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Last Updated: April 6, 2025

LEVOCARNITINE SF Drug Patent Profile


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When do Levocarnitine Sf patents expire, and when can generic versions of Levocarnitine Sf launch?

Levocarnitine Sf is a drug marketed by Novitium Pharma and is included in one NDA.

The generic ingredient in LEVOCARNITINE SF is levocarnitine. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Levocarnitine Sf

A generic version of LEVOCARNITINE SF was approved as levocarnitine by HIKMA on March 29th, 2001.

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Drug patent expirations by year for LEVOCARNITINE SF
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Recent Clinical Trials for LEVOCARNITINE SF

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

SponsorPhase
Children's Oncology GroupPhase 3
University of California, IrvineEarly Phase 1
Children's Hospital of Orange CountyEarly Phase 1

See all LEVOCARNITINE SF clinical trials

Pharmacology for LEVOCARNITINE SF
Drug ClassCarnitine Analog

US Patents and Regulatory Information for LEVOCARNITINE SF

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Novitium Pharma LEVOCARNITINE SF levocarnitine SOLUTION;ORAL 211676-002 Aug 14, 2019 AA RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Levocarnitine (L-Carnitine)

Market Size and Growth Projections

The global L-carnitine market, which includes levocarnitine, is experiencing significant growth driven by several key factors. As of 2022, the market size was valued at USD 203.4 million and is projected to expand at a compound annual growth rate (CAGR) of 4.9% from 2023 to 2030, reaching USD 298.7 million by 2030[1][3][4].

Driving Factors

Health-Conscious Consumer Base

The increasing health awareness among consumers is a major driver for the L-carnitine market. Consumers are more inclined towards functional foods and beverages that include L-carnitine, which is known for its benefits in muscle repair, reduction in muscle soreness, and weight management[1][3].

Product Launches and Innovations

The market is witnessing a surge in product launches that incorporate L-carnitine, further boosting its demand. These products range from healthcare supplements to functional drinks, all of which highlight the versatility and benefits of L-carnitine[1][3].

Animal Feed Industry

L-carnitine is an essential micronutrient for various animal species, including poultry, swine, and companion animals. Its use in animal feed is increasing due to its beneficial effects on animal nutrition, providing dietary energy and protein[1].

Regional Market Dynamics

North America

North America dominates the L-carnitine market with a significant revenue share of 37.9% in 2022. This is attributed to the expanding health-conscious consumer base and the high prevalence of obesity in countries like the U.S. and Mexico, which drives the demand for weight management supplements[1][3].

Europe and Other Regions

Europe is expected to be the fastest-growing market during the forecast period. Other regions, such as the Middle East and Africa, are also anticipated to grow due to factors like increasing incidence of sedentary-related diseases and the expansion of the pharmaceutical and animal feed industries[3].

Application Segments

Healthcare Products

The healthcare application segment is the most dominant, accounting for over 34.7% of the market revenue in 2022. L-carnitine is widely used in supplements for weight loss, enhanced stamina, and post-exercise recovery. Its benefits in treating various ailments, including type 2 diabetes, dyslipidemia, and cardiovascular diseases, further drive its demand in the healthcare sector[1][3].

Animal Feed

L-carnitine's role in animal nutrition is crucial, and its use in animal feed is expected to continue growing. This segment benefits from the low raw material costs and efficient production methods, particularly in regions like South Africa[1][3].

Pharmacological and Clinical Use

Primary Systemic Carnitine Deficiency

Levocarnitine is indicated for the treatment of primary systemic carnitine deficiency, characterized by symptoms such as Reye-like encephalopathy, hypoketotic hypoglycemia, and cardiomyopathy. It is also used to prevent and treat carnitine deficiency in patients with kidney disease on dialysis[2][5].

Pharmacokinetics

The pharmacokinetics of levocarnitine show that it has a bioavailability of around 15% when administered orally. It is not bound to plasma proteins and is primarily excreted in the urine. The drug's metabolism involves the formation of metabolites such as trimethylamine N-oxide and γ-butyrobetaine[2].

Consumer Trends and Awareness

Weight Management and Healthy Aging

Consumers are increasingly using L-carnitine supplements for weight management and healthy aging. This trend is driven by the growing awareness of the product's benefits in improving muscle repair, reducing muscle soreness, and enhancing overall health[1][3].

Functional Foods and Beverages

The inclination towards functional foods and beverages that include L-carnitine is on the rise. This is due to the perceived health benefits and the convenience of incorporating these products into daily diets[1][3].

Market Opportunities and Challenges

Opportunities

The expanding dietary supplement market, particularly in regions with growing middle-class households and increasing consumer discretionary income, presents lucrative opportunities for L-carnitine manufacturers. The product's versatility in various application fields, including pharmaceuticals, nutraceuticals, and animal feed, further enhances its market potential[1][3].

Challenges

Despite the growth prospects, the market faces challenges such as regulatory hurdles and the need for continuous research to validate the efficacy and safety of L-carnitine in various applications. Additionally, competition from other nutritional supplements could impact market share[1][3].

Key Takeaways

  • The global L-carnitine market is projected to grow at a CAGR of 4.9% from 2023 to 2030.
  • North America dominates the market, driven by a health-conscious consumer base and high obesity rates.
  • Healthcare products and animal feed are significant application segments.
  • L-carnitine is crucial for treating primary systemic carnitine deficiency and other health conditions.
  • Consumer trends towards functional foods and weight management supplements drive market growth.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the global L-carnitine market? A: The global L-carnitine market size was valued at USD 203.4 million in 2022[1].

Q: What is the expected CAGR of the L-carnitine market from 2023 to 2030? A: The market is expected to grow at a CAGR of 4.9% from 2023 to 2030[1][3][4].

Q: Which region dominates the L-carnitine market? A: North America dominates the L-carnitine market with a significant revenue share[1][3].

Q: What are the primary applications of L-carnitine? A: The primary applications include healthcare products, animal feed, and functional foods and beverages[1][3].

Q: What are the health benefits of L-carnitine? A: L-carnitine is beneficial for muscle repair, reduction in muscle soreness, weight management, and treating various health conditions such as type 2 diabetes and cardiovascular diseases[1][3][5].

Cited Sources:

  1. Grand View Research - L-carnitine Market Size, Share & Trends Analysis Report, 2030
  2. DailyMed - CARNITOR SF- levocarnitine solution
  3. Straits Research - L-Carnitine Market Size, Share & Trends Analysis Report 2030
  4. Grand View Research - L-Carnitine Market Worth $298.7 Billion By 2030 | CAGR: 4.9%
  5. Mayo Clinic - Levocarnitine (oral route, intravenous route)

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