HYDROCORTISONE AND ACETIC ACID Drug Patent Profile

Which patents cover Hydrocortisone And Acetic Acid, and what generic alternatives are available?

Hydrocortisone And Acetic Acid is a drug marketed by Bausch And Lomb, Cosette Pharms Nc, Taro, and Wockhardt. and is included in four NDAs.

The generic ingredient in HYDROCORTISONE AND ACETIC ACID is acetic acid, glacial; hydrocortisone. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the acetic acid, glacial; hydrocortisone profile page.

Summary for HYDROCORTISONE AND ACETIC ACID

US Patents:	0
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	5,207
What excipients (inactive ingredients) are in HYDROCORTISONE AND ACETIC ACID?	HYDROCORTISONE AND ACETIC ACID excipients list
DailyMed Link:	HYDROCORTISONE AND ACETIC ACID at DailyMed

Pharmacology for HYDROCORTISONE AND ACETIC ACID

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for HYDROCORTISONE AND ACETIC ACID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	HYDROCORTISONE AND ACETIC ACID	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	040097-001	Oct 31, 1994		DISCN	No	No
Wockhardt	HYDROCORTISONE AND ACETIC ACID	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	040168-001	Aug 30, 1996		DISCN	No	No
Cosette Pharms Nc	HYDROCORTISONE AND ACETIC ACID	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	040609-001	Feb 6, 2006	AT	RX	No	No
Taro	HYDROCORTISONE AND ACETIC ACID	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	088759-001	Mar 4, 1985	AT	RX	Yes	Yes

Hydrocortisone and Acetic Acid Market Dynamics, Patent Status, and Financial Trajectory

Last updated: September 17, 2026

Hydrocortisone and acetic acid is a generic otic solution containing hydrocortisone, usually 1%, and acetic acid, usually 2%. It is used to treat inflammation and superficial infections of the external auditory canal. The product is a mature, low-revenue pharmaceutical with limited patent protection, multiple generic suppliers, modest clinical differentiation, and high sensitivity to pharmacy pricing and product availability.

The commercial market is driven by prescriptions for otitis externa, chronic otitis externa, and inflammatory ear-canal conditions. Revenue is fragmented across manufacturers and is not generally disclosed as a standalone product category by public companies.

What is hydrocortisone and acetic acid used for?

Hydrocortisone and acetic acid otic solution combines an anti-inflammatory corticosteroid with an acidifying antimicrobial component.

Component	Typical concentration	Function
Hydrocortisone	1%	Reduces inflammation, itching, redness, and swelling
Acetic acid	2%	Acidifies the ear canal and inhibits susceptible organisms
Dosage form	Otic solution	Applied directly to the external ear canal

The FDA labeling identifies the product for superficial infections of the external auditory canal caused by organisms susceptible to acetic acid and for inflammatory conditions that respond to corticosteroids. It is not intended for systemic use or treatment of middle-ear infections without appropriate clinical evaluation (DailyMed, n.d.-a).

The product is generally prescribed for external ear disease rather than bacterial infections requiring a topical antibiotic such as ciprofloxacin or neomycin. Its positioning is strongest where inflammation and canal acidification are clinically relevant.

What brands and generic products contain hydrocortisone and acetic acid?

The principal historical brand is Vosol HC, a hydrocortisone and acetic acid otic solution. Generic versions are marketed under the active-ingredient name and may be supplied by different manufacturers depending on market availability and wholesaler contracts.

Product	Active ingredients	FDA pathway	Commercial status
Vosol HC	Hydrocortisone 1%, acetic acid 2%	NDA	Legacy branded product
Hydrocortisone and acetic acid otic solution	Hydrocortisone 1%, acetic acid 2%	ANDA	Generic market
Acetasol HC-related products	Hydrocortisone and acetic acid	NDA or generic-equivalent commercialization, depending on listing	Historical and market-specific availability

Product availability can change because small otic products are vulnerable to manufacturing interruptions, contract-manufacturing changes, and wholesaler delisting. FDA labeling and current product listings should be checked through Drugs@FDA and DailyMed before making a procurement or regulatory decision (FDA, n.d.-a; DailyMed, n.d.-b).

What is the FDA regulatory status of hydrocortisone and acetic acid?

Hydrocortisone and acetic acid otic solution is an FDA-approved prescription product. Generic versions are approved through abbreviated new drug applications, provided they meet applicable requirements for pharmaceutical equivalence, bioequivalence where required, quality, labeling, and manufacturing controls.

