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Last Updated: December 22, 2024

MEDIGESIC PLUS Drug Patent Profile


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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-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.

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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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

MEDIGESIC PLUS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Maxigesic (Similar to Medigesic Plus)

Introduction

Maxigesic, a pain relief medication, is a key product for AFT Pharmaceuticals, a company that has been expanding its global presence and product portfolio. Understanding the market dynamics and financial trajectory of Maxigesic can provide insights into the broader pharmaceutical industry and the potential for similar products like Medigesic Plus.

Market Overview

The global pain management drugs market is significant and growing. In 2023, this market was valued at US$81.15 billion and is projected to reach US$120.16 billion by 2033, growing at a CAGR of 4% from 2024 to 2033[4].

Product Specifics: Maxigesic

Maxigesic is a combination analgesic that combines ibuprofen and paracetamol (acetaminophen), designed to provide effective pain relief. Here are some key points about Maxigesic:

Geographical Expansion

Maxigesic has been successfully launched in several regions, including New Zealand, Australia, Italy, and the UK. Initial orders in Italy and the UK were substantial, indicating strong market demand[2].

Revenue Growth

AFT Pharmaceuticals has seen significant revenue growth driven by Maxigesic. The company has grown revenues at a CAGR of 19% over the past decade and expects this growth to continue, with revenues projected to grow at an average annual rate of 25% through FY20[2].

Market Share and Distribution

Maxigesic is part of a diversified product portfolio for AFT Pharmaceuticals, which has expanded from 63 products in 2008 to over 130 currently. The product is distributed through various channels, including retail pharmacies, which accounted for a significant market share in 2023[2].

Factors Influencing Spending Growth

Utilization and Pricing

Historical data on prescription drug spending indicates that both utilization and pricing are critical factors. For insured populations, changes in days per enrollee accounted for about 60% of spending growth, while cost per day accounted for about 40%[1].

New Drug Approvals and Pipeline

New drug approvals and those in the pipeline are significant drivers of spending growth. For Maxigesic, the introduction into new markets and the potential for further approvals (e.g., an IV version) are crucial for continued growth[2].

Regulatory and Pricing Pressures

Regulatory pressures, such as those from government purchasing agencies in Australia and New Zealand, can impact pricing and margins. AFT Pharmaceuticals has faced downward pricing pressure, which has affected its gross margins[2].

Financial Trajectory

Revenue Projections

AFT Pharmaceuticals expects revenues to grow from NZ$64.0 million in FY16 to NZ$157.0 million by FY20, a CAGR of 25% from FY16-20. Licensing revenue from new geographies is also expected to increase significantly[2].

Operating Margins and Expenses

The company anticipates operating margins to move into positive territory by FY18, driven by a greater portion of sales in out-licensed territories and overall operating margin expansion. R&D expenses are expected to plateau after 2017, and selling expenses are forecast to double as the company expands its salesforce[2].

Cash Flow and Funding

AFT Pharmaceuticals has raised significant capital, including NZ$35 million in its December 2015 public offering. The company is expected to burn through NZ$11 million before returning to profitability but does not anticipate needing additional funds in the foreseeable future[2].

Market Segments and Trends

Pain Management Market

The pain management market is segmented by drug class, indication, and distribution channel. Opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and combined non-opioid and weak opioid analgesic therapies are key segments. Post-operative pain and retail pharmacies are significant segments in terms of market share[4].

Specialty and Generic Drugs

Specialty drugs, including those for conditions like hepatitis C, cancer, and multiple sclerosis, have driven significant spending growth in the pharmaceutical industry. Generic drugs also play a crucial role, especially as patent expiries impact branded drug spending[5].

Future Projections and Challenges

Growth Projections

For 2024, overall prescription drug spending is expected to rise by 10.0% to 12.0%, with clinics and hospitals anticipating an 11.0% to 13.0% increase. New drugs, utilization, and pricing dynamics will continue to drive this growth[3].

Challenges and Sensitivities

AFT Pharmaceuticals faces challenges such as execution risks, regulatory hurdles, and pricing pressures. The FDA may require additional R&D spending, and government purchasing agencies may continue to exert downward pricing pressure[2].

Key Takeaways

  • Market Growth: The pain management market is growing, with Maxigesic contributing significantly to AFT Pharmaceuticals' revenue.
  • Utilization and Pricing: Both factors are crucial for spending growth, with utilization often being more significant when measured in terms of days rather than prescriptions.
  • Regulatory and Pricing Pressures: These can impact margins and require strategic management.
  • Financial Projections: AFT Pharmaceuticals expects strong revenue growth and a return to profitability driven by expanding its product portfolio and geographical reach.
  • Market Segments: Understanding the segments within the pain management market is essential for targeting and growth strategies.

FAQs

Q: What are the key drivers of spending growth in the pharmaceutical industry? A: The key drivers include utilization, pricing, and the introduction of new drugs. Utilization changes, especially when measured in terms of days rather than prescriptions, and price increases are significant factors[1].

Q: How is the pain management market segmented? A: The pain management market is segmented by drug class (e.g., opioids, NSAIDs), indication (e.g., post-operative pain), and distribution channel (e.g., retail pharmacies)[4].

Q: What are the financial projections for AFT Pharmaceuticals? A: AFT Pharmaceuticals expects revenues to grow at a CAGR of 25% from FY16-20, with operating margins moving into positive territory by FY18 and a return to profitability anticipated[2].

Q: What challenges does AFT Pharmaceuticals face? A: The company faces execution risks, regulatory hurdles, and pricing pressures from government purchasing agencies[2].

Q: How does the regulatory environment impact pharmaceutical companies like AFT Pharmaceuticals? A: Regulatory systems around the world are broadly aligned, but local differences and specific regulations (e.g., FDA approvals) can impact product approvals and pricing. Government purchasing agencies can also exert downward pricing pressure[2].

Sources

  1. Explaining the Growth in Prescription Drug Spending: A Review of Recent Studies - ASPE.HHS.GOV
  2. AFT Pharmaceuticals - Edison Investment Research - Edison Investment Research
  3. National trends in prescription drug expenditures and projections for 2024 - PubMed
  4. Pain Management Drugs Market Size to Hit US$ 120.16 billion by 2033 - BioSpace
  5. Medicines Use and Spending Shifts in the US in 2014 - IQVIA

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