HYDROGEN PEROXIDE - Generic Drug Details

What are the generic sources for hydrogen peroxide and what is the scope of patent protection?

Hydrogen peroxide is the generic ingredient in one branded drug marketed by Aclaris and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydrogen peroxide has nineteen patent family members in sixteen countries.

There are four drug master file entries for hydrogen peroxide.

Summary for HYDROGEN PEROXIDE

International Patents:	19
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	113
Patent Applications:	5,547
Drug Prices:	Drug price trends for HYDROGEN PEROXIDE
What excipients (inactive ingredients) are in HYDROGEN PEROXIDE?	HYDROGEN PEROXIDE excipients list
DailyMed Link:	HYDROGEN PEROXIDE at DailyMed

See drug prices for HYDROGEN PEROXIDE

See drug sales revenues for HYDROGEN PEROXIDE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for HYDROGEN PEROXIDE

Constraining patent/regulatory exclusivity:

10,098,910

Dosage:

SOLUTION;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for HYDROGEN PEROXIDE

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

Sponsor	Phase
Misr University for Science and Technology	PHASE1
Universidade Federal do Para	PHASE1
Mersin University	NA

See all HYDROGEN PEROXIDE clinical trials

Medical Subject Heading (MeSH) Categories for HYDROGEN PEROXIDE

Anti-Infective Agents, Local

Oxidants

Anatomical Therapeutic Chemical (ATC) Classes for HYDROGEN PEROXIDE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D08AX	Other antiseptics and disinfectants
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for HYDROGEN PEROXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	9,980,983
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	9,675,639		Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	10,098,910		Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	10,493,103		Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No	10,729,720		Y

Expired US Patents for HYDROGEN PEROXIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017	7,381,427

International Patents for HYDROGEN PEROXIDE

Country	Patent Number	Title	Estimated Expiration
Singapore	11201608775X
Mexico	2016013826	FORMULACIONES DE PEROXIDO Y METODOS Y APLICACIONES PARA UTILIZARLAS. (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME.)
South Korea	20170029413	과산화물 제제 및 이를 사용하기 위한 방법 및 어플리케이터 (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME)
Mexico	2016013826
Russian Federation	2016145236
Denmark	3134061
Australia	2015249841

Supplementary Protection Certificates for HYDROGEN PEROXIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0302769	98C0036	Belgium		PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001
3106463	20C1012	France		PRODUCT NAME: LAROTRECTINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SULFATE DE LAROTRECTINIB TEL QUE L'HYDROGENOSULFATE DE LAROTRECTINIB; NAT. REGISTRATION NO/DATE: EU/1/19/1385 20190923; FIRST REGISTRATION: DE - EU/1/19/1385 20190923
1968948	2190048-5	Sweden		PRODUCT NAME: SELUMETINIB HYDROGEN SULFATE, INCLUDING ANY SOLVATES AND ANHYDROUS FORMS THEREOF; REG. NO/DATE: EU/1/21/1552 20210619
0281459	98C0036	France		PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001
1968948	2021C/549	Belgium		PRODUCT NAME: SELUMETINIB (Y COMPRIS TOUS SELS PHARMACEUTIQUEMENT ACCEPTABLES (EN PARTICULIER HYDROGENOSULFATE), ESTERS, SOLVATES OU ENANTIOMERES DE CEUX-CI); AUTHORISATION NUMBER AND DATE: EU/1/21/1552 20210619
3106463	CA 2020 00013	Denmark		PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923
1968948	CA 2021 00044	Denmark		PRODUCT NAME: SELUMETINIB, INKLUSIV FARMACEUTISK ACCEPTABLE SALTE (ISAER HYDROGENSULFAT), ESTRE, SOLVATER OG ENANTIOMERE DERAF; REG. NO/DATE: EU/1/21/1552 20210619

Last updated: July 30, 2025

rket Dynamics and Financial Trajectory for Hydrogen Peroxide as a Pharmaceutical Drug

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Introduction

Hydrogen peroxide (H₂O₂), long recognized as a versatile chemical, has evolved from a household disinfectant to a compound with emerging pharmaceutical applications. Its potential in wound care, sterilization, and emerging therapeutics has garnered increasing attention amidst a complex global market landscape. This article explores the market forces, innovation trajectories, regulatory frameworks, and financial prospects shaping hydrogen peroxide's role within the pharmaceutical industry.