The product is a nonsterile otic solution. Its regulatory burden is lower than that of sterile ophthalmic products, injectable corticosteroids, or biologics. The main regulatory risks relate to:

• Active-ingredient identity and assay
• Solution uniformity
• pH and preservative performance
• Container-closure compatibility
• Microbial quality
• Stability and shelf life
• Labeling consistency
• Dropper performance and dosing accuracy

Acetic acid creates formulation-specific requirements because the product must maintain an acidic environment without causing unacceptable irritation. Hydrocortisone also requires adequate solubilization and stability in the finished solution.

What is the Orange Book status of hydrocortisone and acetic acid?

The product’s commercial exclusivity is primarily historical rather than current. Hydrocortisone and acetic acid otic solution has been available in generic form, which means an active patent or regulatory exclusivity period does not generally block market entry.

The FDA Orange Book is the principal source for listed patents, exclusivity, therapeutic-equivalence evaluations, and reference-listed drug information. Current Orange Book review should be performed by product name, active ingredients, dosage form, and reference-listed drug status (FDA, n.d.-b).

Exclusivity category	Current commercial relevance
New chemical entity exclusivity	None expected for this long-established combination
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No material current barrier identified
New-product exclusivity	Historical relevance only
Listed formulation patents	No material blocking estate generally associated with the mature generic product
Generic substitution	Available where an FDA-rated therapeutically equivalent product is listed

The absence of a current blocking estate does not eliminate product-specific regulatory or supply risks. A manufacturer can still face FDA observations, manufacturing delays, recalls, or shortages.

What patents protect hydrocortisone and acetic acid?

The core active-ingredient combination is old, and its basic composition, indication, and administration method are unlikely to support enforceable modern exclusivity in the United States.

Potential historical or peripheral patent categories include:

1. The original composition of hydrocortisone and acetic acid in an otic vehicle.
2. Specific solution formulations.
3. Preservative systems.
4. Container-closure or delivery components.
5. Manufacturing and filling processes.
6. Narrow method-of-use claims.

For a mature generic product, these categories are generally less important than FDA approval, manufacturing economics, and distribution access. No material, current U.S. patent estate is generally associated with the basic hydrocortisone and acetic acid otic solution. Patent numbers and expiration dates should be validated in the current USPTO Patent Center, FDA Orange Book, and relevant national registers before a freedom-to-operate opinion is issued (USPTO, n.d.; FDA, n.d.-b).

When does hydrocortisone and acetic acid lose exclusivity?

Hydrocortisone and acetic acid lost practical market exclusivity years ago. Generic competition has already replaced any original branded exclusivity.

The relevant commercial timeline is:

Period	Market event
Original launch period	Branded hydrocortisone-acetic acid otic products entered the prescription market
Patent-protected period	Any original formulation or product claims were limited to their statutory terms
Generic-entry period	ANDA-approved products entered after applicable patents and exclusivities no longer blocked approval
Current market	Mature generic competition with price and supply-chain pressure

There is no commercially meaningful future “loss of exclusivity” date comparable to a still-protected blockbuster. The key question is whether individual suppliers remain active and whether pharmacy benefit managers continue to reimburse the product.

How many patents cover hydrocortisone and acetic acid?

The basic drug combination has no widely recognized active U.S. patent estate that would materially delay generic entry. Historical patents may exist in older records, but their practical value depends on claim scope, expiration, terminal disclaimers, maintenance status, and whether they were listed for the relevant reference product.

For market-entry analysis, the product should be treated as having:

• No known active composition-of-matter protection.
• No expected regulatory exclusivity.
• No major formulation-patent barrier.
• Limited exposure to patent litigation.
• Greater operational risk than patent risk.

This profile differs from newer otic products using novel delivery systems, antibiotic combinations, sustained-release technologies, or proprietary vehicles.

Are there Paragraph IV challenges for hydrocortisone and acetic acid?

Paragraph IV litigation is not a central current market issue for this product because generic entry has already occurred. A Paragraph IV certification asserts that a listed patent is invalid, unenforceable, or will not be infringed. It is most commercially important before the first generic launch or when a later entrant challenges a still-relevant patent.

For hydrocortisone and acetic acid:

• Generic products are already established.
• No high-value blocking patent is generally associated with the core product.
• Any historical Paragraph IV activity would have had limited economic value relative to blockbuster drugs.
• The principal competitive issue is supplier participation rather than first-filer exclusivity.

