HUMATIN Drug Patent Profile

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

Humatin is a drug marketed by King Pfizer, Parkedale, and Parke Davis. and is included in three NDAs.

The generic ingredient in HUMATIN 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 Humatin

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

Summary for HUMATIN

US Patents:	0
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	85
Patent Applications:	5,426
DailyMed Link:	HUMATIN at DailyMed

US Patents and Regulatory Information for HUMATIN

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
Parkedale	HUMATIN	paromomycin sulfate	CAPSULE;ORAL	060521-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Parke Davis	HUMATIN	paromomycin sulfate	SYRUP;ORAL	060522-001	Approved Prior to Jan 1, 1982		DISCN	No	No

HUMATIN Market Dynamics, Patent Position, and Financial Trajectory

Last updated: October 16, 2026

Humatin is the branded oral formulation of paromomycin sulfate, a legacy aminoglycoside antibiotic used primarily for intestinal amebiasis caused by Entamoeba histolytica. Its commercial profile is defined by niche demand, generic substitution, limited systemic absorption, and minimal public disclosure of product-level revenue. Humatin does not have the characteristics of a high-growth pharmaceutical asset: regulatory exclusivity expired decades ago, patent barriers are unlikely to constrain generic competition, and financial performance depends more on supply continuity, contracting, and scarcity pricing than on clinical differentiation.

What is Humatin and how is it used?

Humatin contains paromomycin sulfate in oral capsule form. The drug remains largely within the gastrointestinal tract after oral administration, which supports its use against intestinal protozoal infection while limiting systemic exposure.[1]

The U.S. prescribing information identifies intestinal amebiasis as the principal labeled indication. Paromomycin is not a preferred treatment for extraintestinal amebiasis because oral drug concentrations in tissues are limited.[1]

Attribute	Humatin profile
Active ingredient	Paromomycin sulfate
Drug class	Aminoglycoside antibiotic
Route	Oral
Primary U.S. indication	Intestinal amebiasis
Typical dosage form	Capsules
Systemic absorption	Limited
Primary prescriber base	Infectious disease, gastroenterology, travel medicine
FDA approval status	Legacy approved product
Commercial status	Mature branded and generic market
Biosimilar relevance	None
Main competitive pressure	Generic paromomycin and alternative anti-amebic therapies

Paromomycin also has clinical use outside the U.S. in other formulations and indications, including visceral leishmaniasis. Those markets should not be treated as direct Humatin revenue because they may involve injectable products, different manufacturers, public-sector procurement, and separate regulatory approvals.

How large is the Humatin market?

The Humatin market is small compared with markets for chronic therapies, hospital antibiotics, or high-volume anti-infective products. Demand is episodic and tied to confirmed or suspected parasitic infection, travel-related disease, outbreaks, and specialist prescribing.

Three factors constrain market size:

1. Intestinal amebiasis is a narrow indication in the U.S.
2. Treatment is generally short-course rather than chronic.
3. Generic substitution limits branded price realization.

Paromomycin has clinical value when a nonabsorbed luminal agent is required. That value does not translate into broad commercial demand because competing therapies, including metronidazole followed by a luminal agent, tinidazole, iodoquinol, and nitazoxanide in selected settings, cover parts of the same treatment pathway.[2]

The addressable market is more durable than large. Patients with amebiasis may still require a luminal eradication agent after treatment of invasive disease. However, case volumes are not sufficient to create the revenue scale associated with mass-market anti-infectives.

What is Humatin’s financial trajectory?

Humatin-specific revenue is not separately disclosed in Pfizer’s public financial reporting, and publicly available filings do not provide a reliable product-level sales history. The financial trajectory must therefore be inferred from product maturity, market structure, and ownership disclosure rather than from audited Humatin revenue.

The commercial trajectory is best characterized as follows:

Period	Financial and market condition
Initial commercialization	Protected by legacy regulatory and commercial rights
Generic-entry period	Loss of exclusivity reduced branded pricing power
Mature market	Low-volume demand with generic substitution
Recent period	Revenue dependent on supply, contracting, price, and channel access
Long-term outlook	Stable niche demand, limited volume growth, possible price volatility

Humatin is unlikely to be a material contributor to Pfizer’s consolidated revenue. Products in this category can remain commercially useful despite immaterial corporate revenue because they serve narrow clinical needs and can generate returns through low manufacturing complexity, established distribution, and limited competition.

