Ciprofloxacin - Generic Drug Details

What are the generic drug sources for ciprofloxacin and what is the scope of freedom to operate?

Ciprofloxacin is the generic ingredient in eighteen branded drugs marketed by Bayer Hlthcare, Chartwell, Alk Abello, Bayer Pharms, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Baxter Hlthcare, Bedford, Inforlife, Teva Pharms, Sandoz, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Sciegen Pharms Inc, The J Molner, Watson Labs Inc, Key Therap, Identirx, Depomed Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Laboratorios Salvat, Ani Pharms, Endo Operations, Fosun Pharma, Sentiss, and Sun Pharm, and is included in sixty-seven NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ciprofloxacin has one hundred and fifty patent family members in twenty countries.

There are thirty-four drug master file entries for ciprofloxacin. Four suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for ciprofloxacin

International Patents:	150
US Patents:	10
Tradenames:	18
Applicants:	49
NDAs:	67
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	301
Patent Applications:	6,788
Drug Prices:	Drug price trends for ciprofloxacin
Drug Sales Revenues:	Drug sales revenues for ciprofloxacin
What excipients (inactive ingredients) are in ciprofloxacin?	ciprofloxacin excipients list
DailyMed Link:	ciprofloxacin at DailyMed

See drug prices for ciprofloxacin

See drug sales revenues for ciprofloxacin

Recent Clinical Trials for ciprofloxacin

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

Sponsor	Phase
Institute of Cancer Research, United Kingdom	Phase 1/Phase 2
Prostate Cancer Foundation	Phase 1/Phase 2
Shanghai Pulmonary Hospital, Shanghai, China	Phase 4

See all ciprofloxacin clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN

Applicant	Application No.	Strength	Dosage Form
		EQ 750MG BASE	TABLET;ORAL
		EQ 500MG BASE	TABLET;ORAL
		EQ 250MG BASE	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ciprofloxacin

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

Medical Subject Heading (MeSH) Categories for ciprofloxacin

Anti-Bacterial Agents

Cytochrome P-450 CYP1A2 Inhibitors

Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ciprofloxacin

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

Paragraph IV (Patent) Challenges for CIPROFLOXACIN

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 ciprofloxacin

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 EXTENDED RELEASE	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077701-001	Mar 26, 2007		RX	No	Yes
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-003	Dec 26, 1990		DISCN	No	No
Sun Pharm Inds Ltd	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	075747-002	Jun 9, 2004		DISCN	No	No
Natco	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	075685-001	Jun 9, 2004		DISCN	No	No

Expired US Patents for ciprofloxacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990
Bayer Pharms	CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019858-001	Dec 26, 1990
Bayer Pharms	CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019858-001	Dec 26, 1990
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-002	Sep 26, 1997

International Patents for ciprofloxacin

Country	Patent Number	Title	Estimated Expiration
South Korea	20110025867	CONTROLLED-RELEASE APOPTOSIS MODULATING COMPOSITIONS AND METHODS FOR THE TREATMENT OF OTIC DISORDERS
World Intellectual Property Organization (WIPO)	2010062413
Peru	20091954	COMPOSICIONES CORTICOESTEROIDES DE LIBERACION CONTROLADA Y METODOS PARA EL TRATAMIENTO DE ENFERMEDADES OTICAS
Japan	2017160232	耳の障害の処置のための耳感覚細胞モジュレータ組成物の制御放出及びその方法 (CONTROLLED RELEASE OF AURIS SENSORY CELL MODULATOR COMPOSITIONS FOR TREATMENT OF OTIC DISORDERS AND METHODS THEREFOR)

Supplementary Protection Certificates for ciprofloxacin

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

Ciprofloxacin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ciprofloxacin

Introduction to Ciprofloxacin

Ciprofloxacin, a member of the fluoroquinolone family of antibiotics, is a broad-spectrum medication effective against both Gram-positive and Gram-negative bacteria, as well as various other microorganisms. It is widely used to treat numerous bacterial illnesses, including urinary tract infections, skin and soft tissue infections, respiratory tract infections, and intra-abdominal infections.

Global Market Size and Growth Forecast

The global market for ciprofloxacin is experiencing significant growth, driven by several key factors.

• Ciprofloxacin Ophthalmic Solution Market: This segment is projected to grow from USD 160.46 million in 2023 to 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].
• Ciprofloxacin Hydrochloride Market: The market size is expected to grow from USD 970.53 million in 2023 to USD 1684.78 million by 2032, at a CAGR of 6.32% during the forecast period of 2024 to 2032[4].

Market Segmentation

The ciprofloxacin market is segmented based on several criteria:

• Type:
  • Ciprofloxacin ophthalmic solutions are categorized into branded and generic types[1].
  • Ciprofloxacin hydrochloride is segmented into injection, oral, and eye drop forms[2][3].
• Application:
  • Ciprofloxacin ophthalmic solutions are used for corneal ulcers and bacterial conjunctivitis[1].
  • Ciprofloxacin hydrochloride is used for urogenital infections, respiratory tract infections, gastrointestinal infections, typhoid, bone and joint infections, skin and soft tissue infections, and sepsis among other systemic infections[3].
• End-Users:
  • Hospitals, homecare, specialty clinics, and others are key end-users for ciprofloxacin ophthalmic solutions[1].
  • Hospital pharmacies, retail pharmacies, and online pharmacies are significant distribution channels for ciprofloxacin hydrochloride[2][3].
• Geographical Regions:
  • North America, Europe, Asia-Pacific, South America, and the Middle East and Africa are the primary geographical regions driving the market[1][2][3].

