CETRAXAL Drug Patent Profile

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Which patents cover Cetraxal, and when can generic versions of Cetraxal launch?

Cetraxal is a drug marketed by Lab Salvat and is included in one NDA.

The generic ingredient in CETRAXAL is ciprofloxacin hydrochloride. There is one drug master file entry for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cetraxal

A generic version of CETRAXAL was approved as ciprofloxacin hydrochloride by RUBICON RESEARCH on June 9^th, 2004.

Summary for CETRAXAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,071
What excipients (inactive ingredients) are in CETRAXAL?	CETRAXAL excipients list
DailyMed Link:	CETRAXAL at DailyMed

US Patents and Regulatory Information for CETRAXAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lab Salvat	CETRAXAL	ciprofloxacin hydrochloride	SOLUTION/DROPS;OTIC	021918-001	May 1, 2009	AB	RX	Yes	Yes

Cetraxal Market Dynamics, Patent Position, FDA Status, and Financial Trajectory

Last updated: October 28, 2026

Cetraxal is a branded ciprofloxacin otic solution used for acute otitis externa. Its commercial position is limited by an old small-molecule product profile, generic substitution, low treatment duration, and the absence of a durable biologic or device barrier. The core product was approved in the United States under NDA 021918, but publicly available information does not show a separately reported Cetraxal revenue stream or a material active Orange Book patent estate. Financial exposure is therefore likely modest and concentrated in branded prescriptions, licensing or distribution economics, and any related Cetraxal product extensions.

What is Cetraxal and how is it used?

Cetraxal is ciprofloxacin otic solution 0.2%, a topical fluoroquinolone antibiotic.

Attribute	Cetraxal
Active ingredient	Ciprofloxacin
Dosage form	Otic solution
Strength	0.2%
U.S. application	NDA 021918
Primary indication	Acute otitis externa
Typical course	Twice daily for seven days
FDA approval	2006
Product type	Small-molecule prescription drug
Biosimilar pathway	Not applicable
Main competitors	Generic ciprofloxacin otic products, ofloxacin otic, ciprofloxacin/dexamethasone products

The FDA label provides for administration of 0.25 mL into the affected ear twice daily for seven days in adults and pediatric patients aged one year and older. Cetraxal is applied locally, which limits systemic exposure relative to oral fluoroquinolone treatment.[1]

Cetraxal should be distinguished from Cetraxal Plus, which combines ciprofloxacin with dexamethasone. The combination product has a separate regulatory and competitive profile and should not be used to estimate the value of plain Cetraxal.

What is the FDA regulatory status of Cetraxal?

Cetraxal is an FDA-approved prescription otic product. Its approval is based on the NDA pathway rather than an abbreviated new drug application.

The FDA approval created a regulated branded product, but it did not create the type of long-term exclusivity associated with a new chemical entity. Ciprofloxacin was already an established active ingredient when Cetraxal entered the market. Any commercial protection therefore depended primarily on formulation differentiation, regulatory exclusivity, trademarks, distribution, and brand demand.

The product’s regulatory attributes include:

• FDA-approved ciprofloxacin otic formulation.
• Treatment of acute otitis externa.
• Pediatric use beginning at one year of age.
• Seven-day treatment duration.
• Local administration without the adherence burden associated with oral therapy.
• Fluoroquinolone-class contraindication risk in patients with hypersensitivity to ciprofloxacin or other quinolones.

The primary clinical substitute is generic ciprofloxacin otic solution. Ofloxacin otic and ciprofloxacin/dexamethasone otic products compete in the same broader treatment category.

What is the Orange Book status of Cetraxal?

Cetraxal is associated with NDA 021918 in FDA product records. Publicly available FDA Orange Book information does not establish a material, currently enforceable patent barrier for plain Cetraxal comparable to the patent estates supporting newer branded drugs.[2]

The commercial implication is important. A branded NDA can remain active after its principal patent and exclusivity protections have expired. Continued listing in FDA databases does not mean that the product retains meaningful market exclusivity.

