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Last Updated: December 16, 2025

CYSTEINE HYDROCHLORIDE - Generic Drug Details


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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
Recent Clinical Trials for CYSTEINE HYDROCHLORIDE

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

SponsorPhase
Mansoura University HospitalPHASE4
ScandiBio Therapeutics ABPHASE3
Tanta UniversityPHASE3

See all CYSTEINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for CYSTEINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Get Started Free⤷  Get Started Free500MG/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 10,905,713 ⤷  Get Started Free Y ⤷  Get Started Free
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes 10,905,714 ⤷  Get Started Free Y ⤷  Get Started Free
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes 10,918,662 ⤷  Get Started Free Y ⤷  Get Started Free
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes 10,653,719 ⤷  Get Started Free Y ⤷  Get Started Free
Exela Pharma ELCYS cysteine hydrochloride SOLUTION;INTRAVENOUS 210660-001 Apr 16, 2019 RX Yes Yes 11,684,636 ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for CYSTEINE HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0107734 93C0042 Belgium ⤷  Get Started Free 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for Cysteine Hydrochloride

Last updated: July 27, 2025

Introduction

Cysteine hydrochloride, a semi-essential amino acid derivative, plays a pivotal role across various industries, particularly in pharmaceuticals, food, and cosmetic sectors. Its multifaceted applications—ranging from nutritional supplements to pharmaceutical excipients—position the compound as a strategically significant commodity. This analysis examines the current market landscape, key drivers, challenges, and financial forecasts shaping the trajectory of cysteine hydrochloride within the global pharmaceutical substrate and beyond.

Market Overview

The global cysteine hydrochloride market has witnessed notable growth driven by increasing pharmaceutical and nutritional supplement demand. As of 2022, the market was valued approximately at USD 150 million, with projections indicating a compound annual growth rate (CAGR) of about 4.8% over the next five years (2023–2028). The primary production methods involve chemical synthesis, enzymatic processes, and fermentation, with China serving as a dominant manufacturing hub due to cost competitiveness and established supply chains.

Market Dynamics

Demand Drivers

1. Pharmaceutical Industry Expansion

Cysteine hydrochloride is integral to formulation of injectable and oral medicines, notably in treatments involving liver detoxification, amino acid supplementation, and antioxidant therapies. The increasing prevalence of liver diseases, metabolic disorders, and nutritional deficiencies sustains robust demand.

2. Nutritional and Dietary Supplements

Rising consumer awareness regarding health and wellness initiatives propels demand for amino acid supplements, including cysteine hydrochloride. The surge in vegetarian and vegan populations further amplifies the necessity for amino acid supplements, given plant-based diets’ typical amino acid profiles.

3. Food Industry Applications

As a preservative and flavor enhancer, cysteine hydrochloride’s role in bakery, meat products, and processed foods contributes to steady market utilization. Regulatory approvals, such as FDA recognition as a safe additive, underpin this demand.

4. Cosmetic and Personal Care Industry

The antioxidant and skin-protective properties of cysteine derivative formulations foster opportunities within cosmeceuticals, particularly in anti-aging and skincare products.

Supply Chain and Production Factors

Consolidation of Supply

Manufacturing predominantly occurs in China, India, and other Asian countries, creating an economically advantageous environment but also exposing markets to geopolitical and supply chain risks. Centralized production raises concerns over quality consistency and regulatory scrutiny, influencing supply stability.

Technological Advancements

Innovations in enzymatic and fermentation processes aim to increase yield efficiency, reduce costs, and mitigate environmental impact. These technological improvements are crucial for sustaining profit margins amid fluctuating raw material costs.

Regulatory Environment

Stringent regulatory benchmarks by agencies like the FDA, EMA, and other national authorities influence market entrants and product standards. Certification processes and compliance requirements affect manufacturing costs and time-to-market. The adoption of Good Manufacturing Practices (GMP) and the registration of new formulations can either accelerate or hinder growth trajectories.

