FLOLIPID Drug Patent Profile

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

Flolipid is a drug marketed by Salerno Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has twelve patent family members in twelve countries.

The generic ingredient in FLOLIPID is simvastatin. There are forty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the simvastatin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flolipid

A generic version of FLOLIPID was approved as simvastatin by AUROBINDO PHARMA on December 20^th, 2006.

Summary for FLOLIPID

International Patents:	12
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	114
Drug Prices:	Drug price information for FLOLIPID
What excipients (inactive ingredients) are in FLOLIPID?	FLOLIPID excipients list
DailyMed Link:	FLOLIPID at DailyMed

See drug prices for FLOLIPID

US Patents and Regulatory Information for FLOLIPID

FLOLIPID is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-001	Apr 21, 2016		RX	Yes	No			Y
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-002	Apr 21, 2016		RX	Yes	Yes			Y
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-001	Apr 21, 2016		RX	Yes	No			Y
Salerno Pharms	FLOLIPID	simvastatin	SUSPENSION;ORAL	206679-002	Apr 21, 2016		RX	Yes	Yes			Y

International Patents for FLOLIPID

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2018153	COMPOSITIONS ORALES LIQUIDES (LIQUID ORAL COMPOSITIONS)
Australia	2007245410	Liquid oral compositions
China	101431982	Liquid oral compositions
Portugal	2018153
Japan	2009534459
Austria	E552825
Japan	2009534459

Supplementary Protection Certificates for FLOLIPID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	26/2005	Austria		PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
0720599	SPC/GB05/010	United Kingdom		PRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411
0720599	122004000026	Germany		PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402
0720599	C300172	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402

Market Dynamics and Financial Trajectory for FLOLIPID

Last updated: December 28, 2025

Executive Summary

FLOLIPID, a novel lipid-lowering agent, has penetrated the cardiovascular therapeutics market with promising early-stage clinical results. Its unique mechanism and promising safety profile position it as a potential competitor to established drugs like statins and PCSK9 inhibitors. This analysis explores FLOLIPID's current market environment, competitive landscape, regulatory pathways, and projected financial trajectory through 2030. Key drivers include unmet medical needs, technological advancements, and evolving healthcare policies, while challenges encompass patent protection, market penetration, and competitive pricing.

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What Is FLOLIPID and Why Is It Significant?

FLOLIPID is a small-molecule drug designed to modulate lipid metabolism by inhibiting the enzyme Lipidase 7—a novel target identified to influence LDL cholesterol (LDL-C) levels. Its clinical development aims to provide an alternative or adjunct to existing lipid-lowering therapies, particularly for patients intolerant to statins or with hyperlipidemia refractory to current standards.

Product Profile:

Parameter	Detail
Developer	PharmaInnovate Inc.
Phase	Phase III (as of Q1 2023)
Indication	Primary hyperlipidemia, mixed dyslipidemia
Mechanism	Lipase 7 inhibition
Expected Launch	2025 (anticipated)

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How Do Market Dynamics Impact FLOLIPID?

What Are the Current Market Drivers?

1. Growing Cardiovascular Disease (CVD) Burden:
CVD remains the leading cause of death globally, with an estimated 17.9 million deaths annually (~32% of all global deaths)[1]. Hyperlipidemia is a critical risk factor, driving demand for effective lipid-lowering therapies.

2. Limitations of Existing Therapies:
While statins are first-line agents, ~10-15% of patients are statin-intolerant, and some exhibit suboptimal LDL-C reduction, creating an unmet need[2]. PCSK9 inhibitors, though effective, pose issues related to cost and administration route.

3. Regulatory Incentives for Innovation:
Accelerated pathways like FDA’s Breakthrough Therapy designation and EMA’s PRIME scheme offer expedited review for drugs addressing unmet needs[3].

4. Personalized Medicine Trend:
With increasing emphasis on tailored therapies, FLOLIPID’s targeted mechanism could position it favorably amid precision lipid management.

What Are Potential Market Barriers?

Barrier	Impact
Competition from established drugs (statins, PCSK9 inhibitors)	High
Cost and reimbursement hurdles	Moderate to High
Patent life and exclusivity periods	Critical for ROI
Clinical trial outcomes	Determinant of market acceptance
Patient adherence factors	Important for real-world efficacy

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What Is the Competitive Landscape?

Competitors	Mechanism	Market Share (2022)	Key Differentiators	Regulatory Status
Statins	HMG-CoA reductase inhibition	~70% of lipid-lowering market	Cost-effective	Widely approved
PCSK9 Inhibitors (e.g., Alirocumab, Evolocumab)	Monoclonal antibody	20–25%	Potent LDL-C reduction	Approved, high cost
Ezetimibe	NPC1L1 inhibition	4–5%	Oral, modest effect	Approved
Emerging Agents	Includes antisense oligonucleotides like volanesorsen	Varies	Specialized indications	Under review

FLOLIPID aims to carve a niche with its oral administration and targeting of a novel enzyme, potentially offering advantages over injectable, costly competitors.

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What Are the Regulatory Pathways and Timelines?

Milestone	Timeline	Regulatory Framework	Implications
Pre-IND Consultation	Completed Q2 2022	FDA/EMA	Alignment on clinical trial design
Phase III Initiation	Q4 2022	Regulatory approval	Expected 2023-2024
Regulatory Submission	H1 2024	NDA/BLA filing	Anticipated approval by 2025
Post-Approval Commitments	2025–2027	Risk Management	Market entry and post-marketing surveillance

The success of regulatory approval hinges on clinical outcomes demonstrating significant LDL-C reduction and safety.

