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-eight 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
Finished Product Suppliers / Packagers:	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

Pharmacology for FLOLIPID

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

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

International Patents for FLOLIPID

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1112917
World Intellectual Property Organization (WIPO)	2007125339
Denmark	2018153

Supplementary Protection Certificates for FLOLIPID

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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

FLOLIPID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FLOLIPID

Introduction to FLOLIPID

FLOLIPID, a brand name for simvastatin, is a lipid-lowering agent used to treat various forms of hyperlipidemia. It is derived synthetically from a fermentation product of Aspergillus terreus and works by inhibiting the enzyme HMG-CoA reductase, which is crucial in the biosynthesis of cholesterol[2].

Global Hyperlipidemia Drugs Market Overview

The global hyperlipidemia drugs market, within which FLOLIPID operates, is projected to grow significantly. As of 2024, the market size is estimated at USD 22.93 billion and is expected to reach USD 33.94 billion by 2034, growing at a CAGR of 4% during this period[1].

Market Segments and Regional Performance

The hyperlipidemia drugs market is segmented by drug class and route of administration, with statins like FLOLIPID being a dominant class. Regionally, Europe currently holds the largest market share, valued at USD 10.32 billion in 2024, and is expected to grow at a CAGR of 4.11% until 2034. However, the Asia-Pacific region is anticipated to experience the fastest expansion, with a CAGR of 6.1%, driven by increasing lifestyle-related ailments and a growing elderly population[1].

Demand Drivers for Lipid-Lowering Drugs

Several factors are driving the demand for lipid-lowering drugs like FLOLIPID:

• Increasing Prevalence of Cardiovascular Diseases: The rise in heart diseases and high cholesterol levels among the population is a significant driver. For instance, in the U.S., almost 94 million people aged 20 and above have high cholesterol levels, greater than 200 mg/dL[4].
• Growing Awareness and Healthcare Spending: Increased awareness about the health risks associated with high cholesterol and rising healthcare spending are fueling market growth. The geriatric population, particularly in regions like Asia-Pacific, is also contributing to the demand[4].
• Advancements in Drug Development: Continuous investments in R&D by pharmaceutical companies to introduce effective and safe medications are further boosting the market[4].

Competitive Landscape

The lipid-lowering drugs market is highly competitive and fragmented, with numerous local and international players. Key players such as Sanofi, Pfizer, GlaxoSmithKline, Novartis, and Merck & Co. are implementing strategies like product portfolio expansion and mergers & acquisitions to strengthen their market share[4].

Challenges and Opportunities

Despite the growth potential, the market faces several challenges:

• Pricing Pressures: The availability of generic versions of frequently prescribed medications, such as statins, has intensified pricing competition, potentially affecting profit margins[1].
• Regulatory Hurdles: Navigating stringent regulatory landscapes governing drug approvals can lead to prolonged development timelines and increased costs for drug developers[1].

However, these challenges also present opportunities for innovation and collaboration. Strategic partnerships between pharmaceutical firms and research institutions can lead to innovative therapeutic solutions, and the market offers prospects for the implementation of new technologies and treatment approaches[1].

Financial Trajectory for FLOLIPID

Given the broader market trends, FLOLIPID is likely to benefit from the growing demand for lipid-lowering drugs. Here are some key financial insights:

• Market Size and Growth: As part of the larger hyperlipidemia drugs market, FLOLIPID will likely contribute to the projected market size of USD 33.94 billion by 2034[1].
• Revenue Potential: With a significant patient base and increasing prevalence of hyperlipidemia, FLOLIPID can expect substantial revenue growth. For instance, the U.S. market alone presents a significant opportunity, with estimates suggesting a multi-billion-dollar market potential for lipid-lowering drugs[3].
• Pricing and Competition: While generic competition may impact pricing, FLOLIPID's established brand and clinical efficacy will help maintain its market position. However, the net price of these drugs is expected to decrease over time as access grows and competition intensifies[3].

Dosage and Administration

The financial trajectory of FLOLIPID is also influenced by its dosage and administration guidelines. The usual dosage range is 5 to 40 mg/day, with specific recommendations for different patient groups. For example, patients at high risk for coronary heart disease (CHD) may start with a higher dose of 40 mg/day. These guidelines ensure that the drug is used effectively, which can impact patient compliance and overall market performance[5].

Key Takeaways

• The global hyperlipidemia drugs market, including FLOLIPID, is expected to grow significantly, reaching USD 33.94 billion by 2034.
• The Asia-Pacific region is anticipated to experience the fastest growth due to lifestyle changes and an aging population.
• Increasing prevalence of cardiovascular diseases, growing awareness, and advancements in drug development are key drivers.
• The market faces challenges such as pricing pressures and regulatory hurdles but offers opportunities for innovation and collaboration.
• FLOLIPID’s financial trajectory is influenced by its established brand, clinical efficacy, and market demand.

FAQs

1. What is the primary mechanism of action of FLOLIPID? FLOLIPID works by inhibiting the enzyme HMG-CoA reductase, which is crucial in the biosynthesis of cholesterol[2].

2. What are the common indications for FLOLIPID? FLOLIPID is indicated to reduce elevated total cholesterol, LDL-C, Apo B, and triglycerides, and to increase HDL-C in patients with primary hyperlipidemia, mixed dyslipidemia, and other lipid disorders[2].

3. What are the potential side effects of FLOLIPID? Common side effects include upper respiratory infections, headache, abdominal pain, constipation, and nausea. Serious side effects can include myopathy and rhabdomyolysis, especially with higher doses[2].

4. How does the Asia-Pacific region influence the market for FLOLIPID? The Asia-Pacific region is expected to observe the fastest expansion due to lifestyle-related ailments, an aging population, and advancing healthcare infrastructure[1].

5. What are the key challenges facing the hyperlipidemia drugs market, including FLOLIPID? The market faces challenges such as pricing pressures from generic versions, intense competition, and stringent regulatory landscapes governing drug approvals[1].

Cited Sources

1. Precedence Research: "Hyperlipidemia Drugs Market Size To Hit USD 33.94 Bn By 2034"
2. MedicineNet: "FloLipid (simvastatin) Cholesterol Medication: Side Effects & Dosage"
3. Baron Capital Group: "A Multi-Billion-Dollar Drug Market"
4. Transparency Market Research: "Lipid-lowering Drugs Market Size, Share, Industry Growth - 2031"
5. Drugs.com: "Flolipid Dosage Guide"