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Last Updated: December 27, 2024

BUTICAPS Drug Patent Profile


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Which patents cover Buticaps, and when can generic versions of Buticaps launch?

Buticaps is a drug marketed by Medpointe Pharm Hlc and is included in one NDA.

The generic ingredient in BUTICAPS is butabarbital sodium. There are nine drug master file entries for this compound. Additional details are available on the butabarbital sodium profile page.

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Summary for BUTICAPS
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 29
Patent Applications: 3,628
DailyMed Link:BUTICAPS at DailyMed
Drug patent expirations by year for BUTICAPS

US Patents and Regulatory Information for BUTICAPS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medpointe Pharm Hlc BUTICAPS butabarbital sodium CAPSULE;ORAL 085381-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medpointe Pharm Hlc BUTICAPS butabarbital sodium CAPSULE;ORAL 085381-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medpointe Pharm Hlc BUTICAPS butabarbital sodium CAPSULE;ORAL 085381-002 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

BUTICAPS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Pharmaceutical Industry: Implications for Drugs Like BUTICAPS

Introduction

The pharmaceutical industry, including drugs like BUTICAPS, is undergoing significant transformations driven by various market dynamics, regulatory changes, and financial trends. This article delves into the key factors influencing the industry and how these changes might impact the financial trajectory of pharmaceuticals.

Consolidation and Vertical Integration

The pharmacy market has seen substantial consolidation and vertical integration over the past two decades. This trend involves large pharmacy chains, pharmacy benefit managers (PBMs), and health insurance companies merging or acquiring each other. Such consolidation can lead to increased bargaining power over drug prices, affecting the profitability of pharmaceutical manufacturers[1].

Impact on Independent Pharmacies

Independent pharmacies face rising challenges due to the dominance of consolidated entities. These smaller pharmacies often struggle to compete with the pricing power and scale of larger chains, which can impact their ability to stock and sell drugs like BUTICAPS[1].

Growth of Specialty Pharmacies

Specialty pharmacies have emerged as a significant segment, particularly for high-cost and complex medications. These pharmacies often have vertical integration with PBMs and health systems, enabling them to manage formularies and negotiate better prices. This trend can influence the market access and pricing strategies for specialty drugs[1].

Role of Mail-Order Pharmacies and E-Commerce

Mail-order pharmacies and e-commerce platforms are becoming more prominent, offering convenience and sometimes lower prices. This shift can alter patient behavior and affect how drugs are distributed and sold, potentially impacting the sales volume and revenue of drugs like BUTICAPS[1].

Regulatory Environment and Pricing Pressures

The Inflation Reduction Act (IRA) and other regulatory changes are reshaping the pharmaceutical market. Manufacturers are adjusting to new economic realities, including price controls and the need to launch products at higher list prices to account for inevitable net price declines over the product lifecycle. This environment places significant pressure on manufacturers to manage their pricing strategies carefully[3].

Market Access Trends

In 2024, several trends are expected to persist and emerge:

  • Portfolio Rationalization: Manufacturers are rationalizing their portfolios to reduce marginal assets and focus on key molecules.
  • Indication Stacking: There is a shift from indication sequencing to indication stacking, with more emphasis on evidence throughout the product lifecycle.
  • Vertical Integration: The integration of PBMs and specialty pharmacies accelerates their ability to switch to formulary-preferred, interchangeable biosimilars, which can impact the market share of branded drugs[3].

Generic Drugs Market

The generics market is facing conflicting forces: rising demand but deteriorating economics due to consolidation among buyers. Generic drug manufacturers face intense pricing pressure, leading to reduced profitability and potential market exits. The demand for generics is expected to grow, driven by patent expirations, but suppliers must navigate supply constraints and disrupted offshore supply chains[4].

Financial Trajectory for Pharmaceutical Companies

Fundraising and Investment Environment

The current fundraising environment for private equity firms is challenging, with a shift in power from general partners (GPs) to limited partners (LPs). Top performers are still able to raise capital, but middle-market buyout shops face significant hurdles. The pressure to deploy capital and make exits is high, with many GPs turning to secondary markets and continuation funds[2].

M&A Activity

Mergers and acquisitions (M&A) activity in the healthcare sector, including pharmaceuticals, is expected to increase, driven by the need for financial sponsors to deploy their dry powder. However, this environment requires more creativity and insight to drive growth, given the higher cost capital structure[2].

Pricing and Revenue Implications

For drugs like BUTICAPS, the pricing environment is complex. Net price increases have stabilized at or below the rate of inflation since 2017, and manufacturers must launch products at higher list prices to combat future net price declines. The use of cash pay options and drug discount cards is also on the rise, affecting traditional market models and pricing strategies[3].

Patient Access and Channel Preferences

Patients are increasingly using alternative channels such as cash pay options, drug discount cards, and telehealth services. This shift is driven by more favorable pricing and restricted access through traditional insurance models. Over 500 million prescriptions are now filled outside of insurance, indicating a significant change in patient behavior[3].

Persisting Challenges

340B Program

The 340B program continues to impact the supply chain and manufacturer net prices. Despite efforts by manufacturers to limit the program's reach, its utilization has accelerated in non-retail channels, affecting insurance premiums and manufacturer revenues[3].

Supply Chain Disruptions

Offshore supply chains for generic drugs are being disrupted by issues like COVID-19, leading to product shortages and further complicating the profitability of generic manufacturers[4].

Key Takeaways

  • Consolidation and Vertical Integration: These trends are reshaping the pharmacy market, affecting competition and pricing.
  • Regulatory Changes: Acts like the IRA are impacting pricing strategies and market access.
  • Market Access Trends: Portfolio rationalization, indication stacking, and vertical integration are key trends in 2024.
  • Generic Drugs Market: Rising demand but deteriorating economics due to buyer consolidation.
  • Financial Trajectory: Challenging fundraising environment, increased M&A activity, and complex pricing strategies.
  • Patient Access: Alternative channels are gaining popularity, affecting traditional market models.

FAQs

What are the main factors affecting the pharmacy market?

The main factors include increased pharmacy consolidation and vertical integration, rising challenges for independent pharmacies, growth of specialty pharmacies, and the evolving role of mail-order pharmacies and e-commerce platforms.

How is the Inflation Reduction Act impacting pharmaceutical pricing?

The IRA is leading to price controls, necessitating higher list prices at launch to account for future net price declines, and emphasizing evidence throughout the product lifecycle.

What is the outlook for the generics market?

The generics market faces rising demand but deteriorating economics due to buyer consolidation, supply constraints, and disrupted offshore supply chains.

How are patients accessing pharmaceuticals differently in 2024?

Patients are increasingly using cash pay options, drug discount cards, and telehealth services due to more favorable pricing and restricted access through traditional insurance models.

What are the implications of 340B program changes for pharmaceutical manufacturers?

The 340B program continues to impact manufacturer net prices and insurance premiums, despite efforts to limit its reach, and its utilization has accelerated in non-retail channels.

Sources

  1. The Commonwealth Fund: "Competition, Consolidation, and Evolution in the Pharmacy Market"
  2. Ion Analytics: "North America PE Trendspotter: Buyouts start to bounce back..."
  3. IQVIA: "Top 10 U.S. Market Access Trends for 2024"
  4. KPMG: "Generics 2030"

More… ↓

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