PRIMAQUINE PHOSPHATE - Generic Drug Details

What are the generic sources for primaquine phosphate and what is the scope of freedom to operate?

Primaquine phosphate is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Alvogen, Bayshore Pharms Llc, and Novast Labs, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for primaquine phosphate. Six suppliers are listed for this compound.

Summary for PRIMAQUINE PHOSPHATE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	40
Patent Applications:	1,310
What excipients (inactive ingredients) are in PRIMAQUINE PHOSPHATE?	PRIMAQUINE PHOSPHATE excipients list
DailyMed Link:	PRIMAQUINE PHOSPHATE at DailyMed

Recent Clinical Trials for PRIMAQUINE PHOSPHATE

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

Sponsor	Phase
University of California, San Francisco	Phase 2/Phase 3
Pan American Health Organization	Phase 2/Phase 3
Mahidol Oxford Tropical Medicine Research Unit	Phase 4

See all PRIMAQUINE PHOSPHATE clinical trials

Pharmacology for PRIMAQUINE PHOSPHATE

Drug Class

Antimalarial

Medical Subject Heading (MeSH) Categories for PRIMAQUINE PHOSPHATE

Antimalarials

Anatomical Therapeutic Chemical (ATC) Classes for PRIMAQUINE PHOSPHATE

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

US Patents and Regulatory Information for PRIMAQUINE PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novast Labs	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	206043-001	Jun 23, 2016	AB	RX	No	No
Sanofi Aventis Us	PRIMAQUINE	primaquine phosphate	TABLET;ORAL	008316-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Bayshore Pharms Llc	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	204476-001	Feb 25, 2014	AB	RX	No	No
Alvogen	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	203924-001	Feb 3, 2014		DISCN	No	No

PRIMAQUINE PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Primaquine Phosphate

Introduction

Primaquine phosphate is a crucial antimalarial drug, particularly for treating the liver stages of Plasmodium vivax malaria. Despite its importance, the market for primaquine phosphate is influenced by several factors, including regulatory requirements, patient adherence, and the presence of alternative treatments.

Market Size and Forecast

The global market for primaquine phosphate, as part of the broader antimalarial market, has seen significant fluctuations. While specific figures for primaquine phosphate alone are not readily available, the antimalarial market as a whole provides some context.

• The antimalarial medicines market, which includes primaquine phosphate, has been shaped by global health initiatives and changing market dynamics. For instance, the Global Fund has played a significant role in financing and market shaping, which has impacted the availability and pricing of antimalarial drugs[3].

Pricing and Cost-Effectiveness

Pricing Trends

The pricing of primaquine phosphate is influenced by several factors, including production costs, regulatory requirements, and market demand.

• Historically, the prices of antimalarial drugs, including primaquine phosphate, have been subject to volatility. Factors such as over-capacity in production, poor demand visibility, and speculative market practices have contributed to price fluctuations[3].

Cost-Effectiveness

The cost-effectiveness of primaquine phosphate is a critical consideration, especially in resource-poor settings where malaria is prevalent.

• A study comparing tafenoquine with primaquine for the treatment of P. vivax malaria found that tafenoquine, despite being more expensive, could be highly cost-effective due to its single-dose regimen and higher patient adherence rates. This suggests that while primaquine phosphate is cheaper per dose, its overall cost-effectiveness may be lower due to adherence issues[2].

Regulatory and Safety Considerations

G6PD Deficiency Screening

One of the significant regulatory and safety considerations for primaquine phosphate is the need for glucose-6-phosphate dehydrogenase (G6PD) deficiency screening. Primaquine can cause severe hemolysis in patients with G6PD deficiency, which is prevalent in malaria-endemic areas.

• The necessity for G6PD screening adds to the overall cost and complexity of using primaquine phosphate. This has led to the development of alternative treatments like tafenoquine, which also require G6PD screening but offer a single-dose regimen[2][5].

Patient Adherence

Patient adherence to the treatment regimen is a critical factor in the effectiveness and cost-effectiveness of primaquine phosphate.

• The traditional 7-day low-dose primaquine treatment regimen has suboptimal adherence rates, ranging from 62% to 86% in some studies. This low adherence can lead to reduced efficacy and increased transmission of malaria[2].