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Market Overview and Growth Drivers

Hydrogen peroxide's global demand is primarily driven by its dual utility as a disinfectant and a chemical intermediate. Historically confined to industrial and topical uses, recent research underscores its potential in pharmaceutical applications, such as antiseptics, drug delivery systems, and antimicrobial therapies. The chemical's inherent oxidizing properties exhibit broad-spectrum antimicrobial activity, positioning it as a candidate for novel therapeutic formulations.

The expansion of global healthcare infrastructure, especially in emerging markets, amplifies demand. Moreover, increasing emphasis on antiseptic agents during the COVID-19 pandemic accelerated the adoption of disinfectants, further catalyzing market growth. According to a report by MarketsandMarkets, the global hydrogen peroxide market is projected to expand at a compound annual growth rate (CAGR) of approximately 6% through 2030, driven by packaging, pulp & paper, textiles, and healthcare sectors (2022). While primarily industrial, a proportion of this growth is influencing pharmaceutical sector developments, especially in sterilization and topical formulations.

Pharmaceutical Application Landscape

Hydrogen peroxide’s applicability in pharmaceuticals remains largely adjunct to its traditional uses, but emerging trends show promise:

• Wound Care and Topical Antiseptics: Topical hydrogen peroxide solutions are used for wound cleansing owing to their oxidizing and antimicrobial properties. However, concerns over cytotoxicity at high concentrations limit systemic use. The development of controlled-release formulations or stabilized derivatives could expand its pharmaceutical applicability.

• Sterilization of Medical Equipment: The current sterilization market relies heavily on hydrogen peroxide vapor (HPV) and plasma sterilization systems. Growing demand for minimally invasive surgeries and sterilization of complex medical devices accentuates the financial trajectory for sterilization technologies based on H₂O₂.

• Potential Therapeutic Roles: Preclinical studies explore hydrogen peroxide's role in anticancer therapies, where controlled oxidative stress may induce tumor cell apoptosis. Nonetheless, clinical trials remain nascent, and commercialization is contingent on overcoming toxicity and delivery challenges.

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Regulatory and Safety Challenges

Hydrogen peroxide’s transition from industrial to pharmaceutical use hinges on stringent regulatory approval. Agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) evaluate compound safety, efficacy, and manufacturing quality standards. Its oxidizing nature raises toxicity concerns:

• Concentration-dependent Toxicity: Higher concentrations (>3%) pose risks of tissue damage, cytotoxicity, and oxidative stress, necessitating precise formulation controls.

• Standardization and Quality Control: Ensuring batch-to-batch consistency is imperative for regulatory approval, especially for pharmaceutical-grade hydrogen peroxide.

• Environmental and Occupational Safety: Handling and disposal safety protocols directly impact market dynamics, influencing adoption costs and manufacturing practices.

The regulatory landscape’s rigor underpins the financial trajectory, as companies investing in compliant product development face significant hurdles but with high potential returns upon approval.

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Market Players and Innovation Trends

The hydrogen peroxide market is fragmented, characterized by established chemical producers such as Kemira, Solvay, and Nouryon, alongside emerging biotech firms exploring pharmaceutical formulations. Recent innovations include:

• Stabilized and Targeted Delivery Systems: Encapsulation of hydrogen peroxide in nanoparticles or hydrogels to mitigate cytotoxicity and enable controlled release, thereby expanding therapeutic windows.

• Combination Therapies: Integrating hydrogen peroxide with other antimicrobials or drugs to enhance efficacy for infectious diseases or cancer.

• Green Manufacturing and Sustainability: Emphasis on environmentally friendly production processes aligns with global sustainability trends, appealing to pharma companies seeking eco-conscious sourcing.

Investment in R&D is critical as the market shifts toward niche formulations and clinical validation efforts.

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Financial Trajectory and Investment Outlook

The financial trajectory of hydrogen peroxide in pharmaceuticals remains cautiously optimistic, contingent on technological breakthroughs and regulatory approvals. The sterilization segment is already established, contributing significantly to revenue streams, with global sterilization markets valued at over $7 billion in 2022 (marketsandmarkets). As patent landscapes evolve and new formulations reach clinical stages, additional revenue streams are projected to emerge.