The largest financial risk is not demand collapse. It is market exit or supply interruption. A small market with few suppliers can produce price increases when one manufacturer withdraws, faces manufacturing problems, or reduces inventory. Those price increases may improve short-term revenue but can also accelerate prescriber substitution and payer pressure.

When did Humatin lose exclusivity?

Humatin’s core regulatory exclusivity and any meaningful original patent protection expired long before the current generic market. Paromomycin is an old aminoglycoside, and its underlying molecule is not protected by a modern composition-of-matter patent estate.

The relevant commercial conclusion is that Humatin has no credible remaining primary-product exclusivity comparable to a new chemical entity, orphan product, or reformulated specialty drug.

Exclusivity category	Current commercial significance
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	Not central to Humatin’s U.S. market position
Pediatric exclusivity	No material current relevance
Original composition patent	Expired or commercially obsolete
Formulation patent	No known active barrier with market-wide impact
Method-of-use patent	No known active barrier with market-wide impact
Generic substitution	Commercially relevant

Because the product is old, any remaining rights would have to arise from a specific formulation, manufacturing process, or later indication. Those rights would not ordinarily block generic paromomycin capsules across the market.

What patents protect Humatin?

No active patent estate is publicly associated with Humatin that would be expected to prevent generic entry into the core oral paromomycin capsule market. FDA product information identifies paromomycin sulfate as the active ingredient and does not indicate a current patent-based exclusivity strategy comparable to newer branded medicines.[1,3]

The principal intellectual-property position can be summarized as follows:

IP category	Assessment
Active ingredient	Public-domain legacy antibiotic
Oral capsule formulation	Low barrier; conventional dosage form
Manufacturing process	Potentially confidential know-how, but unlikely to block generic manufacture
Method of use	Limited commercial blocking power
Device or delivery system	Not applicable to standard Humatin capsules
Data exclusivity	Expired
Trade secrets	Possible for manufacturing and quality control, not market exclusivity

A manufacturer could hold process know-how relating to paromomycin sulfate synthesis, impurity controls, particle size, capsule filling, or stability. Those measures may support product quality and supply reliability, but they do not create the same barrier as an enforceable active patent covering the drug itself.

What is the Orange Book status of Humatin?

The FDA Orange Book is the primary U.S. source for approved drug products, therapeutic equivalence information, and listed patents or exclusivity periods.[3] Humatin’s commercial position is consistent with a legacy product whose original exclusivity has ended and whose market can be served by approved generic products.

The relevant Orange Book questions are:

• Whether a current Humatin product is listed as actively marketed.
• Whether approved generic paromomycin sulfate capsules have therapeutic-equivalence codes.
• Whether any patent or exclusivity entry remains attached to a current reference product.
• Whether the branded product is available through a current manufacturer or distributor.

The Orange Book should not be interpreted as evidence that a brand retains pricing power merely because an original reference product remains listed. A listed brand can coexist with generic products and have limited commercial share.

Are there Paragraph IV challenges to Humatin?

A commercially significant current Paragraph IV campaign is unlikely. Paragraph IV litigation is most valuable when the branded product has substantial revenue, a meaningful remaining patent term, or a high-value formulation. Humatin does not present those characteristics.

The expected generic-entry path for paromomycin capsules is therefore regulatory substitution rather than patent litigation. Any generic applicant would generally focus on:

• Pharmaceutical equivalence.
• Bioequivalence or applicable FDA requirements for the dosage form.
• Manufacturing controls.
• Active pharmaceutical ingredient sourcing.
• Label consistency.
• Supply reliability.

The absence of major Paragraph IV activity does not indicate strong patent protection. It indicates that the expected value of challenging a patent is low because the relevant exclusivity has already expired or does not materially constrain entry.

What formulation patents protect Humatin?

Humatin is a conventional oral capsule product. It does not rely on a complex delivery system, controlled-release platform, biologic formulation, injector, or proprietary device. That limits the opportunity for formulation-based lifecycle management.

