PAROMOMYCIN SULFATE Drug Patent Profile

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

Paromomycin Sulfate is a drug marketed by Heritage and Sun Pharm Inds Inc and is included in two NDAs.

The generic ingredient in PAROMOMYCIN SULFATE is paromomycin sulfate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the paromomycin sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Paromomycin Sulfate

A generic version of PAROMOMYCIN SULFATE was approved as paromomycin sulfate by HERITAGE on December 14^th, 2007.

Summary for PAROMOMYCIN SULFATE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	9
Patent Applications:	5,772
DailyMed Link:	PAROMOMYCIN SULFATE at DailyMed

Recent Clinical Trials for PAROMOMYCIN SULFATE

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

Sponsor	Phase
Makerere University	Phase 3
The Netherlands Cancer Institute	Phase 3
Kenya Medical Research Institute	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
Heritage	PAROMOMYCIN SULFATE	paromomycin sulfate	CAPSULE;ORAL	065173-001	Dec 14, 2007		RX	No	Yes
Sun Pharm Inds Inc	PAROMOMYCIN SULFATE	paromomycin sulfate	CAPSULE;ORAL	064171-001	Jun 30, 1997		DISCN	No	No

Paromomycin Sulfate Market Dynamics, Financial Trajectory, Patents, and Competitive Outlook

Last updated: September 3, 2026

Paromomycin sulfate is a mature, low-revenue anti-infective with limited patent protection, modest commercial differentiation, and demand concentrated in intestinal amebiasis, selected parasitic infections, and public-health programs. The product’s financial trajectory is driven by generic pricing, hospital and public-sector procurement, API availability, and intermittent supply constraints rather than by exclusivity or premium innovation.

The molecule has no meaningful remaining composition-of-matter patent barrier in major markets. U.S. commercial exposure is concentrated in oral paromomycin products such as Humatin and generic equivalents. Public company filings generally do not disclose paromomycin revenue separately, preventing a reliable molecule-level sales estimate.

What is paromomycin sulfate used for?

Paromomycin sulfate is an aminoglycoside antibiotic derived from Streptomyces species. It has poor gastrointestinal absorption when administered orally, allowing high intestinal concentrations.

The FDA-approved oral indication is intestinal amebiasis caused by Entamoeba histolytica. The U.S. label also identifies use as an adjunct in the management of hepatic coma, although contemporary treatment practice is more selective. Paromomycin is also used off label or through non-U.S. regulatory pathways for:

• Cryptosporidiosis, particularly in immunocompromised patients
• Visceral leishmaniasis through intramuscular formulations
• Other intestinal protozoal infections
• Selected veterinary and animal-health applications

The oral product is not interchangeable with injectable paromomycin used in visceral leishmaniasis. These products have different delivery systems, dosing regimens, manufacturers, and regulatory histories.

How does paromomycin sulfate work?

Paromomycin binds to bacterial and protozoal ribosomal structures and disrupts protein synthesis. Its poor oral absorption limits systemic exposure but supports treatment of intestinal infections. Systemic administration can cause aminoglycoside-class toxicities, including nephrotoxicity and ototoxicity.

What is the FDA regulatory status of paromomycin sulfate?

The FDA-approved U.S. product is oral paromomycin sulfate, historically marketed as Humatin capsules. The product is an established small-molecule drug rather than a biologic and does not require a biosimilar pathway.

Regulatory attribute	Status
Active ingredient	Paromomycin sulfate
Drug class	Aminoglycoside antibiotic
U.S. dosage form	Oral capsules
FDA-approved indication	Intestinal amebiasis
Additional labeled use	Adjunctive management of hepatic coma
Approval pathway for generics	ANDA, subject to reference-product requirements
Biologic classification	Not applicable
REMS	No major product-specific REMS identified
Pediatric exclusivity	No current material exclusivity identified
Orphan-drug exclusivity	No material U.S. orphan exclusivity identified for the core oral product

The FDA label identifies paromomycin sulfate capsules in 250 mg strength. DailyMed lists the prescribing information and manufacturer-specific product records for marketed presentations.[1]

What is the Orange Book status of paromomycin sulfate?

Paromomycin sulfate has no commercially meaningful remaining patent exclusivity in the United States. The key commercial question is whether any current reference product has active, listed patents or regulatory exclusivities that could delay an ANDA launch.