Challenges and Risks

  • Raw Material Volatility: Fluctuations in precursor amino acids (e.g., cysteine and other sulfur amino acids) can impact production costs.
  • Environmental and Ethical Concerns: Sustainability pressures and regulations on waste management, especially in chemical synthesis processes, may increase operational costs.
  • Intellectual Property Limitations: Patent expirations on specific synthesis methods might empower competitors, affecting pricing strategies.
  • Market Saturation and Competition: The proliferation of low-cost producers intensifies price competition, squeezing profit margins.

Financial Trajectory and Projections

Historical Financial Performance

In recent years, cysteine hydrochloride’s revenue growth has closely correlated with pharmaceutical and nutraceutical markets’ expansion. The compounded growth rate aligns with broader amino acid industry trends, which benefited from increased health consciousness and aging populations.

Future Market Forecast

Analysts project the cysteine hydrochloride market will grow at a CAGR of approximately 4.8% between 2023 and 2028. Key factors influencing this trajectory include:

  • Increased Pharmaceutical R&D: Investment in personalized medicine and amino acid-based therapeutics augments demand.
  • Growth in Emerging Markets: Asia-Pacific regions are expected to outpace developed economies due to expanding healthcare infrastructure and manufacturing capabilities.
  • Innovation and Product Diversification: Development of new cysteine derivatives with enhanced bioavailability or specific functionalities can unlock additional revenue streams.

Revenue Forecast

By 2028, the market could exceed USD 210 million, driven significantly by pharmaceutical segment growth—potentially accounting for over 60% of total revenues. The food and cosmetic sectors are projected to maintain steady contributions, buoyed by consumer trends and regulatory acceptance.

Investment and Profitability Outlook

The capital expenditure for establishing or expanding manufacturing facilities remains considerable, albeit with declining unit costs owing to process optimizations. Profit margins are anticipated to improve marginally as technological advancements offset raw material and compliance expenses.

Competitive Landscape

Major industry players include Ajinomoto, Evonik Industries, and Adisseo, leveraging integrated supply chains and R&D capabilities to maintain market share. Emerging manufacturers from China and India are disrupting traditional pricing models with aggressive cost strategies and technological innovations.

Strategic Outlook

To capitalize on growing demand, companies must focus on:

  • Process Innovation: Emphasize green synthesis techniques that minimize environmental footprint.
  • Regulatory Navigation: Foster global compliance to facilitate entry into key markets.
  • Diversification: Expand into specialty derivatives or combination products tailored for pharmaceutical or nutraceutical applications.
  • Supply Chain Resilience: Develop diversified sourcing and production bases to mitigate geopolitical risks.

Key Takeaways

  • The cysteine hydrochloride market is poised for steady growth driven by pharmaceutical, nutraceutical, and food industries.
  • Technological innovations underpin cost reduction and sustainability initiatives, enhancing long-term profitability.
  • Geopolitical, regulatory, and supply chain risks necessitate strategic diversification and proactive compliance management.
  • Emerging markets offer substantial growth opportunities, particularly in Asia-Pacific regions.
  • Investment in process enhancements and product diversification remains vital for capturing increasing demand.

FAQs

  1. What are the primary applications of cysteine hydrochloride in pharmaceuticals?
    It is used as an excipient, antioxidant, and in formulations for liver health, amino acid supplementation, and detoxification therapies.

  2. How do raw material prices impact the profitability of cysteine hydrochloride manufacturing?
    Volatility in precursor amino acids can significantly affect production costs, influencing profit margins and pricing strategies.

  3. What regulatory challenges does the cysteine hydrochloride market face?
    Compliance with strict pharmaceutical standards, environmental regulations, and safety certifications can delay product launches and increase costs.

  4. Which regions are expected to experience the highest growth for cysteine hydrochloride?
    Asia-Pacific—particularly China and India—is projected to lead growth due to expanding manufacturing capacity and rising domestic demand.

  5. How does technological innovation influence the future of cysteine hydrochloride?
    It enhances yield efficiency, reduces environmental impact, and enables the development of derivative products, driving market expansion.


References

[1] MarketResearch.com. "Global Cysteine Market Size, Share & Trends Analysis." 2022.
[2] Grand View Research. "Amino Acids Market Size, Share & Trends." 2023.
[3] Transparency Market Research. "Pharmaceutical Excipients by Type, Application, and Region." 2022.
[4] Industry reports from Ajinomoto, Evonik Industries, and Adisseo.

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