Hydroxyurea - Generic Drug Details

What are the generic drug sources for hydroxyurea and what is the scope of patent protection?

Hydroxyurea is the generic ingredient in five branded drugs marketed by Cheplapharm, Barr, Barr Labs Inc, Endo Operations, Leading, Qilu, Roxane, Nova Labs Ltd, and Theravia, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for hydroxyurea

US Patents:	0
Tradenames:	5
Applicants:	9
NDAs:	10
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	159
Clinical Trials:	288
Patent Applications:	3,970
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
Italfarmaco	Phase 3
Merck Sharp & Dohme LLC	Phase 3
Novartis	Phase 1/Phase 2

See all hydroxyurea clinical trials

Generic filers with tentative approvals for HYDROXYUREA

Applicant	Application No.	Strength	Dosage Form
		100MG/ML	SOLUTION;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
Nova Labs Ltd	XROMI	hydroxyurea	SOLUTION;ORAL	216593-001	Apr 4, 2024		RX	Yes	Yes
Roxane	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	074476-001	Aug 18, 1995		DISCN	No	No
Barr	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	075143-001	Oct 16, 1998	AB	RX	No	No
Cheplapharm	DROXIA	hydroxyurea	CAPSULE;ORAL	016295-003	Feb 25, 1998		DISCN	Yes	No
Barr Labs Inc	HYDROXYUREA	hydroxyurea	CAPSULE;ORAL	075020-001	Jul 30, 1998		DISCN	No	No
Cheplapharm	HYDREA	hydroxyurea	CAPSULE;ORAL	016295-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Theravia	SIKLOS	hydroxyurea	TABLET;ORAL	208843-001	Dec 21, 2017		RX	Yes	No

Expired US Patents for hydroxyurea

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	HYDREA	hydroxyurea	CAPSULE;ORAL	016295-001	Approved Prior to Jan 1, 1982	3,968,249

Hydroxyurea Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hydroxyurea

Introduction

Hydroxyurea, a medication with a wide range of therapeutic applications, is experiencing significant growth in the global pharmaceutical market. This article delves into the market dynamics, financial trajectory, and key factors influencing the hydroxyurea market.

Market Size and Forecast

The hydroxyurea market is projected to grow substantially over the next few years. As of 2023, the market size was valued at USD 1.2 billion and is expected to reach USD 2 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5% during the forecast period from 2024 to 2031[1].

Key Drivers of Market Growth

Rising Prevalence of Sickle Cell Disease

The increasing global incidence of sickle cell disease is a major driver for the hydroxyurea market. Hydroxyurea is a primary treatment for managing sickle cell disease, reducing the frequency of painful crises and the need for blood transfusions[4].

Cancer Treatment Applications

Hydroxyurea is also used in the treatment of certain cancers, such as chronic myelogenous leukemia and myeloproliferative disorders. The rising rates of cancer globally are boosting the demand for hydroxyurea in oncology[1][4].

Regulatory Approvals

The approval of hydroxyurea for new indications or formulations can significantly expand its market presence. Recent approvals, such as the FDA approval for pediatric patients with sickle cell anemia, have contributed to market growth[5].

Awareness and Education

Increased awareness among healthcare providers and patients about the benefits of hydroxyurea is leading to higher adoption rates. Educational initiatives, especially targeting young female SCD patients, are crucial for improving treatment adherence[5].

Generic Availability

The availability of generic versions of hydroxyurea makes the drug more accessible to a broader patient population, particularly in resource-limited settings. This has driven up usage and contributed to market growth[1].

Research and Development

Ongoing clinical trials and research into additional therapeutic uses of hydroxyurea are expected to enhance market growth. Major pharmaceutical and biotechnology companies are investing heavily in research and development, particularly for leukemia treatments[4].

Market Segmentation

By Formulation

The hydroxyurea market can be segmented into oral tablets and injectable forms. Oral tablets dominate the market due to their ease of administration and high patient compliance. Injectable forms are crucial in clinical settings where immediate therapeutic action is necessary[1].

By Geography

The market is segmented geographically into North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America. North America, particularly the United States, holds a prominent position due to advanced healthcare infrastructure and high disease prevalence. The Asia-Pacific region is emerging as a lucrative market driven by rising incidence rates of hematological conditions and increased government funding for healthcare initiatives[1].

Key Players

Major players in the hydroxyurea market include Bristol-Myers Squibb Company, Teva Pharmaceutical Industries Ltd., Novartis AG, Pfizer Inc., Mylan N.V., Hikma Pharmaceuticals PLC, Amgen Inc., Merck & Co., Inc., Apotex Inc., and Fresenius Kabi AG. These companies are adopting strategies such as partnerships, mergers and acquisitions, and research collaborations to maintain their market positions[1].

Challenges and Limitations

Regulatory Challenges

Stringent regulations regarding drug approval and safety can hinder market entry for new products. Regulatory challenges can slow down the approval process and impact the overall market growth[1].