The Orange Book is the controlling public source for listed patents and exclusivity associated with FDA-approved products. For a mature product such as oral paromomycin, the practical market expectation is:

Orange Book issue	Commercial effect
New chemical entity exclusivity	Expired
Original composition-of-matter patents	Expired
Pediatric exclusivity	Not a current market barrier
Active formulation patent estate	No material barrier generally associated with the legacy oral product
Active method-of-use patent estate	No material barrier generally associated with the approved core indication
ANDA pathway	Available subject to FDA requirements
Generic substitution	Possible where state and pharmacy rules permit

A current Orange Book review remains important for product-specific certification strategy because listings can change by sponsor and dosage form. The existence of an FDA-approved reference product does not, by itself, create a durable commercial moat.[2]

What patents protect paromomycin sulfate?

The original intellectual-property estate for paromomycin is historical and expired. No active composition-of-matter patent is expected to block generic development in the United States, Europe, or other mature pharmaceutical markets.

Potentially relevant intellectual-property categories include:

1. Formulation patents covering modified-release or combination products.
2. Manufacturing patents covering purification, crystallization, impurity control, or fermentation.
3. Method-of-use patents covering specific parasite populations or dosing schedules.
4. Device or packaging patents for injectable products.
5. Country-specific patents relating to a particular commercial formulation.

These categories have limited relevance to the established oral capsule market unless a sponsor introduces a differentiated product. A patent on a manufacturing process would not normally prevent a competitor from using an independent process.

How strong is the paromomycin patent estate?

The patent estate is weak for conventional oral paromomycin sulfate. Its strength is higher only for a sponsor that controls a newer formulation, a proprietary manufacturing process with difficult-to-design-around claims, or a regulated combination product.

Patent category	Current strength for standard oral product
Composition of matter	Very weak or expired
Conventional capsule formulation	Weak
Amebiasis method of use	Weak
API manufacturing process	Potentially moderate if claims remain enforceable
Injectable leishmaniasis product	Product-specific and jurisdiction-dependent
Novel delivery system	Potentially strong, but not inherent to paromomycin

When does paromomycin sulfate lose exclusivity?

Paromomycin lost its foundational market exclusivity decades ago. The molecule was discovered and developed in the mid-20th century, placing any original U.S. patent protection well beyond its statutory term.

The relevant exclusivity timeline is:

Period	Event
1950s	Paromomycin identified and developed as an aminoglycoside
1960s and 1970s	Early clinical and commercial use
Later decades	Oral products marketed for intestinal amebiasis
1990s onward	Generic and multi-source competition becomes commercially feasible
Current market	Mature generic product with no meaningful foundational exclusivity

The financial implications are direct. Revenue cannot be protected through price premiums based on patent status. Sponsors compete through supply reliability, regulatory compliance, procurement access, and manufacturing economics.

Are there Paragraph IV challenges to paromomycin sulfate?

A Paragraph IV challenge is not expected to be a central current issue for paromomycin sulfate. Paragraph IV certifications apply when an ANDA applicant asserts that a listed patent is invalid, unenforceable, or not infringed.

For a mature oral product with no material active patent barrier, an ANDA applicant would more commonly rely on a certification that no relevant patent is listed or that the patent-related requirements do not apply. A Paragraph IV litigation cycle would require a current Orange Book-listed patent with sufficient commercial value to justify litigation.

No widely reported, market-defining U.S. Paragraph IV litigation campaign is associated with the standard oral paromomycin product in the public record reviewed for this analysis.

What formulations are protected by paromomycin sulfate patents?

The conventional 250 mg oral capsule is a mature dosage form with little differentiation. More defensible opportunities would involve formulations that solve a recognized commercial or clinical problem.

Oral formulations

Oral capsules and other immediate-release forms are technically straightforward. The main barriers are bioequivalence, content uniformity, stability, sulfate salt control, and reliable API supply.

Injectable formulations

Intramuscular paromomycin used for visceral leishmaniasis has a separate commercial profile. Injectable development requires sterile manufacturing, container-closure validation, endotoxin control, stability data, and country-specific regulatory approvals.

Combination and targeted-delivery products

Potentially protectable approaches include:

• Paromomycin combined with another anti-infective
• Gastrointestinal-retention formulations
• Pediatric liquid or dispersible dosage forms
• Formulations designed to reduce excipient intolerance
• Region-specific products for neglected tropical diseases

These opportunities may support new patents, but they do not automatically expand the market. Clinical guidelines, procurement budgets, and disease prevalence remain the primary demand constraints.

What companies manufacture or market paromomycin sulfate?

The market includes the historical Humatin product and generic manufacturers operating across the United States, Europe, India, and other regulated or semi-regulated markets. Manufacturer participation varies by country and can change because of discontinuations, contract manufacturing arrangements, tender awards, and API availability.

Pfizer is historically associated with Humatin in the United States. Generic competition has emerged through companies able to source compliant paromomycin sulfate API and satisfy FDA or national regulatory requirements.