The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations and Drugs@FDA databases remain the primary sources for identifying approved ANDAs and reference products (FDA, n.d.-a; FDA, n.d.-b).

What formulations are protected by hydrocortisone and acetic acid?

The principal formulation is an otic solution. The commercial value of formulation know-how lies in maintaining stability, pH, solubility, preservative performance, and acceptable tolerability.

Important technical parameters include:

Formulation issue	Commercial importance
Acidic pH	Supports acetic-acid activity but can affect tolerability
Hydrocortisone solubility	Controls dose uniformity and product stability
Preservative system	Limits microbial growth during use
Dropper design	Affects dose delivery and patient adherence
Container compatibility	Reduces evaporation, leakage, and material interaction
Shelf life	Determines inventory and wholesale economics

These features can create manufacturing know-how but do not necessarily create enforceable patent protection. A technically difficult formulation can still be commercially unattractive if the market has low prescription volume and aggressive generic pricing.

What patent litigation affects hydrocortisone and acetic acid?

No major active U.S. patent litigation is generally associated with the mature hydrocortisone and acetic acid otic market. The product has limited annual revenue potential, which reduces the incentive for branded manufacturers to pursue extensive infringement litigation.

Potential disputes are more likely to involve:

• ANDA approval timing
• Product quality or manufacturing compliance
• Trademark and trade-dress rights
• Contract manufacturing
• Distribution agreements
• Product liability
• Supply shortages or allocation decisions

These issues are commercially relevant but distinct from patent litigation.

Which companies are challenging hydrocortisone and acetic acid?

The competitive field consists primarily of generic manufacturers and distributors rather than companies pursuing a major branded challenge.

Generic participation can vary by time and geography. Manufacturers may enter or exit because of:

• Low net pricing
• Limited prescription volume
• Small production batches
• API sourcing constraints
• Quality-system costs
• Wholesale purchasing concentration
• Low return on regulatory maintenance

The market may therefore show several approved suppliers but only a smaller number of products actively available through pharmacies. An approved ANDA does not guarantee continuous commercial supply.

How strong is the patent estate for hydrocortisone and acetic acid?

The patent estate is weak from a defensive or exclusivity perspective. Its commercial strength rests on execution rather than intellectual property.

Factor	Assessment
Composition-of-matter protection	Weak or expired
Formulation protection	Limited and likely narrow
Method-of-use protection	Limited
Regulatory exclusivity	No material current exclusivity
Manufacturing barrier	Low to moderate
Brand loyalty	Low
Switching barriers	Low where therapeutically equivalent products are available
Litigation risk	Low
Supply-chain risk	Moderate

A manufacturer seeking entry would generally focus on ANDA strategy, reliable formulation scale-up, quality compliance, and channel access rather than patent licensing.

What is the financial trajectory for hydrocortisone and acetic acid?

The financial trajectory is mature to declining in nominal brand value, with episodic increases caused by shortages, supplier exits, price adjustments, or temporary demand shifts. Product-specific revenue is not typically reported separately in public company filings.

The market has several characteristics:

• Low average selling prices compared with branded otic anti-infectives.
• Limited promotional spending.
• High generic substitution.
• Low prescriber switching costs.
• Small absolute revenue per manufacturer.
• Margin exposure to API, packaging, and quality-control costs.
• Potential price spikes when one or more suppliers leave the market.

Revenue is likely concentrated in a small number of generic suppliers at any given time, but concentration can change quickly. A manufacturer with reliable supply may obtain temporary pricing power without having durable market exclusivity.

Publicly reported company revenue should not be attributed to hydrocortisone and acetic acid unless the company separately discloses product-level sales. Standard financial filings generally aggregate products into broader prescription, generic, or specialty-pharmaceutical categories (SEC, n.d.).

How does hydrocortisone and acetic acid compare with competing otic drugs?

Product category	Main advantage	Main limitation	Competitive position
Hydrocortisone and acetic acid	Low-cost anti-inflammatory and acidifying therapy	Limited against infections requiring modern antibiotics	Mature, price-sensitive
Ciprofloxacin otic	Broad antibacterial activity and favorable use in some perforated-eardrum settings	Higher cost and antibiotic stewardship concerns	Stronger for bacterial infection
Neomycin/polymyxin B/hydrocortisone	Established antibiotic-steroid combination	Ototoxicity and sensitization considerations	Common alternative
Ofloxacin otic	Antibacterial treatment with established otic use	More expensive than simple acidifying products	Competes in bacterial disease
Steroid-only otic products	Anti-inflammatory activity	No meaningful antimicrobial activity	Niche use
Acetic acid alone	Acidifying and antimicrobial effect	Less anti-inflammatory benefit	Lower-cost alternative

Clinical selection depends on the suspected condition, tympanic membrane status, pathogen risk, inflammation, patient age, and local prescribing practice. The product competes less directly with systemic therapies than with other topical otic solutions.

