HYDROXYUREA - Generic Drug Details

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

Hydroxyurea is the generic ingredient in five branded drugs marketed by Waylis Therap, Barr, Barr Labs Inc, Leading, Ph Health, Qilu, Roxane, Nova Labs Ltd, and Theravia, and is included in ten NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydroxyurea has nine patent family members in seven countries.

There are ten drug master file entries for hydroxyurea. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for HYDROXYUREA

International Patents:	9
US Patents:	1
Tradenames:	5
Applicants:	9
NDAs:	10
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	311
Patent Applications:	6,287
Drug Prices:	Drug price trends for HYDROXYUREA
What excipients (inactive ingredients) are in HYDROXYUREA?	HYDROXYUREA excipients list
DailyMed Link:	HYDROXYUREA at DailyMed

See drug prices for HYDROXYUREA

Recent Clinical Trials for HYDROXYUREA

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

Sponsor	Phase
Uma Borate	PHASE2
Kura Oncology	PHASE2
Biossil Inc.	PHASE2

See all HYDROXYUREA clinical trials

Generic filers with tentative approvals for HYDROXYUREA

Applicant	Application No.	Strength	Dosage Form
		1GM	TABLET;ORAL
		100MG	TABLET;ORAL

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

Pharmacology for HYDROXYUREA

Drug Class

Antimetabolite

Medical Subject Heading (MeSH) Categories for HYDROXYUREA

Antineoplastic Agents

Antisickling Agents

Enzyme Inhibitors

Nucleic Acid Synthesis Inhibitors

US Patents and Regulatory Information for HYDROXYUREA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Theravia	SIKLOS	hydroxyurea	TABLET;ORAL	208843-002	Dec 21, 2017		RX	Yes	Yes
Barr Labs Inc	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	075020-001	Jul 30, 1998		DISCN	No	No
Waylis Therap	DROXIA	hydroxyurea	CAPSULE;ORAL	016295-002	Feb 25, 1998		DISCN	Yes	No
Nova Labs Ltd	XROMI	hydroxyurea	SOLUTION;ORAL	216593-001	Apr 4, 2024		RX	Yes	Yes			Y
Leading	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	213438-001	Apr 8, 2020	AB	RX	No	No
Ph Health	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	075340-001	Feb 24, 1999	AB	RX	No	No
Waylis Therap	HYDREA	hydroxyurea	CAPSULE;ORAL	016295-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Expired US Patents for HYDROXYUREA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	HYDREA	hydroxyurea	CAPSULE;ORAL	016295-001	Approved Prior to Jan 1, 1982

International Patents for HYDROXYUREA

Country	Patent Number	Title	Estimated Expiration
United Kingdom	201808013
Australia	2019269123	A stable aqueous hydroxycarbamide solution
United Kingdom	2573784	A stable aqueous hydroxycarbamide solution
European Patent Office	4434580	SOLUTION AQUEUSE STABLE D'HYDROXYCARBAMIDE (A STABLE AQUEOUS HYDROXYCARBAMIDE SOLUTION)
World Intellectual Property Organization (WIPO)	2019220134
Spain	2992016
European Patent Office	3644967	SOLUTION AQUEUSE STABLE D'HYDROXYCARBAMIDE (A STABLE AQUEOUS HYDROXYCARBAMIDE SOLUTION)

Market Dynamics and Financial Trajectory for Hydroxyurea

Last updated: February 19, 2026

Hydroxyurea remains an established drug primarily used to treat sickle cell disease (SCD) and certain cancers, including chronic myelogenous leukemia (CML). Its market position is influenced by patent status, competition, regulatory approvals, and emerging therapeutic alternatives.

Market Overview

Hydroxyurea's global market size was valued at approximately USD 400 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2028, driven by increasing sickle cell disease prevalence and expanding use in myeloproliferative neoplasms.

