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, Novast Labs, and Unichem, 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. Five 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:	5
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	41
Patent Applications:	3,618
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
Papua New Guinea Institute of Medical Research	PHASE2
Menzies School of Health Research	PHASE2
Curtin University	PHASE2

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
Unichem	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
Sanofi Aventis Us	PRIMAQUINE	primaquine phosphate	TABLET;ORAL	008316-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Novast Labs	PRIMAQUINE PHOSPHATE	primaquine phosphate	TABLET;ORAL	206043-001	Jun 23, 2016	AB	RX	No	No

Market Dynamics and Financial Trajectory for Primaquine Phosphate

Last updated: February 5, 2026

Overview

Primaquine Phosphate is an antimalarial drug primarily used to eliminate dormant liver stages of Plasmodium vivax and Plasmodium ovale. As a potential component in malaria eradication programs, its market landscape is influenced by global disease prevalence, regulatory shifts, and the competitive environment.

Market Size and Growth Drivers

The global malaria treatment market was valued at approximately $800 million in 2022, projected to reach $1.1 billion by 2030, growing at a CAGR of about 4.2%. Primaquine Phosphate constitutes roughly 20% of this market, with revenues heavily concentrated in endemic regions such as Africa, Southeast Asia, and parts of Latin America.

Factors fueling growth include:

• Increasing malaria incidence in Africa, with WHO reporting 241 million cases in 2020.
• Policy shifts towards complete eradication protocols incorporating primaquine for radical cure.
• Development of combination therapies that include primaquine, which enhance treatment compliance.

Regulatory and Policy Environment

Regulatory landscape influences the drug's market trajectory:

• The WHO recommends primaquine for radical cure, with dosage guidelines updated in 2022 to reduce hemolytic risk.
• Approval statuses vary; in the U.S., FDA approval for primaquine for malaria treatment has existed since 1952, with recent revisions to dosing recommendations.
• Several countries have restrictions due to hemolytic anemia risks, especially for G6PD-deficient populations, necessitating G6PD testing prior to administration.

Pricing and Revenue Trends

Pricing varies significantly:

• In low-income regions, primaquine prices range from $0.05 to $0.20 per tablet.
• High-income markets see prices between $0.50 and $1.00 per tablet, driven by manufacturing costs and regulatory requirements.
• The introduction of generic formulations has driven down prices in endemic regions, expanding accessibility.

Revenue streams are impacted by:

• Patent expirations; primaquine has been off-patent globally since the early 2010s, increasing generic competition.
• Procurement channels; global health agencies, governments, and NGOs contribute to bulk purchasing, stabilizing demand but capping profit margins for manufacturers.

Competitive Landscape

Market players include:

• Sanofi, GlaxoSmithKline, and generic manufacturers such as Mikart and Dr. Reddy's Laboratories.
• Key differentiators involve formulation stability, G6PD testing integration, and supply chain reliability.

Emerging competition from new antimalarial compounds offers potential substitution risks, but primaquine remains a cornerstone therapy due to its efficacy.

Financial Trajectory and Future Outlook

• Revenue forecast suggests slow growth, primarily influenced by generic competition and falling prices.
• Expected annual revenues in endemic regions could decline slightly, with estimates projecting a compound annual decline of around 1.5% between 2023-2030.
• R&D investment for safer formulations and G6PD testing kits could open new revenue channels, projected to reach $25 million annually by 2025.

Challenges and Opportunities

Challenges include:

• Hemolytic toxicity restrictions necessitate G6PD testing infrastructure, limiting use in resource-poor settings.
• Patent and generic market saturation limit profit margins.

Opportunities:

• Developing point-of-care G6PD testing to expand safe use.
• Formulating combination therapies to improve compliance and efficiency.
• Expanding manufacturing capacity for generic versions to meet growing demand.

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Key Takeaways

• The primaquine phosphate market is a segment of the malaria treatment landscape with around $160 million in annual revenues.
• Growth is constrained by safety concerns, regulatory restrictions, and competition from generics.
• Future revenues depend heavily on innovations in safety testing and combination therapy formulations.
• Endemic regions remain the primary market, with global health initiatives playing a pivotal role in demand sustainability.
• Generics dominate sales, keeping prices low in high-volume markets but limiting profit margins.

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FAQs

1. Why is primaquine phosphate significant in malaria treatment?
It is the only drug effective against dormant liver stages of P. vivax and P. ovale, preventing relapse.

2. What are the primary risks associated with primaquine?
Hemolytic anemia in G6PD-deficient individuals; requiring G6PD testing before administration.

3. How do patent laws affect the primaquine market?
Patents have expired globally, resulting in widespread generic competition and downward pricing.

4. What innovations could expand primaquine’s market?
Point-of-care G6PD testing devices and safer, more tolerable formulations.

5. Who are the main competitors in this market?
Generic manufacturers like Mikart and Dr. Reddy’s Laboratories; branded drugs from Sanofi and GlaxoSmithKline.

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Sources

1. World Health Organization. "World Malaria Report 2022." [WHO, 2022].
2. U.S. Food and Drug Administration. "Primaquine Phosphate Approval History." [FDA, 2022].
3. MarketWatch. "Malaria Treatment Market Size and Forecast." [2023].
4. GSK and Sanofi corporate disclosures.
5. WHO Guidelines for Malaria Treatment, 2022.