Ciprofloxacin; dexamethasone - Generic Drug Details

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

Ciprofloxacin; dexamethasone is the generic ingredient in three branded drugs marketed by Sandoz, Dr Reddys, Sentiss, Sun Pharm, and Amneal, and is included in five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ciprofloxacin; dexamethasone has nineteen patent family members in sixteen countries.

Ten suppliers are listed for this compound.

Summary for ciprofloxacin; dexamethasone

International Patents:	19
US Patents:	1
Tradenames:	3
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	10
Clinical Trials:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ciprofloxacin; dexamethasone
DailyMed Link:	ciprofloxacin; dexamethasone at DailyMed

Recent Clinical Trials for ciprofloxacin; dexamethasone

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

Sponsor	Phase
University of Campinas, Brazil	Phase 2
St. Paul's Hospital, Canada	Phase 4
National University of Malaysia	Phase 1/Phase 2

See all ciprofloxacin; dexamethasone clinical trials

Pharmacology for ciprofloxacin; dexamethasone

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

Anatomical Therapeutic Chemical (ATC) Classes for ciprofloxacin; dexamethasone

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

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

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XB	Corticosteroids, moderately potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D10AA	Corticosteroids, combinations for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

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

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

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

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
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

S03BA	Corticosteroids
S03B	CORTICOSTEROIDS
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

Paragraph IV (Patent) Challenges for CIPROFLOXACIN; DEXAMETHASONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CIPRODEX	Otic Suspension	ciprofloxacin; dexamethasone	0.3%/0.1%	021537	1	2012-07-31

US Patents and Regulatory Information for ciprofloxacin; dexamethasone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	CIPROFLOXACIN AND DEXAMETHASONE	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	210470-001	Aug 30, 2022	AB	RX	No	No
Amneal	CIPROFLOXACIN; DEXAMETHASONE	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	216501-001	Mar 22, 2024	AB	RX	No	No
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003	AB	RX	Yes	Yes			Y
Sentiss	CIPROFLOXACIN AND DEXAMETHASONE	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	215768-001	Jun 9, 2023	AB	RX	No	No
Dr Reddys	CIPROFLOXACIN AND DEXAMETHASONE	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	205548-001	Aug 10, 2020	AB	RX	No	No

Expired US Patents for ciprofloxacin; dexamethasone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003

International Patents for ciprofloxacin; dexamethasone

Country	Patent Number	Title	Estimated Expiration
South Korea	20040035760
Japan	2005504804
Canada	2459930	PROCEDE DE TRAITEMENT DE L'INFECTION DE L'OREILLE MOYENNE (METHOD OF TREATING MIDDLE EAR INFECTIONS)
World Intellectual Property Organization (WIPO)	03026671
Spain	2250739

Supplementary Protection Certificates for ciprofloxacin; dexamethasone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	132013902137451	Italy		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
1429780	CA 2012 00045	Denmark
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	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

Ciprofloxacin; dexamethasone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ciprofloxacin and Dexamethasone

Introduction to Ciprofloxacin and Dexamethasone

Ciprofloxacin, a fluoroquinolone antibiotic, and dexamethasone, a corticosteroid, are commonly used in combination to treat various infections. This article delves into the market dynamics and financial trajectory of these drugs, particularly in their combined form.

Market Size and Growth Forecast

The global market for ciprofloxacin, particularly in its ophthalmic solution form, is projected to grow significantly. By 2031, the market size is expected to reach USD 244.40 million from USD 160.46 million in 2023, with a Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period of 2024-2031[1].

For ciprofloxacin hydrochloride (HCl), the global market is anticipated to expand from USD 970.53 million in 2023 to USD 1,684.78 million by 2032, at a CAGR of 6.32% during the forecast period of 2024-2032[5].

Geographical Market Segmentation

North America

North America dominates the ciprofloxacin market due to its advanced healthcare infrastructure and robust medical facilities. This region benefits from technological advancements, facilitating widespread adoption of ciprofloxacin solutions for various ocular and other infections[1][3].

Asia-Pacific

The Asia-Pacific region is expected to grow significantly, driven by increased investments in healthcare infrastructure and rising awareness about health issues. This region, particularly East Asia, is anticipated to see higher utilization of ciprofloxacin for renal infections, contributing to market growth[1][3].

Product Approvals and Impact

FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension

Amneal Pharmaceuticals recently received FDA approval for a ciprofloxacin and dexamethasone otic suspension, which is a significant addition to their generics portfolio. This product addresses the need for potent anti-inflammatory and antibacterial effects in treating ear infections like Acute Otitis Externa. The approval is seen as a positive indicator of Amneal's potential to capture market share in the otic therapy space, potentially influencing the company's stock performance positively[2].

