CIPRODEX Drug Patent Profile

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

Ciprodex is a drug marketed by Sandoz and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nineteen patent family members in sixteen countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ciprodex

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

Summary for CIPRODEX

International Patents:	19
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	10
Patent Applications:	60
Drug Prices:	Drug price information for CIPRODEX
Drug Sales Revenues:	Drug sales revenues for CIPRODEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CIPRODEX
What excipients (inactive ingredients) are in CIPRODEX?	CIPRODEX excipients list
DailyMed Link:	CIPRODEX at DailyMed

See drug prices for CIPRODEX

See drug sales revenues for CIPRODEX

Recent Clinical Trials for CIPRODEX

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

Sponsor	Phase
St. Paul's Hospital, Canada	Phase 4
Boston Medical Center	Phase 4
Exela Pharma Sciences, LLC.	Phase 3

See all CIPRODEX clinical trials

Pharmacology for CIPRODEX

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

Paragraph IV (Patent) Challenges for CIPRODEX

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 CIPRODEX

CIPRODEX is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003	AB	RX	Yes	Yes			Y

Expired US Patents for CIPRODEX

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

International Patents for CIPRODEX

See the table below for patents covering CIPRODEX around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	7057000
China	1231218
Denmark	1214056
Japan	2003510263

Supplementary Protection Certificates for CIPRODEX

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

Market Dynamics and Financial Trajectory for Ciprodex

Introduction to Ciprodex

Ciprodex, a combination of ciprofloxacin and dexamethasone, is a potent antibiotic and corticosteroid formulation used to treat various bacterial infections, particularly in the eyes and ears. Understanding the market dynamics and financial trajectory of Ciprodex is crucial for stakeholders, including investors, healthcare providers, and pharmaceutical companies.

Market Size and Growth Forecast

The market for ciprofloxacin ophthalmic solutions, which includes Ciprodex, is projected to grow significantly. As of 2023, the global ciprofloxacin ophthalmic solution market was valued at USD 160.46 million and is expected to reach USD 244.40 million by 2031, with a Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period of 2024 to 2031[1].

Drivers of Market Growth

Increasing Prevalence of Eye Infections

The widespread occurrence of bacterial eye infections such as conjunctivitis and keratitis drives the demand for ciprofloxacin ophthalmic solutions. These conditions require potent antibiotics to prevent complications and preserve vision, making Ciprodex a critical treatment option[1].

Government Initiatives and Healthcare Policies

Government initiatives aimed at reducing preventable blindness and enhancing medication accessibility are instrumental in driving demand. Programs like the National Programme for Control of Blindness and Visual Impairment in India provide free eye care services and medications, including ciprofloxacin eye drops, to economically disadvantaged populations, promoting affordability and accessibility[1].

Regional Market Dynamics

North America

North America is expected to dominate the market due to its advanced healthcare infrastructure. Robust medical facilities and technological advancements in this region facilitate the widespread adoption of ciprofloxacin ophthalmic solutions, driving market growth[1].

Asia-Pacific

The Asia-Pacific region is also expected to grow significantly, driven by increased investments in healthcare infrastructure and rising awareness about eye health. This surge in demand for advanced treatments and therapies in the region contributes to the overall market growth[1].

Impact of Generic Competition

Generic versions of Ciprodex, such as the recently approved ciprofloxacin and dexamethasone otic suspension by Amneal Pharmaceuticals, can significantly impact the market. Generics typically offer lower margins but achieve significant volume sales, potentially disrupting the current market dynamics and eroding the sales of branded counterparts post-patent expiry[3].

Financial Implications

Revenue and Sales

The approval of generic versions can lead to increased revenue streams for companies like Amneal, despite lower margins compared to branded drugs. The financial impact may be limited in the immediate term but can enhance the company's valuation over time through diversification of its generics portfolio[3].

Market Penetration and Competition

The success of generic Ciprodex alternatives depends on market penetration and the competitive landscape. Investors should monitor the execution of product launches, market uptake, and competitive responses to gauge the long-term financial implications[3].

