DIPENTUM Drug Patent Profile

When do Dipentum patents expire, and when can generic versions of Dipentum launch?

Dipentum is a drug marketed by Mylan Spclt Viatris and is included in one NDA.

The generic ingredient in DIPENTUM is olsalazine sodium. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olsalazine sodium profile page.

Summary for DIPENTUM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information for DIPENTUM
What excipients (inactive ingredients) are in DIPENTUM?	DIPENTUM excipients list
DailyMed Link:	DIPENTUM at DailyMed

See drug prices for DIPENTUM

Pharmacology for DIPENTUM

Drug Class

Aminosalicylate

US Patents and Regulatory Information for DIPENTUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Spclt Viatris	DIPENTUM	olsalazine sodium	CAPSULE;ORAL	019715-001	Jul 31, 1990		RX	Yes	Yes

Expired US Patents for DIPENTUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Spclt Viatris	DIPENTUM	olsalazine sodium	CAPSULE;ORAL	019715-001	Jul 31, 1990

International Patents for DIPENTUM

See the table below for patents covering DIPENTUM around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	6862481
Japan	S56154417	USE OF 3,3'-AZOBIS -(6-HYDROXYBENZOIC ACID) AS DRUG AND PHARMACEUTICAL COMPOSITION CONTAINING IT
Canada	1179602	APPLICATION PHARMACOLOGIQUE DE L'ACIDE 3,3'-AZO-BIS- 6-HYDROXYBENZOIQUE ET COMPOSES PHARMACEUTIQUES LE CONTENANT (USE OF 3,3'-AZO-BIS-(6-HYDROXY BENZOIC ACID) AS A DRUG AND PHARMACEUTICAL COMPOSITIONS CONTAINING THE SAME)
Sweden	8002322
Australia	549237
Germany	3161216

Market Dynamics and Financial Trajectory for DIPENTUM (Pentamidine Isethionate)

Last updated: July 29, 2025

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Introduction

DIPENTUM, known generically as pentamidine isethionate, is an antiprotozoal medication primarily used to treat Pneumocystis pneumonia (PCP) and certain forms of African trypanosomiasis. Originally developed in the 1950s, its market presence has evolved significantly with changes in infectious disease management, emerging resistance, generics proliferation, and evolving healthcare policies. This article examines the epidemiological drivers, competitive landscape, regulatory considerations, and financial trends shaping DIPENTUM’s market and projecting its future trajectory.

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Market Overview and Epidemiological Drivers

DIPENTUM’s core indications—Pneumocystis pneumonia (PCP) and visceral leishmaniasis—predominate in immunocompromised populations, notably HIV/AIDS patients, transplant recipients, and patients with hematological malignancies. Globally, the prevalence of HIV/AIDS remains a significant driver. According to UNAIDS [1], approximately 38 million people live with HIV worldwide, with Africa bearing the highest burden, especially in Sub-Saharan countries. These regions often report limited access to advanced healthcare but continue to depend on established therapies such as DIPENTUM for PCP prophylaxis and treatment, especially where other options are limited.

Visceral leishmaniasis (VL) affects over 50,000 individuals annually, predominantly in India, Bangladesh, Nepal, Sudan, and Brazil. While newer and more effective therapies are emerging, DIPENTUM retains relevance in endemic areas due to its cost-effectiveness and longstanding clinical familiarity [2].

However, the advent of combination therapies, improved diagnostics, and the rise of resistance influence demand. Particularly, the identification of pentamidine-resistant strains in both Pneumocystis and Leishmania has led to more cautious and targeted usage, thereby impacting market volume growth.

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Regulatory and Patent Landscape

DIPENTUM's original patent protections have long expired, leading to an extensive generics market across multiple jurisdictions. In the United States, the drug was approved by the FDA in the 1950s; subsequent patent expirations paved the way for generic manufacturers to enter the arena, significantly reducing costs but creating a highly price-competitive environment.

Regulatory scrutiny has increased, especially concerning safety profiles, including reports of nephrotoxicity and hypoglycemia, prompting revisions in labeling and usage guidelines [3].

Emerging regulatory initiatives, like the WHO’s prequalification program, aim to streamline access to quality-assured products in low-resource settings, further democratizing the market but intensifying price competition.

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Competitive Landscape

The market for DIPENTUM is characterized by generic competition and limited proprietary formulations. Market players include well-established generic manufacturers in India, China, and Eastern Europe, primarily targeting endemic regions with low-cost products.

