CIPRO XR Drug Patent Profile

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

Cipro Xr is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in CIPRO XR is ciprofloxacin; ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Additional details are available on the ciprofloxacin; ciprofloxacin hydrochloride profile page.

Summary for CIPRO XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	123
Drug Prices:	Drug price information for CIPRO XR
DailyMed Link:	CIPRO XR at DailyMed

See drug prices for CIPRO XR

US Patents and Regulatory Information for CIPRO XR

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 XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-001	Dec 13, 2002		DISCN	No	No
Bayer Hlthcare	CIPRO XR	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021473-002	Aug 28, 2003		DISCN	No	No

Expired US Patents for CIPRO XR

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

International Patents for CIPRO XR

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

Country	Patent Number	Title	Estimated Expiration
Australia	7140587
Norway	158018
Denmark	160491
Hungary	187580	PROCESS FOR PRODUCING 1-CYCLOPROPY-6-FLUORO-1,4-DIHYDRO-4-OXO-7-PIPERAZINO-QUINOLINE-3-CARBOXYLIC ACID DERIVATIVES AND ANTIBACTERIAL COMPOSITIONS CONTAINING THEM AS ACTIVE AGENTS
Ireland	53709	1-CYCLOPROPYL-6-FLUORO-1, 4-DIHYDRO-4-OXO-7-PIPERAZINO-QUINOLINE-3-CARBOXYLIC ACIDS, A PROCESS FOR THEIR PREPARATION AND ANTI-BACTERIAL AGENTS CONTAINING THESE COMPOUNDS
Spain	505138
Israel	76999	ETHYL 2,4-DICHLORO-5-FLUOROBENZOYL-ACETATE

CIPRO XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CIPRO XR

Introduction

CIPRO XR, the extended-release formulation of the antibiotic ciprofloxacin, has been a significant player in the pharmaceutical market, particularly in the treatment of urinary tract infections and other bacterial infections. Here, we delve into the market dynamics and financial trajectory of CIPRO XR, exploring its launch, market performance, and the factors influencing its success.

Launch and Initial Market Performance

CIPRO XR was introduced to the market as an extension of the already successful ciprofloxacin franchise. The launch of CIPRO XR was part of Bayer's strategy to expand its market share in the antibiotic sector. Unlike its immediate-release counterpart, CIPRO XR offered the convenience of once-daily dosing, which was a significant selling point.

Forecast and Actual Performance

Prior to its launch, forecasts suggested that CIPRO XR would achieve substantial sales. For instance, the initial forecast for Cipro (the immediate-release version) in its first year was $100 million, a figure that was met and exceeded expectations[5].

Market Indications and Approval

CIPRO XR is approved for treating various infections, including complicated urinary tract infections, acute uncomplicated pyelonephritis, and infections caused by specific bacteria such as Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa[2].

Clinical Efficacy and Pharmacokinetics

The drug's efficacy is supported by clinical trials that demonstrate its pharmacokinetic profile. CIPRO XR achieves higher maximum plasma concentrations (Cmax) and equivalent area under the curve (AUC) compared to the immediate-release formulation, making it an effective once-daily treatment option[2].

Market Dynamics

Competition and Market Share

CIPRO XR entered a market dominated by other antibiotics, but its unique dosing regimen and broad spectrum of activity helped it gain a significant market share. The support from an international network of opinion leaders and the extensive research base contributed to its acceptance and adoption by healthcare providers[5].

Pricing and Pharmacoeconomic Arguments

The economic argument for CIPRO XR was strong, particularly in the context of reducing hospital stays. The cost savings from avoiding prolonged hospitalization were a key selling point, with estimates suggesting savings of up to $5,000 per day[5].

Financial Trajectory

Revenue Performance

CIPRO XR, along with its immediate-release counterpart, achieved remarkable financial success. The drug had several billion-dollar years in a row, even nearing the end of its patent life. This success was partly due to its wide range of indications and its dominance in the urinary tract infection market[5].

Lifecycle Management

Bayer's lifecycle management strategies played a crucial role in extending the market life of CIPRO XR. The company continuously added new indications, such as typhoid fever, chronic bacterial prostatitis, and intra-abdominal infections, which helped maintain and grow its market share[5].

Challenges and Risks

Resistance and Safety Concerns

One of the significant challenges facing CIPRO XR is the increasing resistance to ciprofloxacin, particularly in hospital settings. This resistance has necessitated careful evaluation of its use as empiric therapy[3].

Adverse Effects

CIPRO XR, like other fluoroquinolones, is associated with risks such as tendinitis and tendon rupture, especially in older patients and those with certain underlying conditions. These safety concerns have led to cautionary recommendations and monitoring during treatment[2].

Regulatory Commitments and Postmarketing Studies

Following its approval, Bayer was required to conduct postmarketing studies to further evaluate the efficacy and safety of CIPRO XR. These studies included investigations into its use in patients with renal impairment and its efficacy against specific pathogens like Pseudomonas aeruginosa[1].

Global Market and Brand Recognition

CIPRO XR, known by different names in various countries (e.g., Ciprobay in Germany, Ciproxan in Japan), has maintained a strong global presence. The consistent messaging and support from opinion leaders have contributed to its brand recognition and trust among healthcare professionals worldwide[5].

Financial Incentives and Public Health Impact

The development and marketing of antibiotics like CIPRO XR are influenced by financial incentives and public health needs. Studies suggest that significant financial rewards are necessary to incentivize the development of new antibiotics, given the high costs and risks involved. For instance, estimates indicate that a yearly pull incentive of $260 million over ten years could be required to achieve an 11% internal rate of return (IRR) for such investments[4].

Key Takeaways

• Market Performance: CIPRO XR achieved significant financial success, driven by its once-daily dosing regimen and broad spectrum of activity.
• Clinical Efficacy: The drug's pharmacokinetic profile supports its efficacy in treating various infections.
• Market Dynamics: Strong support from opinion leaders and pharmacoeconomic arguments contributed to its market acceptance.
• Challenges: Increasing resistance and safety concerns are critical factors to consider.
• Regulatory Commitments: Postmarketing studies have been essential in further evaluating the drug's safety and efficacy.
• Global Recognition: CIPRO XR has maintained a strong global presence under various brand names.

FAQs

What is CIPRO XR used for?

CIPRO XR is used to treat complicated urinary tract infections, acute uncomplicated pyelonephritis, and other bacterial infections caused by specific pathogens.

What are the key pharmacokinetic differences between CIPRO XR and immediate-release ciprofloxacin?

CIPRO XR achieves higher maximum plasma concentrations (Cmax) and equivalent area under the curve (AUC) compared to the immediate-release formulation, allowing for once-daily dosing[2].

What are the safety concerns associated with CIPRO XR?

CIPRO XR is associated with an increased risk of tendinitis and tendon rupture, especially in older patients and those with certain underlying conditions. It also carries risks of CNS side effects and Clostridium difficile-associated diarrhea[2].

How has CIPRO XR performed financially?

CIPRO XR has achieved significant financial success, with several billion-dollar years in a row, even nearing the end of its patent life[5].

What are the postmarketing study commitments for CIPRO XR?

Bayer was required to conduct postmarketing studies to evaluate the efficacy of CIPRO XR in treating complicated urinary tract infections caused by Pseudomonas aeruginosa and to perform Monte Carlo simulations to assess systemic exposure in patients with renal impairment[1].

How does the development of antibiotics like CIPRO XR impact public health?

The development of antibiotics like CIPRO XR is crucial for addressing the growing threat of antimicrobial resistance. Significant financial incentives are often necessary to encourage the development of new antibiotics[4].