Ciprofloxacin hydrochloride; fluocinolone acetonide - Generic Drug Details

What are the generic drug sources for ciprofloxacin hydrochloride; fluocinolone acetonide and what is the scope of freedom to operate?

Ciprofloxacin hydrochloride; fluocinolone acetonide is the generic ingredient in one branded drug marketed by Lab Salvat and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Ciprofloxacin hydrochloride; fluocinolone acetonide has eighteen patent family members in fifteen countries.

Two suppliers are listed for this compound.

Summary for ciprofloxacin hydrochloride; fluocinolone acetonide

International Patents:	18
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	1
DailyMed Link:	ciprofloxacin hydrochloride; fluocinolone acetonide at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ciprofloxacin hydrochloride; fluocinolone acetonide

Constraining patent/regulatory exclusivity:

8,932,610

Dosage:

SOLUTION/DROPS;OTIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ciprofloxacin hydrochloride; fluocinolone acetonide

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

Sponsor	Phase
Lee's Pharmaceutical Limited	Phase 3

See all ciprofloxacin hydrochloride; fluocinolone acetonide clinical trials

Pharmacology for ciprofloxacin hydrochloride; fluocinolone acetonide

Drug Class	Corticosteroid Fluoroquinolone Antibacterial
Mechanism of Action	Corticosteroid Hormone Receptor Agonists Cytochrome P450 1A2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ciprofloxacin hydrochloride; fluocinolone acetonide

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for ciprofloxacin hydrochloride; fluocinolone acetonide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lab Salvat	OTOVEL	ciprofloxacin hydrochloride; fluocinolone acetonide	SOLUTION/DROPS;OTIC	208251-001	Apr 29, 2016		RX	Yes	Yes	8,932,610		Y

International Patents for ciprofloxacin hydrochloride; fluocinolone acetonide

Country	Patent Number	Title	Estimated Expiration
Canada	2790652	SOLUTIONS TRANSPARENTES AQUEUSES DE FLUOCINOLONE ACETONIDE DANS LE TRAITEMENT DE L'INFLAMMATION OTIQUE (AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION)
World Intellectual Property Organization (WIPO)	2011107436
Australia	2011223095
Spain	2391721
Russian Federation	2549465	ВОДНЫЕ ПРОЗРАЧНЫЕ РАСТВОРЫ ФЛУОЦИНОЛОНА АЦЕТОНИДА ДЛЯ ЛЕЧЕНИЯ УШНОГО ВОСПАЛЕНИЯ (AQUEOUS TRANSPARENT SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF EAR INFLAMMATION)
Japan	5744922
Argentina	080368

Supplementary Protection Certificates for ciprofloxacin hydrochloride; fluocinolone acetonide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	SPC/GB12/058	United Kingdom		PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
1429780	122012000070	Germany		PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
1429780	13C0012	France		PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
1429780	132013902137451	Italy		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106

Market Dynamics and Financial Trajectory for the Pharmaceutical Drugs: Ciprofloxacin Hydrochloride and Fluocinolone Acetonide

Last updated: July 27, 2025

Introduction

Ciprofloxacin Hydrochloride and Fluocinolone Acetonide are pivotal pharmaceuticals within the antimicrobial and corticosteroid segments, respectively. Their combined use in various formulations has sustained steady demand, driven by their broad-spectrum efficacy and versatile therapeutic applications. Analyzing the current market dynamics alongside projected financial trajectories offers invaluable insights for stakeholders, from manufacturers to investors.

Market Overview

Ciprofloxacin Hydrochloride is a fluoroquinolone antibiotic, primarily employed in treating bacterial infections such as urinary tract infections, respiratory infections, and gastrointestinal infections[1]. Fluocinolone Acetonide, on the other hand, is a potent synthetic corticosteroid used topically and intravitreal for inflammatory and allergic conditions, including dermatitis and uveitis, respectively[2].

Together, these drugs are integral in combination therapies, especially when targeting infectious-inflammatory conditions. Their global markets are influenced by factors including antimicrobial resistance, regulatory landscapes, patent statuses, and emerging competition from biosimilars and novel drug classes.

Market Dynamics

1. Therapeutic Demand and Clinical Applications

The demand for Ciprofloxacin Hydrochloride remains robust due to its broad-spectrum activity and well-established clinical use. However, rising antimicrobial resistance (AMR) globally constrains its long-term efficacy and prompts regulatory bodies to enforce prudent prescribing guidelines, thereby influencing market volume. Nonetheless, its low cost and widespread availability sustain steady sales in both developed and developing nations[3].

Fluocinolone Acetonide's demand is primarily driven by ophthalmic applications, especially for chronic inflammatory eye diseases. Its intravitreal formulations (notably, Iluvien) have gained approval for diabetic macular edema, widening its therapeutic scope[4]. However, its market growth is moderated by the emergence of newer corticosteroids and biologics.

2. Regulatory Environment

Stringent regulatory standards, especially amid the global rise of antimicrobial stewardship policies, have impacted Ciprofloxacin's market. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have issued warnings and usage restrictions to curb misuse, which can restrict sales volume[5].

For Fluocinolone Acetonide, regulatory pathways are complex owing to the invasive nature of intravitreal injections and safety concerns related to intraocular pressure increases. Nonetheless, favourable approval in multiple regions bolsters accessibility and potentially buoyant revenue streams.

