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Last Updated: December 22, 2024

BACI-RX Drug Patent Profile


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When do Baci-rx patents expire, and what generic alternatives are available?

Baci-rx is a drug marketed by X Gen Pharms and is included in one NDA.

The generic ingredient in BACI-RX is bacitracin. There are twenty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bacitracin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Baci-rx

A generic version of BACI-RX was approved as bacitracin by PADAGIS US on December 31st, 1969.

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Summary for BACI-RX
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 20
Patent Applications: 2,723
DailyMed Link:BACI-RX at DailyMed
Drug patent expirations by year for BACI-RX

US Patents and Regulatory Information for BACI-RX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
X Gen Pharms BACI-RX bacitracin POWDER;FOR RX COMPOUNDING 061580-001 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

BACI-RX Market Analysis and Financial Projection Experimental

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

Introduction

The pharmaceutical industry is a complex and dynamic market, influenced by various factors including competition, regulatory environments, and consumer preferences. To understand the market dynamics and financial trajectory of prescription drugs, we will delve into recent trends, particularly focusing on the distinctions between small molecule drugs and biological products.

Market Segmentation: Small Molecule Drugs vs. Biological Products

The pharmaceutical market can be broadly segmented into small molecule drugs and biological products. Each segment has distinct characteristics that influence their market dynamics and financial performance.

Small Molecule Drugs

  • Competition and Pricing: Small molecule drugs have a higher level of competition, especially with the presence of generics. Between 2017 and 2022, the number of small molecule drugs with 6+ manufacturers increased, while those with a single manufacturer declined. This competition led to a drop in the price per small molecule drug, resulting in relatively flat spending despite a 19.2% increase in the number of prescriptions[1].
  • Market Share: The share of total expenditures on small molecule drugs decreased from 69% in 2017 to 59% in 2022, indicating a shift towards biological products[1].

Biological Products

  • Competition and Pricing: Biological products have significantly lower competition compared to small molecule drugs. In 2022, 81% of biological products had only one manufacturer, and the number of products with multiple manufacturers remained relatively low[1].
  • Market Share: Despite the lower competition, the number of biological products on the market increased by 28% from 2017 to 2022. Biological products represent a growing share of specialty drug spending, with a 10-percentage-point increase in spending share over the same period[1].

Specialty Drugs: A Growing Segment

Specialty drugs, which include both small molecule and biological products, have seen significant growth.

  • Expenditures: Total inflation-adjusted expenditures on specialty drugs increased by 39.9% from $226 billion in 2017 to $316 billion in 2022[1].
  • Prescriptions: Despite the increase in spending, the number of specialty prescriptions decreased by 6.2% during this period, indicating a rise in spending per prescription from $195 to $291[1].

Financial Trajectory of Prescription Drugs

Spending Trends

  • The primary driver of increased spending on biological products is the higher spending per prescription rather than an increase in the number of prescriptions. This contrasts with small molecule drugs, where spending remained relatively flat due to decreasing prices[1].

Revenue and Competition

  • Generic antibiotics, for example, dominate the market in terms of volume and revenue, with products like Amoxicillin and Vancomycin being top sellers. However, brand antibiotics face challenges in achieving high revenues due to the prevalence of generic alternatives[3].

Market Forecast

  • The OTC pharmaceuticals market, while distinct from prescription drugs, indicates broader consumer trends. The OTC market is projected to grow by 4.91% from 2024 to 2029, driven by consumer preferences for self-medication and increasing healthcare costs[4].

Regulatory Environment and Its Impact

The regulatory environment plays a crucial role in shaping the market dynamics of prescription drugs.

  • Generic and Biosimilar Pathways: The generic drug approval pathway, established in 1984 under the Hatch-Waxman Act, has facilitated the entry of many generic drugs into the market. In contrast, the biosimilar pathway, established in 2010 as part of the Affordable Care Act, has seen slower adoption due to its complexity and higher barriers to entry[1].

Economic Incentives for Innovation

The development of new drugs, especially antibiotics, faces significant economic challenges.

  • Revenue and Incentives: New antibiotics launched between 2010 and 2020 had an average global annual revenue of $46 million. To incentivize the development of new antibiotics, substantial rewards are proposed, such as a yearly pull incentive of $260 million over ten years to achieve an 11% internal rate of return (IRR)[3].

Consumer Preferences and Healthcare Costs

Consumer preferences and rising healthcare costs are key drivers of the pharmaceutical market.

  • Self-Medication: The convenience and accessibility of OTC drugs, coupled with increasing consumer awareness about self-care, are driving the demand for these products. This trend is also reflected in the prescription drug market, where patients are seeking more cost-effective and accessible treatment options[4].

Key Takeaways

  • Competition: Small molecule drugs face higher competition, leading to lower prices, while biological products have lower competition but are growing in market share.
  • Spending Trends: Spending per prescription is increasing, especially for biological products and specialty drugs.
  • Regulatory Environment: The generic and biosimilar approval pathways significantly influence market dynamics.
  • Economic Incentives: Substantial incentives are needed to encourage the development of new drugs, particularly antibiotics.
  • Consumer Preferences: Rising healthcare costs and consumer preferences for self-medication are driving market trends.

FAQs

What is the main driver of increased spending on biological products?

The main driver is the higher spending per prescription rather than an increase in the number of prescriptions.

How does the level of competition differ between small molecule drugs and biological products?

Small molecule drugs have a higher level of competition, especially with generics, while biological products have significantly lower competition with most having only one manufacturer.

What is the forecast for the OTC pharmaceuticals market?

The OTC pharmaceuticals market is projected to grow by 4.91% from 2024 to 2029, driven by consumer preferences for self-medication and increasing healthcare costs.

Why do new antibiotics face economic challenges?

New antibiotics face economic challenges due to the dominance of generic, low-priced products, and the need for substantial incentives to encourage their development.

How do regulatory pathways impact the pharmaceutical market?

The generic drug approval pathway has facilitated the entry of many generic drugs, while the biosimilar pathway has seen slower adoption due to its complexity and higher barriers to entry.

Sources

  1. Competition in Prescription Drug Markets, 2017-2022 - ASPE
  2. 2014 General Corporation Tax Allocation Percentage Report - New York City Department of Finance
  3. Sizing A Market Entry Reward for the Development of New Antibiotics - Harvard Kennedy School
  4. OTC Pharmaceuticals - Worldwide - Statista Market Forecast
  5. A study on the capital accumulation system, distribution regulation mechanism and the stakeholder relationships - Emerald Insight

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