Hydroxychloroquine sulfate - Generic Drug Details

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

Hydroxychloroquine sulfate is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Alkaloida Zrt, Amneal Pharms Co, Appco, Aurobindo Pharma Usa, Chartwell Rx, Creekwood Pharms, Hikma Pharms, Ipca Labs Ltd, Laurus, Sandoz, Senores Pharms, Teva Pharms, Watson Labs, Zydus Pharms Usa Inc, Concordia, and Novitium Pharma, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for hydroxychloroquine sulfate. Twenty-eight suppliers are listed for this compound.

Summary for hydroxychloroquine sulfate

US Patents:	0
Tradenames:	3
Applicants:	17
NDAs:	17
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	46
Patent Applications:	3,852
Drug Sales Revenues:	Drug sales revenues for hydroxychloroquine sulfate
What excipients (inactive ingredients) are in hydroxychloroquine sulfate?	hydroxychloroquine sulfate excipients list
DailyMed Link:	hydroxychloroquine sulfate at DailyMed

See drug sales revenues for hydroxychloroquine sulfate

Recent Clinical Trials for hydroxychloroquine sulfate

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

Sponsor	Phase
Henan Cancer Hospital	Phase 2
West Virginia University	Phase 1/Phase 2
Abramson Cancer Center of the University of Pennsylvania	Phase 2

See all hydroxychloroquine sulfate clinical trials

Pharmacology for hydroxychloroquine sulfate

Drug Class

Antimalarial Antirheumatic Agent

Medical Subject Heading (MeSH) Categories for hydroxychloroquine sulfate

Antimalarials

Antirheumatic Agents

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for hydroxychloroquine sulfate

P01BA	Aminoquinolines
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

P01BA	Aminoquinolines
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for hydroxychloroquine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ipca Labs Ltd	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	040766-001	Jun 14, 2007	AB	RX	No	No
Hikma Pharms	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	040760-001	Aug 15, 2007		DISCN	No	No
Accord Hlthcare	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	213342-004	Aug 18, 2021	AB	RX	No	Yes
Zydus Pharms Usa Inc	HYDROXYCHLOROQUINE SULFATE	hydroxychloroquine sulfate	TABLET;ORAL	040657-001	Sep 21, 2007	AB	RX	No	No

Hydroxychloroquine sulfate Market Analysis and Financial Projection Experimental

Hydroxychloroquine Sulfate Market Dynamics and Financial Trajectory

Market Overview

The hydroxychloroquine sulfate market is experiencing significant growth, driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global hydroxychloroquine market was valued at USD 1,270.86 million in 2022 and is projected to reach USD 3,246.88 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 12.44% during the forecast period of 2023 to 2030[1].

Another estimate suggests that the global hydroxychloroquine market will be valued at US$ 599.8 million in 2023 and is expected to exhibit a CAGR of 5.7% until 2030, reaching a value of US$ 882.8 million by the end of the forecast period[3].

Drivers of Market Growth

Rise in Malaria Prevalence

The increasing prevalence of malaria, particularly in low-income countries, is a significant driver of the hydroxychloroquine market. In 2018, there were over 228 million malaria cases reported worldwide, with 405,000 malaria-related deaths, highlighting the ongoing need for effective antimalarial treatments like hydroxychloroquine[1].

COVID-19 Impact

The COVID-19 pandemic has also boosted the demand for hydroxychloroquine. The drug was explored as a potential treatment for COVID-19, leading to increased production and distribution. For instance, Novartis International AG delivered 30 million doses of hydroxychloroquine tablets to the U.S. Department of Health and Human Services for clinical trials during the pandemic[1].

Government Support and Regulatory Approvals

Enhanced government support and regulatory approvals have further accelerated the market growth. The U.S. Food and Drug Administration (FDA) approved hydroxychloroquine for emergency use in treating COVID-19 patients, and similar approvals were seen in other regions, such as Europe[1][3].

Generic Drug Penetration

The increasing availability of generic hydroxychloroquine is another factor driving market growth. Generic versions of the drug are more affordable, making it accessible to a wider population and contributing to the overall market expansion[1].

Restraints and Challenges

Side Effects and Safety Concerns

Despite the growth drivers, the hydroxychloroquine market faces several challenges, including the side effects associated with the drug. Hydroxychloroquine can cause irreversible retinal damage, cardiomyopathy, and QT prolongation, among other serious side effects. These safety concerns necessitate careful monitoring and can limit the drug's use in certain patient populations[1][5].

