Paromomycin sulfate - Generic Drug Details

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

Paromomycin sulfate is the generic ingredient in two branded drugs marketed by King Pfizer, Parkedale, Heritage, Sun Pharm Inds Inc, and Parke Davis, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for paromomycin sulfate. One supplier is listed for this compound.

Summary for paromomycin sulfate

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	9
Patent Applications:	6,615
What excipients (inactive ingredients) are in paromomycin sulfate?	paromomycin sulfate excipients list
DailyMed Link:	paromomycin sulfate at DailyMed

Recent Clinical Trials for paromomycin sulfate

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

Sponsor	Phase
Drugs for Neglected Diseases	Phase 3
The Institute of Endemic Diseases (IEND), University of Khartoum	Phase 3
University of Gondar	Phase 3

See all paromomycin sulfate clinical trials

Pharmacology for paromomycin sulfate

Drug Class

Antiprotozoal

Medical Subject Heading (MeSH) Categories for paromomycin sulfate

Amebicides

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for paromomycin sulfate

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for paromomycin sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pfizer	HUMATIN	paromomycin sulfate	CAPSULE;ORAL	062310-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sun Pharm Inds Inc	PAROMOMYCIN SULFATE	paromomycin sulfate	CAPSULE;ORAL	064171-001	Jun 30, 1997		DISCN	No	No
Parke Davis	HUMATIN	paromomycin sulfate	SYRUP;ORAL	060522-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Parkedale	HUMATIN	paromomycin sulfate	CAPSULE;ORAL	060521-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Heritage	PAROMOMYCIN SULFATE	paromomycin sulfate	CAPSULE;ORAL	065173-001	Dec 14, 2007		RX	No	Yes

Last updated: February 15, 2026

mmary:
Paromomycin sulfate, an aminoglycoside antibiotic used primarily for parasitic infections and certain bacterial conditions, faces a mixed market outlook. Its production, utilization, and revenue prospects depend on evolving clinical applications, regulatory pathways, and competitive landscape. Existing patents have expired or are nearing expiry, expanding generic entry. Market growth hinges on expanded indications, regulatory approvals, and regional adoption, particularly in low- and middle-income countries. Revenue generation remains constrained by limited patent exclusivity and competition from newer agents.

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What Are the Current Market Drivers for Paromomycin Sulfate?

Medical Use and Indications

Paromomycin sulfate is approved for treating amoebiasis and intestinal parasitic infections. It is also used in topical formulations for cutaneous leishmaniasis in some regions. Its off-label and investigational uses include tuberculosis adjunct therapy. The drug’s appeal lies in its low cost and oral administration.

Global Disease Burden and Demand

According to WHO data, approximately 200 million people are infected with various intestinal parasitic infections worldwide. The drug is in demand in endemic regions like South Asia, Africa, and Latin America. The World Health Organization promotes the use of affordable antiparasitic treatments, favoring older drugs like paromomycin.

Patent and Regulatory Status

Most patents expired by 2010, allowing generic manufacturers to produce and market the drug globally. Regulatory approvals are maintained mainly in developing countries and certain emerging markets. Limited approval in high-income markets restricts sales growth in those regions.

Regional Market Factors

• Developing Countries: High demand due to endemic infections and cost sensitivity.
• Developed Countries: Limited use; mainly investigational or niche applications.
• Regulation: Generic entry in markets like India, China, and Africa accelerates competition.

What Challenges Affect the Market for Paromomycin Sulfate?

Competition from Newer Agents

Alternatives such as metronidazole and tinidazole now dominate amoebiasis treatments. Liposomal formulations and combination therapies have improved efficacy and compliance, reducing paromomycin’s relative market share.

Limited Patent Protection and Market Exclusivity

Expired patents since 2010 mean no exclusivity rights. This has led to an influx of generics, pressuring prices downward. The absence of patent-driven margins discourages R&D investment and marketing.

Regulatory Hurdles and Geographic Variability

Limited approvals outside endemic regions impede expansion into established markets like North America and Europe. Variable regulatory pathways slow global dissemination.

Market Size Constraints

While significant in endemic regions, the global market size is limited compared to blockbuster drugs. Revenues primarily come from volume sales rather than high margins.

What Are the Future Revenue and Growth Opportunities?

Expanded Indications and Clinical Trials

Research into paromomycin’s use as an adjunct in tuberculosis and broader parasitic diseases could generate new indications. Clinical trials are ongoing or proposed in several countries, aiming to establish efficacy in leishmaniasis and other parasitic diseases.

Regional Market Expansion

Growth prospects lie in increasing adoption in Africa and Southeast Asia, where endemic infections remain a public health concern. Supportive policies by WHO and regional health authorities may facilitate access.

Formulation Innovations

Developments in oral delivery, fixed-dose combinations, and topical formulations can improve patient compliance and expand use cases.

Regulatory Pathways and Collaborations

Engagement with WHO prequalification programs or approval through local regulatory authorities can facilitate broader market access. Strategic partnerships with local manufacturers may boost distribution and affordability.

What Is the Financial Outlook for Paromomycin Sulfate?

Revenue Trends

The global market for antiparasitic agents was valued at approximately $4.2 billion in 2021 (Grand View Research). Paromomycin-alone is a minor component, likely under $100 million annually, largely driven by volume sales in endemic regions.

Margins and Pricing

Generic competition suppresses prices. Estimated retail prices vary by region; in India, a 1g vial costs around $0.20–$0.50. Margins are thin but compensate through high volume sales.

Investment and R&D

Limited R&D investment exists outside clinical trials for new indications. Most revenue stems from existing formulations. Future growth depends on expanding indications or formulations rather than new drug development.

What Are the Strategic Considerations for Stakeholders?

• Manufacturers: Focus on expanding regional access, producing affordable formulations, and pursuing expanded indications through clinical trials.
• Investors: Evaluate growth potential in endemic markets and regulatory pathways for new uses versus competitive dilution from generics.
• Regulators: Streamlining approval processes and supporting WHO prequalification could accelerate access in low-income regions.

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Key Takeaways

• Paromomycin sulfate benefits from low-cost manufacturing and high demand in endemic regions.
• Patent expiration has led to widespread generic competition, suppressing prices and margins.
• Market growth depends largely on expanding indications, formulations, and regional adoption.
• Competition from newer agents limits its use in developed markets.
• Investment opportunities include regional expansion and clinical development of new indications.

FAQs

1. What are the main clinical applications of paromomycin sulfate?
   It treats amoebiasis, intestinal parasitic infections, and topical leishmaniasis. Emerging research explores its role in tuberculosis adjunct therapy.

2. In which regions is paromomycin sulfate most widely used?
   Primarily in developing countries within Africa, South Asia, and Latin America due to high endemic infection rates and cost factors.

3. How does patent expiration affect the market for paromomycin?
   It permits widespread generic manufacturing, leading to price competition and reduced profit margins for original producers.

4. Are there opportunities for expanding the market for paromomycin sulfate?
   Yes. Clinical trials for new indications, formulation innovations, and regulatory approvals in additional regions can foster growth.

5. What limits the revenue potential of paromomycin?
   Patent expiry, competition from other drugs, limited approved indications outside certain regions, and the focus on volume sales over high margins.

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Sources:
[1] WHO. "Soil-transmitted helminth infections." 2022.
[2] Grand View Research. "Antiparasitic Drugs Market Size & Share." 2022.
[3] US FDA. "Generic Drug Approvals." 2021.