Key Therapeutic Segments

Segment	Market Share (2022)	Growth Drivers
Sickle Cell Disease (SCD)	60%	Rising prevalence, expanded indications
Chronic Myelogenous Leukemia (CML)	25%	New combination therapies, expanding treatment guidelines
Other Indications	15%	Polycythemia vera, other myeloproliferative disorders

Geographic Distribution

Region	Market Share (2022)	Notes
North America	55%	Established use, favorable regulatory environment
Europe	20%	Growing adoption, approval renewals
Asia-Pacific	15%	Increasing awareness, healthcare infrastructure improvement
Rest of World	10%	Market entry, importation barriers

Patent and Regulatory Landscape

Hydroxyurea is off-patent globally. Eli Lilly's original patent expired in most jurisdictions by 2010, leading to generic manufacturers' entry. This has significantly reduced drug prices and increased market competition.

Regulatory frameworks emphasize safety and efficacy. The U.S. Food and Drug Administration (FDA) approved hydroxyurea in 1998 for SCD and later expanded indications. The European Medicines Agency (EMA) grants market authorization, with variations across countries.

Competitive Landscape

Generic manufacturers dominate the hydroxyurea market, offering low-cost formulations. Key players include:

• Mylan (now part of Viatris)
• Teva Pharmaceuticals
• Sun Pharmaceutical Industries

Innovative efforts focus on formulations that improve bioavailability, reduce side effects, or extend shelf-life. No new branded hydroxyurea drugs are under active development as of 2023, given its patent expiry and generic competition.

Financial Trajectory

Revenue Trends

Year	Estimated Global Revenue (USD million)	Growth Rate
2020	380	2.5%
2021	390	2.6%
2022	400	2.6%
2023*	420 (projected)	5% (projected)

*Projection based on current growth rates and market expansion in emerging regions.

Cost Structure

Manufacturing costs have declined due to generic competition, with APIs produced in low-cost regions reducing overall prices. Margins for manufacturers are thin, typically in the range of 10-15%.

Future Revenue Drivers

• Increasing prevalence and diagnosis of sickle cell disease, especially in sub-Saharan Africa.
• Expansion into new indications such as myeloproliferative disorders.
• Potential price increases in markets where patent protections are renewed or new formulations are introduced.

Risks and Challenges

• Development of alternative therapies for SCD (e.g., voxelotor, L-glutamine).
• Regulatory hurdles in certain jurisdictions.
• Economic and supply chain disruptions affecting production costs.

Strategic Implications

Manufacturers are likely to focus on cost-efficient production, global access programs, and collaborations with healthcare providers. Market entry in underrepresented regions, along with educational initiatives for physicians, could stimulate further demand.

Key Takeaways

• Hydroxyurea's market is stable, with ongoing expansion driven by SCD prevalence.
• Generic competition has driven prices down but stabilizes revenues for incumbent producers.
• No significant pipeline developments are expected for branded hydroxyurea, given patent expiry.
• Growth prospects hinge on increasing diagnosis rates, expanding indications, and improving access in emerging markets.
• Innovations in formulation may marginally influence market share but are unlikely to disrupt the overall market dominance of generics.

FAQs

Q1: What factors limit hydroxyurea's market growth?
A1: Competition from newer agents and generics reduces profitability; regulatory hurdles and the slow adoption in some regions also constrain expansion.

Q2: Are there upcoming patent protections for hydroxyurea?
A2: No. Hydroxyurea filed no new patents beyond the original, which expired in most jurisdictions by 2010.

Q3: How has COVID-19 impacted hydroxyurea sales?
A3: The pandemic caused temporary disruptions in supply chains and healthcare services, but demand remained steady due to the chronic nature of its indications.

Q4: What alternatives threaten hydroxyurea's market?
A4: Drugs like voxelotor and L-glutamine for sickle cell disease and targeted therapies for certain cancers could substitute hydroxyurea in specific indications.

Q5: Which regions offer the most growth potential?
A5: Sub-Saharan Africa and South Asia have high sickle cell disease burdens and expanding healthcare infrastructure, offering growth opportunities.

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References

[1] Statista. (2023). Hydroxyurea market size and forecast. Retrieved from https://www.statista.com
[2] MarketWatch. (2023). Global hydroxyurea market analysis. Retrieved from https://www.marketwatch.com
[3] U.S. Food and Drug Administration. (2022). Drug approvals and indications for hydroxyurea. Retrieved from https://www.fda.gov
[4] European Medicines Agency. (2022). Market authorizations for hydroxyurea. Retrieved from https://www.ema.europa.eu