Side Effects

Potential adverse effects such as bone marrow suppression and gastrointestinal issues may limit the use of hydroxyurea and affect patient compliance. These side effects can be a significant barrier to widespread adoption[1].

Competition

The availability of alternative treatments for conditions like sickle cell disease and certain cancers can restrict hydroxyurea’s market share. New disease-modifying treatments (DMTs) like l-glutamine, crizanlizumab, and voxelotor are also competing with hydroxyurea[2].

Market Awareness

Limited awareness among healthcare professionals and patients about the benefits and uses of hydroxyurea can impede its adoption. Educational programs and awareness campaigns are necessary to address this issue[1].

Cost Considerations

Pricing pressures from generic competition and healthcare budgets can restrict profitability for manufacturers. The cost-effectiveness of hydroxyurea, however, remains a significant driver, especially in resource-limited settings[1].

Supply Chain Issues

Disruptions in the supply chain can affect the availability of hydroxyurea, impacting market growth. Ensuring a stable supply chain is crucial for maintaining market momentum[1].

Clinical Limitations

Hydroxyurea is not suitable for all patients or conditions, which can limit its overall market potential. For instance, its use is contraindicated in certain patient groups, and it may not be effective for all types of cancers or hematological disorders[1].

Real-World Evidence and Uptake

Despite the proven benefits of hydroxyurea, real-world evidence shows that it remains underused. Studies have indicated that more than 75% of individuals hospitalized or receiving emergency care for SCD pain were not receiving recommended hydroxyurea. Interventions to increase the uptake of DMTs, including hydroxyurea, are necessary to improve patient outcomes[2].

Financial Trajectory

Revenue Growth

The projected revenue growth from USD 1.2 billion in 2023 to USD 2 billion by 2031 indicates a robust financial trajectory for the hydroxyurea market. This growth is driven by increasing demand, expanding applications, and growing awareness[1].

Investment in Research and Development

Major pharmaceutical companies are investing significantly in research and development to explore new therapeutic uses of hydroxyurea. This investment is expected to yield new indications and formulations, further driving market growth[4].

Market Expansion Strategies

Companies operating in the hydroxyurea market are focusing on various strategies such as partnerships, mergers and acquisitions, and collaborations to retain their market positions. These strategies are aimed at enhancing market presence and driving revenue growth[4].

Regional Dynamics

North America

North America, particularly the United States, is a leading market for hydroxyurea due to the high incidence of sickle cell disease and certain cancers, along with advanced healthcare infrastructure and significant R&D investments[1].

Europe

Europe is another critical market, with countries like Germany and France leading in demand due to sophisticated healthcare policies and growing awareness about rare diseases[1].

Asia-Pacific

The Asia-Pacific region is rapidly emerging as a lucrative market driven by the rise in incidence rates of hematological conditions and increased government funding for healthcare initiatives. Countries like China, India, and Japan are key contributors to this growth[1].

Key Takeaways

• The hydroxyurea market is expected to grow from USD 1.2 billion in 2023 to USD 2 billion by 2031, driven by increasing demand for sickle cell disease and cancer treatments.
• Regulatory approvals, awareness, and generic availability are key drivers of market growth.
• The market is segmented into oral and injectable forms, with oral tablets dominating due to ease of administration.
• North America and Europe are significant markets, while the Asia-Pacific region is emerging as a major player.
• Despite its benefits, hydroxyurea remains underused, highlighting the need for interventions to increase its uptake.

FAQs

What are the primary applications of hydroxyurea?

Hydroxyurea is primarily used to manage sickle cell disease, treat certain types of cancers such as chronic myelogenous leukemia, and in some cases, polycythemia vera[1][4].

Why is the hydroxyurea market growing?

The market is growing due to the rising prevalence of sickle cell disease, increasing cancer rates, regulatory approvals, and growing awareness among healthcare providers and patients[1].

What are the main challenges facing the hydroxyurea market?

Key challenges include regulatory hurdles, potential side effects, competition from alternative treatments, limited market awareness, cost considerations, supply chain issues, and clinical limitations[1].

Which regions are leading the hydroxyurea market?

North America, particularly the United States, and Europe are leading markets, while the Asia-Pacific region is rapidly emerging as a significant player[1].

What strategies are companies using to maintain their market positions?

Companies are adopting strategies such as partnerships, mergers and acquisitions, collaborations, and significant investments in research and development to retain their market positions[4].

Sources

1. Verified Market Research: Hydroxyurea Market Trends, Size, & Forecast.
2. JAMA Network Open: Use of Disease-Modifying Treatments in Patients With Sickle Cell Disease.
3. Market Research Future: Polycythemia Vera Market Size, Growth Prediction - 2032.
4. BioSpace: Hydroxyurea Market: Increase in research & development on leukemia treatment to drive the market.
5. MDPI: Prescribing Hydroxyurea in Sickle Cell Disease Patients.