Fluvastatin sodium - Generic Drug Details

What are the generic drug sources for fluvastatin sodium and what is the scope of patent protection?

Fluvastatin sodium is the generic ingredient in three branded drugs marketed by Mylan Pharms Inc, Teva Pharms, Novartis, Beijing, Norvium Bioscience, Teva Pharms Usa, and Sandoz, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for fluvastatin sodium. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fluvastatin sodium

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	7
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	5
Patent Applications:	6,205
Drug Prices:	Drug price trends for fluvastatin sodium
What excipients (inactive ingredients) are in fluvastatin sodium?	fluvastatin sodium excipients list
DailyMed Link:	fluvastatin sodium at DailyMed

See drug prices for fluvastatin sodium

Recent Clinical Trials for fluvastatin sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Novartis Pharmaceuticals	Phase 4

See all fluvastatin sodium clinical trials

Generic filers with tentative approvals for FLUVASTATIN SODIUM

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fluvastatin sodium

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

Anatomical Therapeutic Chemical (ATC) Classes for fluvastatin sodium

C10AA	HMG CoA reductase inhibitors
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for FLUVASTATIN SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LESCOL	Capsules	fluvastatin sodium	20 mg and 40 mg	020261	1	2008-06-04
LESCOL XL	Extended-release Tablets	fluvastatin sodium	80 mg	021192	1	2007-03-15

US Patents and Regulatory Information for fluvastatin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	FLUVASTATIN SODIUM	fluvastatin sodium	CAPSULE;ORAL	078407-002	Jun 12, 2012	AB	RX	No	No
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993		DISCN	Yes	No
Mylan Pharms Inc	FLUVASTATIN SODIUM	fluvastatin sodium	CAPSULE;ORAL	090595-001	Apr 11, 2012	AB	RX	No	No
Beijing	FLUVASTATIN SODIUM	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	209397-001	Apr 26, 2021	AB	RX	No	No
Teva Pharms Usa	FLUVASTATIN SODIUM	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	079011-001	Jan 27, 2016	AB	RX	No	No

Expired US Patents for fluvastatin sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	5,354,772*PED
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-001	Dec 31, 1993	5,354,772*PED
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	6,242,003*PED
Sandoz	LESCOL XL	fluvastatin sodium	TABLET, EXTENDED RELEASE;ORAL	021192-001	Oct 6, 2000	5,356,896*PED
Novartis	LESCOL	fluvastatin sodium	CAPSULE;ORAL	020261-002	Dec 31, 1993	5,356,896*PED

Fluvastatin sodium Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluvastatin Sodium

Introduction to Fluvastatin Sodium

Fluvastatin sodium, a member of the statin class of drugs, is used to lower high cholesterol levels and triglycerides in the blood. It works by blocking an enzyme necessary for cholesterol production, thereby reducing the risk of heart and blood vessel problems[2].

Market Size and Growth Projections

The global fluvastatin sodium drug market has been experiencing steady growth and is expected to continue this trend. As of 2023, the market size was valued at USD 0.131 billion. Projections indicate that the market will reach USD 0.22 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 5.9% during this period[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the fluvastatin sodium market:

Increasing Prevalence of Cardiovascular Diseases

The rising incidence of cardiovascular diseases, largely due to high cholesterol levels, is a significant driver. As the global population ages and lifestyles become more sedentary, the demand for cholesterol-lowering medications like fluvastatin sodium is expected to increase.

Expanding Patient Base

The drug's efficacy in treating hypercholesterolemia and preventing heart problems in patients with risk factors for heart disease expands its patient base. This includes individuals with familial hypercholesterolemia (heFH), a condition characterized by very high LDL-C levels[3].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure and increased access to medical services in developing countries are also contributing to the market's growth.

Market Segmentation

The fluvastatin sodium market can be segmented based on several factors:

By Dosage Form

The drug is available in various forms, including immediate-release capsules (20 and 40 mg) and extended-release tablets (80 mg). The extended-release formulation is particularly popular due to its convenience and once-daily dosing regimen[3].

