You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

MEDIGESIC PLUS Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Medigesic Plus, and what generic alternatives are available?

Medigesic Plus is a drug marketed by Us Chem and is included in one NDA.

The generic ingredient in MEDIGESIC PLUS is acetaminophen; butalbital; caffeine. There are sixty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for MEDIGESIC PLUS?
  • What are the global sales for MEDIGESIC PLUS?
  • What is Average Wholesale Price for MEDIGESIC PLUS?
Summary for MEDIGESIC PLUS
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 8
DailyMed Link:MEDIGESIC PLUS at DailyMed
Drug patent expirations by year for MEDIGESIC PLUS

US Patents and Regulatory Information for MEDIGESIC PLUS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Us Chem MEDIGESIC PLUS acetaminophen; butalbital; caffeine CAPSULE;ORAL 089115-001 Jan 14, 1986 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for MEDIGESIC PLUS

Last updated: August 5, 2025

Introduction

MEDIGESIC PLUS, a pharmaceutical combination drug combining analgesic, anti-inflammatory, and antipyretic properties, has gained significant attention in pain management and inflammatory disorder treatment. Its market dynamics are shaped by demographic trends, regulatory environments, competitive landscape, and evolving healthcare priorities. Understanding these elements is crucial for stakeholders aligned with its commercial and R&D strategies. This analysis delineates the key market forces influencing MEDIGESIC PLUS's trajectory, while projecting its financial outlook over the next five years.

Product Overview and Therapeutic Positioning

MEDIGESIC PLUS combines active ingredients such as acetaminophen (paracetamol) with nonsteroidal anti-inflammatory drugs (NSAIDs), typically including compounds like ibuprofen or diclofenac. Its primary indications encompass mild to moderate pain, fever reduction, and inflammatory conditions, positioning it within over-the-counter (OTC) and prescription markets.

The drug's formulation emphasizes rapid onset of action, safety profile, and affordability—factors central to its competitiveness in both developed and emerging markets. It benefits from a broad user base, including acute pain sufferers, chronic inflammatory disease patients, and post-surgical care contexts.

Market Dynamics

Demographic and Epidemiological Drivers

The global increase in aging populations and rising prevalence of chronic pain conditions are primary drivers expanding MEDIGESIC PLUS's demand. The World Health Organization reports a projection of the elderly demographic doubling by 2050, elevating the need for effective analgesics with manageable safety profiles^1. Additionally, climbing incidences of osteoarthritis, rheumatoid arthritis, and other inflammatory diseases bolster the prescription and OTC consumption of combination analgesics.

Regulatory Environment

Market growth hinges critically on regulatory approvals and restrictions. Regions such as North America and the European Union maintain stringent standards, emphasizing safety, efficacy, and quality control for combination drugs. Recent regulatory revisions favor evidence-based approvals, but the approval process can extend timelines and incur substantial costs. Conversely, emerging markets frequently demonstrate faster approval pathways, albeit with varying quality assurance standards.

Legal regulations around opioid-like ingredients are also influencing formulations. Medications with lower dependency potentials, like MEDIGESIC PLUS, benefit from regulatory leniency, facilitating wider distribution channels^2.

Competitive Landscape

MEDIGESIC PLUS faces competition from both single-agent analgesics and alternative combination therapies. Major players include multinational pharmaceutical giants and local generic manufacturers. Competitive advantages stem from pharmacokinetic profiles, safety margins, and pricing strategies. Notably, the rise of novel analgesics with improved safety profiles, and the advent of non-opioid pain management therapies, pose risks of market marginalization.

Genericization accelerates price erosion, challenging profitability for originators. However, product differentiation through manufacturing quality, branding, and clinical evidence can sustain market share.

Healthcare System and Prescribing Trends

Shifting clinician prescribing behaviors favor safer, evidence-based analgesics with minimal adverse effects. Cost containment within healthcare systems incentivizes favoring affordable, effective drugs like MEDIGESIC PLUS. Patient preferences for OTC accessibility bolster retail sales channels.

Emerging digital health tools and electronic prescribing systems further influence market access, data collection, and post-market surveillance.

Distribution and Supply Chain Factors

Global supply chain stability impacts availability and cost. Recent disruptions due to geopolitical tensions, pandemics, and raw material shortages can hinder production and distribution. Logistics strategies focusing on diversification and inventory management are vital to mitigate these risks.

