CIPRO Drug Patent Profile

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

Cipro is a drug marketed by Bayer Hlthcare, Sandoz, Bayer Pharms, Chartwell, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Sentiss, Sun Pharm, Ani Pharms, Dr Reddys Labs Ltd, Endo Operations, Fosun Pharma, Rising, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rubicon, Sciegen Pharms Inc, The J Molner, Watson Labs Inc, Identirx, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms. and is included in sixty-one NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in CIPRO 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 Cipro

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

Summary for CIPRO

US Patents:	0
Applicants:	45
NDAs:	61
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	123
Patent Applications:	1,169
Drug Prices:	Drug price information for CIPRO
Drug Sales Revenues:	Drug sales revenues for CIPRO
What excipients (inactive ingredients) are in CIPRO?	CIPRO excipients list
DailyMed Link:	CIPRO at DailyMed

See drug prices for CIPRO

See drug sales revenues for CIPRO

Pharmacology for CIPRO

Drug Class	Fluoroquinolone Antibacterial
Mechanism of Action	Cytochrome P450 1A2 Inhibitors

Paragraph IV (Patent) Challenges for CIPRO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CIPRO	Oral Suspension	ciprofloxacin	250 mg/5 mL and 500 mg/ 5 mL	020780	1	2009-10-16

US Patents and Regulatory Information for CIPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	075593-001	Jun 9, 2004	AB	RX	No	No
Unique	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076639-002	Sep 10, 2004	AB	RX	No	No
Rising	CIPROFLOXACIN EXTENDED RELEASE	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	078183-001	Mar 22, 2007		DISCN	No	No
Sentiss	CIPROFLOXACIN AND DEXAMETHASONE	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	215768-001	Jun 9, 2023	AB	RX	No	No

Expired US Patents for CIPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-002	Oct 22, 1987
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-004	Oct 22, 1987
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-002	Sep 26, 1997
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-001	Dec 26, 1990

International Patents for CIPRO

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

Country	Patent Number	Title	Estimated Expiration
Hungary	219592	Hatóanyagként ciprofloxacint tartalmazó, ízmaszkírozott gyógyászati készítmények és eljárás előállításukra (PHARMACEUTICAL COMPOSITIONS WITH COVERING FLAVOUR CONSISTING CYPROFLOXACINE AS ACTIVE INGREDIENT AND METHOD FOR PREPARING THEM)
Canada	1322334	COMPOSITIONS QUI CONTIENNENT DE L'ACIDE 1-CYCLOPROPYL-6-FLUORO-1,4-DIHYDRO-4-OXO-7- PIPERAZINO-QUINOLINE-3-CARBOXYLIQUE, ET LEUR UTILISATION (1-CYCLOPROPYL-6-FLUORO-1,4-DIHYDRO-4-OXO-7-PIPERAZINO- QUINOLINE-3-CARBOXYLIC ACID- CONTAINING COMPOSITIONS AND USES THEREOF)
South Africa	9300234
Hungary	T42951

Supplementary Protection Certificates for CIPRO

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
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

CIPRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ciprofloxacin Ophthalmic Solution

Introduction to Ciprofloxacin Ophthalmic Solution

Ciprofloxacin ophthalmic solution is an antibiotic eye drop used to treat various bacterial eye infections, including corneal ulcers and bacterial conjunctivitis. The market for this medication is experiencing significant growth, driven by several key factors.

Market Size and Growth Forecast

The global ciprofloxacin ophthalmic solution market was valued at USD 160.46 million in 2023 and is projected to reach USD 244.40 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period from 2024 to 2031[1][4].

Segmentation of the Market

By Type

The market is segmented into branded and generic ciprofloxacin ophthalmic solutions. Generic versions are expected to see significant growth due to their cost-effectiveness and increasing acceptance by healthcare providers and patients.

By Dosage

The dosage segmentation includes 1-2 drops/2 hours, 2 drops/15 minutes, and 2 drops/30 minutes. The 1-2 drops/2 hours dosage was predicted to show the maximum market share in 2022, indicating a preference for this regimen in clinical practice[4].

By Application

The primary applications are in treating corneal ulcers and bacterial conjunctivitis. The growing prevalence of these eye infections is a major driver of market growth.

By End-Users

Hospitals are the leading end-users, followed by homecare, specialty clinics, and other healthcare settings. Hospitals dominate due to their advanced healthcare infrastructure and the need for immediate and effective treatment of severe eye infections[4].

