PHISOHEX Drug Patent Profile
When do Phisohex patents expire, and what generic alternatives are available?
Phisohex is a drug marketed by Sanofi Aventis Us and is included in two NDAs.
The generic ingredient in PHISOHEX is hexachlorophene. There is one drug master file entry for this compound. Additional details are available on the hexachlorophene profile page.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for PHISOHEX?
- What are the global sales for PHISOHEX?
- What is Average Wholesale Price for PHISOHEX?
Summary for PHISOHEX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 1 |
| Patent Applications: | 4,181 |
| DailyMed Link: | PHISOHEX at DailyMed |
Recent Clinical Trials for PHISOHEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Natividad Medical Center | N/A |
US Patents and Regulatory Information for PHISOHEX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | PHISOHEX | hexachlorophene | EMULSION;TOPICAL | 006882-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Sanofi Aventis Us | PHISOHEX | hexachlorophene | EMULSION;TOPICAL | 008402-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
PHISOHEX Market Dynamics, Financial Trajectory, FDA Status, and Patent Position
PHISOHEX is a legacy prescription antiseptic containing 3% hexachlorophene. Its commercial market contracted sharply after reports of neurotoxicity, regulatory restrictions in the early 1970s, and the adoption of safer alternatives such as chlorhexidine and povidone-iodine. PHISOHEX has no meaningful current branded-drug growth profile, no material biosimilar exposure, and no identifiable patent-driven exclusivity strategy. Public sources do not report standalone PHISOHEX revenue.
What is PHISOHEX and what was it used for?
PHISOHEX is a topical emulsion containing hexachlorophene, a chlorinated bisphenol antimicrobial agent. It was marketed primarily as a prescription surgical scrub, hand cleanser, and skin antiseptic.
Historically, hospitals used hexachlorophene products for:
- Preoperative skin preparation
- Surgical handwashing
- Repeated cleansing of patients at risk of bacterial infection
- Neonatal bathing and infection-control protocols
- Treatment or prevention of superficial bacterial contamination
The product’s commercial identity was tied to its 3% hexachlorophene concentration. That concentration provided persistent antibacterial activity but also created a narrow safety margin, particularly in infants and when applied repeatedly or to damaged skin.
PHISOHEX is distinct from lower-concentration hexachlorophene products and from modern chlorhexidine-based antiseptics. Its active ingredient is hexachlorophene, not chlorhexidine gluconate.
When did PHISOHEX lose market exclusivity?
PHISOHEX’s commercial decline resulted primarily from safety regulation and therapeutic substitution, not from a conventional patent cliff.
Key historical timeline
| Period | Event | Market impact |
|---|---|---|
| 1950s-1960s | Hexachlorophene products gain hospital and neonatal use | Broad institutional adoption |
| Late 1960s | Reports associate repeated neonatal exposure with central nervous system injury | Safety scrutiny increases |
| 1971 | FDA announces restrictions on hexachlorophene-containing products | OTC and routine-use channels contract |
| 1972 | FDA limits use of 3% hexachlorophene products to prescription settings and requires warnings | Hospital protocols change |
| 1970s onward | Chlorhexidine, iodophors, and other antiseptics gain share | PHISOHEX loses substitution-sensitive demand |
| 2000s-2010s | Product availability becomes limited and intermittent | Commercial relevance declines |
| Current market | No significant branded growth platform is evident | Product is a legacy or discontinued-market asset |
The FDA determined that hexachlorophene should not be used routinely for bathing infants or for general cleansing when safer alternatives were available. The agency’s actions reduced the addressable market well before any conventional patent-expiration event became commercially important.[1][2]
What is the FDA regulatory status of PHISOHEX?
PHISOHEX is a legacy prescription topical antiseptic rather than a modern growth product. Its regulatory profile is defined by safety restrictions.
