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Last Updated: December 23, 2024

DIDREX Drug Patent Profile


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

Didrex is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in DIDREX is benzphetamine hydrochloride. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the benzphetamine hydrochloride profile page.

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Summary for DIDREX
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 11
Patent Applications: 1,427
DailyMed Link:DIDREX at DailyMed
Drug patent expirations by year for DIDREX

US Patents and Regulatory Information for DIDREX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer DIDREX benzphetamine hydrochloride TABLET;ORAL 012427-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pfizer DIDREX benzphetamine hydrochloride TABLET;ORAL 012427-002 Approved Prior to Jan 1, 1982 DISCN Yes 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

DIDREX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DIDREX

Introduction

DIDREX, a brand name for the drug benzphetamine, is indicated for the short-term management of exogenous obesity as part of a comprehensive weight reduction program. To understand the market dynamics and financial trajectory of DIDREX, it is essential to delve into various aspects including prescription trends, market competition, and broader healthcare industry shifts.

Prescription Trends and Usage

Historical Context

The use of stimulant medications like DIDREX has been subject to significant regulatory and market changes. According to the IQVIA Report on Stimulant Trends from 2012 to 2022, the overall number of stimulant prescriptions has increased, but the context for DIDREX is more nuanced. Stimulant prescriptions, including those for obesity management, saw a decline in certain age groups and an increase in others. For instance, prescriptions among the 11-20 year old group decreased, while those in the 31-40 year old group more than tripled since 2012[1].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the dispensing of stimulant prescriptions, including those for DIDREX. There was a steep decline in stimulant prescriptions immediately after the pandemic restrictions were implemented, but by October 2020, the dispensing had rebounded to pre-pandemic levels. This rebound continued, with the highest year-over-year increase in stimulant prescriptions observed between 2021 and 2022[1].

Market Competition

Obesity Drug Market

The obesity drug market has seen significant innovation and growth in recent years. The emergence of GLP-1 drugs, such as semaglutide (Wegovy) and tirzepatide (Mounjaro), has transformed the treatment landscape for obesity. These drugs have shown substantial efficacy in weight loss and are projected to dominate the market, potentially impacting the demand for traditional stimulant-based obesity medications like DIDREX. The GLP-1 market is estimated to reach $100 billion globally, driven by their effectiveness in treating obesity and other related health conditions[3].

Direct-to-Consumer Marketing

The obesity drug market is also influenced by direct-to-consumer marketing strategies. Companies like Lilly and Pfizer are offering drugs directly to patients, and consumer-focused services like Ro/Hims & Hers are using social media platforms to promote obesity treatments. This shift could further marginalize traditional prescription-only medications like DIDREX unless they adapt to these marketing strategies[5].

Financial Trajectory

Revenue and Sales

The financial trajectory of DIDREX is closely tied to its prescription volume and market share. Given the increasing competition from more effective and safer obesity treatments, the revenue from DIDREX is likely to decline. The market for obesity drugs is expanding, but the share of traditional stimulants is expected to shrink as newer, more effective treatments gain traction.

Pricing and Reimbursement

DIDREX, like many other obesity medications, faces challenges related to pricing and reimbursement. In the U.S., obesity drugs are not reimbursed by the government, which limits their accessibility and affordability for many patients. This lack of reimbursement can significantly impact the financial performance of DIDREX, as patients may opt for treatments that are covered by insurance or have more favorable pricing strategies[5].

Regulatory Environment

FDA and Regulatory Changes

The regulatory environment plays a crucial role in the market dynamics of DIDREX. Any changes in FDA guidelines or approvals for new obesity treatments can significantly impact the market share of existing medications. For instance, the approval of oral GLP-1s could further reduce the demand for injectable or oral stimulants like DIDREX[3].

Patient Demographics and Prescriber Trends

Sex and Age Distribution

The patient demographics for DIDREX have shifted over the years. While the 11-20 year old group historically had the highest percentage of stimulant prescriptions, this group's share has decreased. In contrast, the 31-40 year old group has seen a significant increase in prescriptions. Female patients have also seen a higher percent increase in prescriptions compared to males, particularly between 2020 and 2021[1].

Prescriber Specialties

The specialties of prescribers also influence the market dynamics. The top prescriber specialties for stimulants include psychiatry, family medicine, and internal medicine. Changes in prescribing patterns among these specialties can impact the overall demand for DIDREX[1].

Future Outlook

Emerging Treatments and Technologies

The future outlook for DIDREX is challenging given the emergence of more effective and safer treatments. The development of oral GLP-1s, triple incretin agonists, and other innovative obesity treatments is expected to continue, further eroding the market share of traditional stimulants. The potential for lower-priced, more tolerable treatments could make DIDREX less competitive in the market[3][5].

Market Adaptation

For DIDREX to remain relevant, it would need to adapt to the changing market landscape. This could involve repositioning the drug for specific patient segments, improving its safety profile, or adopting innovative marketing strategies to compete with direct-to-consumer services.

Key Takeaways

  • Increasing Competition: The obesity drug market is dominated by newer, more effective treatments like GLP-1s, which are expected to continue growing.
  • Regulatory and Reimbursement Challenges: Lack of government reimbursement and potential regulatory changes can impact the financial performance of DIDREX.
  • Shifting Patient Demographics: Changes in patient demographics and prescriber trends affect the demand for DIDREX.
  • Adaptation Needed: To remain competitive, DIDREX needs to adapt to the evolving market landscape through innovative strategies.

FAQs

1. What is DIDREX used for? DIDREX is used for the short-term management of exogenous obesity as part of a comprehensive weight reduction program.

2. How has the COVID-19 pandemic affected the dispensing of DIDREX? The COVID-19 pandemic led to an initial decline in stimulant prescriptions, including DIDREX, but dispensing rebounded to pre-pandemic levels by October 2020 and continued to increase thereafter.

3. What are the main competitors to DIDREX in the obesity drug market? The main competitors to DIDREX include GLP-1 drugs such as semaglutide (Wegovy) and tirzepatide (Mounjaro), which have shown significant efficacy in weight loss.

4. Why is the financial trajectory of DIDREX challenging? The financial trajectory of DIDREX is challenging due to increasing competition from more effective treatments, lack of government reimbursement, and potential regulatory changes.

5. What adaptations might DIDREX need to remain competitive? To remain competitive, DIDREX might need to be repositioned for specific patient segments, improve its safety profile, or adopt innovative marketing strategies to compete with direct-to-consumer services.

Sources

  1. IQVIA Report on Stimulant Trends from 2012 - 2022.
  2. Direxion Press Releases.
  3. Goldman Sachs - Weighing the GLP-1 market.
  4. Drugs.com - Didrex: Package Insert / Prescribing Information.
  5. Stifel - Obesity Market Review - July 8, 2024.

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