Ciprofloxacin; ciprofloxacin hydrochloride - Generic Drug Details

What are the generic sources for ciprofloxacin; ciprofloxacin hydrochloride and what is the scope of patent protection?

Ciprofloxacin; ciprofloxacin hydrochloride is the generic ingredient in two branded drugs marketed by Bayer Hlthcare, Ani Pharms, Dr Reddys Labs Ltd, Endo Operations, Fosun Pharma, and Rising, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ciprofloxacin; ciprofloxacin hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Clinical Trials:	267
DailyMed Link:	ciprofloxacin; ciprofloxacin hydrochloride at DailyMed

Recent Clinical Trials for ciprofloxacin; ciprofloxacin hydrochloride

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; ciprofloxacin hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ciprofloxacin; ciprofloxacin hydrochloride

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

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

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

US Patents and Regulatory Information for ciprofloxacin; ciprofloxacin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	CIPROFLOXACIN EXTENDED RELEASE	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	078166-001	Nov 27, 2007		DISCN	No	No
Ani Pharms	CIPROFLOXACIN EXTENDED RELEASE	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077809-002	Nov 30, 2010		DISCN	No	No
Fosun Pharma	CIPROFLOXACIN EXTENDED RELEASE	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	078712-001	Dec 11, 2007		DISCN	No	No
Rising	CIPROFLOXACIN EXTENDED RELEASE	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	078183-001	Mar 22, 2007		DISCN	No	No
Ani Pharms	CIPROFLOXACIN EXTENDED RELEASE	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077809-001	Nov 30, 2010		DISCN	No	No
Dr Reddys Labs Ltd	CIPROFLOXACIN EXTENDED RELEASE	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	077701-001	Mar 26, 2007		RX	No	Yes

Expired US Patents for ciprofloxacin; ciprofloxacin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003	7,709,022*PED
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-001	Dec 13, 2002	4,670,444*PED
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003	8,187,632*PED
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003	4,670,444*PED
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-001	Dec 13, 2002	8,187,632*PED
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-001	Dec 13, 2002	7,709,022*PED

Ciprofloxacin; ciprofloxacin hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ciprofloxacin and Ciprofloxacin Hydrochloride

Introduction to Ciprofloxacin and Ciprofloxacin Hydrochloride

Ciprofloxacin, a broad-spectrum synthetic fluoroquinolone antibiotic, is effective against both aerobic gram-positive and gram-negative bacteria. Its hydrochloride salt, ciprofloxacin hydrochloride, is widely used in various medical applications. Here, we delve into the market dynamics and financial trajectory of these compounds.

Market Size and Growth Forecast

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

For ciprofloxacin hydrochloride, the global market was valued at USD 634 million in 2016 and is expected to grow at a CAGR of 5.9% from 2022 to 2031[3].

Market Segmentation

By Type

• Ciprofloxacin hydrochloride is segmented into injection, oral, and eye drop forms. The eye drop segment is particularly significant, given its use in treating ocular infections such as corneal ulcers and bacterial conjunctivitis[2].

By Application

• The market is segmented by application into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are a major segment due to the frequent use of ciprofloxacin in treating various bacterial infections[2].

By End-Users

• The end-users include hospitals, homecare, specialty clinics, and others. Hospitals and specialty clinics are key drivers due to the high demand for ciprofloxacin in these settings[1].

By Distribution Channel

• The distribution channels include hospital pharmacy, online pharmacy, and retail pharmacy. The convenience and accessibility of online pharmacies are expected to contribute to market growth[1].

Geographical Analysis

North America

• North America is expected to dominate the market due to its advanced healthcare infrastructure and robust medical facilities. This region benefits from technological advancements, facilitating widespread adoption of ciprofloxacin solutions[1].

Asia-Pacific

• The Asia-Pacific region is anticipated to grow significantly, driven by increased investments in healthcare infrastructure and rising awareness about eye health. This region is expected to be a key growth driver in the coming years[1].

East Asia

• In East Asia, particularly high market growth rates are expected due to the higher utilization of ciprofloxacin in treating renal infections[4].

Drivers of Market Growth

Rising Bacterial Infections

• The increasing prevalence of bacterial infections is a major driver of the ciprofloxacin market. The need for effective antibiotics to treat these infections is driving demand for ciprofloxacin[3].