The FDA has warned that hexachlorophene can cause central nervous system toxicity, including encephalopathy, when absorbed systemically. Risk is higher in premature infants, newborns, patients with damaged or extensively burned skin, and patients exposed repeatedly or over large body areas.[1]
Current regulatory implications include:
- Prescription-only positioning for 3% hexachlorophene formulations
- Restrictions against routine neonatal bathing
- Warnings against use on mucous membranes, eyes, and severely damaged skin
- Limited use where the anticipated benefit outweighs the safety risk
- Reduced suitability for broad hospital infection-control protocols
PHISOHEX should not be evaluated as a direct equivalent to current FDA-cleared chlorhexidine surgical-preparation products. Its active ingredient, safety profile, labeling, and market positioning differ materially.
Is PHISOHEX currently marketed in the United States?
Public drug databases and product listings have treated PHISOHEX as discontinued or commercially unavailable in the United States. Availability may vary by residual inventory, institutional procurement, or non-U.S. regulatory status.
A discontinued listing does not necessarily mean that every historical supply channel ended on the same date. It indicates that the product is not functioning as a regularly supplied, actively promoted branded medicine in the U.S. market.
What is the Orange Book status of PHISOHEX?
PHISOHEX does not have a commercially important Orange Book exclusivity position.
The Orange Book is designed primarily to identify approved drug products, therapeutic-equivalence information, patent listings, and regulatory exclusivity relevant to abbreviated new drug applications. For a legacy topical antiseptic with limited or discontinued commercial distribution, the practical importance of Orange Book patents is low.[3]
No active, commercially meaningful patent estate is publicly associated with PHISOHEX that would support a current branded-product strategy. The relevant barriers are regulatory, manufacturing, safety, and market substitution barriers rather than patent exclusivity.
How many patents cover PHISOHEX?
There is no identifiable active patent portfolio that materially protects current PHISOHEX sales.
Historical patents may have covered:
- Hexachlorophene chemistry
- Antiseptic compositions
- Emulsion vehicles
- Manufacturing processes
- Packaging or dispensing systems
- Methods for topical antimicrobial use
Those rights would generally have expired after the statutory patent term. A pharmaceutical product launched several decades ago cannot ordinarily rely on its original composition-of-matter patents today.
Modern patents could theoretically cover a new formulation, delivery system, or use, but those would protect a new product configuration rather than restore the original PHISOHEX franchise.
What caused the PHISOHEX market decline?
The market decline reflects four related forces.
Safety restrictions
Neurotoxicity reports materially reduced routine use. The FDA’s restrictions changed the risk-benefit calculation for hospitals, pediatric institutions, and manufacturers.[1]
Therapeutic substitution
Chlorhexidine became the leading substitute for many surgical and hospital antisepsis applications. Povidone-iodine and alcohol-based preparations also captured use in surgical preparation, hand antisepsis, and infection-control programs.
These alternatives offered stronger commercial advantages:
- Broader institutional acceptance
- Better alignment with modern infection-control protocols
- More favorable safety perceptions
- Greater availability across concentrations and delivery systems
- Product formats designed for preoperative preparation and repeated use
Procurement and protocol changes
Hospital formularies increasingly favored standardized antiseptic protocols. Products with neonatal or neurotoxicity concerns faced greater barriers to formulary inclusion, even where a narrow labeled use remained permissible.
Weak commercial differentiation
PHISOHEX’s historical differentiation was persistent antibacterial activity. That advantage became less valuable once hospitals prioritized safety, standardized protocols, and broader compatibility with modern skin-preparation systems.
What is the financial trajectory for PHISOHEX?
PHISOHEX has no publicly disclosed standalone revenue series, current market-growth forecast, or meaningful public-company earnings contribution.
Its financial trajectory can be summarized as follows:
| Phase | Revenue direction | Principal driver |
|---|---|---|
| Initial adoption | Rising | Hospital and neonatal antisepsis demand |
| Pre-regulatory peak | Established | Broad institutional use |
| Early 1970s | Sharp decline | FDA restrictions and safety concerns |
| 1980s-2000s | Continuing contraction | Substitution by chlorhexidine and iodophors |
| Recent period | Minimal or zero branded revenue | Discontinuation, limited supply, and weak demand |
Any estimate of PHISOHEX revenue would require proprietary company sales data, distributor records, or historical product-level filings. Public financial statements typically aggregate topical products, hospital products, or mature brands and do not isolate PHISOHEX.
