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Last Updated: December 23, 2024

DIAL Drug Patent Profile


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

Dial is a drug marketed by Dial and B Braun and is included in three NDAs.

The generic ingredient in DIAL is calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate profile page.

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US Patents and Regulatory Information for DIAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dial DIAL hexachlorophene SOLUTION;TOPICAL 017421-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 018460-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium acetate; sodium chloride SOLUTION;INTRAPERITONEAL 018807-002 Aug 26, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 018460-004 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

DIAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Pharmaceutical Industry: Key Insights

Introduction

The pharmaceutical industry is undergoing significant transformations driven by various market dynamics, technological advancements, and changing consumer behaviors. This article delves into the current state of the U.S. pharmaceutical market, highlighting key trends, financial performances, and future outlooks that are crucial for understanding the industry's trajectory.

Growth of Specialty Medicines

Specialty medicines have emerged as a dominant force in the pharmaceutical market. As of 2023, these medicines account for 55% of net spending, up from 28% in 2011. This growth is primarily driven by the autoimmune and oncology sectors, with specialty product growth outpacing traditional product growth by a significant margin. In the moving annual total (MAT) to January 2023, specialty spend grew by 11.7%, while traditional growth was at 7.3% on an invoice price basis[1].

Biologics and Biosimilars

Biologics continue to grow faster than non-biologics, currently accounting for 46% of spending in the U.S. pharmaceutical market. This segment includes $260 billion in spending, with $38 billion accounted for by molecules facing biosimilar competition and $181 billion by molecules with potential future biosimilars. The launch of 30 biosimilars in the U.S. since 2007, with 10 more approved and set to launch by the end of 2023, further underscores the importance of this market segment[1].

Retail Pharmacy Dynamics

The retail pharmacy landscape is experiencing significant changes. Almost 700 pharmacies have closed in the U.S. retail sector over the last two years, with numbers forecast to continue decreasing. This trend includes closures at major chains like CVS, Walgreens, and Rite Aid. Additionally, reduced pharmacy store hours due to staffing issues and the launch of new services, such as Amazon Pharmacy's unlimited generic drug prescriptions for a flat fee, are reshaping the retail pharmacy sector[1].

Payment Methods and Market Share

Medicare Part D has seen the largest volume growth over the last four years, increasing from 33.7% market share in 2019 to 34.9% in 2022. Discount cards have also seen significant growth, tied to the availability of generics and biosimilars. However, the use of cash continues to decline, and third-party payments from private health insurers are diminishing, from 45.3% in 2019 to 42.9% in 2022[1].

Financial Performance of Pharmaceutical Companies

Companies like Servier have reported strong financial performances. Servier's overall revenue from brand-name medicines increased by 9.4% to €4.041 billion for the 2022-2023 financial year, while generics revenue grew by 8.8% to €1.286 billion. The company's EBITDA stood at €1.015 billion, with a 19.1% margin, reflecting higher sales and tight cost control[2].

Emerging Trends and Strategies

The pharmaceutical industry is facing uncertainty and significant pressure on its revenue model. Companies are deploying various strategies to stay ahead, including investing in research and development, expanding into new markets, and leveraging technological advancements. For instance, Adial Pharmaceuticals, a clinical-stage biopharmaceutical company, is focusing on developing therapies for addiction and related disorders. The company has seen an increase in research and development expenses due to activities related to drug development planning and has secured additional funding through warrant exercises to accelerate its development pipeline[5].

Impact of Regulatory and Legal Factors

Regulatory and legal factors can significantly impact a company's financial trajectory. For example, Servier faced a substantial loss in consolidated net income due to the Court of Appeal’s decision on the Mediator trial and increased income tax expenses. Such events highlight the importance of navigating legal and regulatory landscapes effectively[2].

Geographic Market Dynamics

The pharmaceutical market is not uniform across different regions. Servier's international revenue, particularly from the American continent, grew by 27.9% to reach €1,119 billion, representing 21% of the company's total revenue. In contrast, European Union revenue accounted for 43.4% of consolidated revenue, up 8.1% over the previous year[2].

Future Outlook

The future of the pharmaceutical industry will be shaped by several key themes, including the continued growth of specialty and biologic medicines, the impact of biosimilars, and the evolving retail pharmacy landscape. Companies will need to adapt to these changes by investing in innovative technologies, expanding their product portfolios, and navigating complex regulatory environments[3].

Key Takeaways

  • Specialty Medicines Dominance: Specialty medicines are driving growth in the pharmaceutical market, particularly in autoimmune and oncology sectors.
  • Biologics and Biosimilars: Biologics are growing faster than non-biologics, with a significant impact from biosimilars.
  • Retail Pharmacy Changes: The retail pharmacy sector is experiencing closures and changes in service offerings.
  • Financial Performance: Companies are reporting strong revenues but face challenges from regulatory and legal factors.
  • Emerging Trends: Investing in R&D, expanding into new markets, and leveraging technology are key strategies for future success.

FAQs

What is the current trend in the growth of specialty medicines in the U.S. pharmaceutical market?

Specialty medicines are growing at a higher pace than traditional medicines, accounting for 55% of net spending as of 2023, driven primarily by the autoimmune and oncology sectors[1].

How are biologics impacting the pharmaceutical market?

Biologics are growing faster than non-biologics, accounting for 46% of spending in the U.S. market, with significant contributions from molecules facing biosimilar competition and those with potential future biosimilars[1].

What changes are occurring in the retail pharmacy sector?

The retail pharmacy sector is experiencing store closures, reduced store hours due to staffing issues, and new service offerings such as Amazon Pharmacy's unlimited generic drug prescriptions[1].

How are payment methods evolving in the pharmaceutical market?

Medicare Part D has seen significant growth, while discount cards are also increasing in use. However, cash payments are declining, and third-party payments from private health insurers are diminishing[1].

What strategies are pharmaceutical companies adopting to stay competitive?

Companies are investing in research and development, expanding into new markets, and leveraging technological advancements to stay ahead in the rapidly changing pharmaceutical landscape[3][5].

Sources

  1. IQVIA, "Insights Into the 2023 U.S. Pharmaceutical Market," July 25, 2023.
  2. Servier, "Servier confirms its 2025 trajectory to achieve its 2030 ambition," February 7, 2024.
  3. ZS, "Pharma trends 2024: Shaping the future landscape," February 13, 2024.
  4. Brookings Institution, "The dynamics of US drug markets," December 4, 2024.
  5. Adial Pharmaceuticals, "Adial Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update," May 15, 2024.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.