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Last Updated: December 22, 2024

CIPROFLOXACIN; DEXAMETHASONE Drug Patent Profile


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Which patents cover Ciprofloxacin; Dexamethasone, and when can generic versions of Ciprofloxacin; Dexamethasone launch?

Ciprofloxacin; Dexamethasone is a drug marketed by Amneal and is included in one NDA.

The generic ingredient in CIPROFLOXACIN; DEXAMETHASONE is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ciprofloxacin; Dexamethasone

A generic version of CIPROFLOXACIN; DEXAMETHASONE was approved as ciprofloxacin; dexamethasone by DR REDDYS on August 10th, 2020.

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Drug patent expirations by year for CIPROFLOXACIN; DEXAMETHASONE
Recent Clinical Trials for CIPROFLOXACIN; DEXAMETHASONE

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

SponsorPhase
University of Campinas, BrazilPhase 2
St. Paul's Hospital, CanadaPhase 4
National University of MalaysiaPhase 1/Phase 2

See all CIPROFLOXACIN; DEXAMETHASONE clinical trials

Pharmacology for CIPROFLOXACIN; DEXAMETHASONE
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
Amneal CIPROFLOXACIN; DEXAMETHASONE ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 216501-001 Mar 22, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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