Key factors influencing financial prospects include:

• R&D Expenditure: Significant investment is necessary to develop safe, effective pharmaceutical formulations and to navigate regulatory pathways.

• Market Penetration and Adoption: Adoption rates hinge on demonstrating clinical benefits over existing standards such as iodine, chlorhexidine, or alcohol-based agents.

• Partnerships and Licensing: Strategic collaborations between chemical companies, biotech firms, and device manufacturers are vital for accelerating market entry.

Cumulatively, industry analysts anticipate that the pharmaceutical segment’s contribution to the overall hydrogen peroxide market could grow at a CAGR of approximately 8% over the next decade, driven by innovations in wound care, sterilization, and emerging therapeutics.

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Challenges and Future Outlook

Despite promising prospects, notable challenges hinder rapid growth:

• Toxicity and Cytotoxicity Risks: Balancing antimicrobial efficacy with tissue safety remains complex, requiring advanced formulation strategies.

• Regulatory Bottlenecks: Lengthy approval processes delay commercialization, impacting the financial return on R&D investments.

• Market Competition: Established disinfectants and sterilization methods wield significant market influence, potentially restricting hydrogen peroxide’s penetration into new therapeutic niches.

Looking forward, the integration of hydrogen peroxide into personalized medicine, nanotechnology-enabled delivery systems, and combination therapies could redefine its pharmaceutical value, unlocking new revenue streams. Harnessing advances in biocompatibility and targeted delivery will be crucial for translating laboratory success into commercial viability.

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Key Takeaways

• Growing Market Potential: Hydrogen peroxide’s expanding role in sterilization and emerging pharmaceutical applications signals a favorable growth trajectory, with projected CAGR of 6–8% up to 2030.

• Innovation Imperative: Next-generation formulations leveraging nanotechnology and stabilization techniques are central to overcoming toxicity barriers and expanding therapeutic uses.

• Regulatory Pathway: Navigating complex safety and efficacy standards is a vital determinant of market entry and subsequent financial success.

• Investment Opportunities: Companies investing in R&D, strategic collaborations, and green manufacturing will position themselves for growth amid increasing demand for safe, effective antiseptics and sterilization solutions.

• Market Challenges: Toxicity concerns, regulatory delays, and fierce competition necessitate targeted innovation and strategic positioning for commercial success.

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FAQs

Q1: What are the main pharmaceutical applications of hydrogen peroxide currently approved or in development?
A1: The primary applications include sterilization of medical devices, wound cleansing antiseptics with controlled release formulations, and exploring emerging roles in anticancer therapies through preclinical studies.

Q2: How does hydrogen peroxide compare to traditional antiseptics like iodine or alcohol?
A2: Hydrogen peroxide offers broad-spectrum antimicrobial activity with oxidative mechanisms, but its cytotoxicity at higher concentrations limits systemic use. Advances in formulations aim to improve safety and efficacy, but it remains secondary to established antiseptics for some applications.

Q3: What regulatory hurdles must hydrogen peroxide-based pharmaceuticals overcome?
A3: They must demonstrate safety, efficacy, and manufacturing quality in compliance with agencies like the FDA/EMA. Toxicity concerns and standardization are key hurdles for approval.

Q4: How significant is the sterilization market segment for hydrogen peroxide's financial outlook?
A4: Highly significant; global sterilization markets exceeding $7 billion present immediate revenue opportunities, with hydrogen peroxide vapor and plasma sterilization seeing rapid growth driven by demand in healthcare and pharmaceuticals.

Q5: What innovations could accelerate hydrogen peroxide’s pharmaceutical market penetration?
A5: Innovations include nanotechnology-based delivery systems, stabilization techniques, combination therapies, and environmentally sustainable manufacturing processes. These enable safer, targeted, and more effective formulations.

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References

[1] MarketsandMarkets, "Hydrogen Peroxide Market by Application (Paper & Pulp, Textile, Healthcare, Food & Beverages), Region – Global Forecast to 2030," 2022.