Regulatory Hurdles

Regulatory hurdles and the need for prior authorization from insurance companies can also affect the market. The stringent regulatory environment and the requirement for ongoing clinical monitoring can slow down market penetration[2].

Market Segmentation

The hydroxychloroquine market is segmented based on several criteria:

Strength

• The drug is available in various strengths, including 200 mg, 400 mg, and 800 mg[1].

Grade

• The market includes different grades such as USP Standards Grade, EP Standards Grade, and Pharmaceutical Standards Grade[1].

Drug Class

• Hydroxychloroquine is classified as an antimalarial drug[2].

Dosage Forms and Route of Administration

• The drug is primarily administered orally in tablet form[2].

End-Users and Distribution Channel

• The market is segmented by end-users such as hospitals, clinics, and pharmacies, and by distribution channels including retail and online pharmacies[1][3].

Regional Analysis

North America

• This region dominated the hydroxychloroquine market due to its well-developed healthcare infrastructure and high spending on research and development. The presence of qualified workers and advanced manufacturing facilities further supports market growth in this area[1].

Asia-Pacific

• This region is expected to grow at the highest rate during the forecast period, driven by expanded government awareness campaigns and increasing healthcare costs. However, the growing availability of generic medications may slow the market expansion in this region[1].

Financial Considerations

Cost and Pricing

• The cost of hydroxychloroquine can vary based on factors such as treatment plan, insurance coverage, and the pharmacy used. For instance, the cost of a 200 mg tablet can differ significantly depending on whether the patient has insurance or is paying out of pocket[2].

Financial Assistance and Savings

• Patients can reduce the cost of hydroxychloroquine by obtaining a 90-day supply, using savings cards, and exploring drug assistance programs. Various websites and organizations provide resources to help patients manage the cost of the medication[2].

Recent Developments

Novel Drug Approvals

• The market has seen an increase in novel drug approvals, which is expected to boost growth. For example, the European Medical Agency clarified the use of hydroxychloroquine for COVID-19 patients in critical conditions[3].

Clinical Trials and Emergency Use

• The drug has been used in national emergency use programs for COVID-19 patients, highlighting its potential as a treatment option during public health crises[1][3].

Key Takeaways

• The hydroxychloroquine market is expected to grow significantly due to the rise in malaria prevalence and the COVID-19 pandemic.
• Government support and regulatory approvals are key drivers of market growth.
• The market faces challenges such as side effects and regulatory hurdles.
• The drug is segmented based on strength, grade, dosage forms, and end-users.
• North America and Asia-Pacific are significant regions in the market, with the latter expected to grow at the highest rate.

FAQs

Q: What is the projected market size of hydroxychloroquine by 2030?

A: The hydroxychloroquine market is expected to reach USD 3,246.88 million by 2030, growing at a CAGR of 12.44% during the forecast period[1].

Q: What are the main drivers of the hydroxychloroquine market?

A: The main drivers include the rise in malaria prevalence, the impact of the COVID-19 pandemic, and increased government support and regulatory approvals[1][3].

Q: What are the potential side effects of hydroxychloroquine?

A: Hydroxychloroquine can cause irreversible retinal damage, cardiomyopathy, and QT prolongation, among other serious side effects[1][5].

Q: How can patients reduce the cost of hydroxychloroquine?

A: Patients can reduce the cost by obtaining a 90-day supply, using savings cards, and exploring drug assistance programs[2].

Q: Which regions are expected to see significant growth in the hydroxychloroquine market?

A: North America currently dominates the market, but the Asia-Pacific region is expected to grow at the highest rate during the forecast period[1].

Sources

1. Data Bridge Market Research: "Hydroxychloroquine Market Size Value & Industry Statistics By 2030"
2. Medical News Today: "Hydroxychloroquine cost 2024: Coupons and more"
3. Coherent Market Insights: "Hydroxychloroquine Market - Share, Size and Industry Analysis"
4. Business Research Insights: "Hydroxychloroquine Sulfate Market Size & Trend [2032]"
5. FDA: "PLAQUENIL HYDROXYCHLOROQUINE SULFATE TABLETS, USP"