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Last Updated: December 22, 2024

VERMIDOL Drug Patent Profile


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Which patents cover Vermidol, and what generic alternatives are available?

Vermidol is a drug marketed by Solvay and is included in one NDA.

The generic ingredient in VERMIDOL is piperazine citrate. There are eighteen drug master file entries for this compound. Additional details are available on the piperazine citrate profile page.

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Summary for VERMIDOL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 45
DailyMed Link:VERMIDOL at DailyMed
Drug patent expirations by year for VERMIDOL

US Patents and Regulatory Information for VERMIDOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Solvay VERMIDOL piperazine citrate SYRUP;ORAL 080992-001 Approved Prior to Jan 1, 1982 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

VERMIDOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pharmaceutical Drugs: Lessons from Similar Cases

When analyzing the market dynamics and financial trajectory of a pharmaceutical drug like VERMIDOL, it is crucial to consider several key factors, including the timing of market entry, therapeutic advantage, market size, competition, and the overall commercial strategy.

Timing of Market Entry

The timing of market entry is a critical factor in determining the commercial success of a pharmaceutical drug. Research by the Boston Consulting Group highlights that being the first to market can provide a significant advantage, but it is not the only factor.

  • First-in-Class vs. Best-in-Class: While being the first to market can capture a larger share of the market, being the best-in-class can also lead to substantial success. For example, atorvastatin (Lipitor), despite being the fifth statin on the market, captured nearly double the market share of the first statin, lovastatin (Mevacor)[1].

Therapeutic Advantage

The therapeutic advantage of a drug, or its ability to address patient needs effectively, is another vital factor.

  • Therapeutic Value Matrix: A study by the Boston Consulting Group shows that drugs with high therapeutic value but late market entry can still achieve significant commercial success. However, the value captured drops precipitously if the second entry is not within a narrow window (typically 2-5 years after the first-in-class drug)[1].

Market Size and Competition

The size of the market and the level of competition also play significant roles.

  • Generic Drug Market: In the generic drug market, prices decline as the number of competitors increases. Generic prices can be 35-50% above long-run marginal costs when there is only one generic competitor, but they approach long-run marginal costs with eight or more competitors[3].
  • Biosimilars: The entry of biosimilars can disrupt the market, but their penetration can be hindered by strategies employed by the original brand, such as exclusive contracts and discounts to providers[4].

Commercial Strategy

A robust commercial strategy is essential for maximizing the financial trajectory of a drug.

  • Launch Speed and Marketing: Fast followers need to be quick to market to capture significant value. The commercial success of a drug is highly dependent on the speed of launch and the effectiveness of the marketing strategy[1].
  • Formulary Coverage: Securing favorable formulary coverage is crucial for market penetration. For example, biosimilars like Inflectra faced significant barriers in penetrating the market due to the incumbent's strong formulary positions[4].

Financial Performance

The financial performance of a pharmaceutical company is influenced by various factors, including revenue growth, gross margins, research and development expenses, and financial expenses.

  • Revenue Growth: Companies like MediWound have seen revenue growth driven by new contracts and partnerships. For instance, MediWound's revenue increased from $3.8 million in Q1 2023 to $5.0 million in Q1 2024, primarily due to revenue from Vericel and new contracts with the U.S. Department of Defense[2][5].
  • Gross Margins: Changes in revenue mix can affect gross margins. MediWound experienced a decrease in gross margin from 21.7% in Q1 2023 to 12.2% in Q1 2024 due to changes in the revenue mix[2][5].
  • Research and Development Expenses: R&D expenses are a significant component of a pharmaceutical company's expenditures. MediWound's R&D expenses decreased from $2.1 million in Q1 2023 to $1.5 million in Q1 2024, largely due to the completion of the EscharEx Phase II study[2][5].

Operating and Net Loss

Operating and net losses are critical indicators of a company's financial health.

  • Operating Loss: MediWound reported an operating loss of $3.7 million in Q1 2024, compared to $4.4 million in Q1 2023. This reduction is a positive sign, despite the overall loss[2][5].
  • Net Loss: The net loss can be influenced by various factors, including financial expenses. MediWound's net loss increased to $9.7 million in Q1 2024, primarily due to financial expenses from the revaluation of warrants driven by a 40% increase in the company's share price[2][5].

Adjusted EBITDA

Adjusted EBITDA provides a clearer picture of a company's operational performance by adjusting for non-operational items.

  • Adjusted EBITDA: MediWound's adjusted EBITDA was a loss of $2.9 million in Q1 2024, compared to a loss of $3.4 million in Q1 2023. This improvement indicates better operational efficiency[2][5].

Cash Flow and Funding

Cash flow and funding are essential for sustaining operations and investing in growth.

  • Cash and Cash Equivalents: As of March 31, 2024, MediWound had $36.0 million in cash and cash equivalents, restricted cash, and deposits. The company also received $0.5 million from the exercise of Series A warrants and utilized $6.5 million to fund its activities in Q1 2024[2][5].

Key Takeaways

  • Timing and Therapeutic Advantage: Being first to market or having a significant therapeutic advantage can drive commercial success.
  • Market Size and Competition: The size of the market and the level of competition significantly impact a drug's financial trajectory.
  • Commercial Strategy: A robust commercial strategy, including launch speed and formulary coverage, is crucial.
  • Financial Performance: Revenue growth, gross margins, R&D expenses, and financial expenses all influence a company's financial health.
  • Operational Efficiency: Adjusted EBITDA provides a clearer picture of operational performance.
  • Cash Flow: Adequate cash flow and funding are essential for sustaining operations and growth.

FAQs

Q: What is the impact of being the first to market on a pharmaceutical drug's commercial success?

Being the first to market can provide a significant advantage, but it is not the only factor. Being the best-in-class can also lead to substantial success, especially if the drug offers a high therapeutic value.

Q: How does the therapeutic advantage of a drug affect its market performance?

The therapeutic advantage of a drug is crucial. Drugs with high therapeutic value but late market entry can still achieve significant commercial success, but the value captured drops if the second entry is not within a narrow window.

Q: What role does market size play in the financial trajectory of a pharmaceutical drug?

The size of the market greatly affects the financial trajectory. Larger markets can accommodate multiple entrants, and even late entrants can achieve significant sales if the market is large enough.

Q: How do generic drugs and biosimilars impact the market dynamics of pharmaceuticals?

Generic drugs and biosimilars can significantly impact market dynamics. Generic prices decline with the number of competitors, and biosimilars can disrupt the market, although their penetration can be hindered by strategies employed by the original brand.

Q: What are the key financial metrics to monitor for a pharmaceutical company?

Key financial metrics include revenue growth, gross margins, R&D expenses, operating and net losses, adjusted EBITDA, and cash flow. These metrics provide a comprehensive view of the company's financial health and operational efficiency.

Sources

  1. Boston Consulting Group: "What Matters Most in Commercial Success: First-in-Class or Best-in-Class"[1]
  2. GlobeNewswire: "MediWound Reports First Quarter 2024 Financial Results and Provides Company Update"[2]
  3. Federal Trade Commission: "Generic Drug Industry Dynamics"[3]
  4. Federal Trade Commission: "Entry and Supply Chain Dynamics - Understanding Competition in Prescription Drug Markets"[4]
  5. MediWound: "MediWound Reports First Quarter 2024 Financial Results and Provides Company Update"[5]

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