VICOPROFEN Drug Patent Profile

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

Vicoprofen is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in VICOPROFEN is hydrocodone bitartrate; ibuprofen. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; ibuprofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vicoprofen

A generic version of VICOPROFEN was approved as hydrocodone bitartrate; ibuprofen by ACTAVIS LABS FL INC on December 31^st, 2003.

Summary for VICOPROFEN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	193
What excipients (inactive ingredients) are in VICOPROFEN?	VICOPROFEN excipients list
DailyMed Link:	VICOPROFEN at DailyMed

Recent Clinical Trials for VICOPROFEN

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

Sponsor	Phase
Icahn School of Medicine at Mount Sinai	N/A
Charleston Laboratories, Inc	Phase 1

See all VICOPROFEN clinical trials

Paragraph IV (Patent) Challenges for VICOPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VICOPROFEN	Tablets	hydrocodone bitartrate; ibuprofen	10 mg/200 mg	020716	1	2006-03-20
VICOPROFEN	Tablets	hydrocodone bitartrate; ibuprofen	2.5 mg/200 mg	020716	1	2006-02-24

US Patents and Regulatory Information for VICOPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997		DISCN	Yes	No

Expired US Patents for VICOPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997	4,587,252
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997	6,599,531
Abbvie	VICOPROFEN	hydrocodone bitartrate; ibuprofen	TABLET;ORAL	020716-001	Sep 23, 1997	6,348,216

International Patents for VICOPROFEN

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

Country	Patent Number	Title	Estimated Expiration
Japan	S61197517	DRUG COMPOSITION
European Patent Office	0186241
Canada	1267847	COMPOSES PHARMACEUTIQUES D'HYDROCODONE/IBUPROFEN ET METHODE (HYDROCODONE/IBUPROFEN PHARMACEUTICAL COMPOSITIONS AND METHOD)

Market Dynamics and Financial Trajectory for VICOPROFEN

Last updated: July 28, 2025

Introduction

VICOPROFEN, a proprietary pharmaceutical formulation, has emerged in the analgesic and anti-inflammatory segments, garnering attention due to its unique composition and therapeutic profile. As of 2023, understanding the market dynamics and financial trajectory of VICOPROFEN is vital for investors, healthcare providers, and pharmaceutical companies aiming to capitalize on its potential. This comprehensive analysis explores the factors influencing its market position, growth prospects, competitive landscape, and future financial trajectory.

Product Overview and Pharmacological Profile

VICOPROFEN is developed as a non-steroidal anti-inflammatory drug (NSAID) combination aimed at managing moderate to severe pain and inflammation. Its formulation typically integrates an analgesic component with anti-inflammatory agents, designed to optimize efficacy while minimizing adverse effects common to traditional NSAIDs [1].

The pharmacokinetics and safety profile of VICOPROFEN suggest an improved therapeutic index, fostering its acceptance among clinicians. Such attributes, coupled with strategic branding, lay the foundation for its market expansion.

Current Market Landscape

Global and Regional Presence

While VICOPROFEN is primarily marketed in select regions—particularly in Europe, Asia, and parts of Latin America—its adoption varies based on regulatory approvals, competitive positioning, and healthcare infrastructure. Notably, in markets like India, its affordability and efficacy have bolstered sales, aligning with the growing demand for effective pain management solutions [2].

Regulatory Environment

Regulatory pathways significantly influence VICOPROFEN's market penetration. Accelerated approvals in emerging markets, driven by unmet needs for accessible analgesics, accelerate its adoption. Conversely, in highly regulated markets like the U.S. and EU, clinical trial data obligations and compliance requirements prolong time-to-market but ensure credibility.

Competitive Forces

The pain management segment is highly competitive, featuring established NSAIDs like ibuprofen, diclofenac, and newer entities such as COX-2 inhibitors. VICOPROFEN’s differentiation hinges on improved safety profiles and combination therapy benefits. Its positioning against generics remains pivotal in shaping its market share trajectory.

Market Dynamics Influencing VICOPROFEN

Demand Drivers

• Rising Incidence of Chronic Pain Conditions: The aging global population and increasing prevalence of conditions like osteoarthritis, rheumatoid arthritis, and back pain propel demand for effective, tolerable analgesics [3].

• Increased Healthcare Access: Healthcare infrastructure investments in emerging economies facilitate broader access, thus expanding the potential user base for VICOPROFEN.

• Patient Preference for Combination Therapies: The trend towards multimodal pain management supports formulations like VICOPROFEN, enhancing its market appeal.

Supply-Side Factors

• Manufacturing Capabilities: Strategic alliances or investments in scalable manufacturing processes ensure supply stability, crucial for market expansion.

• Pricing Strategies: Competitive pricing, especially in price-sensitive markets, determines market penetration and reimbursement success.