Financial Trajectory Analysis

Revenue Projections

Analyzing current market penetration, demographic drivers, and competitive dynamics suggests a steady revenue increase for MEDIGESIC PLUS over the next five years. Industry estimates project a compound annual growth rate (CAGR) of approximately 6-8% in key markets[^3].

In developed markets, growth will depend on regulatory approvals and formulary positioning, with potential saturation at maturity. Conversely, emerging markets exhibit higher growth potential, driven by increasing healthcare access and unmet needs. Entry into these regions may grow revenues at double-digit rates initially, stabilizing as market penetration approaches saturation.

Pricing Strategies and Margins

Pricing in mature markets remains competitive, especially among generics, with margins narrowing accordingly. Premium formulations with added safety features or sustained-release profiles could command higher prices, enhancing margins.

In emerging markets, price sensitivity is higher, necessitating tiered pricing models. Local manufacturing and volume scaling can improve profitability, contingent upon regulatory compliance.

Cost Structures and Investment Needs

Research and development (R&D), regulatory compliance, manufacturing, and marketing collectively influence profitability. R&D investment is crucial for product improvements and new indications, especially in a competitive landscape favoring innovation.

Operational costs are rising with adherence to Good Manufacturing Practices (GMP) and increased quality assurance. Supply chain resilience investments are increasingly necessary, especially post-pandemic.

Market Risks and Opportunities

Market risks include regulatory delays, negative post-market safety data, and rising competition. Intellectual property challenges are less pronounced for generics but significant for novel formulations.

Opportunities lie in developing extended-release versions, pediatric formulations, and combination therapies addressing unmet needs, which could command premium pricing.

Projected Financial Trajectory (2023–2028)

  • Year 1–2: Stabilization of existing markets, with modest organic growth of 4-6%. Investment in regulatory and market access activities. Revenue stabilization as patent expirations for some formulations occur.
  • Year 3–4: Expansion into emerging markets, where growth rates could reach 10-12%. Introduction of new formulations and combination variations to diversify portfolio.
  • Year 5: Peak market penetration in established markets, plateauing growth, and reliance on market share retention strategies. Revenue growth moderates to 2-4%, focused on value-added product lines and specialty indications.

Overall, the financial trajectory indicates modest but steady growth, contingent on regulatory compliance, innovation, and market expansion. Profitability hinges on good manufacturing practices and efficient cost management, especially in emerging markets.

Key Takeaways

  • Growing Demand: Demographic shifts and rising chronic pain cases underpin sustained demand for MEDIGESIC PLUS globally.
  • Regulatory Navigation: Success depends on proactive regulatory strategy, especially for approvals in diverse jurisdictions.
  • Competitive Positioning: Differentiation via formulation innovations and safety profiles is critical amidst generic erosion.
  • Market Diversification: Expanding into emerging markets offers substantial growth opportunities, balanced by cost and regulatory considerations.
  • Innovation Focus: Investing in new formulations and indications can bolster long-term profitability and defend against competitive threats.

Conclusion

MEDIGESIC PLUS stands at a pivotal juncture where strategic alignment with regulatory, market, and technological trends can enhance its financial trajectory. While challenges persist — including intense competition and regulatory variability — deliberate expansion and product innovation present viable pathways for sustained growth over the next five years.


FAQs

1. What factors most significantly influence MEDIGESIC PLUS’s market growth?
Demographic trends, regulatory approval processes, competitive innovations, healthcare system prescription preferences, and supply chain stability primarily shape its growth trajectory.

2. How do regulatory differences across regions impact MEDIGESIC PLUS's commercialization?
Stringent regulatory environments in North America and Europe require robust clinical evidence, delaying approvals but potentially enhancing product credibility. Emerging markets may offer faster pathways but pose regulatory and quality assurance challenges.

3. What competitive threats does MEDIGESIC PLUS face within its therapeutic class?
The entry of new non-opioid pain management therapies, patent expirations leading to generics, and evolving consumer preferences for alternative remedies threaten its market foothold.

4. How important is product innovation for MEDIGESIC PLUS’s future?
Highly significant. Innovation in formulation, safety profile, and new indications can sustain competitive advantage, open new markets, and justify premium pricing.

5. What strategies can maximize profitability amid increasing generic competition?
Developing differentiated formulations, expanding into emerging markets, optimizing manufacturing efficiencies, and investing in post-market safety data to reinforce brand trust are paramount.


Sources:

[^3]: MarketWatch. "Analgesics Market Forecast," 2022.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.