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Last Updated: December 22, 2024

INVERSINE Drug Patent Profile


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

Inversine is a drug marketed by Targacept and is included in one NDA.

The generic ingredient in INVERSINE is mecamylamine hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mecamylamine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Inversine

A generic version of INVERSINE was approved as mecamylamine hydrochloride by LGM PHARMA on March 19th, 2013.

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Summary for INVERSINE
Drug patent expirations by year for INVERSINE
Recent Clinical Trials for INVERSINE

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

SponsorPhase
National Alliance for Research on Schizophrenia and DepressionPhase 3
Yale UniversityPhase 3
Ohio State UniversityPhase 1

See all INVERSINE clinical trials

US Patents and Regulatory Information for INVERSINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Targacept INVERSINE mecamylamine hydrochloride TABLET;ORAL 010251-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

INVERSINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prescription Drugs: A Case Study on INVERSINE

Introduction

Understanding the market dynamics and financial trajectory of prescription drugs is crucial for pharmaceutical companies, investors, and healthcare policymakers. This article will delve into the broader context of prescription drug markets, using the example of INVERSINE, a drug that, while not specifically mentioned in the sources, can be analyzed through the lens of general market trends and dynamics.

Market Competition in Prescription Drugs

The level of competition in the prescription drug market significantly influences pricing and profitability. According to the ASPE report, drugs with fewer or only one manufacturer tend to have higher prices compared to those with multiple manufacturers[1].

Pricing and Expenditures

The average cost of prescription drugs varies widely between small molecule drugs and biological products. In 2022, the average cost of a biological product was $174 per prescription, which is 3.7 times greater than the average cost of a small molecule drug at $48 per prescription[1].

Specialty Drugs and Biological Products

Specialty drugs, including biological products, have seen a significant increase in spending. Between 2017 and 2022, total inflation-adjusted expenditures on specialty drugs grew from $226 billion to $316 billion, a 39.9% increase. This growth was driven by an increase in spending per prescription rather than an increase in the number of prescriptions[1].

Impact of Competition on Prices

The Federal Trade Commission's study on generic drug industry dynamics highlights that generic drug prices fall with the number of competitors. Prices for the initial generic monopolist are 35% to 50% above long-run marginal costs and begin to approach these costs when there are 8 or more competitors[4].

Market Access Trends

The Inflation Reduction Act (IRA) and other regulatory changes are altering market access strategies for pharmaceutical companies. Manufacturers are adjusting their portfolios, accelerating R&D for key molecules, and focusing on indication stacking and evidence-based value conversations[3].

Biosimilar Adoption

Biosimilars, which are biological products that are highly similar to an already approved biological product, are gaining traction. Despite initial rebate walls and channel tactics by innovators to slow adoption, recent changes indicate that biosimilar market share is expected to increase, especially through vertically integrated systems[3].

Financial Trajectory of Prescription Drugs

Revenue and Profitability

The financial trajectory of a drug like INVERSINE would be heavily influenced by its market position and competition. For drugs with high competition, such as generic or biosimilar markets, prices tend to decrease over time as more competitors enter the market[4].

Cost of Capital and Growth

The valuation of pharmaceutical companies, including those producing INVERSINE, can be significantly affected by growth rates and the cost of capital. According to Morgan Stanley, small changes in growth expectations can lead to large changes in the P/E multiple, especially when growth rates are high[2].

Investment and ROI

Companies investing heavily in intangible assets, such as R&D for new indications or biosimilars, may show poor short-term profits but can create significant long-term value. The return on incremental invested capital (ROIIC) is a critical metric, as it must exceed the cost of capital to generate value[2].

Case Study: INVERSINE in the Market Context

Market Position

If INVERSINE is a small molecule drug with multiple manufacturers, it would likely experience downward pressure on prices as competition increases. However, if it is a biological product or has a unique market position with limited competition, it could maintain higher prices.

Pricing Strategy

Given the trend of increasing spending per prescription for specialty drugs, INVERSINE's pricing strategy would need to balance the need for revenue with the pressure from payers and regulatory bodies to control costs. Launching at a higher list price to account for future discounts and net price declines could be a strategic approach[3].

Biosimilar and Generic Competition

If INVERSINE has biosimilar or generic competitors, the company would need to prepare for a potential decline in market share and revenue. Strategies such as indication stacking, evidence-based value conversations, and vertical integration with PBMs and specialty pharmacies could help mitigate these effects[3].

Regulatory and Policy Impacts

Inflation Reduction Act

The IRA's impact on pharmaceutical pricing and market access would be significant for INVERSINE. Manufacturers would need to adjust their portfolios and pricing strategies to comply with new regulations and economic realities[3].

340B Program

The 340B program, which allows certain healthcare providers to purchase drugs at discounted prices, could affect INVERSINE's net prices and overall revenue. Manufacturers may need to limit their participation in the 340B program to mitigate these impacts[3].

Key Takeaways

  • Competition Drives Pricing: The number of competitors significantly affects the pricing power of prescription drugs.
  • Specialty Drugs Growth: Biological products and specialty drugs are seeing increased spending, driven by higher costs per prescription.
  • Regulatory Impact: The Inflation Reduction Act and other regulatory changes are altering market access and pricing strategies.
  • Biosimilar Adoption: Biosimilars are gaining traction, and their adoption is expected to increase through vertically integrated systems.
  • Financial Metrics: Growth rates, ROIIC, and cost of capital are crucial in valuing pharmaceutical companies and their products.

FAQs

Q: How does competition affect the pricing of prescription drugs?

A: Competition significantly reduces the pricing power of prescription drugs. With more competitors, prices tend to fall, especially in generic and biosimilar markets[1][4].

Q: What is the impact of the Inflation Reduction Act on pharmaceutical companies?

A: The IRA is leading to portfolio rationalization, R&D acceleration, and a focus on evidence-based value conversations. It also affects pricing strategies and market access[3].

Q: How do biosimilars affect the market for biological products?

A: Biosimilars can significantly reduce the market share and revenue of original biological products. However, their adoption is influenced by rebate walls, channel tactics, and vertical integration[3].

Q: What financial metrics are important for valuing pharmaceutical companies?

A: Key metrics include growth rates, return on incremental invested capital (ROIIC), and the cost of capital. These metrics influence the P/E multiple and overall valuation of the company[2].

Q: How does the 340B program affect pharmaceutical manufacturers?

A: The 340B program can reduce net prices and revenue for manufacturers. Companies may limit their participation in the program to mitigate these impacts[3].

Sources

  1. Competition in Prescription Drug Markets, 2017-2022 - ASPE
  2. The Math of Value and Growth - Morgan Stanley
  3. Top 10 U.S. Market Access Trends for 2024 - IQVIA
  4. Generic Drug Industry Dynamics - Federal Trade Commission

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