Key Drivers and Opportunities

Several factors are driving the growth of the ciprofloxacin market:

• Increasing Healthcare Infrastructure: Investments in healthcare infrastructure, particularly in the Asia-Pacific region, are driving demand for advanced treatments and therapies, including ciprofloxacin[1].
• Rising Awareness and Access to Healthcare: Improved healthcare access and rising awareness about the importance of antibiotics in treating bacterial infections are enhancing the utilization of ciprofloxacin in various healthcare settings[4].
• Strategic Investments and Partnerships: Pharmaceutical companies are strategically investing and forming partnerships to tap into the growing market, especially in emerging regions[4].
• Government Initiatives: Government policies aimed at enhancing public health and improving access to essential medicines are contributing to the market growth[4].

Market Challenges and Restraints

Despite the positive outlook, the ciprofloxacin market faces several challenges:

• Antibiotic Resistance: The increasing resistance to antibiotics, including fluoroquinolones like ciprofloxacin, poses a significant challenge to the market[3].
• Regulatory Frameworks: Strict regulatory frameworks and the need for continuous monitoring of antibiotic use can act as restraints to market growth[1][2][3].

Financial Impact and Cost Savings

Ciprofloxacin has been shown to offer significant financial benefits:

• Cost Savings: A study found that switching to oral ciprofloxacin after 3 days of intravenous antibiotics resulted in an average cost savings of $293 per patient, highlighting the economic viability of ciprofloxacin treatment[5].

Regional Market Dynamics

• North America: This region is expected to dominate the market due to its advanced healthcare infrastructure and robust medical facilities, facilitating widespread adoption of ciprofloxacin ophthalmic solutions[1].
• Asia-Pacific: This region is anticipated to grow significantly due to increased investments in healthcare infrastructure and rising awareness about eye health and other bacterial infections[1][4].

Key Players

Several key players are active in the ciprofloxacin market:

• Baiyunshan Pharma, Wujing Medicine, Minsheng Pharma, Jiangbo Pharma, HPGC, Central Pharm, Bikai Pharma, Sino Pharma, Hongqi Pharma, SANDOZ, Alcon, Zaneka Healthcare, Biophar Lifescience are some of the notable companies in the ciprofloxacin hydrochloride market[2].

Market Outlook

The overall outlook for the ciprofloxacin market is positive, with projections indicating sustained and significant expansion from 2023 to 2031 and beyond. The market is expected to benefit from rising awareness, improved healthcare access, and strategic investments by pharmaceutical companies.

"The upward trajectory in market dynamics and the anticipated expansion suggest the likelihood of strong growth rates in the coming years"[2].

Key Takeaways

• The global ciprofloxacin market is projected to grow significantly, driven by increasing healthcare infrastructure and rising awareness about bacterial infections.
• The market is segmented into various types, applications, and geographical regions.
• Key drivers include investments in healthcare, strategic partnerships, and government initiatives.
• Challenges such as antibiotic resistance and regulatory frameworks need to be addressed.
• Ciprofloxacin offers significant cost savings and is economically viable.
• North America and Asia-Pacific are key regions driving market growth.

FAQs

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

Q: Which regions are expected to drive the growth of the ciprofloxacin market? A: North America and the Asia-Pacific region are expected to be significant drivers of the ciprofloxacin market[1][4].

Q: What are the common applications of ciprofloxacin hydrochloride? A: Ciprofloxacin hydrochloride is used to treat urogenital infections, respiratory tract infections, gastrointestinal infections, typhoid, bone and joint infections, skin and soft tissue infections, and sepsis among other systemic infections[3].

Q: How does ciprofloxacin impact healthcare costs? A: Ciprofloxacin has been shown to offer significant cost savings, with an average cost savings of $293 per patient when used after 3 days of intravenous antibiotics[5].

Q: Who are some of the key players in the ciprofloxacin hydrochloride market? A: Key players include Baiyunshan Pharma, Wujing Medicine, Minsheng Pharma, Jiangbo Pharma, HPGC, Central Pharm, Bikai Pharma, Sino Pharma, Hongqi Pharma, SANDOZ, Alcon, Zaneka Healthcare, and Biophar Lifescience[2].

Sources

1. Data Bridge Market Research - Global Ciprofloxacin Ophthalmic Solution Market Size & Growth Forecast.
2. Market Research Intellect - Global Ciprofloxacin Hydrochloride Market Size, Trends and Forecast.
3. Market Research Intellect - Global Ciprofloxacin HCl Market Size, Scope And Forecast Report.
4. Introspectivemarketresearch - Ciprofloxacin HCl Market - Overview and Outlook.
5. PubMed - Clinical and economic evaluation of oral ciprofloxacin after an initial course of intravenous antibiotics.