The commercial value of the brand is constrained by:

• Long-established generic substitution
• Limited prescribing volume
• Low treatment duration for many intestinal infections
• Price sensitivity in public-health procurement
• Lack of broad primary-care use
• Limited promotional return on investment

No single manufacturer’s public filings are generally sufficient to isolate paromomycin revenue from broader anti-infective sales.

What is the competitive landscape for paromomycin sulfate?

Paromomycin competes by indication rather than as a broad-spectrum antibiotic.

Clinical use	Paromomycin competitors	Relative market position
Intestinal amebiasis	Metronidazole, tinidazole, diloxanide furoate, iodoquinol	Niche, often used for luminal eradication or selected patients
Cryptosporidiosis	Nitazoxanide, supportive care, immune restoration	Limited and off-label in many settings
Visceral leishmaniasis	Liposomal amphotericin B, miltefosine, antimonials	Regionally relevant injectable option
Hepatic coma adjunct	Lactulose, rifaximin	Narrow and clinically selective
Veterinary infections	Species-specific anti-infectives	Separate regulatory and procurement market

Paromomycin’s strongest commercial position is where low cost, local availability, and suitability for intestinal or neglected tropical disease treatment outweigh the convenience or broader evidence base of competing products.

How does paromomycin compare with metronidazole?

Metronidazole has a much larger commercial market, broader indications, higher prescribing frequency, and deeper generic competition. Paromomycin is more specialized and is often used to address intestinal protozoal disease after systemic therapy or where a nonabsorbed agent is clinically preferred.

How does paromomycin compare with liposomal amphotericin B?

For visceral leishmaniasis, liposomal amphotericin B has major efficacy and procurement advantages in many programs but carries substantially higher manufacturing and treatment costs. Paromomycin can compete in lower-cost treatment programs, particularly in regions where injectable administration and local health-system capacity are available.

What is the market size and financial trajectory for paromomycin sulfate?

A reliable standalone global revenue figure is not publicly established. Public disclosures usually aggregate paromomycin into broader anti-infective, hospital-product, or international-health portfolios.

The financial trajectory is best described as mature, low growth, and procurement-sensitive:

Driver	Directional impact
Patent expiry	Sustained price pressure
Generic entry	Lower unit prices and fragmented share
Neglected tropical disease programs	Periodic volume support
Hospital shortages	Short-term price and allocation volatility
API concentration	Margin and supply risk
New formulations	Potential price uplift, but limited addressable demand
Public tenders	Volume growth with lower margins
Developed-market demand	Stable but narrow
Emerging-market demand	More variable and program-dependent

Revenue generally follows a low-volume generic trajectory rather than a conventional branded-drug lifecycle. A manufacturer with a reliable supply position can produce attractive niche margins even when total market revenue is small. The value lies in dependable procurement access, not in high unit pricing.

What financial risks affect paromomycin sulfate?

The principal risks are operational:

• API supply interruption
• Failure to maintain GMP compliance
• Product discontinuation by a low-volume supplier
• Tender loss in endemic-country programs
• Substitution by metronidazole, nitazoxanide, or newer leishmaniasis regimens
• Regulatory noncompliance in injectable manufacturing
• Low commercial return from required post-approval maintenance

Shortages can temporarily increase revenue for an available supplier, but they do not create durable pricing power unless the supplier controls a scarce API or has few qualified competitors.

What manufacturing and IP barriers affect paromomycin sulfate?

The API is produced through fermentation and downstream purification rather than conventional small-molecule chemical synthesis. Manufacturing complexity includes:

• Fermentation yield control
• Removal of related aminoglycoside impurities
• Sulfate salt conversion
• Assay and potency testing
• Residual solvent and microbial controls
• Batch-to-batch consistency
• Validation of impurity specifications

For oral capsules, finished-dose manufacturing is comparatively straightforward. Injectable products create higher barriers because of sterile processing and quality-system requirements.

The most important barrier is often regulatory execution. A manufacturer may have access to API but still fail to compete because of inadequate supplier qualification, incomplete stability data, inspection findings, or an inability to support country-specific dossiers.

Which companies are challenging paromomycin sulfate commercially?

Commercial challenge comes primarily from generic manufacturers and therapeutic substitutes rather than branded patent challengers. The market has no widely visible high-value patent contest comparable to those affecting blockbuster drugs.

The relevant competitive groups are:

1. Generic oral-capsule manufacturers in the United States and Europe.
2. Indian manufacturers serving leishmaniasis and tropical-disease programs.
3. API suppliers supporting multiple finished-dose companies.
4. Producers of competing anti-infectives, particularly metronidazole, tinidazole, nitazoxanide, and miltefosine.
5. Public-health suppliers competing for government and nongovernmental tenders.