Exclusivity category	Cetraxal position
New chemical entity exclusivity	Not applicable to ciprofloxacin
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No material stand-alone protection identified for current commercial analysis
Listed formulation patent	No material active barrier identified in public Orange Book records
Regulatory exclusivity	Expired or no longer commercially significant
Generic substitution risk	High

The relevant business question is not whether the NDA remains active. It is whether an ANDA applicant faces an active patent or regulatory obstacle. For plain Cetraxal, the public record indicates a relatively open generic pathway.

When did Cetraxal lose exclusivity?

Cetraxal’s meaningful market exclusivity expired years ago. The product was approved in 2006, and ciprofloxacin was already a mature active ingredient. Any period of market protection associated with the original product has ended.

A precise single “loss of exclusivity” date is not commercially useful because Cetraxal’s market protection depended on several overlapping elements:

1. FDA regulatory exclusivity.
2. Any listed formulation or manufacturing patents.
3. Trademark protection.
4. The timing of generic approvals.
5. Payer substitution and pharmacy reimbursement.

For a mature otic product, generic entry is usually driven less by patent litigation than by the availability of an FDA-approved equivalent and the willingness of payers and pharmacies to substitute it.

How many patents cover Cetraxal?

No substantial active patent estate covering plain Cetraxal is evident from the public FDA Orange Book record. The product does not have the profile of a heavily patented modified-release, injectable, device-enabled, or complex biologic product.

Potential intellectual-property categories include:

• Formulation composition.
• Sterility and packaging.
• Dropper or delivery configuration.
• Manufacturing process.
• Brand trademark.
• Product-specific labeling.

These categories do not necessarily prevent generic approval. Process and packaging rights may affect a particular manufacturer, but they rarely support durable product-level exclusivity unless they are listed, valid, enforceable, and difficult to design around.

Cetraxal’s strongest remaining IP is likely trademark and know-how rather than a broad composition-of-matter patent.

What formulations are protected by Cetraxal-related patents?

The commercial distinction for plain Cetraxal is the 0.2% ciprofloxacin otic solution. No publicly established active patent barrier has been identified that would broadly prevent competitors from marketing ciprofloxacin otic solution.

A formulation challenger could potentially design around any narrow claim involving:

• Excipient concentration.
• Preservative selection.
• pH range.
• Container closure.
• Drop size.
• Sterile filling process.

This creates a low-to-moderate technical barrier. The product does not require the complex manufacturing infrastructure associated with sterile injectables, long-acting products, liposomal systems, or biologics.

Cetraxal Plus has a separate formulation involving dexamethasone and should be assessed independently. Combining the antibiotic with a corticosteroid may provide clinical and commercial differentiation, but it does not expand the patent position of plain Cetraxal.

Are there Paragraph IV challenges to Cetraxal?

No major publicly documented Paragraph IV litigation involving plain Cetraxal is established in the core public record used for this assessment.

That result is consistent with the product’s apparent Orange Book position. A Paragraph IV certification is most commercially consequential when an active patent is listed against the reference product. If no relevant patent remains listed, an ANDA applicant may pursue approval without creating the same patent-litigation trigger associated with a patented branded product.

Generic entry could still involve:

• Paragraph III certifications if a patent remains but has not expired.
• Patent litigation based on a listed formulation or use patent.
• Regulatory disputes over product sameness.
• Administrative challenges involving labeling or dosage form.
• Trademark and packaging disputes.

The principal Cetraxal risk is therefore ordinary generic substitution rather than a high-value patent challenge.

What generic entry risks exist for Cetraxal?

Generic entry risk is high.

The product has several characteristics that support competition:

• Ciprofloxacin is a well-characterized active ingredient.
• The dosage form is a topical otic solution.
• The treatment course is short.
• The product is not a biologic.
• The formulation is less complex than suspension, emulsion, depot, or combination-device products.
• Clinical demand is spread across primary care, urgent care, pediatrics, and otolaryngology.
• Payers have incentives to substitute low-cost products.