Is PHISOHEX commercially material to its historical manufacturers?
No current material revenue exposure is evident from public information. PHISOHEX is not comparable with an active specialty pharmaceutical that contributes measurable sales, gross margin, or pipeline value.
Its economic value is more likely to arise from:
- Residual inventory liquidation
- Contract manufacturing
- Product-rights transfers
- Legacy regulatory files
- Institutional demand in narrow markets
- Potential reformulation or relaunch economics
Those opportunities would face substantial regulatory and commercial barriers.
What formulations are protected by PHISOHEX patents?
No active formulation patent is known to protect the historical PHISOHEX emulsion as a current commercial franchise.
The legacy formulation is generally described as a 3% hexachlorophene emulsion. Any surviving formulation-related rights would need to be evaluated by claim scope, expiration, ownership, and jurisdiction. In practical terms, the original emulsion is unlikely to have meaningful patent protection.
A new formulation could potentially seek protection through:
- Reduced systemic absorption
- Controlled-release topical delivery
- Improved tolerability
- A redesigned vehicle
- A combination with another antiseptic
- A defined use in a narrow patient population
A reformulated product would still require a new FDA regulatory and clinical strategy. It could not rely solely on the commercial history of PHISOHEX.
What generic entry risks exist for PHISOHEX?
Traditional generic-entry risk is low because PHISOHEX has limited commercial demand and no apparent high-value branded franchise.
The principal competitive risks are:
- Generic or compounded hexachlorophene products entering narrow clinical markets.
- Hospitals substituting chlorhexidine or povidone-iodine products.
- Institutional protocols excluding hexachlorophene because of safety concerns.
- Supply interruptions caused by low manufacturing volume.
- Regulatory scrutiny affecting labeling, distribution, or use restrictions.
For a company considering a PHISOHEX reintroduction, the greater risk is market acceptance rather than Paragraph IV litigation.
Are there Paragraph IV challenges to PHISOHEX?
No material, current Paragraph IV litigation involving PHISOHEX is evident in the public record.
Paragraph IV activity is generally associated with active branded products that have valuable Orange Book-listed patents and meaningful generic revenue at risk. PHISOHEX does not present that profile.
Which companies are challenging PHISOHEX?
The competitive challenge is primarily product substitution rather than named-company patent litigation.
Relevant competitive categories include:
- Chlorhexidine manufacturers
- Povidone-iodine manufacturers
- Alcohol-based surgical-preparation suppliers
- Hospital antiseptic and infection-control companies
- Compounding pharmacies or limited-market suppliers
Representative competing product franchises have historically included chlorhexidine products from manufacturers such as BD, Mölnlycke, and other hospital-supply companies, along with povidone-iodine products supplied by major surgical and healthcare manufacturers. These products compete for the same procedural and institutional budgets but are not necessarily direct pharmaceutical equivalents.
How strong is the PHISOHEX patent estate?
The patent estate is weak from a current commercial perspective.
| Patent-estate factor | Assessment |
|---|---|
| Original active-ingredient protection | Expired or commercially irrelevant |
| Current composition patents | No material active estate identified |
| Formulation protection | No publicly meaningful current barrier identified |
| Method-of-use protection | Limited practical value |
| Orange Book leverage | Low |
| Paragraph IV leverage | Low |
| Manufacturing know-how | Potentially relevant |
| Regulatory history | Important but restrictive |
| Brand recognition | Historical, with limited current demand |
| Relaunch potential | Dependent on new safety and positioning strategy |
Manufacturing know-how may matter more than patents. A supplier would need validated production, quality controls, raw-material sourcing, stability data, packaging compatibility, and compliance with current FDA requirements. Those barriers can deter entry without creating durable pricing power.