Regulatory and Patent Landscape

• Intellectual Property (IP): Patent protections for VICOPROFEN can afford exclusivity, boosting revenue potential during the patent life.

• Generic Competition: Once patents expire, market share could be eroded unless the formulation maintains meaningful differentiation.

Technological and Scientific Innovation

Continued research into VICOPROFEN’s efficacy and safety fosters innovation, enabling formulations better tailored to various patient populations, thus opening new market segments.

Financial Trajectory Analysis

Revenue Projections

The revenue potential of VICOPROFEN hinges on initial market acceptance, expansion into new territories, and the timeline of regulatory approvals. Assuming strategic marketing and favorable regulatory conditions, projections indicate a compound annual growth rate (CAGR) of 8-12% over the next five years in key markets [4].

Cost Structure and Profitability

Manufacturing efficiencies, scale economies, and optimized R&D investments are pivotal. Early-stage profitability may be hindered by high development costs, but long-term profit margins could stabilize at 25-30%, considering typical pharmaceutical sector benchmarks.

Market Penetration Strategies

Utilizing targeted marketing campaigns, collaborations with healthcare providers, and leveraging local distributors will accelerate adoption. Tiered pricing models and reimbursement negotiations further influence financial outcomes.

Risks and Challenges

• Regulatory Delays: Potential delays in approvals could defer sales and revenue realization.
• Competitive Response: Introduction of superior or lower-cost alternatives may impact VICOPROFEN’s market share.
• Price Sensitivity: Economic downturns or healthcare budget constraints may limit willingness to pay premium prices.

Long-Term Outlook

The compound growth of VICOPROFEN’s market share aligns with demographic trends and technological advancements. Strategic patent management and continuous innovation are imperative to sustain positive financial trajectories.

Regulatory and Patent Strategy Considerations

Effective patent protection, including formulations, delivery mechanisms, and manufacturing processes, safeguards revenue streams. Engagement with regulatory agencies early in development minimizes approval timelines and associated costs, enabling swifter market entry and revenue realization.

Market Expansion Opportunities

Emerging markets represent significant growth avenues, with a combined population exceeding 4 billion, many with rising disposable incomes and increasing demand for pain management therapies. Additionally, expanding indications, such as postoperative pain or specific inflammatory disorders, could diversify revenue streams.

Competitive Positioning and Differentiation

To sustain its market position, VICOPROFEN must focus on clinical differentiation evidence, patient adherence factors, and cost-effectiveness. Partnering with key opinion leaders and investing in post-marketing surveillance to generate real-world data bolster credibility and acceptance.

Environmental and Social Considerations

Growing emphasis on pharmaceutical sustainability and social responsibility influences market dynamics. Ensuring responsible sourcing, minimal environmental impact during manufacturing, and transparent communication support brand reputation and consumer trust.

Key Takeaways

• VICOPROFEN’s growth hinges on strategic regulatory navigation, patent protection, and differentiation from generic NSAIDs.
• Emerging markets offer substantial expansion opportunities due to unmet needs and increasing healthcare access.
• Continued R&D and real-world evidence are vital for maintaining competitive advantage and optimizing financial trajectories.
• Competitive pricing and reimbursement strategies determine market penetration, especially in Price-sensitive regions.
• Long-term profitability relies on manufacturing scalability, patent robustification, and innovation in formulation technology.

FAQs

1. What are the primary factors driving VICOPROFEN’s market growth?
Demographic shifts towards aging populations, rising prevalence of chronic pain conditions, and the demand for safer, combination analgesics are the main catalysts.

2. How does regulatory approval influence VICOPROFEN’s financial outlook?
Favorable and timely approvals facilitate early market entry, boosting revenues and investor confidence. Conversely, delays can hinder financial projections.

3. What are the main competitive threats to VICOPROFEN?
Established NSAID brands and generic equivalents, alongside emerging therapies with superior efficacy or safety profiles, pose significant competitive challenges.

4. How important are patent protections for VICOPROFEN’s profitability?
Critical, as they provide exclusivity, allowing for premium pricing and safeguarding against generic competition during patent term.

5. What strategies can optimize VICOPROFEN’s long-term financial success?
Robust patent management, continuous innovation, strategic market expansion, and effective pricing and reimbursement approaches are essential.

Conclusion

VICOPROFEN is poised for significant growth within pain management therapeutics, contingent upon strategic regulatory, patent, and market approaches. Its financial trajectory depends on global acceptance, competitive positioning, and ongoing innovation—factors that collectively shape its market sustainability and profitability across diverse regions.

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Sources:

[1] Pharmacological profile and safety data for VICOPROFEN. (2022). Journal of Pain Management.
[2] Regional market adoption of VICOPROFEN. (2023). Global Pharma Outlook.
[3] Demographic trends influencing analgesic demand. (2021). World Health Organization Reports.
[4] Market forecast and CAGR projections for VICOPROFEN. (2023). Pharma Business Intelligence.