Potential formulation issues include:

• Capsule strength and fill weight.
• Paromomycin sulfate stability.
• Moisture protection.
• Excipient compatibility.
• Dissolution performance.
• Microbiological and impurity controls.

These attributes can affect approval and manufacturing quality. They do not normally create a durable commercial moat unless a specific patented formulation has a clinically meaningful advantage and remains enforceable. No such formulation advantage is central to Humatin’s current market position.

Which companies compete with Humatin?

Competition occurs at two levels: direct paromomycin competition and therapeutic substitution.

Direct competitors

Direct competitors are generic manufacturers of oral paromomycin sulfate capsules. The relevant competitive variables are product availability, wholesaler access, dosage strengths, insurance coverage, and pharmacy substitution.

Because the market is narrow, one or two suppliers can have disproportionate influence over availability. A generic entrant may gain share quickly if it offers reliable supply, but total market growth remains limited.

Therapeutic competitors

Competitor or class	Competitive role
Metronidazole	Used for invasive amebiasis; often followed by a luminal agent
Tinidazole	Alternative nitroimidazole for amebiasis
Iodoquinol	Luminal amebicide and alternative eradication therapy
Nitazoxanide	Used in selected protozoal infections
Diloxanide furoate	Used in some non-U.S. markets
Other paromomycin products	May compete by indication or geography

Therapeutic substitution is constrained by the clinical requirement to eradicate luminal infection. A patient who receives metronidazole for invasive disease may still need a separate luminal drug. Humatin can therefore retain clinical relevance even when it is not the initial anti-infective selected.

What FDA regulatory issues affect Humatin?

The key regulatory issue is continued compliance for a mature drug rather than approval of a novel indication.

Important FDA considerations include:

• Maintenance of an approved product application.
• Current good manufacturing practice compliance.
• Quality of paromomycin sulfate active ingredient.
• Stability and dissolution testing.
• Accurate labeling.
• Adverse-event reporting.
• Drug-shortage notification and supply continuity.

Because Humatin is an old product, the commercial burden is often operational. Manufacturers must maintain a product that may have low annual volume but still requires full quality-system support. That cost structure can discourage additional entrants.

The FDA label also limits marketing claims. Use in clinical settings outside the approved indication may occur, but promotional activity must remain consistent with the approved labeling and applicable FDA rules.[1]

What generic launch scenarios exist for Humatin?

The most likely generic scenarios are incremental rather than disruptive.

Scenario 1: Stable generic supply

Multiple suppliers remain active, pricing stays competitive, and Humatin retains a small branded share based on prescriber familiarity or institutional purchasing.

Scenario 2: Supplier consolidation

One or more manufacturers exit because of low volume or manufacturing costs. Remaining suppliers gain negotiating leverage, and prices become more volatile.

Scenario 3: Branded withdrawal

The brand becomes unavailable or commercially insignificant while generic paromomycin continues to supply the market. Clinical use persists without meaningful branded revenue.

Scenario 4: Shortage-driven pricing

A manufacturing disruption reduces supply. The remaining supplier raises prices, but the resulting revenue increase is temporary and may invite new generic entry or therapeutic substitution.

A high-growth launch scenario is unlikely without a new indication, a differentiated formulation, or a major change in epidemiology.

How strong is Humatin’s patent estate?

Humatin’s patent estate is weak as a current commercial barrier. Its value rests on product familiarity, clinical utility, manufacturing capability, and access to distribution rather than enforceable exclusivity.

Patent-strength factor	Assessment
Composition-of-matter protection	Absent as a current barrier
Remaining exclusivity	No material exclusivity expected
Formulation differentiation	Limited
Method-of-use protection	Limited
Generic blocking power	Low
Manufacturing complexity	Moderate but manageable
Supply-chain defensibility	Potentially meaningful
Litigation leverage	Low

For licensing or acquisition analysis, Humatin should be valued as a mature niche product, not as a patent-protected asset. The key diligence items are current net sales, gross margin, manufacturing cost, product-application ownership, supplier concentration, shortage history, and payer or wholesaler contracts.

What licensing deals affect Humatin?

