Ciprofloxacin hydrochloride - Generic Drug Details

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

Ciprofloxacin hydrochloride is the generic ingredient in seven branded drugs marketed by Sandoz, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Sciegen Pharms Inc, The J Molner, Watson Labs Inc, Key Therap, Identirx, Depomed Inc, Bayer Hlthcare, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, and Laboratorios Salvat, and is included in thirty-five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for ciprofloxacin hydrochloride. Fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ciprofloxacin hydrochloride

US Patents:	1
Tradenames:	7
Applicants:	32
NDAs:	35
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	56
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	301
Patent Applications:	4,714
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ciprofloxacin hydrochloride
What excipients (inactive ingredients) are in ciprofloxacin hydrochloride?	ciprofloxacin hydrochloride excipients list
DailyMed Link:	ciprofloxacin hydrochloride at DailyMed

Recent Clinical Trials for 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 hydrochloride clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN HYDROCHLORIDE

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 hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for 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 hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-003	Oct 22, 1987	AB	RX	Yes	Yes
Yiling	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	208921-001	Jun 22, 2018	AB	RX	No	No
Unique	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076639-001	Sep 10, 2004	AB	RX	No	No
Watson Labs	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076794-003	Jun 9, 2004	AB	RX	No	No
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-002	Oct 22, 1987	AB	RX	Yes	No
Amring Pharms	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	078598-001	Jan 16, 2008		DISCN	No	No

Expired US Patents for ciprofloxacin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-003	Oct 22, 1987	5,286,754*PED
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	6,488,962
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-003	Oct 22, 1987	4,670,444*PED
Sandoz	CILOXAN	ciprofloxacin hydrochloride	OINTMENT;OPHTHALMIC	020369-001	Mar 30, 1998	4,670,444*PED
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-002	Oct 22, 1987	4,670,444*PED
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-004	Oct 22, 1987	4,670,444*PED

Ciprofloxacin hydrochloride Market Analysis and Financial Projection Experimental

Ciprofloxacin Hydrochloride Market Dynamics and Financial Trajectory

Introduction to Ciprofloxacin Hydrochloride

Ciprofloxacin hydrochloride, a synthetic fluoroquinolone antibiotic, has been a cornerstone in the treatment of bacterial infections since its approval in 1986. This broad-spectrum antibiotic is effective against both Gram-positive and Gram-negative bacteria, making it a versatile tool in the pharmaceutical arsenal.

Market Size and Growth Projections

The global ciprofloxacin hydrochloride market has witnessed significant growth in recent years and is expected to continue this upward trend. As of 2023, the market size was valued at approximately USD 970.53 million and is projected to grow to USD 1684.78 million by 2032, at a Compound Annual Growth Rate (CAGR) of 6.32% during the forecast period from 2024 to 2032[4].

Market Segmentation

The ciprofloxacin hydrochloride market is segmented based on several key factors:

By Type

• The market is categorized into injection, oral, and eye drop formulations. Each type serves different medical needs and patient preferences, contributing to the overall market growth[2].

By Application

• The primary applications include hospital pharmacies, retail pharmacies, and online pharmacies. The rise in online pharmacies has particularly boosted the market, offering convenience and accessibility to patients[2].

By Geography

• The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The Asia-Pacific region is expected to dominate the market due to rising healthcare awareness and improved access to antibiotics[4].

Drivers of Market Growth

Several factors are driving the growth of the ciprofloxacin hydrochloride market:

Rising Bacterial Infections

• The increasing prevalence of bacterial infections, such as urinary tract infections (UTIs), skin and soft tissue infections, respiratory tract infections, and intra-abdominal infections, has significantly boosted the demand for effective antibiotics like ciprofloxacin hydrochloride[4].

Growing Demand in Emerging Markets

• Rapid economic development, increased healthcare awareness, and changing lifestyles in emerging markets have led to a surge in antibiotic demand. The rising incidence of infectious diseases in these regions further fuels the market growth[4].

Convenience and Efficacy

• The versatility of ciprofloxacin hydrochloride in treating a wide range of bacterial infections, along with its proven clinical efficacy and multiple formulations, enhances patient compliance and preference[4].

Restraints and Challenges

Despite the positive growth trajectory, the market faces several challenges:

Antibiotic Resistance

• The increasing prevalence of resistance to ciprofloxacin hydrochloride among bacteria is a significant concern. This resistance can limit the effectiveness of the antibiotic and hinder market growth[3].