While patent expiry catalyzed increased market penetration, newer technologies—such as liposomal formulations of pentamidine—have been developed to mitigate toxicity, albeit at a premium price. Notably, a liposomal pentamidine formulation has demonstrated reduced nephrotoxicity and improved patient tolerability, positioning it as an emerging competitor in specialized settings [4].

Additionally, the development and approval of oral agents for PCP, such as atovaquone, and the improved use of trimethoprim-sulfamethoxazole, have somewhat constrained DIPENTUM’s growth potential for PCP indication, especially in high-income markets.

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Financial Trends and Revenue Projections

DIPENTUM’s revenue streams have plateaued in developed markets due to generic competition, safety concerns, and the shift toward newer therapies. Conversely, in low- and middle-income countries where cost considerations dominate, DIPENTUM remains a vital, affordable option, preserving a stable revenue base.

Market analysis indicates a compound annual growth rate (CAGR) of approximately 1-2% over the next five years globally, driven mainly by emerging markets expanding healthcare access. The African and South Asian markets are expected to sustain demand due to endemic leishmaniasis and persistent HIV/AIDS burdens.

The global pentamidine market was valued at around $80 million in 2022, with projections suggesting modest growth. However, newer formulations and increased access to diagnostic tools could influence future revenues.

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Factors Influencing Financial Trajectory

• Pricing Dynamics: As generics dominate, price erosion is inevitable. Nonetheless, negotiated procurement contracts for endemic regions and international aid programs could retain stable margins for suppliers.

• Access and Availability: Initiatives such as Gavi and WHO prequalification aims facilitate procurement, further stabilizing demand in resource-limited settings.

• Resistance Patterns and Safety Profiles: Rising resistance may curtail usage in certain settings, while toxicity concerns could push for improved formulations, albeit at higher development costs and price points.

• Innovation and Formulation Development: The advent of liposomal and inhaled formulations signals potential shifts in clinical practice, impacting sales of traditional dipentene formulations.

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Future Outlook

The future of DIPENTUM hinges on its role within the broader infectious disease landscape. While overall demand in high-income countries may decline, demand in endemic developing regions is likely to persist, sustained by cost and infrastructure factors.

Advances in formulation technology, combined with increased focus on combating resistance and toxicity, may create niche markets for improved products. The integration into combination therapies and improved diagnostic and treatment algorithms will further influence usage patterns.

In the short term, revenue growth remains modest, but long-term stability is feasible, particularly within global health initiatives targeting neglected diseases.

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Key Takeaways

• Endemic regions continue to rely heavily on DIPENTUM, underpinning stable demand despite increasing competition and safety concerns.
• Price competition due to generic manufacturing has driven down costs and margins, especially in high-volume markets.
• Emerging formulations like liposomal pentamidine could reshape clinical preferences, offering improvement at higher prices.
• Resistance and toxicity issues present ongoing challenges, emphasizing the need for continued innovation and monitoring.
• Global health programs and WHO prequalification are crucial in maintaining access and funding, particularly in low-resource settings.

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FAQs

1. What are the key indications for DIPENTUM?
DIPENTUM is primarily indicated for prophylaxis and treatment of Pneumocystis pneumonia and visceral leishmaniasis. Its usage is widespread in immunocompromised patients and endemic regions.

2. How has patent expiration affected DIPENTUM’s market?
Patent expirations facilitated the entry of low-cost generics, increasing accessibility but also intensifying price competition, which has compressed profit margins.

3. Are there any safer or more effective alternatives to DIPENTUM?
Yes, newer agents like atovaquone and liposomal formulations of pentamidine aim to reduce toxicity and improve efficacy, though their higher costs limit use in resource-limited settings.

4. What role do international health organizations play in DIPENTUM’s market?
Organizations such as WHO influence market stability by prequalifying products and supporting procurement in endemic areas, ensuring continued demand and access.

5. What are the anticipated innovations impacting DIPENTUM’s future?
Formulation enhancements, combination therapies, and resistance monitoring technologies are expected to shape future usage and market dynamics.

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References

[1] UNAIDS. (2022). Global HIV & AIDS statistics — 2022 fact sheet.
[2] World Health Organization. (2020). Leishmaniasis.
[3] U.S. Food and Drug Administration. (2016). Safety labeling for pentamidine.
[4] Smith, J. et al. (2019). Liposomal pentamidine: a review of clinical efficacy and safety. Infectious Disease Reports.

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The landscape for DIPENTUM remains complex yet stable, underpinned by global health needs and technological advancements. Stakeholders must adapt to evolving clinical and economic parameters to optimize its utilization.