LEVOCARNITINE - Generic Drug Details

What are the generic sources for levocarnitine and what is the scope of freedom to operate?

Levocarnitine is the generic ingredient in four branded drugs marketed by Leadiant Biosci Inc, Am Regent, Hikma, Teva Pharms Usa, Novitium Pharma, Rising, and Sciegen Pharms Inc, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for levocarnitine. Seven suppliers are listed for this compound.

Summary for LEVOCARNITINE

US Patents:	0
Tradenames:	4
Applicants:	7
NDAs:	12
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	24
Patent Applications:	7,459
Drug Prices:	Drug price trends for LEVOCARNITINE
What excipients (inactive ingredients) are in LEVOCARNITINE?	LEVOCARNITINE excipients list
DailyMed Link:	LEVOCARNITINE at DailyMed

See drug prices for LEVOCARNITINE

Recent Clinical Trials for LEVOCARNITINE

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

Sponsor	Phase
Children's Oncology Group	Phase 3
University of California, Irvine	Early Phase 1
Children's Hospital of Orange County	Early Phase 1

See all LEVOCARNITINE clinical trials

Pharmacology for LEVOCARNITINE

Drug Class

Carnitine Analog

Anatomical Therapeutic Chemical (ATC) Classes for LEVOCARNITINE

A16AA	Amino acids and derivatives
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for LEVOCARNITINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	LEVOCARNITINE	levocarnitine	TABLET;ORAL	076858-001	Sep 20, 2004	AB	RX	No	No
Novitium Pharma	LEVOCARNITINE	levocarnitine	TABLET;ORAL	216384-001	Dec 9, 2022	AB	RX	No	No
Teva Pharms Usa	LEVOCARNITINE	levocarnitine	INJECTABLE;INJECTION	075881-001	Mar 29, 2001		DISCN	No	No
Leadiant Biosci Inc	CARNITOR	levocarnitine	TABLET;ORAL	018948-001	Dec 27, 1985	AB	RX	Yes	Yes
Leadiant Biosci Inc	CARNITOR	levocarnitine	SOLUTION;ORAL	018948-002	Apr 27, 1988		DISCN	No	No
Leadiant Biosci Inc	CARNITOR	levocarnitine	INJECTABLE;INJECTION	020182-001	Dec 16, 1992	AP	RX	Yes	Yes
Leadiant Biosci Inc	CARNITOR SF	levocarnitine	SOLUTION;ORAL	019257-002	Mar 28, 2007	AA	RX	Yes	No

Expired US Patents for LEVOCARNITINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leadiant Biosci Inc	CARNITOR	levocarnitine	INJECTABLE;INJECTION	020182-001	Dec 16, 1992
Leadiant Biosci Inc	CARNITOR	levocarnitine	INJECTABLE;INJECTION	020182-001	Dec 16, 1992
Leadiant Biosci Inc	CARNITOR	levocarnitine	INJECTABLE;INJECTION	020182-001	Dec 16, 1992

LEVOCARNITINE Market Analysis and Financial Projection Experimental

LEVOCARNITINE Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The global LEVOCARNITINE, or L-carnitine, market is poised for significant growth over the coming years. As of 2022, the market was valued at approximately USD 203.4 million and is expected to reach USD 298.7 million by 2030, growing at a compound annual growth rate (CAGR) of 4.9% from 2023 to 2030[1].

Another estimate suggests that the market was valued at USD 177 million in 2021 and is projected to reach USD 267.60 million by 2030, with a CAGR of 4.7% during the forecast period[2].

Key Drivers of Market Growth

Several factors are driving the growth of the L-carnitine market:

Health-Conscious Consumer Base

The increasing awareness and demand for health and wellness products are significant drivers. Consumers are more inclined towards functional foods and beverages that include L-carnitine due to its benefits in muscle repair, reduction in muscle soreness, and overall muscle gain[1].

Animal Feed Industry

The demand from the animal feed industry is also on the rise. L-carnitine supplementation in animal feed enhances development, performance, and reproductive processes in animals such as broiler chickens and racing pigeons. This is particularly driven by growing concerns about the safety and quality of meat and the increasing consumption of chicken among fitness enthusiasts[2].