What generic launch scenarios exist?

A new generic entrant would face low patent risk but uncertain commercial returns. Three launch scenarios are most relevant:

Standard multi-source launch

The entrant receives FDA approval and competes with several generic suppliers. Pricing declines quickly, and success depends on manufacturing cost and wholesaler access.

Supply-disruption launch

One or more incumbent suppliers experience a shortage or exit. The entrant gains temporary volume and improved pricing, but the opportunity may disappear when supply normalizes.

Contract or private-label launch

A manufacturer supplies the product to a distributor, pharmacy group, or private-label operator. This can reduce selling costs but increases dependence on a small number of commercial customers.

What manufacturing and intellectual-property barriers exist?

Manufacturing barriers are modest but meaningful. The product requires controlled formulation conditions, compatible packaging, validated filling, stability data, and consistent microbiological quality. These requirements are sufficient to deter very small entrants but do not create the barrier associated with sterile injectables or complex biologics.

The most important practical barriers are:

• Maintaining compliant API supply.
• Producing economically at low volumes.
• Securing suitable dropper packaging.
• Managing stability and pH specifications.
• Passing FDA inspections.
• Retaining profitable wholesale contracts.
• Avoiding product discontinuation after low-volume periods.

Geographic protection is also limited. U.S. approval does not confer equivalent protection in Europe, Canada, or other markets. Each jurisdiction applies its own drug-registration, labeling, patent, and reimbursement rules.

What licensing deals affect hydrocortisone and acetic acid?

No major current licensing transaction is generally associated with the core generic product. Licensing is more likely to occur through:

• Contract manufacturing agreements.
• Product-acquisition transactions.
• Private-label supply contracts.
• Regional distribution rights.
• Portfolio transfers involving legacy otic products.

Because the drug has limited standalone revenue, companies usually assess it as part of a broader generic or otic portfolio rather than as a strategic licensing asset.

Key Takeaways

• Hydrocortisone and acetic acid is a mature otic solution, commonly containing hydrocortisone 1% and acetic acid 2%.
• Generic competition is established, and practical market exclusivity has ended.
• The current patent estate is weak, with no widely recognized blocking U.S. patent barrier for the basic product.
• Paragraph IV litigation and biosimilar risk are not material commercial issues.
• The product is not a biologic, so biosimilar competition does not apply.
• Revenue is low and generally not disclosed separately by manufacturers.
• Pricing, supply continuity, pharmacy contracting, and manufacturing economics matter more than patent protection.
• The main commercial opportunity is temporary share capture during supplier shortages or competitor exits.
• Formulation and manufacturing know-how have more practical value than patent exclusivity.
• Competition comes from acetic-acid products, steroid-antibiotic combinations, fluoroquinolone otics, and steroid-only therapies.

Frequently Asked Questions

Is hydrocortisone and acetic acid still available as a prescription drug?

Yes. FDA-approved generic products may be available, although individual suppliers and pharmacy inventories can change over time.

Is hydrocortisone and acetic acid a biologic?

No. It is a conventional small-molecule otic solution. Biosimilar approval and interchangeability rules do not apply.

Does hydrocortisone and acetic acid have market exclusivity?

No material current market exclusivity is generally associated with the mature generic product.

Can a new company launch a generic hydrocortisone and acetic acid product?

Yes. The principal requirements are FDA approval, compliant manufacturing, formulation stability, quality controls, and a commercially viable distribution strategy.

Is hydrocortisone and acetic acid more valuable than ciprofloxacin otic?

Usually not on a revenue basis. Ciprofloxacin otic products generally address a broader or higher-value antibacterial market, while hydrocortisone and acetic acid competes primarily as a low-cost treatment for external ear inflammation and superficial infection.

References

DailyMed. (n.d.-a). Hydrocortisone and acetic acid otic solution prescribing information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

DailyMed. (n.d.-b). Vosol HC and related otic product labeling. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

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

U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

U.S. Patent and Trademark Office. (n.d.). Patent Center. https://patentcenter.uspto.gov/

U.S. Securities and Exchange Commission. (n.d.). Company filings and financial reporting. https://www.sec.gov/edgar/search/