By Distribution Channel

The distribution channels include hospital pharmacies, online pharmacies, and retail pharmacies. Hospital pharmacies are a significant segment due to the direct access to patients and the urgency of treatment required for eye infections.

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. This region benefits from widespread adoption of ciprofloxacin ophthalmic solutions for various ocular conditions[1][4].

Asia-Pacific

The Asia-Pacific region is anticipated to grow significantly during the forecast period. This growth is attributed to increased regional investments in healthcare infrastructure and rising awareness about eye health, driving demand for advanced treatments and therapies[1].

Drivers of Market Growth

Increasing Prevalence of Eye Infections

The growing prevalence of eye infections such as corneal ulcers and bacterial conjunctivitis is a major driver of the market. As the population ages and becomes more susceptible to these conditions, the demand for effective treatments like ciprofloxacin ophthalmic solution increases[4].

Advanced Healthcare Infrastructure

Regions with advanced healthcare infrastructure, such as North America, are driving market growth due to better access to diagnostic and treatment facilities. Technological advancements in these regions also facilitate the widespread adoption of ciprofloxacin ophthalmic solutions[1].

Rising Awareness About Eye Health

Increased awareness about eye health, particularly in the Asia-Pacific region, is driving demand for advanced treatments. Public health campaigns and educational programs are contributing to this increased awareness and subsequent demand for ciprofloxacin ophthalmic solutions[1].

Challenges and Restraints

Regulatory Framework

The regulatory framework for pharmaceuticals can be stringent, and any changes in regulations can impact the market. Ensuring compliance with regulatory requirements is crucial for market players[1].

Competition from Alternative Treatments

The presence of alternative treatments and antibiotics can pose a challenge to the market growth of ciprofloxacin ophthalmic solutions. Continuous innovation and clinical trials are necessary to maintain market share[3].

Financial Trajectory

Revenue Growth

The market is projected to grow significantly, with revenue expected to increase from USD 160.46 million in 2023 to USD 244.40 million by 2031. This growth is driven by the increasing demand for ciprofloxacin ophthalmic solutions across various regions[1][4].

Investment and Funding

The growth of the market is also supported by investments in healthcare infrastructure and research and development. Funding from government and private sectors is crucial for the development of new formulations and the expansion of existing product lines[1].

Key Players and Market Competition

The market is characterized by the presence of both branded and generic manufacturers. Major market players are focusing on expanding their product portfolios and enhancing their distribution networks to capture a larger market share. The competition is expected to remain intense, with players investing in research and development to stay ahead in the market[1].

Future Outlook

The future outlook for the ciprofloxacin ophthalmic solution market is positive, driven by the growing demand for effective treatments for eye infections. As healthcare infrastructure continues to improve globally, and awareness about eye health increases, the market is expected to see sustained growth.

Key Takeaways

• The global ciprofloxacin ophthalmic solution market is projected to grow at a CAGR of 5.4% from 2024 to 2031.
• North America is expected to dominate the market, while the Asia-Pacific region will see significant growth.
• The increasing prevalence of eye infections and advanced healthcare infrastructure are key drivers of market growth.
• Regulatory challenges and competition from alternative treatments are restraints to market growth.
• Major market players are focusing on research and development and expanding their distribution networks.

FAQs

Q: What is the projected market size of the ciprofloxacin ophthalmic solution market by 2031? A: The market is projected to reach USD 244.40 million by 2031[1][4].

Q: Which region is expected to dominate the ciprofloxacin ophthalmic solution market? A: North America is expected to dominate the market due to its advanced healthcare infrastructure[1][4].

Q: What are the primary applications of ciprofloxacin ophthalmic solution? A: The primary applications are in treating corneal ulcers and bacterial conjunctivitis[1][4].

Q: What is the expected CAGR of the ciprofloxacin ophthalmic solution market from 2024 to 2031? A: The market is expected to grow at a CAGR of 5.4% during the forecast period[1][4].

Q: Which dosage regimen is predicted to show the maximum market share? A: The 1-2 drops/2 hours dosage regimen was predicted to show the maximum market share in 2022[4].

Sources

1. Data Bridge Market Research - Global Ciprofloxacin Ophthalmic Solution Market Size & Growth Forecast.
2. European Commission - 2023 Country Report - Cyprus - Economy and Finance.
3. Market Research Intellect - Global Ciprofloxacin HCl Market Size, Scope And Forecast Report.
4. GlobeNewswire - Global Ciprofloxacin Ophthalmic Solution Market Size Predicted to Surpass $228.92 Million by 2030.
5. European Commission - Economic forecast for Cyprus - Economy and Finance.