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Last Updated: December 22, 2024

BRYREL Drug Patent Profile


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

Bryrel is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in BRYREL 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 BRYREL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 50
DailyMed Link:BRYREL at DailyMed
Drug patent expirations by year for BRYREL

US Patents and Regulatory Information for BRYREL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us BRYREL piperazine citrate SYRUP;ORAL 017796-001 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

BRYREL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Generic Drugs: A Case Study on Metformin and Broader Industry Trends

Introduction

The pharmaceutical industry, particularly the generic drug market, is a complex and dynamic sector influenced by various factors including regulatory changes, market competition, and quality control. This article will delve into the market dynamics and financial trajectory of generic drugs, using metformin as a case study, and explore broader industry trends.

The Generic Drug Market: An Overview

The generic drug market has grown significantly since the enactment of the Hatch-Waxman Act in 1984, which facilitated the approval of generic versions of branded medications. By 2020, generic medications accounted for 90% of U.S. prescriptions, saving patients billions of dollars annually. For instance, generic medications saved $313 billion in 2019 alone[1].

Market Dynamics: The Case of Metformin

Quality vs. Price

Metformin, a widely used medication for diabetes, has faced several quality issues. Multiple generic metformin drugs were recalled due to the presence of carcinogenic impurities like NDMA. Despite these recalls, the overall supply and pricing of metformin were not significantly impacted. The recalls led to a reduction in NDMA levels in the drug supply, but they did not result in shortages or price inflation. Instead, the market adjusted with increased fills from other manufacturers, and the unit price of non-recalled metformin ER products actually decreased by 19.61%[1].

Impact on Market Utilization

The recalls of contaminated metformin products did not limit prescription fills or increase unit prices at a population level. Patients switched to other generic or branded formulations, demonstrating the resilience and adaptability of the generic drug market. This trend is consistent with other studies, such as the one on metoprolol, which showed that users often switch to alternative formulations after FDA-announced recalls[1].

Financial Trajectory of Generic Drugs

Revenue Growth

The financial performance of companies in the generic drug market has been robust. For example, Servier reported an 8.8% growth in generics revenue to €1.286 billion in the 2022-2023 financial year. This growth was part of a broader increase in the company's consolidated revenue, which rose by 9.2% to €5.327 billion during the same period[2].

Profitability and Cost Control

Despite the challenges posed by quality issues and regulatory recalls, companies have managed to maintain profitability through tight cost control and strategic pricing. Servier's EBITDA margin increased to 19.1% in 2022-2023, driven by higher sales and effective cost management[2].

Broader Industry Trends

Antibody Drugs Market

The biotechnology sector, including antibody drugs, is experiencing significant growth. The global market for antibody drugs is projected to grow from $242.6 billion in 2024 to $412.1 billion by 2029, at a CAGR of 11.2%. This growth is driven by advances in technology and the increasing adoption of monoclonal antibodies in therapeutic applications[3].

Regulatory and Compliance Trends

Regulatory pressures and compliance requirements continue to shape the pharmaceutical industry. The Inflation Reduction Act and other legislative measures are influencing drug pricing and market access. For instance, list price increases have slowed to 4.9% in 2023 and are expected to average 1–4% per year, reflecting the impact of regulatory and public pressure on drug pricing[4].

Regional Market Dynamics

Global Revenue Distribution

The pharmaceutical market is increasingly global, with significant revenue contributions from regions outside the European Union. For Servier, international revenue accounted for 56.6% of consolidated revenue, with the American continent showing a notable 27.9% growth in 2022-2023[2].

Country-Specific Trends

In the U.S., the market is adjusting to post-pandemic healthcare dynamics, with spending trends showing resilience despite broader macroeconomic challenges. The U.S. remains a key market for many pharmaceutical companies, with Servier's U.S. subsidiary being the leading entity for brand-name medicine sales[2][4].

Quality and Safety Considerations

Regulatory Oversight

The FDA plays a crucial role in ensuring the quality and safety of generic drugs. Recalls and regulatory actions have been effective in reducing carcinogenic impurities in drugs like metformin. However, the market cannot rely solely on price competition to ensure quality, highlighting the need for robust regulatory oversight[1].

Industry Response

Companies are investing in research and development to improve drug quality and safety. For example, Blueprint Medicines has initiated clinical trials for new therapeutic agents, such as the wild-type KIT inhibitor BLU-808, reflecting the industry's commitment to innovation and safety[5].

Key Takeaways

  • Generic Drug Market Growth: The generic drug market continues to grow, driven by cost savings and regulatory pathways.
  • Quality and Safety: Regulatory recalls can reduce impurities without causing shortages or price inflation, but quality is not always correlated with price.
  • Financial Performance: Companies in the generic drug market are achieving revenue growth and maintaining profitability through cost control and strategic pricing.
  • Broader Industry Trends: The biotechnology sector, including antibody drugs, is experiencing significant growth driven by technological advances.
  • Regulatory Impact: Regulatory measures and public pressure are influencing drug pricing and market access.

FAQs

What is the current state of the generic drug market?

The generic drug market is robust, accounting for 90% of U.S. prescriptions and saving patients billions annually. However, it faces challenges related to quality and safety.

How have recalls affected the metformin market?

Recalls of contaminated metformin products reduced NDMA levels but did not significantly impact overall supply or pricing. Patients switched to other formulations, demonstrating market resilience.

What are the key drivers of the antibody drugs market?

The antibody drugs market is driven by advances in technology and increasing adoption in therapeutic applications, with a projected CAGR of 11.2% from 2024 to 2029.

How are regulatory measures impacting drug pricing?

Regulatory measures, such as the Inflation Reduction Act, have slowed list price increases to 1–4% per year, reflecting the impact of public pressure and regulatory oversight on drug pricing.

What is the significance of international revenue for pharmaceutical companies?

International revenue, particularly from regions outside the European Union, is increasingly important, with companies like Servier seeing significant growth in these markets.

Sources

  1. Safety vs Price in the Generic Drug Market: Metformin - AJMC
  2. Servier confirms its 2025 trajectory to achieve its 2030 ambition - Servier
  3. Antibody Drugs: Technologies and Global Markets - BCC Research
  4. The Use of Medicines in the U.S. 2024: Usage and Spending - IQVIA
  5. Blueprint Medicines Reports Second Quarter 2024 Results and Raises AYVAKIT®/AYVAKYT® Full Year Revenue Guidance - Blueprint Medicines

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