Efficacy in Treating Infections

• Ciprofloxacin's higher efficacy in treating urinary tract and renal infections, among others, is a significant factor contributing to market growth. The drug's concentration in the renal system makes it particularly effective for these conditions[4].

Advancements in Healthcare Infrastructure

• Improvements in healthcare infrastructure, especially in regions like Asia-Pacific, are driving the adoption of advanced treatments, including ciprofloxacin solutions[1].

Challenges and Restraints

Antibiotic Resistance

• The increasing prevalence of resistance to ciprofloxacin among bacteria is a significant challenge. This resistance can hinder market growth as it reduces the effectiveness of the drug[3].

Regulatory Impositions

• Stringent regulatory impositions, including black box warnings issued by regulatory bodies like the US FDA, can impact market growth. These warnings highlight safety concerns such as adverse reactions on tendons and skin, particularly in children and elderly patients[4].

Competitive Pricing

• The competitive pricing of alternative antibiotics can also restrain market growth. Other pharmaceutical companies often offer lower-cost alternatives, which can affect the market share of ciprofloxacin[5].

Key Players and Market Competition

The ciprofloxacin hydrochloride market includes key players such as Baiyunshan Pharma, Wujing Medicine, Minsheng Pharma, Jiangbo Pharma, HPGC, Central Pharm, Bikai Pharma, Sino Pharma, Hongqi Pharma, SANDOZ, Alcon, Zaneka Healthcare, and Biophar Lifescience. These companies are involved in various strategies to maintain market share, including the development of new formulations and expansion into different geographical regions[2].

Financial Outlook

The financial trajectory of the ciprofloxacin and ciprofloxacin hydrochloride market is positive, with projected growth rates indicating significant expansion. Here are some key financial highlights:

• Global Ciprofloxacin Ophthalmic Solution Market: Expected to grow from USD 160.46 million in 2023 to USD 244.40 million by 2031, at a CAGR of 5.4%[1].
• Global Ciprofloxacin Hydrochloride Market: Valued at USD 634 million in 2016 and expected to grow at a CAGR of 5.9% from 2022 to 2031[3].

Conclusion

The market for ciprofloxacin and ciprofloxacin hydrochloride is poised for significant growth, driven by increasing bacterial infections, advancements in healthcare infrastructure, and the drug's efficacy in treating various infections. However, challenges such as antibiotic resistance and regulatory impositions need to be addressed to sustain this growth.

Key Takeaways

• The global ciprofloxacin ophthalmic solution market is expected to grow at a CAGR of 5.4% from 2024 to 2031.
• The ciprofloxacin hydrochloride market is anticipated to grow at a CAGR of 5.9% from 2022 to 2031.
• North America and Asia-Pacific are key regions driving market growth.
• Rising bacterial infections and the drug's efficacy in treating infections are major drivers.
• Antibiotic resistance and regulatory impositions are significant challenges.

FAQs

Q: What is the projected market size of the global ciprofloxacin ophthalmic solution market by 2031?

A: The global ciprofloxacin ophthalmic solution market is projected to reach USD 244.40 million by 2031[1].

Q: At what CAGR is the ciprofloxacin hydrochloride market expected to grow from 2022 to 2031?

A: The ciprofloxacin hydrochloride market is expected to grow at a CAGR of 5.9% from 2022 to 2031[3].

Q: Which regions are expected to drive the growth of the ciprofloxacin market?

A: North America and Asia-Pacific are expected to be the key regions driving market growth[1][4].

Q: What are the major challenges facing the ciprofloxacin market?

A: The major challenges include antibiotic resistance and stringent regulatory impositions[3][4].

Q: Who are some of the key players in the ciprofloxacin hydrochloride market?

A: Key players include Baiyunshan Pharma, Wujing Medicine, Minsheng Pharma, and others[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. PharmiWeb: Ciprofloxacin HCl Market Is Anticipated To Register Around 5.9% CAGR From 2022 To 2031.
4. Persistence Market Research: Ciprofloxacin Market.
5. Proteopedia: Ciprofloxacin - Proteopedia, life in 3D.