By Distribution Channel

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are a significant segment due to the prescription nature of the drug.

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, and other regions. Developed regions like North America and Europe are major contributors due to higher healthcare spending and greater awareness of cardiovascular health.

Financial Performance and Revenue Streams

Revenue Growth

The projected CAGR of 5.9% indicates a steady and consistent revenue growth trajectory. This growth is supported by increasing demand and expanding market reach.

Key Revenue Streams

• Prescription Sales: The primary revenue stream comes from prescription sales, as fluvastatin sodium is available only with a doctor's prescription.
• Hospital and Retail Sales: Sales through hospital and retail pharmacies constitute a significant portion of the revenue.
• Research and Development: While not a direct revenue stream, investments in R&D can lead to new formulations or indications, further boosting market growth.

Challenges and Limitations

Despite the positive growth projections, the market faces several challenges:

Side Effects and Safety Concerns

Fluvastatin sodium, like other statins, can have side effects such as muscle pain, liver enzyme elevations, and rare but serious conditions like rhabdomyolysis. These safety concerns can impact patient compliance and market growth[2].

Generic Competition

The availability of generic versions of fluvastatin sodium can reduce the market share of branded products, affecting revenue.

Regulatory Scrutiny

Stringent regulatory requirements and the need for continuous monitoring of safety and efficacy can pose challenges to market expansion.

Competitive Landscape

The statin market is highly competitive, with several other drugs available for cholesterol management. However, fluvastatin sodium maintains a niche due to its specific indications and patient population.

Market Players

Key players in the fluvastatin sodium market include pharmaceutical companies that manufacture and distribute the drug. These companies invest heavily in marketing, R&D, and distribution networks to maintain their market share.

Future Outlook

The future outlook for the fluvastatin sodium market is positive, driven by increasing demand for cholesterol-lowering medications and advancements in healthcare.

Emerging Trends

• Personalized Medicine: There is a growing trend towards personalized medicine, which could lead to more targeted and effective use of fluvastatin sodium.
• Combination Therapies: Research into combination therapies involving fluvastatin sodium and other cardiovascular drugs could expand its therapeutic applications.

Key Takeaways

• The fluvastatin sodium market is projected to grow from USD 0.131 billion in 2023 to USD 0.22 billion by 2032, with a CAGR of 5.9%.
• The drug's efficacy in treating hypercholesterolemia and preventing heart problems drives its market growth.
• Market segmentation includes dosage forms, distribution channels, and geography.
• Challenges include side effects, generic competition, and regulatory scrutiny.
• The future outlook is positive, with emerging trends in personalized medicine and combination therapies.

FAQs

Q: What is fluvastatin sodium used for? A: Fluvastatin sodium is used to lower high cholesterol levels and triglycerides in the blood, helping to prevent medical problems like atherosclerosis and heart and blood vessel issues[2].

Q: What are the common side effects of fluvastatin sodium? A: Common side effects include muscle pain, acid or sour stomach, headache, heartburn, and indigestion. Serious side effects can include muscle conditions like rhabdomyolysis[2].

Q: How is fluvastatin sodium administered? A: The drug is available as 20 and 40 mg immediate-release capsules and 80 mg extended-release tablets. Treatment typically starts with a 20 mg daily dose and can be titrated up to 80 mg daily[3].

Q: Can fluvastatin sodium be used during pregnancy or breastfeeding? A: No, using fluvastatin sodium during pregnancy can harm the unborn baby, and it should be avoided during breastfeeding due to potential harmful effects on the infant[2].

Q: What is the projected market size of fluvastatin sodium by 2032? A: The market is expected to reach USD 0.22 billion by 2032, growing at a CAGR of 5.9% from 2023[1][4].

Cited Sources

1. Business Research Insights: Fluvastatin Sodium Drug Market Size 2032.
2. Mayo Clinic: Fluvastatin (oral route).
3. FDA: N20-261N036 Fluvastatin Clinical BPCA.
4. News Channel Nebraska: Fluvastatin Sodium Drug Market Size 2024 Trends Analysis.