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Last Updated: April 12, 2025

DORIDEN Drug Patent Profile


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

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

The generic ingredient in DORIDEN is glutethimide. There are four drug master file entries for this compound. Additional details are available on the glutethimide profile page.

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Summary for DORIDEN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 25
Patent Applications: 3,094
DailyMed Link:DORIDEN at DailyMed
Drug patent expirations by year for DORIDEN

US Patents and Regulatory Information for DORIDEN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Sanofi Aventis Us DORIDEN glutethimide TABLET;ORAL 009519-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sanofi Aventis Us DORIDEN glutethimide TABLET;ORAL 009519-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sanofi Aventis Us DORIDEN glutethimide CAPSULE;ORAL 009519-008 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Doriden (Glutethimide)

Introduction

Doriden, also known as glutethimide, is a sedative-hypnotic drug that has been used historically for the treatment of insomnia and anxiety. Despite its limited current use due to regulatory constraints and concerns about abuse and addiction, the drug still maintains a presence in certain niche medical and research settings.

Market Overview

The glutethimide market, which includes Doriden, is characterized by a complex regulatory environment and evolving market dynamics. Here are some key points:

  • Market Size and Growth: The glutethimide market was valued at approximately USD 80 million in 2023 and is expected to reach around USD 120 million by 2033, growing at a CAGR of 4.2% from 2024 to 2033[4].
  • Regulatory Constraints: The use of glutethimide is significantly restricted due to its potential for abuse and addiction. This has led to stringent controls and monitoring measures to prevent misuse and diversion[4].

Driving Factors

Several factors influence the market dynamics of glutethimide:

  • Increase in Mental Illness and Insomnia: The rise in cases of mental illness and insomnia has driven the demand for sedative-hypnotic drugs, including glutethimide, although its use is heavily regulated[1].
  • Research and Development: Continued research into the pharmacological properties of glutethimide may sustain or increase demand in research settings. Studies have explored its anticonvulsive properties and its use in obstetrics, among other applications[1].
  • Healthcare Expenditure and Skilled Professionals: Increased healthcare expenditure and the availability of skilled professionals have supported the development and use of glutethimide in niche medical settings[1].

Challenges

Despite the potential opportunities, the market for glutethimide faces several challenges:

  • Side Effects and Drug Shortage: Side effects associated with glutethimide and occasional drug shortages hinder market growth. The drug's potential for abuse and addiction is a significant concern[1][4].
  • Regulatory Hurdles: The stringent regulatory environment is a major barrier. Any expansion of approved indications for glutethimide would require extensive research, clinical trials, and regulatory approval, which is a lengthy and resource-intensive process[4].

Market Opportunities

Despite the challenges, there are opportunities for growth:

  • Niche Medical Applications: Glutethimide may still be considered a viable treatment option in cases where other sedative-hypnotic agents have been exhausted or deemed unsuitable. However, this requires careful navigation of the regulatory landscape[4].
  • Research and Development: The demand for glutethimide in research settings could remain stable or increase as researchers continue to explore its pharmacological properties[4].

Financial Trajectory

The financial trajectory of the glutethimide market is influenced by several factors:

  • Revenue Projections: The market is expected to grow from USD 80 million in 2023 to USD 120 million by 2033, indicating a steady but modest growth[4].
  • Cost and ROI: The development and production of glutethimide, like other pharmaceuticals, involve significant costs. The average cost of bringing a new drug to market is about $2.6 billion, and the ROI for pharmaceutical R&D has been declining in recent years[3].

Impact of Broader Pharmaceutical Trends

The glutethimide market is also influenced by broader trends in the pharmaceutical industry:

  • Global Pharmaceutical Market Growth: The global pharmaceutical market is projected to exceed $1.4 trillion by 2028, driven by the escalating global burden of chronic diseases. This growth can indirectly support niche markets like glutethimide through increased R&D investments and healthcare expenditure[3].
  • Investment in R&D: Pharmaceutical companies are strategically aligning their R&D investments to address unmet medical needs, which could include niche areas where glutethimide might be relevant[3].

Key Takeaways

  • The glutethimide market, including Doriden, is expected to grow modestly from 2023 to 2033.
  • Regulatory constraints and concerns about abuse and addiction significantly limit the market.
  • Research and niche medical applications present potential opportunities for growth.
  • The market is influenced by broader pharmaceutical trends, including global market growth and R&D investments.

FAQs

Q: What is the primary use of glutethimide (Doriden)? A: Glutethimide is primarily used as a sedative-hypnotic drug for the treatment of insomnia and anxiety, although its use is heavily regulated due to its potential for abuse and addiction.

Q: What are the key factors driving the growth of the glutethimide market? A: The growth is driven by the rise in cases of mental illness and insomnia, continued research into its pharmacological properties, and increased healthcare expenditure.

Q: What are the main challenges facing the glutethimide market? A: The main challenges include side effects associated with the drug, drug shortages, and stringent regulatory hurdles.

Q: What are the potential opportunities for growth in the glutethimide market? A: Opportunities lie in niche medical applications where other sedative-hypnotic agents are unsuitable and in research settings where the drug's pharmacological properties are being explored.

Q: How is the broader pharmaceutical market influencing the glutethimide market? A: The broader pharmaceutical market's growth, driven by the escalating global burden of chronic diseases, indirectly supports the glutethimide market through increased R&D investments and healthcare expenditure.

Sources

  1. Allied Market Research - Glutethimide Market by Product Type, by Application and by Geography - Global Opportunity Analysis and Industry Forecast, 2023-2030.
  2. University of Virginia Darden School of Business - UVA Darden Ranked No. 1 Public B-School in the World in 2024 Financial Times.
  3. DrugBank Blog - Investment Trends in Pharmaceutical Research.
  4. DataHorizon Research - Glutethimide Market Size, Share & Forecast 2033.

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