The main technical requirements for a generic manufacturer are pharmaceutical equivalence, sterility, suitable packaging, consistent drop delivery, stability, and labeling alignment. These requirements create regulatory work but do not appear to create a durable market barrier.

Which companies compete with Cetraxal?

Competition occurs at the product-class level rather than through a single dominant branded rival.

Competitive product category	Competitive effect
Generic ciprofloxacin otic solution	Direct price and substitution pressure
Ofloxacin otic	Direct alternative for bacterial otic infections
Ciprofloxacin/dexamethasone otic	Differentiated combination product
Neomycin/polymyxin B/hydrocortisone products	Lower-cost alternative with different safety and coverage profile
Non-antibiotic or watchful-waiting approaches	Relevant in selected clinical settings

Manufacturers of generic otic products compete primarily through pharmacy contracts, wholesaler access, supply reliability, reimbursement, and price. Brand equity has limited value when prescribers and pharmacies can substitute an FDA-approved generic.

The relevant commercial participants may include the original sponsor or licensee, generic manufacturers, specialty distributors, wholesalers, pharmacy benefit managers, and integrated health systems. Public ownership and distribution arrangements for a mature private-label product can change over time and should not be inferred from the original NDA sponsor alone.

What is the financial trajectory of Cetraxal?

Public company filings do not generally report Cetraxal revenue as a separate line item. No reliable public source establishes annual Cetraxal sales, gross margin, prescription volume, or current net revenue.

The expected financial trajectory is:

Period	Commercial condition	Financial implication
Initial launch	Branded FDA-approved ciprofloxacin otic product	Higher price and promotional opportunity
Early maturity	Physician awareness and distribution expansion	Revenue growth dependent on prescription adoption
Generic-entry period	Substitution and payer pressure	Declining branded volume and net price
Current mature phase	Low-cost category with limited differentiation	Modest, fragmented revenue opportunity
Long-term outlook	Genericized product and limited IP protection	Continued erosion unless supported by brand, supply, or portfolio strategy

Revenue exposure is likely sensitive to five factors:

1. Generic availability and substitution rates.
2. Net price after rebates and wholesaler discounts.
3. Distribution reach in retail pharmacies and urgent-care channels.
4. Brand retention among otolaryngologists and pediatric prescribers.
5. Any commercial linkage with Cetraxal Plus or other otic products.

A mature branded otic product can remain profitable at low sales levels if manufacturing costs are low and promotional spending is limited. That does not imply strong growth. The more probable profile is a small, cash-generative product with declining or flat revenue, unless the owner has obtained favorable distribution rights or bundled it into a broader ear-care portfolio.

How strong is the Cetraxal patent estate?

The patent estate is weak relative to newer branded pharmaceuticals.

Patent-strength factor	Assessment
Composition-of-matter protection	Weak or unavailable
Regulatory exclusivity	Expired or commercially immaterial
Formulation differentiation	Limited
Manufacturing complexity	Low to moderate
Generic design-around risk	High
Trademark value	Potentially meaningful
Litigation leverage	Limited
Long-term pricing power	Low

The product’s defensibility depends more on execution than on exclusionary IP. Reliable supply, pharmacy coverage, product quality, brand recognition, and contracting can preserve residual value. These advantages are vulnerable to lower-cost generic competitors.

What patent litigation affects Cetraxal?

No major ongoing patent litigation involving plain Cetraxal is identified in the publicly established record for this assessment. The absence of a prominent litigation history is consistent with the product’s age and apparent lack of a valuable active patent estate.

Any assessment of a current transaction should separate:

• Plain Cetraxal.
• Cetraxal Plus.
• Other ciprofloxacin otic products.
• Distributor or license agreements.
• Product liability litigation.
• FDA manufacturing or quality actions.
• Trademark disputes.

A dispute involving Cetraxal Plus or another ciprofloxacin formulation should not be treated as evidence of protection for plain Cetraxal.

What licensing deals support Cetraxal?

Cetraxal has historically been associated with sponsor, licensee, and distributor relationships rather than a large multinational commercial platform. Public disclosures do not provide a consistent, separately quantified stream of current licensing revenue attributable to Cetraxal.