What patent litigation and settlement agreements affect paromomycin sulfate?

No material, widely reported patent litigation or settlement agreement is associated with the standard oral paromomycin sulfate market. The absence of litigation reflects the product’s age, generic structure, and limited revenue pool.

Any future dispute would more likely involve:

• A new formulation
• A sterile injectable product
• API process claims
• Trade-secret allegations
• Manufacturing quality or regulatory issues
• Contractual disputes involving supply or procurement

Traditional Hatch-Waxman litigation is unlikely to materially reshape the established market unless a sponsor secures a new patent position around a reformulated product.

What is the geographic coverage of the paromomycin sulfate market?

Paromomycin has the strongest strategic relevance in regions affected by intestinal protozoal disease and visceral leishmaniasis.

Region	Market characteristics
United States	Small prescription market; FDA-approved oral product; generic economics
Europe	Country-specific authorization and reimbursement; limited volume
India	Important manufacturing and tropical-disease supply base
East Africa	Relevance to visceral leishmaniasis programs and public procurement
South Asia	Demand tied to parasitic disease burden and hospital access
Latin America	Use varies by national guidelines and availability
Global health programs	Tender-driven demand, often price sensitive

Geographic growth is more likely to come from expanded procurement in endemic regions than from increased use in the United States or Western Europe.

What generic launch scenarios exist for paromomycin sulfate?

The most likely launch scenarios are:

Low-price oral generic launch

A manufacturer enters with an ANDA or national equivalent, competes on price, and captures limited share. This scenario produces low revenue per patient but can support recurring institutional demand.

Supply-constrained premium

A manufacturer launches or maintains supply while competitors discontinue. Pricing improves temporarily, particularly in markets with few approved suppliers. The opportunity is vulnerable to rapid re-entry by other generic manufacturers.

Public-health tender expansion

An injectable or oral supplier wins contracts in endemic regions. Volume rises, but tender pricing limits gross margin.

Differentiated formulation launch

A sponsor introduces a pediatric, liquid, dispersible, combination, or modified-release product. This offers the strongest potential for pricing differentiation but requires clinical, regulatory, and commercial investment that may be difficult to justify against a small addressable market.

Key Takeaways

• Paromomycin sulfate is a mature generic anti-infective with limited standalone revenue visibility.
• Original patent and regulatory exclusivities have expired; no meaningful foundational patent barrier remains.
• The U.S. market centers on oral paromomycin sulfate capsules, historically including Humatin.
• Injectable paromomycin for visceral leishmaniasis is a separate, regionally focused opportunity.
• Generic competition, public procurement, and API reliability determine commercial performance.
• Metronidazole, tinidazole, nitazoxanide, miltefosine, and liposomal amphotericin B are the principal therapeutic competitors by indication.
• No major current Paragraph IV litigation or settlement agreement is associated with the standard oral product.
• Financial upside depends on supply continuity, tender access, and differentiated formulations rather than patent exclusivity.
• The highest practical market risk is low demand combined with manufacturing and regulatory costs.

FAQs About Paromomycin Sulfate Market Economics

Is paromomycin sulfate a profitable pharmaceutical product?

It can be profitable as a low-volume niche product when manufacturing costs are controlled and supply is reliable. Its limited demand and generic pricing make blockbuster-level returns unlikely.

Does paromomycin sulfate have biosimilar competition?

No. Paromomycin sulfate is a small-molecule drug, so competitors use generic-drug pathways rather than biosimilar applications.

Can a new company obtain exclusivity for paromomycin sulfate?

A company could seek protection for a novel formulation, manufacturing process, combination, or delivery system. It would not obtain new composition-of-matter exclusivity for the established molecule.

Is paromomycin sulfate included in global health procurement?

Paromomycin can be included in regional or disease-specific procurement programs, particularly for neglected tropical diseases. Procurement volume depends on national protocols, donor funding, and competing treatment availability.

What is the biggest commercial threat to paromomycin sulfate?

The largest threat is not patent expiry, which has already occurred. It is substitution by competing anti-infectives combined with low market volume, supplier discontinuation, and price pressure in government tenders.

References

1. U.S. National Library of Medicine. (n.d.). DailyMed: Paromomycin sulfate capsule prescribing information. https://dailymed.nlm.nih.gov/

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/

4. World Health Organization. (2023). WHO model list of essential medicines: 23rd list. https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2023.02

5. World Health Organization. (2023). Manual for case management of visceral leishmaniasis in the WHO South-East Asia Region. World Health Organization. https://www.who.int/teams/control-of-neglected-tropical-diseases/leishmaniasis-series**