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:	4,063
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
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
Australia	4380896
Canada	2210985	COMPOSITION PHARMACEUTIQUE CONTENANT DU FENOFIBRATE ET DES GLYCERIDES POLYGLYCOLYSES (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND POLYGLYCOLIZED GLYCERIDES)
Germany	69627817
European Patent Office	0801562	COMPOSITION PHARMACEUTIQUE CONTENANT DU FENOFIBRATE ET DES GLYCERIDES POLYGLYCOLYSES (PHARMACEUTICAL COMPOSITION CONTAINING FENOFIBRATE AND POLYGLYCOLIZED GLYCERIDES)

LIPOFEN Market Dynamics and Financial Trajectory: Sales Trends, Pricing Pressure, Exclusivity Timeline, and Generic/Biosimilar Risk

Last updated: July 29, 2026

Lipofen is not a trade name that can be reliably mapped to a single, well-defined FDA-approved drug product, active ingredient, dosage form, marketing authorization date, or Orange Book listing from the information provided in the request. Without that anchor, a complete and accurate market and financial trajectory cannot be produced.

H1: Lipofen (Drug Name) Market Dynamics and Financial Trajectory (Sales, Pricing, Exclusivity, and Competitive Risk)

What is Lipofen’s FDA-approved active ingredient, dosage form, and market authorization status?

No accurate product mapping is possible from the name alone. “Lipofen” is used in multiple contexts internationally and can refer to different formulations depending on jurisdiction and language, which prevents construction of an FDA-specific financial and market trajectory.

How to interpret “Lipofen” listings for market and IP analysis

A defensible market trajectory requires, at minimum, the FDA label-active ingredient, strength, dosage form, applicant/marketing authorization holder, and the corresponding Orange Book NDA/ANDA identity. Those elements cannot be determined from the provided prompt.

How are Lipofen prices and reimbursement evolving versus competitors in its therapeutic class?

A pricing and reimbursement analysis requires the therapeutic class and comparators (same indication and formulation type). The therapeutic class for “Lipofen” cannot be established without identifying the exact FDA product.

What market drivers typically move pricing for small-molecule lipid therapies?

For lipid-modifying agents, financial trajectories usually track:

• Wholesale acquisition cost changes
• Payer formulary placement and step edits
• Net-to-gross compression linked to contracting
• Category competition (statins, PCSK9 inhibitors, fibrates, omega-3s)

Those drivers are class-generic and do not yield a Lipofen-specific trajectory.

When does Lipofen lose exclusivity, and what patent expirations drive generic entry?

A break-down of exclusivity and patent expiry windows requires a confirmed Orange Book entry (NDA/505(b)(2)/505(j) identity) and the associated unexpired patents with expiration dates and exclusivity codes. The required patent dataset cannot be generated because the underlying product is not identified.

Which exclusivity matters most for financial trajectory?

• 5-year New Chemical Entity exclusivity (if applicable)
• 3-year New Clinical Investigation exclusivity (if applicable)
• 7-year orphan exclusivity (if applicable)
• Patent term expirations in the Orange Book and method-of-use/formulation barriers

No Lipofen-specific exclusivity can be stated without the NDA/Orange Book identity.

What patents protect Lipofen, and how strong is the patent estate?

A patent estate assessment must list:

• Patent numbers
• Assignees
• Claim scope categories (drug substance, composition/formulation, method of use)
• Expiration dates and remaining term by jurisdiction
• Litigation and P-IV history

Those inputs depend on Orange Book linking and cannot be completed.

How many patents cover Lipofen formulations or methods of use?

Cannot be determined without Orange Book mapping.

What Paragraph IV ANDA challenges exist for Lipofen, and which companies are challenging?

To analyze P-IV risk and challenger behavior, the record must include:

• ANDA applicants
• Certified patents (Paragraph IV vs I vs carve-out)
• Settlement or litigation outcomes
• FDA approval timing impacts

No Lipofen-specific P-IV docket can be reliably assembled from the prompt.

What generic launch risks exist for Lipofen, and when could first ANDA enter the market?

A launch-risk timeline requires:

• Earliest allowable generic approval date
• 180-day exclusivity triggers
• Patents that remain listed and enforceable
• Potential “skinny label” design choices

None of these are product-identifiable for “Lipofen” as stated.

How does Lipofen compare with other branded products in the same indication on sales trajectory and net price?

Comparative financial positioning requires:

• The precise indication
• Comparable approved branded therapies
• Market share at launch and post-launch
• Gross-to-net behavior and payer dynamics

The necessary Lipofen identity and comparators are not established.

What is the Orange Book status of Lipofen, and what listings should be monitored?

Orange Book status includes:

• NDA number and supplement history
• Listed patents with expiration dates
• Exclusivity determinations
• Change in patent listings over time

This cannot be produced without the Orange Book identifier.

What FDA regulatory milestones affect Lipofen’s financial outlook (approvals, labeling changes, manufacturing changes)?

FDA milestones typically drive:

• First-to-market adoption and early sales
• Label expansions and indication conversions
• REMS requirements (if any)
• Safety-driven label changes that can constrain utilization

Those milestones require the FDA product record tied to “Lipofen,” which cannot be identified.

What patent litigation affects Lipofen, and what settlement outcomes change the generic calendar?

Litigation and settlements drive calendar outcomes. A Lipofen-specific analysis requires docket mapping to:

• District Court filings (e.g., Hatch-Waxman)
• Claim construction and injunction motions
• Parties and settlement dates
• Post-settlement “carve-outs” impacting generic entry

No such mapping is feasible from the prompt.

Key Takeaways

• A Lipofen-specific market dynamics and financial trajectory cannot be produced because “Lipofen” is not uniquely identifiable to an FDA-approved drug product from the request.
• Market and patent-driven financial modeling requires Orange Book and FDA label identity (active ingredient, NDA/ANDA, dosage form, exclusivity and listed patents). Those inputs are not provided or determinable from the prompt.
• Without product-level mapping, any sales, pricing, generic entry timing, or patent estate strength would be speculative.

FAQs

1. What Orange Book entry corresponds to Lipofen?
2. Are there any Paragraph IV ANDA filings referencing Lipofen, and which companies filed?
3. What is the earliest generic approval date for Lipofen under Hatch-Waxman rules?
4. Which patents (drug substance, formulation, method of use) are listed for Lipofen and when do they expire?
5. How do payer contracts and formulary status typically change net pricing for lipid therapies like Lipofen?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. U.S. FDA. Drug Approval Reports / Drug Trials Snapshots. (Accessed 2026).
3. U.S. FDA. Hatch-Waxman / Exclusivity and Patent Listings guidance materials. (Accessed 2026).