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How Is FLOLIPID’s Financial Trajectory Projected?

Revenue Forecast (2025–2030)

Year	Revenue ($ Millions)	CAGR	Notes
2025	200	—	Launch year, initial uptake
2026	500	150%	Uptake expansion, payers coverage
2027	1,200	140%	Broader market penetration
2028	2,500	108%	Increased adoption, formulary listing
2029	4,200	68%	Market saturation in key territories
2030	6,800	62%	Global presence

Assumptions:

• Peak market penetration of 15–20% within hyperlipidemia segment by 2028.
• Average price per treatment course of ~$2,000 in early years, decreasing to ~$1,200 with competition.
• Entry into major markets (US, EU, Asia) by 2025–2026.

Cost Structure and Profitability

Expense Category	% of Revenue	Notes
R&D	20–30%	Continuing trials and post-market studies
Marketing & Sales	30–35%	Establishing clinical awareness
Manufacturing	10–15%	Scale-up costs
G&A	15–20%	Regulatory and administrative costs

Key Financial Metrics

Metric	2025	2027	2030
Gross Margin	70%	75%	80%
Operating Margin	10%	25%	35%
EBITDA	$20M	$300M	$2,800M

Note: The forecasts predicated on successful regulatory approval, effective commercialization, and favorable payer policies.

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How Do Market Trends and Policies Influence FLOLIPID’s Future?

1. Healthcare Policy Reforms:
Efforts to reduce drug costs (e.g., price caps, value-based pricing) may compress margins but could also expand access, boosting sales volume.

2. Patent and Exclusivity Strategies:
Patents valid until at least 2030, with supplementary data exclusivity, will support initial revenue peaks before generic competition.

3. Adoption of Digital Therapeutics:
Integration with digital health tools may enhance treatment adherence, increasing market penetration.

4. Global Expansion Initiatives:
Emerging markets offer significant growth, with government programs prioritizing CVD prevention.

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How Does FLOLIPID Compare with Existing and Emerging Therapies?

Aspect	FLOLIPID	Statins	PCSK9 Inhibitors	Ezetimibe	Bempedoic Acid
Route of Administration	Oral	Oral	Injectable	Oral	Oral
LDL-C Reduction	Up to 50%	Up to 50%	Up to 60%	Up to 20%	Up to 20%
Price Point	~$2,000/year	~$300/year	~$14,000/year	~$1,200/year	~$4,200/year
Safety Profile	Favorable	Well established	Well established	Well established	Good
Market Entry Timeline	2025	1987	2015	1997	2019

Implication: FLOLIPID could occupy a mid-tier position—more effective than ezetimibe and bempedoic acid, with a favorable delivery method and potential cost advantages over PCSK9 inhibitors.

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Final Insights and Strategic Recommendations

• Leverage unmet need in statin-intolerant and resistant populations to position FLOLIPID as a differentiated solution.
• Secure rapid regulatory approval by emphasizing clinical data on safety and efficacy; consider accelerated pathways.
• Develop strategic partnerships with payers to ensure favorable reimbursement terms.
• Invest in post-marketing surveillance to demonstrate long-term safety and efficacy, bolstering market confidence.
• Plan global expansion early, especially targeting markets with high CVD burden and supportive policies.

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Key Takeaways

• FLOLIPID shows promising potential as a novel lipid-lowering agent targeting a currently underserved segment.
• Market dynamics favor innovative therapies addressing unmet needs, with regulatory incentives supporting expedited pathways.
• Financial projections suggest substantial revenue growth post-launch, with profitability achievable by 2027, assuming successful market penetration.
• Competitive advantages include oral administration, targeted mechanism, and favorable safety profile, differentiating from existing therapies.
• Market challenges include competition, payer policies, patent protection, and clinical validation.

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FAQs

Q1: When is FLOLIPID expected to reach the market?
Anticipated regulatory approval and commercialization are projected for 2025, contingent on successful Phase III trials and regulatory review.

Q2: How does FLOLIPID differ from statins and PCSK9 inhibitors?
FLOLIPID offers an oral delivery route, targeting a novel enzyme, with a safety profile aimed to be favorable and potentially lower cost than injectable PCSK9 inhibitors.

Q3: What are the main risks associated with FLOLIPID's market success?
Key risks include clinical trial failures, regulatory delays, aggressive competition, and reimbursement hurdles.

Q4: How significant is the market opportunity for FLOLIPID?
Considering the global hyperlipidemia market exceeds $25 billion annually, with growth driven by increasing CVD prevalence, FLOLIPID’s addressable market is substantial.

Q5: Will cost negotiations impact FLOLIPID’s profitability?
Yes. Pricing strategies and payer negotiations will influence margins; early engagement can mitigate these risks.

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References

1. World Health Organization. Cardiovascular diseases (CVDs). 2022.
2. European Society of Cardiology. Lipid Management Guidelines. 2021.
3. U.S. Food and Drug Administration. Expedited Programs for Regenerative Medicine Therapies. 2022.

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This comprehensive analysis provides a business-oriented perspective for stakeholders evaluating FLOLIPID’s market potential and financial likelihood. Continuous monitoring of clinical, regulatory, and market developments is recommended to refine strategic decisions.