AMINO ACIDS - Generic Drug Details

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

Amino acids is the generic ingredient in one hundred and thirty-nine branded drugs marketed by Hospira, B Braun, Icu Medical Inc, Abbott, Baxter Hlthcare, Hospira Inc, and Fresenius Kabi Usa, and is included in fifty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for amino acids. Three suppliers are listed for this compound.

Summary for AMINO ACIDS

US Patents:	0
Tradenames:	139
Applicants:	7
NDAs:	55
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	3
DailyMed Link:	AMINO ACIDS at DailyMed

Pharmacology for AMINO ACIDS

Drug Class

Amino Acid

Anatomical Therapeutic Chemical (ATC) Classes for AMINO ACIDS

B05BA	Solutions for parenteral nutrition
B05B	I.V. SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for AMINO ACIDS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	019520-006	Sep 23, 1988		DISCN	No	No
Icu Medical Inc	AMINOSYN II 10% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	020015-001	Dec 19, 1991		RX	No	No
Baxter Hlthcare	TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER	amino acids; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride	INJECTABLE;INJECTION	020147-001	Oct 23, 1995		DISCN	No	No
Hospira	AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER	amino acids; dextrose	INJECTABLE;INJECTION	019681-006	Nov 1, 1988		DISCN	No	No

Expired US Patents for AMINO ACIDS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	BRANCHAMIN 4%	amino acids	INJECTABLE;INJECTION	018678-001	Sep 28, 1984	4,438,144
B Braun	HEPATAMINE 8%	amino acids	INJECTABLE;INJECTION	018676-001	Aug 3, 1982	3,950,529
Baxter Hlthcare	BRANCHAMIN 4% IN PLASTIC CONTAINER	amino acids	INJECTABLE;INJECTION	018684-001	Sep 28, 1984	4,438,144

AMINO ACIDS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Amino Acids

Global Market Overview

The global amino acids market is poised for significant growth, driven by diverse and expanding applications. As of 2022, the global amino acids market was valued at US$ 25.28 billion and is expected to exhibit a compound annual growth rate (CAGR) of 8.4% from 2023 to 2030[1].

Key Drivers of Market Growth

Increasing Demand for Dietary Supplements and Functional Foods

The growing awareness of health and wellness among consumers has led to an increased demand for dietary supplements and functional foods, which are rich in amino acids. This trend is particularly prominent in regions where there is a high adoption of healthy lifestyles, such as Asia Pacific and North America[1][3].

Animal Feed Sector

The demand for amino acids in the animal feed sector is driven by the need to enhance nutritional value and prevent metabolic diseases in livestock. Countries like China and India are experiencing rapid growth in livestock production, further boosting the demand for feed amino acids like lysine[1].

Pharmaceutical and Personal Care Industries

Amino acids are increasingly used in the pharmaceutical industry for drug formulations due to their therapeutic properties. Additionally, the personal care and cosmetics industries are driving demand with the introduction of amino acid-based products, such as those announced by The Marquie Group, Inc.[1][3].

Regional Insights

Asia Pacific

Asia Pacific is expected to dominate the global amino acids market due to rapid economic growth, increasing adoption of healthy lifestyles, and strong growth in end-use sectors like pharmaceuticals, nutraceuticals, and personal care. The region's increasing livestock production, particularly in China and India, also contributes to this dominance[1].

North America

North America is the second leading region in the global amino acids market, driven by strong demand from the animal feed and nutraceutical industries. The U.S. and Canada are significant players in animal feed production, with the U.S. feed exports accounting for a substantial portion of global animal feed exports[1].

U.S. Market Specifics

The U.S. amino acids market was estimated at around USD 3.95 billion in 2023 and is projected to reach USD 8.79 billion by 2033, growing at a CAGR of 8.33% from 2024 to 2033. Key factors driving this growth include increasing consumer awareness of health and wellness, expanding applications in pharmaceuticals, and growing demand from the animal feed sector[3][4].

Technological Advancements and Sustainability

Advancements in technology are enhancing the efficiency and quality of amino acid production. There is also a growing trend towards environmentally sustainable and eco-friendly products, which is influencing the development of amino acid-based products[4].

Market Trends

Ready-to-Drink Beverages

The trend of consuming ready-to-drink beverages is influencing the demand for amino acids, particularly aspartame, which includes the amino acids phenylalanine and aspartic acid. This trend is driven by the growing working population and increasing disposable income[1].

Changing Fashion Trends in Personal Care

The growing demand for amino acids from personal care products is another significant trend. Companies are introducing premium amino acid-based products to cater to the increasing demand for health and beauty products[1].

Restraints and Challenges

Price Volatility of Raw Materials

One of the major restraints on the amino acids market is the price volatility of raw materials, which can hamper market growth and stability[1].

Role in Microbial Control and Drug Development

Amino acids play a crucial role in microbial control and drug development. They are used to develop antimicrobial peptides that are highly effective and less prone to microbial resistance. Additionally, d-amino acids are being explored as antibiofilm agents, adjuvants, and potential drug excipients[2].

Financial Trajectory

The financial trajectory of the amino acids market is robust, with significant growth projected over the next decade. The global market is expected to grow at a CAGR of 8.4% from 2023 to 2030, while the U.S. market is anticipated to grow at a CAGR of 8.33% from 2024 to 2033[1][3].

Key Takeaways

• The global amino acids market is valued at US$ 25.28 billion as of 2022 and is expected to grow at a CAGR of 8.4% from 2023 to 2030.
• The U.S. amino acids market is projected to reach USD 8.79 billion by 2033, growing at a CAGR of 8.33% from 2024 to 2033.
• Key drivers include increasing demand for dietary supplements, functional foods, and animal feed, as well as growing applications in pharmaceuticals and personal care.
• Asia Pacific and North America are leading regions in the global amino acids market.
• Technological advancements and the trend towards sustainable products are shaping the market.

FAQs

What is the current size of the global amino acids market?

The global amino acids market was valued at US$ 25.28 billion in 2022[1].

What is the projected CAGR for the global amino acids market from 2023 to 2030?

The global amino acids market is expected to exhibit a CAGR of 8.4% from 2023 to 2030[1].

Which region is expected to dominate the global amino acids market?

Asia Pacific is expected to dominate the global amino acids market due to rapid economic growth and increasing adoption of healthy lifestyles[1].

What are the key drivers of the U.S. amino acids market?

Key drivers include increasing consumer awareness of health and wellness, expanding applications in pharmaceuticals, and growing demand from the animal feed sector[3][4].

How are amino acids used in microbial control and drug development?

Amino acids are used to develop antimicrobial peptides, and d-amino acids are explored as antibiofilm agents, adjuvants, and potential drug excipients[2].

Cited Sources:

1. Coherent Market Insights - Amino Acid Market - Share, Size and Industry Analysis
2. MDPI - Multimodal Role of Amino Acids in Microbial Control and Drug Development
3. Vision Research Reports - U.S. Amino Acids Market Size to Reach USD 8.79 Bn by 2033
4. Grand View Research - U.S. Amino Acids Market Size, Share | Industry Report, 2030