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:	116
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

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
Tanta University	NA
University of Plymouth	EARLY_PHASE1
Misr University for Science and Technology	PHASE1

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			Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No			Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No			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

International Patents for HYDROGEN PEROXIDE

Country	Patent Number	Title	Estimated Expiration
Portugal	3134061
South Korea	20170029413	과산화물 제제 및 이를 사용하기 위한 방법 및 어플리케이터 (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME)
Japan	6622217

Supplementary Protection Certificates for HYDROGEN PEROXIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2523731	2020/020	Ireland		PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE.; REGISTRATION NO/DATE: EU/1/19/1407 20200113
2523731	LUC00159	Luxembourg		PRODUCT NAME: OSILODROSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE DIHYDROGENOPHOSPHATE D'OSILODROSTAT; AUTHORISATION NUMBER AND DATE: EU/1/19/1407 20200113
2523731	CR 2020 00025	Denmark		PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113

Market Dynamics and Financial Trajectory for Hydrogen Peroxide

Last updated: February 19, 2026

Hydrogen peroxide (H₂O₂) is a chemical compound with applications spanning healthcare, industrial, and environmental sectors. Its global market size reached approximately $2.1 billion in 2022. The compound’s growth hinges on the expansion in healthcare sterilization, environmental disinfection, and industrial chemical markets.

Market Overview

Segment	Estimated Market Share (2022)	Key Applications	Growth Rate (CAGR 2023-2028)
Healthcare & Disinfection	45%	Medical sterilization, wound care	6-8%
Industrial Chemicals	30%	Bleaching agents, paper pulp, textiles	4-6%
Environmental & Water Treatment	15%	Wastewater treatment, soil remediation	7-9%
Others (Electronics, Food)	10%	Electronics cleaning, food packaging sterilization	3-5%

Hydrogen peroxide's versatility sustains stable demand, with healthcare and industrial sectors comprising the core markets.

Key Market Drivers

• Healthcare Disinfection: COVID-19 accelerated demand for sterilization products, with H₂O₂ systems increasingly adopted in hospitals.
• Environmental Regulations: Stricter waste and water treatment standards motivate use of environmentally friendly oxidizers like hydrogen peroxide.
• Industrial Expansion: Growth in pulp and paper industries and textile bleaching ensures linear demand.
• Emerging Economies: Asia-Pacific dominates growth, with India and China investing heavily in infrastructure and healthcare.

Regulatory Landscape

• FDA (U.S.): Classifies hydrogen peroxide as a medical device sterilant; approvals for high-concentration formulations have increased.
• EPA (U.S.): Permits H₂O₂ use in water treatment, with regulations stressing environmental safety.
• Europe: CE certification required for industrial uses, aligning with REACH compliance.

Production & Supply Chain

Major producers include:

• Kemira (Finland)
• AkzoNobel (Netherlands)
• Ecolab (U.S.)
• Solvay (Belgium)

Production capacity exceeded 2 million metric tons globally in 2022. Manufacturing relies on anthraquinone process, with innovation focusing on energy efficiency and byproduct reduction.

Supply chain issues emerged in 2021 due to raw material shortages (oxygen, sulfuric acid), affecting pricing and availability.

Financial Trajectory

Year	Market Size (Billions USD)	Projects CAGR 2023-2028	Drivers of Growth
2022	2.1	—	Baseline demand, pandemic effects
2023	2.2	4-6%	Post-pandemic recovery, industrial expansion
2026	2.7	4-6%	Strengthening environmental policies, healthcare use
2028	3.2	5-7%	Increasing environmental regulations, emerging markets

The compound annual growth rate (CAGR) from 2023 to 2028 is forecasted at approximately 4-6%, with some estimates up to 7%.

Investment and Pricing Trends

• Pricing: Prices for high-purity (35-50%) hydrogen peroxide ranged from $1.20 to $1.50 per kg in 2022. Price volatility reflects raw material costs and supply chain dynamics.
• Investments: Major corporations are investing in sustainable production, including catalyst improvements and renewable energy integration.

Market Risks

• Raw Material Scarcity: Dependence on oxygen and sulfuric acid supplies can trigger price hikes.
• Environmental Regulations: Stricter rules around chemical manufacturing may limit production or increase compliance costs.
• Competition from Alternatives: Emerging disinfectants, such as photocatalysts or enzyme-based agents, threaten market share in specific domains.

Conclusion

Hydrogen peroxide remains a resilient chemical with growth prospects centered on environmental applications and healthcare. Its market size is poised to expand from approximately $2.1 billion in 2022 to over $3.2 billion by 2028. Industry investments focus on sustainable production, cost reduction, and meeting regulatory standards.

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Key Takeaways

• Global market size was $2.1 billion in 2022, with a projected CAGR of 4-6% through 2028.
• Demand driven by healthcare disinfection, environmental regulations, and industrial growth.
• Main production relies on the anthraquinone process; supply chain disruptions influence pricing.
• Price per kg was up to $1.50 in 2022, with volatility linked to raw material costs.
• Regulatory environments in the U.S. and Europe shape production and application standards.

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FAQs

1. What are major applications of hydrogen peroxide?
Healthcare sterilization, water and wastewater treatment, bleaching in pulp and paper industries, textile bleaching, and electronics cleaning.

2. How has pandemic growth affected the hydrogen peroxide market?
It increased demand for sterilization and disinfection products, boosting sales and adoption in healthcare.

3. What are the key raw materials for hydrogen peroxide production?
Oxygen, sulfuric acid, and hydrogen. Raw material shortages impact production capacity.

4. Are environmental regulations limiting hydrogen peroxide use?
No, regulations generally promote its use due to its environmentally friendly profile, though manufacturing must comply with strict standards.

5. Which regions are leading growth in hydrogen peroxide demand?
Asia-Pacific, notably China and India, due to expanding healthcare infrastructure and industrial activity.

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References

[1] MarketWatch. (2023). Hydrogen Peroxide Market Size, Share, Growth, Trends, and Forecast 2023-2028.
[2] Grand View Research. (2022). Hydrogen Peroxide Market Analysis.
[3] U.S. Food and Drug Administration. (2022). Regulation of Sterilization Equipment.
[4] European Chemicals Agency. (2022). REACH Compliance for Chemical Products.
[5] Bloomberg Industry Analyst Reports. (2023). Chemical Industry Supply Chain Risks.