Alternative Treatments

The market for primaquine phosphate is also influenced by the availability of alternative treatments.

• Tafenoquine, a recently approved drug, offers a single-dose regimen that overcomes the adherence barrier associated with primaquine phosphate. However, tafenoquine is more expensive and also requires G6PD screening[2].

Global Health Initiatives

Global health initiatives play a significant role in shaping the market for antimalarial drugs, including primaquine phosphate.

• Organizations like the Global Fund have implemented strategies to improve the availability and affordability of quality-assured antimalarial drugs. These initiatives include negotiations with manufacturers, buyer subsidies, and support for effective scale-up of antimalarial treatments[3].

Supply Chain and Production

The supply chain and production dynamics of primaquine phosphate are crucial for its availability and pricing.

• The production of antimalarial drugs, including primaquine phosphate, is affected by factors such as raw material pricing, production capacity, and quality standards. The Global Fund's procurement strategies aim to optimize pricing, ensure long-term product availability, and encourage production closer to demand[3].

Economic Impact

The economic impact of primaquine phosphate extends beyond the direct costs of the drug to include societal and healthcare costs.

• In Brazil, for example, the control of P. vivax malaria, which involves the use of primaquine phosphate, incurs significant societal costs. The estimated national societal cost of P. vivax malaria in Brazil was approximately $17.6 million in 2017[2].

Future Outlook

The future outlook for primaquine phosphate is influenced by ongoing research, regulatory changes, and market dynamics.

• As safer and more effective regimens are developed, the market share of primaquine phosphate may decline. However, its role in treating P. vivax malaria will likely continue, especially in areas where alternative treatments are not readily available or affordable[5].

Key Takeaways

• Market Size and Forecast: The antimalarial market, which includes primaquine phosphate, is subject to fluctuations influenced by global health initiatives and market dynamics.
• Pricing and Cost-Effectiveness: Primaquine phosphate faces pricing volatility and lower cost-effectiveness due to adherence issues compared to alternatives like tafenoquine.
• Regulatory and Safety Considerations: G6PD deficiency screening is a critical regulatory and safety requirement for primaquine phosphate.
• Patient Adherence: Low adherence rates to the traditional 7-day regimen affect the efficacy and cost-effectiveness of primaquine phosphate.
• Alternative Treatments: Tafenoquine offers a single-dose alternative that may reduce the market share of primaquine phosphate.
• Global Health Initiatives: Organizations like the Global Fund play a significant role in shaping the market and improving drug availability and affordability.
• Supply Chain and Production: Production dynamics and supply chain strategies impact the availability and pricing of primaquine phosphate.
• Economic Impact: The economic impact of primaquine phosphate includes significant societal and healthcare costs.

FAQs

1. What is the primary use of primaquine phosphate?

   • Primaquine phosphate is primarily used to treat the liver stages (hypnozoites) of Plasmodium vivax malaria.

2. Why is G6PD deficiency screening necessary for primaquine phosphate?

   • G6PD deficiency screening is necessary because primaquine phosphate can cause severe hemolysis in patients with G6PD deficiency.

3. How does patient adherence affect the efficacy of primaquine phosphate?

   • Low adherence to the traditional 7-day primaquine regimen can significantly reduce its efficacy and increase the transmission of malaria.

4. What are the alternative treatments to primaquine phosphate?

   • Tafenoquine is a recently approved alternative that offers a single-dose regimen for treating P. vivax malaria.

5. How do global health initiatives impact the market for primaquine phosphate?

   • Global health initiatives, such as those by the Global Fund, improve the availability and affordability of quality-assured antimalarial drugs, including primaquine phosphate.

Sources

1. IMARC Group: Chloroquine Phosphate Prices, News, Analysis and Forecast.
2. PLOS Medicine: Tafenoquine following G6PD screening versus primaquine for the treatment of Plasmodium vivax malaria.
3. The Global Fund: Antimalarial Medicines Strategy – Supplier Consultation.
4. Market Research Intellect: Global Primaquine Phosphate API Market Size, Scope And Forecast Report.
5. American Journal of Tropical Medicine and Hygiene: Primaquine-induced Severe Hemolysis in the Absence of Clinical Malaria.