PROQUIN XR Drug Patent Profile

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

Proquin Xr is a drug marketed by Depomed Inc and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Proquin Xr

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

Summary for PROQUIN XR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	92
Patent Applications:	3,275
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROQUIN XR
DailyMed Link:	PROQUIN XR at DailyMed

US Patents and Regulatory Information for PROQUIN XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005		DISCN	No	No

Expired US Patents for PROQUIN XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	5,972,389
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	6,635,280
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	6,488,962
Depomed Inc	PROQUIN XR	ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021744-001	May 19, 2005	6,340,475

International Patents for PROQUIN XR

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100685303
Japan	2001500879
Canada	2266589	FORMES GALENIQUES ORALES RETENUES DANS L'ESTOMAC, POUR LA LIBERATION CONTROLEE DE MEDICAMENTS FAIBLEMENT SOLUBLES ET DE SUBSTANCE INSOLUBLE (GASTRIC-RETENTIVE, ORAL DRUG DOSAGE FORMS FOR THE CONTROLLED-RELEASE OF SPARINGLY SOLUBLE DRUGS AND INSOLUBLE MATTER)
Austria	302597
Indonesia	22124
Australia	2001239893
Canada	2364845	PROLONGATION DE LA DUREE DE LIBERATION DE MEDICAMENT DANS L'ESTOMAC AU COURS DU MODE D'ALIMENTATION (EXTENDING THE DURATION OF DRUG RELEASE WITHIN THE STOMACH DURING THE FED MODE)

Supplementary Protection Certificates for PROQUIN XR

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

PROQUIN XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PROQUIN XR

Introduction

PROQUIN XR, an extended-release formulation of the antibiotic ciprofloxacin, was a significant development in the pharmaceutical industry, particularly for Depomed, the company behind its creation. This article delves into the market dynamics and financial trajectory of PROQUIN XR, highlighting its development, market reception, and the financial implications for Depomed.

Development and FDA Approval

PROQUIN XR was developed using Depomed's proprietary AcuForm oral drug delivery technology. This technology allowed for a once-daily formulation of ciprofloxacin, which was approved by the FDA in May 2005. The approval marked a milestone as PROQUIN XR was the first and only version of ciprofloxacin with nausea and diarrhea listed as "uncommon" adverse events, rather than "common" as seen in other formulations[1].

Licensing and Commercialization

Following FDA approval, Depomed licensed PROQUIN XR to Esprit Pharma, a privately held pharmaceutical company, for marketing in the United States and Puerto Rico. The licensing agreement included a $50 million upfront payment, with additional payments of $10 million each on the first and second anniversaries of the contract, along with escalating royalties ranging from 15 to 25 percent based on increasing sales[1].

Market Reception

The market reception of PROQUIN XR was positive, particularly due to its improved gastrointestinal side effect profile. This differentiation helped in attracting patients who had previously discontinued ciprofloxacin treatment due to adverse effects. Clinical trials showed that PROQUIN XR had similar efficacy to the standard twice-daily ciprofloxacin regimen but with a more favorable side effect profile[3].

Financial Impact on Depomed

The licensing of PROQUIN XR to Esprit Pharma had a significant financial impact on Depomed. The upfront payment and subsequent royalties contributed substantially to Depomed's revenue. For the full year 2006, Depomed reported revenues of $9.6 million, a significant increase from the $4.4 million reported in 2005[2].

Revenue and Royalties

The financial trajectory of Depomed was heavily influenced by the royalties from PROQUIN XR. The escalating royalty structure ensured that as sales of PROQUIN XR increased, so did the royalties paid to Depomed. This provided a steady stream of revenue, helping Depomed to expand its pipeline and invest in further research and development[1].

Clinical Trials and Efficacy

Clinical trials for PROQUIN XR demonstrated its efficacy in treating bacterial infections. The primary efficacy variable was bacteriologic eradication of the baseline organism, which showed similar success rates to the standard ciprofloxacin regimen. This efficacy, combined with the improved side effect profile, made PROQUIN XR a viable option for patients and healthcare providers[3].

Adverse Events and Safety Profile

While PROQUIN XR had a more favorable gastrointestinal side effect profile, it still had other adverse events. Common adverse events included fungal infections, nasopharyngitis, headache, and micturition urgency. However, these events were generally mild to moderate and required no treatment in most cases. The discontinuation rate due to adverse reactions was low, at 0.5% of patients[3].

Pharmacokinetics and Administration

The pharmacokinetics of PROQUIN XR were optimized for administration with food, which significantly increased its bioavailability. When taken with a standardized meal, the Cmax and AUC of ciprofloxacin increased by approximately 120% and 170%, respectively, compared to fasting conditions[5].

Market Expansion and Partnerships

Depomed's strategy included expanding the market reach of PROQUIN XR through partnerships. The company sought broad distribution of its products and actively pursued partnerships for geographic regions outside of those currently licensed. This approach was part of Depomed's broader strategy to leverage its AcuForm technology and collaborate with other pharmaceutical and biotechnology companies to optimize drug formulations[1].

Financial Performance and Future Outlook

Despite the positive financial impact of PROQUIN XR, Depomed faced various challenges, including the need to raise additional capital and the risks associated with clinical trials and market acceptance. However, the company remained optimistic about its future, focusing on expanding its pipeline and developing new products. The success of PROQUIN XR was seen as a stepping stone for further growth and innovation[1].

Key Takeaways

• FDA Approval and Licensing: PROQUIN XR received FDA approval in May 2005 and was licensed to Esprit Pharma for marketing in the U.S. and Puerto Rico.
• Improved Side Effect Profile: PROQUIN XR had a more favorable gastrointestinal side effect profile compared to other ciprofloxacin formulations.
• Financial Impact: The licensing and royalties from PROQUIN XR significantly contributed to Depomed's revenue.
• Clinical Efficacy: Clinical trials showed PROQUIN XR to be as effective as standard ciprofloxacin regimens with fewer gastrointestinal side effects.
• Market Expansion: Depomed sought to expand the market reach of PROQUIN XR through partnerships and geographic expansion.

FAQs

What is PROQUIN XR?

PROQUIN XR is an extended-release formulation of the antibiotic ciprofloxacin, developed by Depomed using its proprietary AcuForm oral drug delivery technology.

When was PROQUIN XR approved by the FDA?

PROQUIN XR was approved by the FDA in May 2005.

Who was PROQUIN XR licensed to for marketing?

PROQUIN XR was licensed to Esprit Pharma for marketing in the United States and Puerto Rico.

What were the key financial terms of the licensing agreement?

The licensing agreement included a $50 million upfront payment, with additional payments of $10 million each on the first and second anniversaries of the contract, along with escalating royalties ranging from 15 to 25 percent based on increasing sales.

How did PROQUIN XR compare to standard ciprofloxacin formulations in terms of side effects?

PROQUIN XR had a more favorable gastrointestinal side effect profile, with nausea and diarrhea listed as "uncommon" adverse events, unlike other formulations where these side effects were "common."

Sources

1. Depomed AR05 - Annual Report 2005, Depomed.
2. Depomed Reports 2006 Year End Financial Results - Gale.
3. Proquin XR (ciprofloxacin hydrochloride) Extended-Release Tablets - FDA Label.
4. Depomed officials provide details on the latest developments - Gale.
5. XR (ciprofloxacin hydrochloride) Extended-Release Tablets, 500 mg - FDA Label.