How does PHISOHEX compare with chlorhexidine and povidone-iodine?
| Factor | PHISOHEX | Chlorhexidine | Povidone-iodine |
|---|---|---|---|
| Active ingredient | Hexachlorophene | Chlorhexidine | Iodophor |
| Current market position | Legacy or limited | Broad hospital use | Broad surgical and topical use |
| Neurotoxicity concern | Material, especially in infants and damaged skin | Different safety risks | Different tolerability and allergy considerations |
| Neonatal routine use | Restricted | Product- and population-specific | Product- and population-specific |
| Patent value | Low | Product-specific | Low to moderate, depending on formulation |
| Institutional acceptance | Limited | Strong | Strong |
| Growth outlook | Declining or negligible | Established demand | Established demand |
| Generic/substitute pressure | High | High | High |
PHISOHEX’s commercial disadvantage is not simply that competing products are cheaper. The alternatives are integrated into current hospital protocols and procurement systems, while PHISOHEX carries a historical safety burden.
What licensing deals or settlement agreements affect PHISOHEX?
No material recent licensing transaction or settlement agreement is publicly associated with PHISOHEX.
Historical rights may have changed hands through corporate acquisitions, product divestitures, or transfers of regulatory files. Those transactions would not necessarily create a current market opportunity unless the acquiring party retained an active product authorization and a viable supply strategy.
There is no evident settlement framework comparable to those associated with major branded drugs facing generic patent challenges.
What generic launch scenarios exist for PHISOHEX?
Three launch scenarios are commercially plausible:
Limited institutional supply
A manufacturer could supply hexachlorophene to a narrow set of institutions with defined clinical needs. This would be a low-volume product with significant compliance and pharmacovigilance obligations.
Compounded or special-access supply
Demand could persist through specialized compounding or restricted procurement channels. This pathway would not recreate the historical branded market and may have limited scalability.
Reformulated relaunch
A new topical delivery system could seek a differentiated regulatory position. The investment case would depend on demonstrating a clinically meaningful safety or usability advantage over chlorhexidine and povidone-iodine.
The third scenario would require the highest investment and carries the greatest regulatory risk.
Key Takeaways
- PHISOHEX is a legacy 3% hexachlorophene antiseptic with a sharply contracted market.
- FDA safety actions in the early 1970s, particularly concerning neurotoxicity, drove the principal commercial decline.
- Chlorhexidine and povidone-iodine displaced PHISOHEX in hospital and surgical settings.
- No meaningful current Orange Book, patent, or Paragraph IV strategy is evident.
- Public sources do not disclose standalone PHISOHEX revenue.
- Current financial exposure is likely negligible unless a company retains a niche supply or licensing position.
- Manufacturing, regulatory compliance, safety labeling, and institutional acceptance are more important barriers than patent exclusivity.
- A relaunch would require a new commercial and regulatory rationale, not merely restoration of the historical brand.
FAQs
Is PHISOHEX still available by prescription?
PHISOHEX has generally been treated as discontinued or commercially unavailable in the United States. Limited availability may depend on residual inventory or specialized supply channels.
Is hexachlorophene the same as chlorhexidine?
No. Hexachlorophene and chlorhexidine are different active ingredients with different pharmacology, labeling, safety profiles, and market histories.
Can hospitals still use PHISOHEX on newborns?
Routine neonatal use is not appropriate under the FDA’s historical safety restrictions. Hexachlorophene exposure in infants carries particular central nervous system risk.
Does PHISOHEX have biosimilar competition?
No. Biosimilar regulation applies to biologic products. PHISOHEX is a small-molecule topical antiseptic.
Could PHISOHEX be relaunched as a new drug?
A relaunch would likely require a current regulatory pathway, validated manufacturing, updated safety justification, and a differentiated clinical use. Historical brand recognition alone would not support a viable commercial reentry.
References
-
U.S. Food and Drug Administration. (1972). Hexachlorophene-containing drug products: Regulatory restrictions and labeling requirements. FDA.
-
U.S. Food and Drug Administration. (2013). FDA drug safety communication: FDA recommends not using soaps and antiseptic products containing 3% hexachlorophene. FDA.
-
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.
More… ↓