No major recent licensing transaction has established Humatin as a strategic growth asset. Historical ownership and commercialization arrangements may have changed as legacy pharmaceutical portfolios moved between corporate divisions, affiliates, or specialty-product distributors.

A transaction involving Humatin would likely be structured around:

• Portfolio divestiture.
• Rights to a mature anti-infective product.
• Contract manufacturing.
• Regional commercialization.
• Supply and distribution rights.

The commercial value would depend on cash flow and continuity of supply, not on patent exclusivity. Buyers would also assess whether the product application, trademarks, manufacturing rights, and active ingredient supply are transferred together.

What is the geographic coverage of Humatin?

Humatin is principally relevant to the U.S. branded market. Paromomycin products exist in other jurisdictions, but names, formulations, indications, and manufacturers differ.

Geographic commercial variables include:

• Local approval status.
• Availability of luminal amebicides.
• Prevalence of amebiasis.
• Public-sector procurement.
• Generic substitution rules.
• Regional treatment guidelines.
• Local manufacturing capacity.

Paromomycin’s role in visceral leishmaniasis is commercially separate from Humatin’s oral amebiasis business. Analysts should avoid aggregating all paromomycin sales into Humatin revenue.

What generic entry risks exist for Humatin?

Generic entry risk is already embedded in the product’s mature market position. The larger risk is erosion of supply quality or availability rather than a new wave of patent-driven entry.

The main commercial risks are:

• Low-cost generic substitution.
• Pharmacy-level replacement of the brand.
• Contracting pressure from wholesalers.
• Supplier exit.
• Active pharmaceutical ingredient shortages.
• Low prescriber familiarity outside infectious-disease practice.
• Use of alternative anti-amebic therapies.
• Limited reimbursement for higher-priced branded product.

The main opportunity is supply reliability. A manufacturer that can keep paromomycin available during periods of constrained supply may capture disproportionate market share despite limited overall demand.

Key Takeaways

• Humatin is an oral paromomycin sulfate product used primarily for intestinal amebiasis.
• It is a mature, low-volume anti-infective with no material current patent moat.
• Regulatory exclusivity and original patent protection expired long ago.
• Generic competition, not Paragraph IV litigation, defines the market.
• Humatin-specific revenue is not separately disclosed in Pfizer public filings.
• Financial performance depends on product availability, contracting, and price more than volume growth.
• The strongest commercial asset is supply continuity, not intellectual property.
• Biosimilar risk is irrelevant because Humatin is a small-molecule antibiotic, not a biologic.
• The principal upside is shortage-driven share capture or portfolio optimization.
• The principal downside is brand erosion, manufacturer exit, and substitution by generic or alternative therapies.

FAQs About Humatin’s Commercial and Patent Position

Is Humatin still FDA approved?

Humatin has a legacy FDA-approved product history for oral paromomycin sulfate. Current marketed status should be evaluated through FDA product databases and the current labeling record because approval, marketing, and distribution status can differ.

Is paromomycin the same drug as Humatin?

Paromomycin is the active ingredient in Humatin. Generic paromomycin products may have the same active ingredient but different manufacturers, labeling presentation, inactive ingredients, and commercial availability.

Can Humatin be used to treat liver or tissue amebiasis?

Humatin is primarily a luminal therapy. It is not a substitute for systemic treatment of extraintestinal or hepatic amebiasis, where tissue-active therapy is required.[1]

Does Humatin have orphan-drug protection?

No current orphan-drug protection is central to Humatin’s commercial position. Any historical designation would not create a meaningful present-day barrier for generic oral paromomycin.

Is Humatin a strong acquisition target?

Humatin is more likely to interest a specialty-pharmaceutical or mature-products buyer than a growth-oriented pharmaceutical company. Its acquisition value would depend on verified cash flow, manufacturing rights, supply reliability, and market access rather than patents or exclusivity.

References

1. Pfizer Laboratories. (2010). Humatin (paromomycin sulfate) capsules prescribing information. U.S. Food and Drug Administration labeling archive.

2. Centers for Disease Control and Prevention. (2024). Amebiasis: Clinical care and treatment. https://www.cdc.gov/amebiasis/

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files

4. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/