CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE - Generic Drug Details

What are the generic drug sources for ciprofloxacin hydrochloride; fluocinolone acetonide and what is the scope of patent protection?

Ciprofloxacin hydrochloride; fluocinolone acetonide is the generic ingredient in one branded drug marketed by Laboratorios 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
Laboratorios 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
Japan	2013521245
Hong Kong	1162145	AQUEOUS CLEAR SOLUTIONS OF FLUOCINOLONE ACETONIDE FOR TREATMENT OF OTIC INFLAMMATION
Brazil	112012021638	composição livre de conservantes estéril ótica farmacêutica na forma de uma solução aquosa clara.

Supplementary Protection Certificates for CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	132013902137451	Italy		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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	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

CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ciprofloxacin Hydrochloride and Fluocinolone Acetonide

Introduction

The pharmaceutical market is witnessing significant growth, driven by the increasing demand for effective treatments against various bacterial and inflammatory conditions. Two key drugs in this landscape are Ciprofloxacin Hydrochloride (Ciprofloxacin HCl) and Fluocinolone Acetonide. This article delves into the market dynamics and financial trajectory of these medications.

Ciprofloxacin Hydrochloride Market Overview

Market Size and Growth

The global Ciprofloxacin HCl market is projected to experience substantial growth. As of 2023, the market size was valued at approximately USD 970.53 million and is expected to reach USD 1684.78 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.32% during the forecast period (2024–2032)[4].

Drivers of Growth

The rise in infectious diseases, particularly urinary tract infections (UTIs), skin and soft tissue infections, respiratory tract infections, and intra-abdominal infections, has significantly boosted the demand for Ciprofloxacin HCl. This broad-spectrum antibiotic is effective against both Gram-positive and Gram-negative bacteria, making it a preferred choice for treating various bacterial infections[4].

Regional Insights

The Asia Pacific region is anticipated to dominate the Ciprofloxacin HCl market over the forecast period. Rising awareness, improved healthcare access, and strategic investments by pharmaceutical companies are driving the growth in this region. Government initiatives aimed at enhancing public health and improving access to essential medicines also contribute to the market's expansion[4].

Key Applications

Ciprofloxacin HCl is versatile and is used to treat a spectrum of bacterial infections, including gastrointestinal ailments. Its effectiveness in managing and containing gastrointestinal infections, such as gastroenteritis and bacterial enteric infections, positions it as a significant contributor to the pharmaceutical market[4].

Fluocinolone Acetonide Market Overview

Market Size and Growth

The Fluocinolone Acetonide market has also experienced rapid and substantial growth in recent years. Projections indicate that this market will continue to expand significantly from 2023 to 2031, with robust growth rates anticipated during the forecasted period[2][5].

Drivers of Growth

The demand for Fluocinolone Acetonide is driven by its efficacy in treating inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. The market's positive momentum is further enhanced by the combination of Fluocinolone Acetonide with other medications, such as Ciprofloxacin HCl, for treating conditions like acute otitis media with tympanostomy tubes (AOMT)[2][3].

Key Applications

Fluocinolone Acetonide is approved for various indications, including the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. When combined with Ciprofloxacin HCl, it demonstrates therapeutic superiority in treating AOMT in pediatric patients, making it a valuable component in otic formulations[3].

Market Dynamics

Drivers

• Increasing Prevalence of Infectious Diseases: The rise in bacterial infections globally has increased the demand for effective antibiotics like Ciprofloxacin HCl and anti-inflammatory agents like Fluocinolone Acetonide[4].
• Combination Therapies: The combination of Ciprofloxacin HCl and Fluocinolone Acetonide has shown superior efficacy in treating certain conditions, driving the growth of both markets[3].

Restraints

• Resistance and Safety Concerns: The overuse of antibiotics like Ciprofloxacin HCl can lead to resistance, while Fluocinolone Acetonide may have side effects that need careful monitoring. These factors can restrain market growth[4].
• Regulatory Challenges: Approval processes and regulatory guidelines can pose challenges to the market expansion of these drugs[3].

Opportunities

• Emerging Markets: The Asia Pacific region and other emerging markets offer significant opportunities for growth due to improving healthcare access and increasing demand for antibiotics and anti-inflammatory medications[4].
• Research and Development: Continuous R&D in combination therapies and new formulations can open up new avenues for market expansion[2].

