CIPROFLOXACIN Drug Patent Profile

When do Ciprofloxacin patents expire, and what generic alternatives are available?

Ciprofloxacin is a drug marketed by 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 fifty-three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ciprofloxacin

A generic version of CIPROFLOXACIN was approved as ciprofloxacin hydrochloride by RUBICON on June 9^th, 2004.

Summary for CIPROFLOXACIN

US Patents:	0
Applicants:	42
NDAs:	53
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	301
Patent Applications:	3,950
Drug Prices:	Drug price information 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

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
Pliva	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076426-004	Jun 15, 2005		DISCN	No	No
Hospira	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	077753-001	Mar 18, 2008	AP	RX	No	Yes
Amneal	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	075939-003	Jun 9, 2004	AB	RX	No	No
Rubicon	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	075928-001	Jun 9, 2004	AT	RX	No	No
Unique	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076639-002	Sep 10, 2004	AB	RX	No	No
Carlsbad	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076126-002	Jun 9, 2004	AB	RX	No	No

CIPROFLOXACIN Market Analysis and Financial Projection

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.