Regulatory Landscape

Navigating the complex regulatory landscape is pivotal for pharmaceutical companies. Approvals like Amneal's ciprofloxacin and dexamethasone otic suspension demonstrate a company's ability to comply with regulatory requirements, which is essential for growth in the generics market[3].

Impact on Stock Performance

The approval and successful launch of generic Ciprodex can positively influence a company's stock performance. It reflects confidence in the company's research and development (R&D) and regulatory capabilities, potentially attracting investor interest and enhancing the company's valuation[3].

Long-term Implications

Shifts in Prescribing Patterns

The introduction of cost-effective generic alternatives can lead to shifts in prescribing patterns, with cost-containment efforts by insurers and healthcare providers favoring generics. This could drive innovation and increase competition in the market as other companies follow suit[3].

Healthcare Industry Impact

Long-term implications include potential changes in the healthcare industry, such as increased focus on affordable treatments and the profitability of generic drug manufacturing. Understanding the balance between demand for affordable treatments and profitability is essential for stakeholders[3].

Key Players and Market Segmentation

The market for ciprofloxacin ophthalmic solutions is segmented by type (branded and generic), dosage, application (corneal ulcers, bacterial conjunctivitis), end-users (hospitals, homecare, specialty clinics), and distribution channels (hospital pharmacy, online pharmacy, retail pharmacy). Major players in this market include pharmaceutical companies that specialize in both branded and generic formulations[1].

Challenges and Opportunities

Price Erosion and Generic Competition

The market faces challenges such as price erosion and generic competition, which can negatively impact the sales of branded drugs. However, these challenges also present opportunities for companies to diversify their portfolios and capture market share in the generics segment[2][3].

Advancements in Drug Delivery Systems

Advancements in drug delivery systems offer opportunities for growth, particularly in regions like Asia-Pacific, where increased investments in healthcare infrastructure are driving demand for advanced treatments and therapies[1].

Key Takeaways

• The global ciprofloxacin ophthalmic solution market, including Ciprodex, is projected to grow at a CAGR of 5.4% from 2024 to 2031.
• Increasing prevalence of eye infections and government healthcare initiatives drive market growth.
• Generic competition can significantly impact the market, offering cost-effective alternatives and potentially disrupting current market dynamics.
• Regulatory approvals and successful market penetration are crucial for the financial trajectory of companies offering generic Ciprodex.
• Long-term implications include shifts in prescribing patterns and increased focus on affordable treatments.

FAQs

Q: What is the projected market size for ciprofloxacin ophthalmic solutions by 2031? A: The global ciprofloxacin ophthalmic solution market is expected to reach USD 244.40 million by 2031[1].

Q: How does generic competition affect the market for Ciprodex? A: Generic competition can erode the sales of branded Ciprodex, but it also offers significant volume sales and cost-effective alternatives, potentially disrupting market dynamics[3].

Q: Which regions are expected to drive the growth of the ciprofloxacin ophthalmic solution market? A: North America and the Asia-Pacific region are expected to drive market growth due to advanced healthcare infrastructure and increasing investments in healthcare, respectively[1].

Q: What are the key drivers of the ciprofloxacin ophthalmic solution market? A: Key drivers include the increasing prevalence of eye infections and government initiatives aimed at reducing preventable blindness and enhancing medication accessibility[1].

Q: How do regulatory approvals impact the financial trajectory of companies offering Ciprodex? A: Regulatory approvals reflect a company's ability to navigate the complex regulatory landscape, which is pivotal for growth in the generics market and can positively influence the company's stock performance[3].

Cited Sources

1. Data Bridge Market Research - Global Ciprofloxacin Ophthalmic Solution Market Size & Growth Forecast.
2. Novartis - Financial Results Q3 2021.
3. Stock Titan - Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension.
4. Cognitive Market Research - Ear Drops Market Report 2024 (Global Edition).
5. Novartis - Financial Results Q4 2021.