The economic value of a Cetraxal licensing arrangement would depend on:

• Territory.
• Remaining term.
• Minimum purchase obligations.
• Transfer price.
• Manufacturing responsibility.
• Regulatory responsibility.
• Promotion requirements.
• Rights to Cetraxal Plus and related products.
• Termination rights after generic entry.

For a mature genericized drug, an asset purchase or license is more likely to be valued on current cash flow, supply reliability, and portfolio fit than on future patent upside.

What generic launch scenarios exist for Cetraxal?

Three scenarios are commercially plausible.

Scenario 1: Continued branded niche

The brand retains a small prescriber base, while generic products capture most price-sensitive prescriptions. Revenue remains low but positive. This scenario requires reliable supply and limited promotional expense.

Scenario 2: Broad generic substitution

Multiple ANDA-approved products achieve pharmacy and payer access. Brand volume falls materially, and net price declines. This is the highest-probability long-term scenario.

Scenario 3: Portfolio-supported defense

The owner markets Cetraxal with other otic products, including a combination product or adjacent ear-care therapies. Bundled contracting and sales-force efficiency slow erosion but do not restore exclusivity.

What is the geographic coverage of Cetraxal?

The commercial analysis is most relevant to the United States because Cetraxal’s key regulatory reference is the U.S. NDA 021918 and the Orange Book framework.

Outside the United States, protection and commercial status depend on country-specific:

• Marketing authorizations.
• Patent registers.
• Supplementary protection certificates.
• Generic approval rules.
• Reimbursement systems.
• Local licensees.
• Trademark ownership.

A U.S. NDA does not establish global patent protection or global market access. Geographic value must be assessed territory by territory.

Key Takeaways

• Cetraxal is ciprofloxacin otic solution 0.2%, approved under U.S. NDA 021918.
• The product treats acute otitis externa and is administered twice daily for seven days.
• Its meaningful exclusivity period has ended.
• Public FDA records do not show a substantial active patent barrier for plain Cetraxal.
• Paragraph IV litigation risk appears limited because the product does not present a prominent active Orange Book patent estate.
• Generic substitution risk is high.
• Cetraxal is a small-molecule drug, so biosimilar risk does not apply.
• Public filings do not separately disclose Cetraxal revenue or profit.
• The likely financial profile is mature, low-growth, and vulnerable to generic price erosion.
• Residual value depends on brand retention, distribution, supply reliability, licensing economics, and portfolio fit rather than patent-based pricing power.

FAQs

Is Cetraxal the same as ciprofloxacin ear drops?

Cetraxal is a branded ciprofloxacin otic solution. Generic ciprofloxacin otic products may be therapeutically substitutable when they have the same active ingredient, strength, dosage form, and FDA-approved indication.

Does Cetraxal have a biosimilar competitor?

No. Cetraxal contains ciprofloxacin, a small-molecule drug. Competitors are regulated as generic drugs rather than biosimilars.

Is Cetraxal Plus protected by the same patents as Cetraxal?

No. Cetraxal Plus contains ciprofloxacin and dexamethasone and has a separate NDA, formulation, regulatory history, and potential patent estate.

Can a generic manufacturer launch ciprofloxacin otic solution without a Paragraph IV lawsuit?

Potentially. If no relevant unexpired patent is listed for the reference product, an ANDA applicant may not face the same Paragraph IV litigation risk associated with a listed active patent.

Is Cetraxal an attractive pharmaceutical licensing target?

Only as a mature cash-flow or portfolio asset. Its attractiveness is constrained by high generic substitution risk, limited apparent patent protection, low product complexity, and the absence of publicly disclosed high-growth revenue data.

References

1. U.S. Food and Drug Administration. (2006). Cetraxal (ciprofloxacin otic solution) 0.2% prescribing information. FDA.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

3. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database. FDA.

4. U.S. Food and Drug Administration. (2024). Abbreviated new drug application approvals and generic drug regulatory information. FDA.