Cysteine hydrochloride - Generic Drug Details

What are the generic sources for cysteine hydrochloride and what is the scope of patent protection?

Cysteine hydrochloride is the generic ingredient in three branded drugs marketed by Hospira, Exela Pharma, and Baxter Hlthcare Corp, and is included in three NDAs. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cysteine hydrochloride has one patent family member in one country.

There are two drug master file entries for cysteine hydrochloride. Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for cysteine hydrochloride

International Patents:	1
US Patents:	20
Tradenames:	3
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	272
Patent Applications:	7,106
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cysteine hydrochloride
What excipients (inactive ingredients) are in cysteine hydrochloride?	cysteine hydrochloride excipients list
DailyMed Link:	cysteine hydrochloride at DailyMed

Recent Clinical Trials for cysteine hydrochloride

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

Sponsor	Phase
Mansoura University Hospital	PHASE4
ScandiBio Therapeutics AB	PHASE3
Tanta University	PHASE3

See all cysteine hydrochloride clinical trials

Generic filers with tentative approvals for CYSTEINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		500MG/10ML (50MG/ML)	SOLUTION;INTRAVENOUS

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

Paragraph IV (Patent) Challenges for CYSTEINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ELCYS	Injection	cysteine hydrochloride	500 mg/10 mL	210660	1	2019-12-10

US Patents and Regulatory Information for cysteine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes	10,918,662		Y
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-002	Dec 4, 2023		DISCN	Yes	No
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes	10,912,795		Y

International Patents for cysteine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	3070798
Canada	3070798	COMPOSITION DE CYSTEINE ET INJECTION (CYSTEINE COMPOSITION AND INJECTION)

Supplementary Protection Certificates for cysteine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0107734	93C0042	Belgium		PROD. NAME TETRAKIS (2-METHOXY-ISOBUTYL-ISONITRILE). CUIVRE (I) TETRAFLUOROBORATE, DIHYDRATE DE CHLORURE STANNEUX, CHLORHYDRATE DE L-CYSTEINE (MONOHYDRATE); REG NO/DATE 923 IS 3 F 12/ 19900924 ; FIRST REG CC NO DATE IE PA 200/9/1 19900817

Market Dynamics and Financial Trajectory for Cysteine Hydrochloride

Last updated: February 12, 2026

Cysteine hydrochloride is a non-essential amino acid derivative predominantly used in pharmaceuticals, dietary supplements, and as a precursor in cosmetic formulations. Its market is shaped by factors including health trends, regulatory policies, manufacturing costs, and competitive landscape.

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Market Overview

The global cysteine hydrochloride market was valued at approximately $200 million in 2022. The compound's applications span pharmaceutical ingredients, nutritional supplements, and cosmetics, with the pharmaceutical sector accounting for nearly 60% of demand.

Key Drivers

• Growing Demand for Nutritional Supplements: Increasing consumer awareness about functional foods and dietary supplements elevates demand for amino acids like cysteine hydrochloride. The surge is driven by trends in health and wellness, especially among aging populations and individuals seeking immune support.

• Pharmaceutical Applications: Cysteine hydrochloride is used in parenteral nutrition solutions and as an antioxidant additive in drug formulations. Development of new therapeutics for neurodegenerative diseases and liver conditions enhances its pharmaceutical demand.

• Cosmetic Industry Expansion: Its antioxidant properties lead to use as a skin-conditioning agent, fueling growth in the cosmetics sector.

Market Restraints

• Regulatory Challenges: Stringent approval processes for food and pharmaceutical uses limit market expansion. Regulatory bodies such as the FDA and EMA demand rigorous safety and efficacy data.

• Manufacturing Costs: Production involves complex synthesis processes with expensive raw materials, which can hinder pricing flexibility and profit margins.

• Supply Chain Constraints: Dependence on raw materials like raw cysteine or sulfur limits scalability during supply disruptions.

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Market Segmentation

Segment	2022 Revenue	Key Applications
Pharmaceutical	60%	Parenteral nutrition, antioxidants
Nutritional Supplements	25%	Dietary powders, capsules
Cosmetics	15%	Skin care formulations

Growth projections indicate a compound annual growth rate (CAGR) of 5.8% from 2023 to 2030, reaching approximately $320 million by 2030.

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Regional Analysis

• Asia-Pacific: Largest market share (>50%), driven by manufacturing hubs in China and India, along with rising domestic consumption.
• North America: Mature market, driven by regulatory approvals and innovation in nutritional and pharmaceutical sectors.
• Europe: Steady growth, supported by cosmetic industry expansion and regulatory standards favoring safe ingredients.

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Competitive Landscape

The industry features key players such as Ajinomoto, Evonik Industries, and Prinova. These companies focus on process optimization to lower costs and on expanding product portfolios to include specialty derivatives.

Company	Market Share (2022)	Strategic Focus
Ajinomoto	30%	Process innovation, vertical integration
Evonik Industries	20%	Custom formulation solutions
Prinova	15%	Supply chain expansion

Innovation pivots include developing greener synthesis pathways and novel delivery systems to enhance stability and efficacy.

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Financial Trajectory

Revenue Trends: A steady increase in revenues reflects growing demand, with revenues rising from $200 million in 2022 to a projected $320 million in 2030.

Profitability: Margins are constrained by raw material costs and regulatory expenses, with EBITDA margins averaging around 12-15%. Companies investing in process efficiency are targeting margins above 20%.

Investment Outlook: Capital expenditure in regionally diversified manufacturing facilities and R&D appears promising, especially in Asia-Pacific, where manufacturing costs are lower.

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Regulatory and Policy Impact

Regulatory approval delays can significantly impact market expansion. Efforts toward standardizing amino acid synthesis methods and increasing transparency are elevating compliance costs but could standardize quality and reduce entry barriers in the long term.

Supply Chain Considerations

Market stability hinges on raw material availability. Supply chain disruptions, such as sulfur shortages or geopolitical conflicts, could temporarily hinder production and inflate prices.

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Key Takeaways

• Cysteine hydrochloride markets grow gradually, propelled by demand in pharmaceuticals, dietary supplements, and cosmetics.
• The global market is poised to reach about $320 million by 2030, driven by Asia-Pacific expansion.
• Raw material costs, regulatory hurdles, and supply chain management influence profitability and scalability.
• Innovation in green synthesis and formulation improves competitive positioning.
• Strategic investments in manufacturing infrastructure, especially in emerging markets, will shape future growth trajectories.

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Frequently Asked Questions

1. What are the primary applications of cysteine hydrochloride?
Uses include nutritional supplements, pharmaceutical formulations such as parenteral nutrition, and cosmetic products due to its antioxidant properties.

2. Which regions dominate the cysteine hydrochloride market?
Asia-Pacific leads with over 50% market share, followed by North America and Europe.

3. What factors limit market expansion?
Regulatory hurdles, raw material costs, and supply chain disruptions are significant constraints.

4. How is the competitive landscape shaping?
Key players invest in process efficiencies, product diversification, and regional manufacturing, with Ajinomoto, Evonik, and Prinova leading.

5. What is the outlook for market growth?
The market expects a CAGR of 5.8%, reaching approximately $320 million by 2030.

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Sources

[1] MarketDataReports, "Global Amino Acid Market," 2023.
[2] Grand View Research, "Cysteine Market Size, Share & Trends," 2022.
[3] Industry Reports, "Pharmaceutical Ingredients and Nutritional Supplement Trends," 2022.