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CYSTEINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for cysteine hydrochloride and what is the scope of freedom to operate?

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:	214
Clinical Trials:	250
Patent Applications:	1,932
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
University of California, San Francisco	Phase 4
National Institute on Aging (NIA)	Phase 4
Vanderbilt University Medical Center	Phase 4

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
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No			Y
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes			Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No			Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No			Y
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes			Y
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes			Y
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes			Y

International Patents for CYSTEINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
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

CYSTEINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cysteine Hydrochloride

Overview of Cysteine Hydrochloride Market

The market for cysteine hydrochloride, a derivative of the amino acid cysteine, is experiencing significant growth driven by its diverse applications across various industries. Here’s a detailed look at the market dynamics and financial trajectory of this crucial compound.

Market Size and Growth Projections

The global cysteine and its hydrochloride market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 3 to 5% from 2023 to 2031, with the market size expected to increase substantially during this period[1][2].

• By 2024, the cysteine market is projected to reach 11.10 kilotons and is expected to grow to 14.57 kilotons by 2029, with a CAGR of greater than 5%[3].
• In terms of value, the market was valued at over USD 403.89 billion in 2024 and is poised to exceed USD 882.84 billion by 2037, growing at a CAGR of over 6.2%[4].

Key Applications and Segments

Food Industry

Cysteine hydrochloride is widely used in the food industry, particularly in baking. It acts as a dough conditioner, improving the texture and volume of baked goods. The growing demand from the bakery sector, especially in regions like Asia-Pacific, is a significant driver for the market[3][4].

Pharmaceutical Industry

In the pharmaceutical sector, cysteine and its derivatives are used in the production of genetically modified proteins and as processing aids. The expansion of the pharmaceutical industry, particularly in regions like North America, is expected to provide lucrative growth opportunities[4].

Cosmetics Industry

Cysteine hydrochloride is also utilized in the cosmetics industry as an anti-aging agent. The rising demand for anti-aging products and the increasing health awareness among consumers are driving the growth in this segment[4].

Animal Feed

The compound is used in animal feed to enhance nutritional value. China's large animal feed production industry, for instance, is a significant consumer of cysteine, contributing to the market's growth[3].

Geographical Distribution

Asia-Pacific

This region is expected to dominate the cysteine market due to high consumption in countries like India and China. The growth of the food and beverage industry, particularly the bakery sector in India, and the large animal feed production in China are key factors[3][4].

North America

North America is projected to hold a significant market share, driven by the growing pharmaceutical industry and the increasing geriatric population requiring anti-aging components[4].

Market Dynamics: Drivers and Restraints

Drivers

• Increasing Demand from Key Industries: The rising demand from the bakery, pharmaceutical, and cosmetics industries is a major driver for the market[3][4].
• Technological Advancements: Developments such as the use of palladium reagents for cysteine S-arylation and the production of cysteine derivatives for medical treatments are expected to boost market growth[3].
• Economic Recovery Post-COVID-19: The recovery from the economic impacts of the COVID-19 pandemic is restoring growth in various industries that use cysteine, thereby driving the market[3].

Restraints

• Concerns Over Animal-Sourced Cysteine: Increasing concerns about the use of animal-sourced cysteine and its potential harmful effects on human health could hamper market growth[3].
• Regulatory Challenges: Strict regulations and compliance requirements, especially in the pharmaceutical and food industries, can pose challenges to market expansion[2].

Competitive Landscape

The global cysteine market is consolidated, with top players holding a significant market share. Key companies include:

• Wacker Chemie AG: Known for its life science division and recent production line expansions in Spain[4].
• Ajinomoto Co., Inc.: A major player in the production of cysteine and its derivatives[3].
• Merck KGaA: Another significant player in the market, contributing to the production and distribution of cysteine products[3].
• Nippon Rika Industries Corporation: Active in the production and supply of cysteine and its hydrochloride[3].

Financial Trajectory

The financial outlook for the cysteine hydrochloride market is positive, with significant growth anticipated over the forecast period.

• Revenue Growth: The market is expected to grow from USD 403.89 billion in 2024 to over USD 882.84 billion by 2037, indicating a robust financial trajectory[4].
• Investments and Expansions: Companies like Wacker Chemie AG are investing in new production lines to meet growing global demand, which is a testament to the market's financial health[4].

Key Takeaways

• The cysteine hydrochloride market is growing at a CAGR of 3 to 5% from 2023 to 2031.
• Key applications include the food, pharmaceutical, cosmetics, and animal feed industries.
• Asia-Pacific is the fastest-growing and largest market region.
• Technological advancements and economic recovery post-COVID-19 are driving market growth.
• Concerns over animal-sourced cysteine and regulatory challenges are potential restraints.
• The market is consolidated with major players like Wacker Chemie AG, Ajinomoto Co., Inc., and Merck KGaA.

FAQs

What is the expected CAGR of the cysteine hydrochloride market from 2023 to 2031?

The cysteine hydrochloride market is expected to grow at a CAGR of 3 to 5% from 2023 to 2031[1][2].

Which region is expected to dominate the cysteine market?

Asia-Pacific is expected to dominate the cysteine market due to high consumption in countries like India and China[3][4].

What are the primary applications of cysteine hydrochloride?

Primary applications include the food industry (baking), pharmaceutical industry (production of genetically modified proteins), cosmetics industry (anti-aging), and animal feed[3][4].

Who are the major players in the cysteine market?

Major players include Wacker Chemie AG, Ajinomoto Co., Inc., Merck KGaA, and Nippon Rika Industries Corporation[3][4].

How has the COVID-19 pandemic impacted the cysteine market?

The COVID-19 pandemic initially hampered the market due to lockdowns and economic uncertainties, but the market is recovering as economic conditions improve[3].

Sources

1. Market Research Intellect - Global L Cysteine And Its Hydrochloride Market
2. Market Research Intellect - Global L Cysteine And Its Hydrochloride Market Size And Forecast
3. Mordor Intelligence - Cysteine Market - Size, Share & Growth Trends
4. Research Nester - Cysteine Market Size & Share, Forecast Report 2025-2037