Challenges

• Competition: The pharmaceutical market is highly competitive, with numerous alternatives available for treating bacterial and inflammatory conditions. This competition can challenge the market share of Ciprofloxacin HCl and Fluocinolone Acetonide[4].
• Economic Factors: Economic fluctuations and healthcare budget constraints can impact the demand for these medications[5].

Financial Trajectory

Revenue Projections

The Ciprofloxacin HCl market is expected to grow from USD 970.53 million in 2023 to USD 1684.78 million by 2032, indicating a strong financial trajectory. Similarly, the Fluocinolone Acetonide market is anticipated to achieve significant revenue growth from 2023 to 2031, though exact figures are not specified[2][4].

Key Players

Several key players are involved in the production and distribution of these drugs. Strategic investments, partnerships, and government initiatives are crucial in driving the financial growth of these markets[4].

Combination Therapies

Ciprofloxacin HCl and Fluocinolone Acetonide Combination

The combination of Ciprofloxacin HCl and Fluocinolone Acetonide in otic solutions has shown therapeutic superiority in treating AOMT in pediatric patients. This combination has been approved in several countries and demonstrates safety and efficacy in clinical trials[3].

"Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% otic solution demonstrated therapeutic superiority over Ciprofloxacin 0.3% otic solution and over Fluocinolone Acetonide 0.025% otic solution for the primary endpoint of time to cessation of otorrhea."[3]

Regional Market Insights

Asia Pacific

The Asia Pacific region is expected to dominate both the Ciprofloxacin HCl and Fluocinolone Acetonide markets. Rising awareness, improved healthcare access, and strategic investments by pharmaceutical companies are driving growth in this region[4].

Other Regions

Other regions, including North America and Europe, also contribute significantly to the market growth of these drugs. However, the Asia Pacific region's influence is expected to remain significant due to its large population and growing healthcare needs[4].

Conclusion

The markets for Ciprofloxacin HCl and Fluocinolone Acetonide are poised for significant growth driven by increasing demand for effective treatments against bacterial and inflammatory conditions. The combination of these drugs in otic solutions has shown promising results, further boosting their market potential.

Key Takeaways

• Growing Demand: The rise in infectious diseases is driving the demand for Ciprofloxacin HCl and Fluocinolone Acetonide.
• Combination Therapies: The combination of Ciprofloxacin HCl and Fluocinolone Acetonide shows therapeutic superiority in treating certain conditions.
• Regional Growth: The Asia Pacific region is expected to dominate the market for both drugs.
• Financial Trajectory: Both markets are projected to achieve significant revenue growth over the forecast period.
• Challenges and Opportunities: Market growth is influenced by factors such as resistance, safety concerns, regulatory challenges, and emerging market opportunities.

FAQs

Q: What is the expected market size of Ciprofloxacin HCl by 2032?

A: The global Ciprofloxacin HCl market is expected to grow from USD 970.53 million in 2023 to USD 1684.78 million by 2032[4].

Q: What are the key applications of Fluocinolone Acetonide?

A: Fluocinolone Acetonide is used to treat inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses and is also combined with Ciprofloxacin HCl for treating AOMT[3].

Q: Which region is expected to dominate the Ciprofloxacin HCl market?

A: The Asia Pacific region is anticipated to dominate the Ciprofloxacin HCl market over the forecast period[4].

Q: What are the benefits of combining Ciprofloxacin HCl and Fluocinolone Acetonide?

A: The combination of Ciprofloxacin HCl and Fluocinolone Acetonide demonstrates therapeutic superiority in treating AOMT in pediatric patients and shows safety and efficacy in clinical trials[3].

Q: What are the major challenges facing the Ciprofloxacin HCl and Fluocinolone Acetonide markets?

A: The major challenges include antibiotic resistance, safety concerns, regulatory challenges, and economic factors[4].

Sources

1. Global Ciprofloxacin HCl Market Size, Scope And Forecast Report - Market Research Intellect
2. Global Fluocinolone Acetonide Market Size, Trends and Projections - Market Research Intellect
3. 208251 Ciprofloxacin and Fluocinolone acetonide Clinical PREA - FDA
4. Ciprofloxacin HCl Market - Overview and Outlook by (2024–2032) - Introspective Market Research
5. Fluocinolone Acetonide Cream Market Size, Scope And Forecast ... - Market Research Intellect