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Last Updated: December 25, 2024

LIMBITROL DS Drug Patent Profile


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When do Limbitrol Ds patents expire, and what generic alternatives are available?

Limbitrol Ds is a drug marketed by Chartwell Rx and is included in one NDA.

The generic ingredient in LIMBITROL DS is amitriptyline hydrochloride; chlordiazepoxide. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride; chlordiazepoxide profile page.

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Summary for LIMBITROL DS
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 120
DailyMed Link:LIMBITROL DS at DailyMed
Drug patent expirations by year for LIMBITROL DS

US Patents and Regulatory Information for LIMBITROL DS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chartwell Rx LIMBITROL DS amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 016949-002 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

LIMBITROL DS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LIMBITROL DS

Introduction

LIMBITROL DS, a combination of chlordiazepoxide and amitriptyline, is a medication indicated for the treatment of moderate to severe depression associated with anxiety. To understand its market dynamics and financial trajectory, it is crucial to analyze various factors including prescription trends, patient demographics, competition, and regulatory considerations.

Prescription Trends and Patient Demographics

While the IQVIA report primarily focuses on stimulant prescriptions, it provides a broader context for understanding prescription trends. Although LIMBITROL DS is not a stimulant, analyzing general prescription trends can offer insights into the broader pharmaceutical market.

  • Prescription Volume: The overall trend in prescriptions for psychiatric medications, including those for depression and anxiety, has seen fluctuations. For instance, the COVID-19 pandemic led to a significant increase in prescriptions for mental health medications due to increased stress and anxiety levels[1].

  • Patient Demographics: The demographic breakdown of patients prescribed psychiatric medications shows a shift towards older age groups. For example, prescriptions among the 31-40 year-old group have increased significantly over the past decade. This trend could impact the market for LIMBITROL DS, as it is often prescribed to adults with moderate to severe depression[1].

Market Competition

Alternatives and Comparisons

LIMBITROL DS faces competition from other antidepressant and anxiolytic medications.

  • Rexulti (Brexpiprazole): This is a more modern alternative with a different mechanism of action. Rexulti has a lower average rating compared to LIMBITROL DS but is still widely prescribed[4].

  • Bupropion: Another competitor, Bupropion, is known for its efficacy in treating depression and has a significant market presence. It has a higher number of user reviews and a moderate rating[4].

Generic Availability

LIMBITROL DS does not have a generic version available, which can impact its pricing and market share. The absence of generic alternatives means that patients may opt for other medications that have lower-cost generic options available[4].

Financial Trajectory

Pricing and Revenue

  • Pricing: The lack of generic competition allows LIMBITROL DS to maintain a higher price point compared to some of its competitors. However, this can also make it less accessible to patients without adequate insurance coverage[4].

  • Revenue: The revenue generated by LIMBITROL DS would be influenced by its prescription volume and pricing. Given the increasing demand for mental health medications, the revenue for LIMBITROL DS could remain stable or see a moderate increase, provided it maintains its market share.

Impact of Regulatory Considerations

  • Safety and Efficacy: The FDA's warnings and precautions regarding the use of benzodiazepines and tricyclic antidepressants, such as those in LIMBITROL DS, can affect prescribing habits. Healthcare providers must carefully assess patients for risks of abuse, misuse, and addiction, which can impact the medication's financial trajectory[3].

  • Compliance and Monitoring: The need for close monitoring of patients, especially the elderly, due to potential side effects and interactions, can add to the overall cost of treatment. This may influence healthcare providers to opt for other medications with fewer monitoring requirements[3].

Effects of the COVID-19 Pandemic

The COVID-19 pandemic has had a significant impact on the mental health sector, leading to an increased demand for medications like LIMBITROL DS.

  • Telemedicine: The pandemic saw a rise in telemedicine, which affected how prescriptions were dispensed. While this increased access to care, it also introduced new challenges in monitoring and managing patients remotely[1].

  • Prescription Trends: The pandemic led to a temporary decline in prescriptions immediately after the onset of COVID-19 restrictions but rebounded strongly by 2021. This trend suggests that LIMBITROL DS could have seen a similar rebound in prescriptions during this period[1].

Key Takeaways

  • Prescription Trends: The market for psychiatric medications, including LIMBITROL DS, has seen fluctuations influenced by broader healthcare trends and the COVID-19 pandemic.
  • Competition: LIMBITROL DS faces competition from newer medications and those with generic alternatives, impacting its market share and pricing.
  • Regulatory Considerations: FDA warnings and the need for careful patient monitoring can affect prescribing habits and the overall financial trajectory of LIMBITROL DS.
  • Pandemic Impact: The COVID-19 pandemic has increased demand for mental health medications but also introduced new challenges in patient management.

FAQs

What is LIMBITROL DS used for?

LIMBITROL DS is used for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety.

Are there generic alternatives to LIMBITROL DS?

No, there are no generic alternatives available for LIMBITROL DS.

How has the COVID-19 pandemic affected prescriptions for LIMBITROL DS?

The pandemic led to a temporary decline in prescriptions but saw a strong rebound by 2021, indicating increased demand for mental health medications.

What are the main competitors to LIMBITROL DS?

Main competitors include Rexulti (brexpiprazole) and Bupropion, among others.

What are the key regulatory considerations for LIMBITROL DS?

Key considerations include the risks of abuse, misuse, and addiction, as well as the need for careful monitoring of patients, especially the elderly, due to potential side effects and interactions.

Sources

  1. IQVIA Report on Stimulant Trends from 2012 - 2022 - Prepared For: Drug Enforcement Administration (DEA) - Prepared By: IQVIA Government Solutions, Inc.
  2. FINAL REPORT Evaluation of Healthcare Costs and Utilization - Interact for Health.
  3. LIMBITROL - accessdata.fda.gov - FDA Label.
  4. Limbitrol Alternatives Compared - Drugs.com - Drugs.com.

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