XARACOLL Drug Patent Profile

When do Xaracoll patents expire, and when can generic versions of Xaracoll launch?

Xaracoll is a drug marketed by Innocoll Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has eighty-three patent family members in twenty-four countries.

The generic ingredient in XARACOLL is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xaracoll

A generic version of XARACOLL was approved as bupivacaine hydrochloride by HOSPIRA on February 17^th, 1986.

Summary for XARACOLL

International Patents:	83
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	4
Patent Applications:	4,671
What excipients (inactive ingredients) are in XARACOLL?	XARACOLL excipients list
DailyMed Link:	XARACOLL at DailyMed

Recent Clinical Trials for XARACOLL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Premier Research Group plc	Phase 3
Cmed	Phase 3
Innocoll	Phase 3

See all XARACOLL clinical trials

US Patents and Regulatory Information for XARACOLL

XARACOLL is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Innocoll Pharms	XARACOLL	bupivacaine hydrochloride	IMPLANT;IMPLANTATION	209511-001	Aug 28, 2020		DISCN	Yes	No
Innocoll Pharms	XARACOLL	bupivacaine hydrochloride	IMPLANT;IMPLANTATION	209511-001	Aug 28, 2020		DISCN	Yes	No			Y

International Patents for XARACOLL

See the table below for patents covering XARACOLL around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1124160
Hungary	E043826
Mexico	2014008327	COLAGENO MODIFICADO. (A MODIFIED COLLAGEN.)
Japan	2015508403	変性コラーゲン
Portugal	3085363

Market Dynamics and Financial Trajectory for XARACOLL

Introduction to XARACOLL

XARACOLL, developed by Innocoll Pharmaceuticals Ltd, is a groundbreaking drug designed to provide acute pain relief for up to 24 hours in adults undergoing open inguinal hernia repair. This medication has garnered significant attention due to its efficacy and potential to transform postoperative pain management.

Market Assessment and Forecast

The market for XARACOLL is poised for remarkable expansion, particularly in the seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Here are some key points from the market assessment:

• Forecasted Sales: The report by DelveInsight provides forecasted sales data for XARACOLL from 2023 to 2032. This detailed forecast is crucial for stakeholders to understand the market trajectory and make informed decisions about their therapeutic portfolios[1][4].

• Market Size: The market size for XARACOLL in the United States is expected to grow significantly, driven by the increasing need for effective postoperative pain management. The report includes a comprehensive analysis of market trends, growth projections, and key factors influencing market dynamics[1][4].

• Competitive Landscape: XARACOLL faces competition from other emerging therapies for postoperative pain. The report highlights the competitive positioning of XARACOLL against these therapies, providing insights into the key players and companies involved in this market segment[1][4].

Clinical and Regulatory Milestones

XARACOLL has achieved several significant clinical and regulatory milestones:

• Clinical Trials: The drug has shown highly statistically significant results in Phase 3 clinical trials, specifically the MATRIX-1 and MATRIX-2 studies. These trials demonstrated XARACOLL's efficacy in reducing pain intensity over 48 hours, a key secondary endpoint[5].

• FDA Approval: XARACOLL has been approved by the US Food and Drug Administration (FDA) for providing acute pain relief in adults undergoing open inguinal hernia repair[1].

• Regulatory Status: The report provides detailed insights into the regulatory milestones and other developmental activities related to XARACOLL, including its safety and efficacy profiles[1][4].

Financial Implications and Investment

The financial trajectory of XARACOLL is closely tied to its market performance and the broader healthcare landscape:

• Revenue Growth: The forecasted sales data indicate a potential for significant revenue growth for XARACOLL. This growth is expected to be driven by increasing demand for effective postoperative pain management solutions[1][4].

• Investment in R&D: Companies like Advanced Medical Solutions (AMS) are investing heavily in research and development, which includes innovative products like XARACOLL. This investment is crucial for maintaining a competitive edge in the market[2].

• Acquisitions and Partnerships: The acquisition of companies like Syntacoll GmbH, a specialist manufacturer of drug-eluting collagens, by AMS, strengthens the group's biosurgical business and supports the development and commercialization of products like XARACOLL[2].

Market Drivers and Barriers

Several factors are driving the market for XARACOLL:

• Increasing Healthcare Spending: Incremental healthcare spending globally is expected to expand the market size for postoperative pain management, benefiting XARACOLL[4].

• Rising Prevalence of Chronic Diseases: The growing prevalence of chronic diseases, such as cancer and tumors, which often require painful surgical procedures, is driving the demand for local anesthesia drugs, including XARACOLL[3].

However, there are also potential barriers:

• Competition from Emerging Therapies: The launch of late-stage emerging therapies for postoperative pain could pose significant competition to XARACOLL, impacting its market share[1][4].

• Regulatory Challenges: The regulatory landscape can be challenging, and any adverse regulatory decisions could affect the marketability of XARACOLL[5].

SWOT Analysis and Analyst Views

A SWOT analysis of XARACOLL highlights its strengths, weaknesses, opportunities, and threats:

• Strengths: XARACOLL's efficacy in clinical trials, its opioid-sparing mechanism, and FDA approval are significant strengths.
• Weaknesses: Dependence on a single indication and potential competition from emerging therapies.
• Opportunities: Growing demand for postoperative pain management and potential expansion into other indications.
• Threats: Regulatory challenges and competition from other local anesthesia drugs[1][4].

Analyst views and Key Opinion Leader (KOL) insights further support the comprehensive analysis of XARACOLL's market position and future prospects[1][4].

Key Takeaways

• XARACOLL is poised for significant market expansion driven by its efficacy in postoperative pain management.
• The drug has achieved key clinical and regulatory milestones, including FDA approval.
• Market forecasts indicate strong revenue growth potential for XARACOLL.
• The competitive landscape is dynamic, with emerging therapies posing potential competition.
• Investment in R&D and strategic acquisitions are crucial for maintaining market competitiveness.

FAQs

Q: What is XARACOLL prescribed for? A: XARACOLL is prescribed for providing acute pain relief for up to 24 hours in adults undergoing open inguinal hernia repair[1].

Q: What are the key clinical trials for XARACOLL? A: The key clinical trials include the MATRIX-1 and MATRIX-2 studies, which demonstrated highly statistically significant results in reducing pain intensity[5].

Q: What is the forecasted market size for XARACOLL by 2032? A: The report provides detailed forecasted sales data for XARACOLL from 2023 to 2032, but specific figures are available in the comprehensive market report[1][4].

Q: How does XARACOLL compete in the market for postoperative pain management? A: XARACOLL competes through its unique mechanism of action, opioid-sparing properties, and strong clinical trial results. However, it faces competition from other emerging therapies[1][4].

Q: What are the regulatory milestones for XARACOLL? A: XARACOLL has been approved by the US FDA for its indicated use. The report provides detailed insights into its regulatory status and developmental activities[1][4].

Cited Sources

1. DelveInsight: XARACOLL Drug Insight and Market Forecast.
2. Advanced Medical Solutions: Unaudited Preliminary Results.
3. Research Dive: Local Anesthesia Drugs Market Size & Industry Trends: 2031.
4. Research and Markets: United States XARACOLL Drug Insight and Market Forecast.
5. Stifel: 5,725,000 Shares INNOCOLL HOLDINGS PLC MORGAN.

Last updated: 2024-12-17