Regulatory Scrutiny

• Strict regulatory environments and the need for continuous monitoring of antibiotic resistance can impose constraints on the market. Regulatory bodies often implement guidelines to control the misuse of antibiotics, which can affect market dynamics[4].

Opportunities and Future Outlook

The ciprofloxacin hydrochloride market presents several opportunities for growth and expansion:

Strategic Partnerships and Collaborations

• Pharmaceutical companies are forming strategic partnerships with local healthcare providers and governments in emerging markets to enhance distribution and access to antibiotics. These collaborations can drive market growth and penetration[4].

Government Initiatives

• Government policies aimed at improving public health and increasing access to essential medicines are expected to contribute significantly to the market's expansion. Initiatives to strengthen healthcare systems in emerging markets will further boost the demand for ciprofloxacin hydrochloride[4].

Financial Impact and Cost Savings

The use of ciprofloxacin hydrochloride has significant financial implications:

Cost Savings in Healthcare

• A study on the clinical and economic impact of oral ciprofloxacin as a follow-up to parenteral antibiotics showed substantial cost savings. The use of oral ciprofloxacin resulted in the avoidance of 16,732 doses of parenteral antibiotics and saved an estimated $980,246.50 in total drug and hospitalization costs[5].

Market Revenue

• The projected revenue growth from USD 970.53 million in 2023 to USD 1684.78 million by 2032 indicates a robust financial trajectory for the ciprofloxacin hydrochloride market[4].

Key Players and Market Competition

The market is competitive, with several key players:

Major Pharmaceutical Companies

• Companies 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 are prominent in the ciprofloxacin hydrochloride market. These companies are adopting various strategies to maintain market share and expand their presence in emerging markets[2].

Regional Insights

Asia-Pacific Dominance

• The Asia-Pacific region is expected to dominate the market due to rising healthcare awareness, improved access to antibiotics, and strategic investments by pharmaceutical companies. Government initiatives and policies aimed at enhancing public health also contribute to the region's significant influence on the market[4].

Conclusion

The ciprofloxacin hydrochloride market is poised for significant growth driven by the rising prevalence of bacterial infections, growing demand in emerging markets, and the convenience and efficacy of the antibiotic. Despite challenges such as antibiotic resistance and regulatory scrutiny, the market presents substantial opportunities for expansion through strategic partnerships, government initiatives, and cost savings in healthcare.

Key Takeaways

• The global ciprofloxacin hydrochloride market is expected to grow from USD 970.53 million in 2023 to USD 1684.78 million by 2032.
• The market is driven by the increasing prevalence of bacterial infections and growing demand in emerging markets.
• The Asia-Pacific region is expected to dominate the market.
• Antibiotic resistance and regulatory scrutiny are significant challenges.
• Strategic partnerships and government initiatives offer opportunities for market growth.

FAQs

Q: What is the projected CAGR for the ciprofloxacin hydrochloride market from 2024 to 2032? A: The market is projected to grow at a CAGR of 6.32% from 2024 to 2032[4].

Q: Which region is expected to dominate the ciprofloxacin hydrochloride market? A: The Asia-Pacific region is expected to dominate the market due to rising healthcare awareness and improved access to antibiotics[4].

Q: What are the primary drivers of the ciprofloxacin hydrochloride market? A: The primary drivers include the rising prevalence of bacterial infections and growing demand in emerging markets[4].

Q: How does antibiotic resistance affect the ciprofloxacin hydrochloride market? A: Antibiotic resistance among bacteria is a significant challenge that can limit the effectiveness of ciprofloxacin hydrochloride and hinder market growth[3].

Q: What are the financial benefits of using ciprofloxacin hydrochloride in healthcare settings? A: The use of ciprofloxacin hydrochloride can result in significant cost savings by reducing the need for parenteral antibiotics and shortening hospital stays[5].

Sources

1. Global Ciprofloxacin HCl Market Size, Scope And Forecast Report - Market Research Intellect
2. Global Ciprofloxacin Hydrochloride Market Size, Trends and ... - Market Research Intellect
3. Ciprofloxacin HCl Market Is Anticipated To Register Around 5.9 ... - PharmiWeb
4. Ciprofloxacin HCl Market - Overview and Outlook by (2024–2032) - Introspective Market Research
5. Clinical and economic impact of oral ciprofloxacin as follow-up to ... - PubMed