Market Drivers

Increasing Prevalence of Infections

The growing prevalence of renal and eye infections, among others, is a major driver for the ciprofloxacin market. The drug's high efficacy in treating these infections contributes to its demand[3].

Cost-Effectiveness

The combination of ciprofloxacin and dexamethasone offers a cost-effective alternative to branded medications. Studies have shown that this combination can be more cost-effective than other treatments, such as olfloxacin otic solution, up to a certain price threshold[4].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in emerging markets like the Asia-Pacific region, are enhancing the utilization of antibiotics, including ciprofloxacin. Government initiatives and public health policies also contribute to the growth of the pharmaceutical market[5].

Market Restraints

Regulatory Impositions

High regulatory impositions, including black box warnings issued by the FDA due to adverse reactions such as tendon and skin issues, are projected to restrain the growth of the ciprofloxacin market. These warnings can reduce revenue generation and impact market dynamics[3].

Financial Implications

Revenue Streams

The approval of generic products like Amneal's ciprofloxacin and dexamethasone otic suspension can lead to increased revenue streams. Although generics typically offer lower margins than branded drugs, they can achieve significant volume sales, which can positively impact the company's financial performance[2].

Market Penetration

The financial impact of such approvals depends on the product's market penetration and the competitive landscape. Investors should monitor the execution of the product launch and market uptake to gauge the long-term financial implications[2].

Competitive Landscape

Market Share and Competition

The introduction of high-value generics like Amneal's ciprofloxacin and dexamethasone otic suspension can erode the sales of their branded counterparts post-patent expiry, leading to a reshuffling of market shares. This competition can drive innovation and cost-containment efforts by insurers and healthcare providers, favoring generics[2].

Long-Term Implications

Shifts in Prescribing Patterns

The approval of cost-effective generics can lead to shifts in prescribing patterns, with healthcare providers and insurers favoring more affordable treatments. This can have a broader impact on the market, encouraging other companies to develop similar products and increasing competition[2].

Strategic Diversification

For companies like Amneal, the diversification towards more complex generics can enhance their valuation over time. This strategic move reflects the company's ability to navigate the complex regulatory landscape and its commitment to providing affordable, high-value medicines[2].

Key Takeaways

• The global ciprofloxacin market, including ophthalmic solutions and HCl forms, is expected to grow significantly over the next decade.
• Geographical regions like North America and the Asia-Pacific are key drivers of this growth.
• Recent FDA approvals for combined ciprofloxacin and dexamethasone products are strategic advancements in the generics market.
• Cost-effectiveness and the increasing prevalence of infections are major market drivers.
• Regulatory impositions and adverse reaction warnings are significant restraints.
• The financial trajectory is influenced by market penetration, competitive landscape, and shifts in prescribing patterns.

FAQs

What is the projected market size for ciprofloxacin ophthalmic solutions by 2031?

The global market size for ciprofloxacin ophthalmic solutions is projected to reach USD 244.40 million by 2031[1].

How does the FDA approval for ciprofloxacin and dexamethasone otic suspension impact Amneal Pharmaceuticals?

The FDA approval for ciprofloxacin and dexamethasone otic suspension is expected to increase revenue streams and enhance Amneal's market share in the otic therapy space, potentially influencing the company's stock performance positively[2].

What are the major drivers for the ciprofloxacin market?

The major drivers include the increasing prevalence of infections, cost-effectiveness of the drug, and advancements in healthcare infrastructure[3][5].

What are the regulatory challenges facing the ciprofloxacin market?

High regulatory impositions, including black box warnings due to adverse reactions, are significant restraints for the ciprofloxacin market[3].

How does the competitive landscape affect the financial trajectory of ciprofloxacin and dexamethasone products?

The competitive landscape, particularly the introduction of high-value generics, can erode the sales of branded counterparts and drive innovation, impacting the financial trajectory of companies involved[2].

Sources

1. Data Bridge Market Research: Global Ciprofloxacin Ophthalmic Solution Market Size & Growth Forecast.
2. Stock Titan: Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension.
3. Persistence Market Research: Ciprofloxacin Market.
4. PubMed: A cost threshold analysis of ciprofloxacin-dexamethasone versus olfloxacin otic solution.
5. Introspective Market Research: Ciprofloxacin HCl Market - Overview and Outlook.