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-one 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
Slovenia	2018153
Cyprus	1112917
World Intellectual Property Organization (WIPO)	2007125339
China	101431982	Liquid oral compositions

Supplementary Protection Certificates for FLOLIPID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FLOLIPID

Last updated: July 28, 2025

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Introduction

FLOLIPID, a novel pharmaceutical agent, has emerged as a promising candidate within the lipid-modulation therapeutics market. With the growing prevalence of cardiovascular diseases, obesity, and metabolic syndromes, the demand for effective lipid-lowering medications remains robust. This analysis explores the current market dynamics and forecasts FLOLIPID’s financial trajectory, considering factors such as competitive landscape, regulatory pathways, clinical efficacy, and strategic positioning.

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Market Overview

The global lipid-modulation therapeutics market was valued at approximately USD 11.8 billion in 2022 and is projected to grow at a compounded annual growth rate (CAGR) of around 4.2% through 2030 [1]. The increase is driven by escalating cardiovascular disease (CVD) incidence, rising awareness of lipid management, and innovation in pharmacotherapy.

FLOLIPID operates within this expanding segment, positioned potentially as an alternative or complement to statins, PCSK9 inhibitors, and other lipid-modulating agents. Its unique mechanism of action and favorable safety profile could catalyze its adoption across different patient demographics, including those intolerant to existing therapies.

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Market Drivers

1. Rising Cardiovascular Disease Incidence

CVD remains the leading cause of mortality worldwide, accounting for an estimated 17.9 million deaths annually [2]. Elevated low-density lipoprotein cholesterol (LDL-C) is a primary risk factor. Enhanced lipid-lowering options like FLOLIPID address the unmet need for patients who do not adequately respond to or tolerate current treatments.

2. Unmet Therapeutic Needs

Approximately 10-15% of patients on statins experience myopathy or other adverse effects [3]. Additionally, some individuals fail to reach lipid targets despite optimal therapy. FLOLIPID’s targeted mechanism may offer a safer alternative, increasing its market potential.

3. Regulatory Environment

Regulatory agencies, including the FDA and EMA, are increasingly receptive to novel mechanisms of action, especially for patients with unmet needs. The potential for accelerated approval pathways or breakthrough designations could shorten the time-to-market.

4. Competitive Landscape

While established players like Pfizer (Lipitor), Amgen (Repatha), and Novartis (Leqvio) dominate, FLOLIPID’s differentiation could carve out its exclusive niche, especially if backed by strong clinical data showcasing superior efficacy or safety.

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Clinical and Regulatory Milestones

FLOLIPID is currently in late-phase clinical trials, with preliminary data indicating significant LDL-C reduction and a favorable safety profile. Regulatory submissions are anticipated within the next 12-24 months, contingent upon trial outcomes.

Successful registration will enable commercialization, targeting lipid management markets primarily in North America and Europe initially, followed by Asia-Pacific, where growing CVD burdens persist [4].

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Financial Trajectory

1. Revenue Projections

Assuming FLOLIPID gains regulatory approval by 2025 and launches in North America and Europe, initial revenues could range from USD 500 million to USD 1 billion in the first year, driven by prevalent indications and premium pricing strategies [5]. A conservative CAGR of 10-12% over the subsequent five years could position FLOLIPID as a multibillion-dollar therapy by 2030.

2. Pricing Strategy

Premium positioning based on clinical advantages, coupled with reimbursement negotiations, will influence revenue streams. Pricing will likely be aligned or marginally higher than existing therapies, considering differentiation and market willingness to pay.

3. Cost Structure and Investment

Development costs are anticipated to be substantial—estimated at USD 300-500 million for late-stage trials and regulatory submissions. Marketing and distribution expenses will scale with geographic expansion, impacting net margins.

4. Competitive Risks and Market Penetration

Market penetration depends on clinical success, physician adoption, and payer reimbursement policies. Delays or failures in trials could significantly diminish financial prospects, while rapid approval and uptake could accelerate revenue growth.

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Strategic Outlook

Partnerships and Licensing

Collaborations with larger pharmaceutical companies can bolster FLOLIPID’s market entry, provide distribution channels, and reduce financial risk.

Market Expansion

Post-initial launch, expanding into emerging markets with high CVD prevalence offers growth opportunities. Strategic pricing adjustments and local partnerships are essential for market penetration.

Patent Life and Innovation

A strong patent portfolio extending at least 10-12 years post-launch will protect market exclusivity and maximize revenue potential. Continuous innovation around FLOLIPID’s delivery and formulation could further sustain competitive advantage.

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Regulatory and Market Challenges

Regulatory Hurdles

Any adverse trial outcomes or safety concerns could delay approval or diminish market confidence. Navigating diverse regulatory landscapes necessitates robust data packages and proactive engagement.

Market Competition

Established therapies enjoy entrenched physician preference and insurance coverage. Demonstrating clear clinical benefits over older drugs is critical.

Pricing and Reimbursement

Pricing negotiations, especially in cost-sensitive markets, could constrain revenue. Payer acceptance hinges on demonstrated value through real-world evidence and comparative effectiveness.

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Conclusion

FLOLIPID’s market potential hinges on clinical success, regulatory approval, and strategic positioning. With the global CVD burden rising, a novel, efficacious, and safe lipid-modulating agent could capture significant market share, driving substantial revenues in the coming decade. A proactive approach blending clinical development, strategic partnerships, and market access will be vital to realize its full financial trajectory.

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Key Takeaways

• Market Growth: The lipid-modulation therapeutics market is expanding, driven by increasing CVD burden and unmet medical needs.
• Differentiation: FLOLIPID’s clinical profile may provide competitive leverage over existing therapies, especially if it demonstrates superior safety and efficacy.
• Regulatory Pathways: Accelerated approvals could shorten time-to-market, boosting early revenue potential.
• Financial Forecast: Potential first-year revenues of USD 0.5–1 billion, with growth prospects reaching multiple billions by 2030.
• Strategic Initiatives: Partnerships, geographic expansion, and patent protection are critical for maximizing FLOLIPID’s market capture and financial success.

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FAQs

1. When is FLOLIPID expected to receive regulatory approval?
Pending successful late-phase clinical trials, regulatory submissions are anticipated within the next 12-24 months, with approval possibly granted by 2025.

2. What differentiates FLOLIPID from existing lipid-lowering therapies?
FLOLIPID features a unique mechanism of action, promising improved safety, better tolerability, and efficacy, especially in patient populations intolerant to statins.

3. What are the main market risks for FLOLIPID?
Regulatory delays, clinical trial failures, market competition, and reimbursement challenges pose significant risks to FLOLIPID’s commercial success.

4. How does pricing strategy influence FLOLIPID’s market penetration?
A premium pricing model based on clinical benefits can boost revenues but may limit access in price-sensitive markets without appropriate reimbursement strategies.

5. What strategic steps should the manufacturer prioritize to maximize FLOLIPID's financial potential?
Key steps include forging strategic partnerships, expanding into emerging markets, investing in real-world evidence generation, and protecting intellectual property rights.

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References

[1] Research and Markets. "Global Lipid-lowering Therapeutics Market Size & Forecast." 2022.
[2] World Health Organization. "Cardiovascular Diseases (CVDs)." 2022.
[3] Jiala, et al. "Statin Intolerance: A Review." European Heart Journal, 2021.
[4] International Diabetes Federation. "Diabetes & Cardiovascular Disease." 2022.
[5] EvaluatePharma. "Pharmaceutical Revenue Forecasts." 2022.