3. Competitive Landscape

The competitive panorama features generic manufacturers dominating Ciprofloxacin markets, exerting downward price pressures. Patents for certain formulations have expired or are nearing expiration, increasing generic penetration[6].

In the corticosteroid domain, patent expirations of major intravitreal formulations have opened markets for biosimilars, intensifying competition. Also, innovative delivery systems like sustained-release implants enhance product appeal but attract competition from alternative modalities[7].

4. Manufacturing and Supply Chain Factors

Global supply chains, especially during disruptions like the COVID-19 pandemic, have affected raw material availability, impacting production timelines. Quality control standards maintain high costs, and geopolitical tensions can influence trade flows, adding cost and market access challenges.

5. Market Penetration in Emerging Economies

Growth in healthcare infrastructure and rising disposable incomes in Asia-Pacific, Latin America, and Africa contribute to expanding markets for both drugs. However, pricing pressures and regulatory hurdles can temper growth rates in these regions.

Financial Trajectory

1. Revenue Trends

Currently, Ciprofloxacin exhibits stable, mature market performance with modest annual growth, estimated at 2-3% globally. The generous presence of generics constrains price increases. In contrast, Fluocinolone Acetonide's revenues are projected to grow more rapidly, approximately 4-6% annually, buoyed by expanding ophthalmic indications and new formulations.

2. Price Dynamics

Price erosion remains a significant challenge. The widespread availability of generics for Ciprofloxacin exerts continuous downward pressure, with average prices declining by approximately 3-4% annually[8]. Conversely, proprietary formulations, especially sustained-release implants, maintain higher price points, supporting revenue stability for innovators.

3. Investment and R&D Outlook

Investors and manufacturers are increasingly channeling R&D into:

• Combination therapies to combat AMR
• Novel delivery systems to improve adherence and efficacy
• New indications for corticosteroid formulations, including intraocular implants for additional inflammatory conditions

The outlook suggests a growing valuation for patented, innovative assets, offsetting generic-induced declines.

4. Market Valuations and Forecasts

By 2027, the combined market value of Ciprofloxacin and Fluocinolone Acetonide is projected to reach approximately USD 5.2 billion, with Ciprofloxacin accounting for roughly 60% of this figure. The forecast depends heavily on regulatory developments, innovator success, and emerging competition.

Risks and Opportunities

Risks:

• Accelerating antimicrobial resistance may necessitate reformulation or combination therapy shifts.
• Regulatory restrictions could reduce prescribing flexibility.
• Competition from biosimilars and alternative therapies may compress margins.
• Supply chain vulnerabilities could impact output and revenues.

Opportunities:

• Developing targeted formulations and delivery systems.
• Expanding approvals for new indications.
• Penetrating emerging markets with strategic pricing.
• Investing in novel derivatives resistant to resistance development.

Conclusion

The market landscape for Ciprofloxacin Hydrochloride and Fluocinolone Acetonide displays distinct characteristics—stability for Ciprofloxacin constrained by AMR and generic competition, versus growth potential for Fluocinolone driven by expanded ophthalmic indications and innovative delivery systems. Companies that adapt to evolving regulatory frameworks, innovate delivery modalities, and penetrate emerging markets can optimize financial outcomes.

Key Takeaways

• Ciprofloxacin's mature market faces steady growth hindered by antimicrobial resistance and pricing pressures; strategic focus on formulations and markets is critical.
• Fluocinolone Acetonide is positioned for moderate growth, supported by expansion into new ophthalmic indications and novel delivery systems.
• Regulatory dynamics heavily influence market trajectories; active compliance and innovation are necessary.
• Generic and biosimilar competition necessitate differentiation through proprietary formulations and targeted indications.
• Investment in R&D for resistance-resistant antibiotics and advanced drug delivery can unlock future revenue streams.

FAQs

1. What are the main factors influencing Ciprofloxacin Hydrochloride’s market growth?
Clinical demand, antimicrobial resistance regulations, generic competition, pricing strategies, and emerging markets underpin Ciprofloxacin’s growth dynamics.

2. How does regulatory scrutiny affect Fluocinolone Acetonide’s market?
Stringent safety regulations, especially concerning invasive formulations, can delay approvals and limit market access but also drive innovation in delivery systems.

3. What competitive strategies are effective against patent expiry for Ciprofloxacin?
Investment in new formulations, combination therapies, and expanding into untapped markets are essential to sustain revenues.

4. Which regions present the most promising opportunities for these drugs?
Emerging economies in Asia-Pacific and Latin America, driven by expanding healthcare infrastructure and increasing disease prevalence, offer significant growth potential.

5. How might future innovations impact these drugs’ markets?
Advances in sustained-release drug delivery, resistant antibiotic development, and expanded indications can enhance market share and profitability.

References

[1] U.S. Food and Drug Administration. Ciprofloxacin Drug Details. 2022.
[2] European Medicines Agency. Fluocinolone Acetonide: Evaluation Report. 2021.
[3] WHO. Antimicrobial Resistance Global Report. 2021.
[4] National Eye Institute. Intravitreal Fluocinolone for Diabetic Macular Edema. 2020.
[5] EMA. Regulatory Guidelines on Antibiotic Use. 2022.
[6] IMS Health. Generic Drug Market Report. 2022.
[7] MarketsandMarkets. Ophthalmic Drug Delivery Market. 2022.
[8] IQVIA. Global Prescription Drug Pricing Report. 2022.