Post-Exercise Recovery and Weight Management

The use of L-carnitine for post-exercise recovery, weight management, and healthy aging is a major growth driver. This is reflected in the increasing adoption of L-carnitine supplements in the healthcare and sports sectors[1][4].

Regional Analysis

North America

North America dominates the L-carnitine market, with a revenue share of 37.9% in 2022. The region is expected to grow at a CAGR of 5.3% during the forecast period, driven by the expansion of the health-conscious consumer base and the presence of significant market players like AbbVie Inc.[1][2].

Europe

Europe is another key region, expected to grow at a CAGR of 4.9% during the forecast period. The nutraceutical industry in Europe is expanding due to increased purchases of supplements as a preventative measure for health problems. Countries like Germany and the UK, with high meat consumption, are also driving the demand for L-carnitine in animal feed[2].

Asia-Pacific

The Asia-Pacific region, particularly countries like China and India, is experiencing a growth in consumption patterns, driving up demand for L-carnitine supplements. This region is expected to register higher growth rates compared to developed markets[4].

Application Segments

Healthcare

The healthcare application segment was the dominant segment in 2022, occupying over 34.7% of the market. This segment is expected to experience significant growth due to the rising use of L-carnitine supplementation for various health benefits[1].

Animal Feed

The animal feed segment is also crucial, driven by the need for nutritional supplements to enhance animal performance and health. This includes applications in broiler chickens and racing pigeons[2].

Functional Food and Beverages

The functional food and beverages segment is growing as consumers increasingly prefer products that include L-carnitine for its health benefits, such as increased energy and stamina[1].

Competitive Landscape

The global L-carnitine market is highly competitive with several key players:

• Lonza
• Northeast Pharmaceutical Group Co., Ltd. (NEPG)
• Biosint S.p.A.
• Cayman Chemical
• Merck KGaA
• Tokyo Chemical Industry Co., Ltd
• Ceva
• Kaiyuan Hengtai Chemical Co., Ltd
• ChengDa PharmaCeuticals Co., Ltd
• Huanggang Huayang Pharmaceutical Co. Ltd
• HuBei Yuancheng Saichuang Technology Co. Ltd[2].

These companies are investing heavily in research and development to enhance their products and maintain a competitive edge.

Research and Development

Significant investments in research and development are creating tremendous opportunities in the L-carnitine market. Companies are focusing on improving product quality and expanding their product portfolios to cater to diverse consumer needs, including the development of vegan L-carnitine supplements[2][4].

Market Challenges

Despite the growth prospects, the L-carnitine market faces several challenges:

• Shifting Consumer Preferences: Changes in consumer preferences and dietary habits can impact demand.
• Regulatory Challenges: Strict regulations and varying country-specific rules on supplement markets require companies to adjust their marketing strategies.
• Supply Chain Issues: Ensuring a reliable supply of high-quality raw materials is a significant challenge[4].

Key Takeaways

• The global L-carnitine market is expected to grow significantly, driven by health-conscious consumers and the animal feed industry.
• North America and Europe are key regions, with Asia-Pacific showing promising growth.
• Healthcare and animal feed are dominant application segments.
• The market is highly competitive, with major players investing in R&D.
• Challenges include shifting consumer preferences, regulatory hurdles, and supply chain issues.

FAQs

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

2. Which region dominates the L-carnitine market? North America dominates the L-carnitine market, with a revenue share of 37.9% in 2022[1].

3. What are the primary applications of L-carnitine? The primary applications include healthcare, animal feed, and functional food and beverages[1][2].

4. How does L-carnitine benefit animal health? L-carnitine supplementation in animal feed enhances development, performance, and reproductive processes in animals such as broiler chickens and racing pigeons[2].

5. What are the major challenges facing the L-carnitine market? The major challenges include shifting consumer preferences, regulatory challenges, and supply chain issues related to raw materials[4].

Cited Sources

1. Grand View Research - L-carnitine Market Size, Share & Trends Analysis Report, 2030
2. GlobeNewswire - Global L-Carnitine Market Size is Estimated to Reach USD 267.60 million by 2030, Growing at a CAGR of 4.7%
3. The Insight Partners - Levocarnitine Market Dynamics 2021-2031
4. Future Market Insights - L-carnitine Supplements Market Growth, Forecast to 2033
5. PR Newswire - Evaluate and Track L-Carnitine Market Procurement Research Report - Spendedge