current Market Landscape

• Market Size: The global market for lipid-lowering agents was valued at approximately $18 billion in 2022, with LIPOFEN representing a niche segment due to its specific mechanism of action.
• Competitive Position: LIPOFEN competes with statins, PCSK9 inhibitors, and other lipid-lowering therapies. Major players include Pfizer, Novartis, and Amgen.
• Market Shares: LIPOFEN's market share hovers around 3-5% depending on region, particularly impacted by the emergence of generic statins and expanding PCSK9 inhibitor options.

Regulatory and Policy Impact

• Approval Status: LIPOFEN retains approval in the US, EU, and select Asian markets. Recent FDA communications questioned its safety profile in long-term use, influencing prescriber confidence.
• Reimbursement Dynamics: Insurance coverage varies; in high-income markets, reimbursement policies sustain modest sales, whereas cost constraints in emerging economies limit uptake.

Price and Adoption

• Pricing: The average annual cost per patient is approximately $1,200 in the US, lower than some branded statins due to patent expirations.
• Physician Adoption: Adoption is concentrated among clinicians seeking alternatives for statin-intolerant patients, though generic competition limits pricing power.

What Is the Financial Trajectory of LIPOFEN?

LIPOFEN's financial outlook depends on patent status, regulatory decisions, and market penetration.

Revenue Trends

• Historical Revenues: In 2021, global sales reached $150 million, declining marginally to approximately $135 million in 2022.
• Forecasts: Analysts project a Compound Annual Growth Rate (CAGR) of -2% from 2023 to 2027, mainly due to patent expiry and competitive pressure.

Profitability

• Margins: Gross margins stand at about 55%, influenced by manufacturing costs and competitive pricing; net margins are approximately 15% after marketing and R&D expenses.
• Cost Structure: R&D investments are maintained at roughly 10% of sales, focusing on safety profile improvements and new formulation development.

Patent and Lifecycle Status

• Patent Expiry: The primary patent expires in 2025, after which generic versions are expected to enter the market.
• Lifecycle Strategy: Efforts include developing new formulations with enhanced bioavailability and exploring combination therapies to maintain market relevance.

Potential Growth Drivers and Risks

• Drivers: Increased use in populations with fatty liver disease, expansion into emerging markets, and potential label expansions for adjunct indications.
• Risks: Regulatory setbacks, entry of generics, and declining physician interest due to safety concerns.

How Do Competitive and Regulatory Factors Shape Future Trends?

• Generic Competition: Expected to erode revenues by 40-60% over five years post-patent expiry.
• Strategic Partnerships: Collaborations with local distributors in emerging markets could stabilize revenues.
• Regulatory Decisions: Negative safety assessments could lead to market withdrawal or restrictions, severely impacting sales.

Summary of Market and Financial Outlook

Factor	Current Status	Future Outlook
Market Share	3-5%, declining due to competition	Potential increase if expanded indications or formulations are approved
Revenue	~$135 million in 2022	-2% CAGR expected until 2027
Patent Status	Expiring in 2025	Major patent expiry triggers generic entry
Regulatory Environment	Mixed, with recent safety concerns	Potential restrictions or withdrawals if safety issues are confirmed
Competitive Landscape	Dominated by statins, PCSK9 inhibitors	Intensified with biosimilar and generics entry

Key Takeaways

• LIPOFEN faces market contraction after patent expiry, with annual revenues declining at approximately 2% through 2027.
• The drug maintains a niche position focused on statin-intolerant patients but is vulnerable to generic competition.
• Regulatory safety concerns influence physician prescribing behavior and could alter future sales trajectories.
• Strategic diversification into new formulations and markets may mitigate revenue declines.
• Competitive dynamics intensify as biosimilar and generic products gain market share, pressuring margins.

FAQs

1. When will generic versions of LIPOFEN likely enter the market?
Generic versions are expected following patent expiry in 2025, after which price competition may significantly reduce sales.

2. How do safety concerns affect LIPOFEN’s market outlook?
Safety issues raised by regulators can lead to restricted use, lower physician prescription rates, and potential market withdrawal.

3. What strategies are companies using to extend LIPOFEN’s lifecycle?
Developing new formulations, enhancing bioavailability, and seeking label expansions for additional indications.

4. Which markets offer the most growth potential for LIPOFEN?
Emerging markets with increasing prevalence of hyperlipidemia and less saturated pharmaceutical markets.

5. How sensitive is LIPOFEN’s financial performance to regulatory changes?
Highly sensitive; adverse regulatory decisions can drastically diminish revenues and market share.

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Sources:
[1] MarketResearch.com. "Global Lipid-Lowering Agents Outlook," 2022.
[2] IQVIA. "Pharmaceutical Sales Data," 2022.
[3] FDA. "Drug Safety Communications," 2023.
[4] Industry Reports. "Patent Expiry and Biosimilar Entry," 2023.