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Last Updated: January 5, 2025

AMITRIL Drug Patent Profile


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

Amitril is a drug marketed by Warner Chilcott and is included in six NDAs.

The generic ingredient in AMITRIL is amitriptyline hydrochloride. There are thirteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.

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Summary for AMITRIL
US Patents:0
Applicants:1
NDAs:6
Raw Ingredient (Bulk) Api Vendors: 124
Patent Applications: 2,956
DailyMed Link:AMITRIL at DailyMed
Drug patent expirations by year for AMITRIL

US Patents and Regulatory Information for AMITRIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott AMITRIL amitriptyline hydrochloride TABLET;ORAL 083939-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Warner Chilcott AMITRIL amitriptyline hydrochloride TABLET;ORAL 084957-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Warner Chilcott AMITRIL amitriptyline hydrochloride TABLET;ORAL 083937-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Warner Chilcott AMITRIL amitriptyline hydrochloride TABLET;ORAL 083938-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Warner Chilcott AMITRIL amitriptyline hydrochloride TABLET;ORAL 086295-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Warner Chilcott AMITRIL amitriptyline hydrochloride TABLET;ORAL 085093-001 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

AMITRIL Market Analysis and Financial Projection

Amitriptyline Market Dynamics and Financial Trajectory

Introduction to Amitriptyline

Amitriptyline, a tricyclic antidepressant, is widely used for treating various conditions including depression, neuropathic pain, migraine, and fibromyalgia. Here, we delve into the market dynamics and financial trajectory of amitriptyline, highlighting key trends, drivers, and challenges.

Market Size and Growth Projections

The global amitriptyline market is estimated to be valued at US$ 607.0 million in 2023 and is expected to exhibit a compound annual growth rate (CAGR) of 5.6% during the forecast period from 2023 to 2030, reaching a projected value of US$ 888.8 million by 2030[1][2].

Key Drivers of Market Growth

Several factors are driving the growth of the amitriptyline market:

Increasing Prevalence of Mental Disorders

The rising cases of mental disorders such as depression and bipolar disorder are significant drivers. According to the World Health Organization (WHO), more than 150 million people in Europe lived with mental disorders in 2021[1].

Neuropathic Pain and Migraine

The increasing prevalence of neuropathic pain and migraine also contributes to the market growth. For instance, migraine is the third most common disease worldwide, affecting 1 billion people globally in 2019[2].

Regulatory Approvals

Increased product approvals by regulatory authorities, such as the U.S. FDA, are driving market growth. For example, Unichem Laboratories Ltd. received ANDA approval for its Amitriptyline HCl Tablets in 2021[1].

Market Segmentation

The global amitriptyline market is segmented by strength, indication, distribution channel, and region.

Distribution Channel

The distribution channel segment holds significant potential, particularly in the U.S., where there are roughly 60,000 retail pharmacies, with one-third being independent and two-thirds being retail chains, supermarkets, and mass retailers[1].

Regional Analysis

North America dominates the market due to the presence of major players like Accord Healthcare Inc., Viatris Inc., and Sun Pharmaceutical Industries Inc. The Europe region is expected to be the second dominant region due to the high prevalence of mental disorders[1].

Competitive Landscape

The market is highly competitive with key players including:

  • Accord Healthcare Inc.
  • Mylan Pharmaceuticals Inc.
  • Sandoz Inc.
  • Sun Pharmaceutical Industries Inc.
  • Vintage Pharmaceuticals Inc.
  • Zydus Pharmaceuticals USA Inc.
  • Watson laboratories Inc.
  • Torrent Pharmaceuticals Ltd.[1][2]

Impact of COVID-19 Pandemic

The COVID-19 pandemic has had a mixed impact on the amitriptyline market. While it has increased the prevalence of mental health disorders, it has also disrupted supply chains and healthcare services, potentially hampering market growth[1].

Clinical Efficacy and Acceptability

Amitriptyline has been associated with higher efficacy and acceptability in improving sleep, fatigue, and health-related quality of life outcomes compared to other treatments. A network meta-analysis of 36 studies involving over 11,000 patients showed that amitriptyline was effective in reducing sleep disturbances and fatigue, and improving quality of life[4].

Side Effects and Challenges

Despite its efficacy, amitriptyline is associated with several side effects, including nausea, vomiting, drowsiness, and changes in sex drive. These side effects can shift patient preference to alternative treatments, potentially hampering market growth[1].

Market Restraints

  • Side Effects: The various side effects associated with amitriptyline can limit its adoption.
  • Alternative Treatments: The availability of alternative treatments, such as duloxetine and pregabalin, which are FDA-approved for conditions like fibromyalgia, can also restrain market growth[1][4].

Future Outlook and Trends

Increasing Demand for Generic and Biosimilar Drugs

The growth of generics and biosimilars is expected to play a crucial role in the pharmaceutical market, including the amitriptyline segment. Generics constitute about 84% of total sales in the U.S. pharmaceutical market, providing cost-effective alternatives[3].

Innovations in Drug Development

The integration of AI in drug discovery and development is set to enhance efficiency and reduce timelines, which could impact the amitriptyline market by introducing new and more effective treatments[3].

Rising Chronic Diseases

The increasing prevalence of chronic diseases will drive the demand for new therapies, contributing to the growth of the pharmaceutical market, including the segment for amitriptyline[3].

Key Takeaways

  • The global amitriptyline market is valued at US$ 607.0 million in 2023 and is expected to grow at a CAGR of 5.6% until 2030.
  • Key drivers include increasing prevalence of mental disorders, neuropathic pain, and migraine, along with regulatory approvals.
  • The market is segmented by strength, indication, distribution channel, and region, with North America and Europe being dominant regions.
  • Major players include Accord Healthcare Inc., Viatris Inc., and Sun Pharmaceutical Industries Inc.
  • Side effects and the availability of alternative treatments are significant restraints.
  • Future trends include the growth of generics and biosimilars, innovations in drug development, and the rising prevalence of chronic diseases.

FAQs

1. What is the current market size of the global amitriptyline market? The global amitriptyline market is estimated to be valued at US$ 607.0 million in 2023[1].

2. What is the expected CAGR of the global amitriptyline market from 2023 to 2030? The global amitriptyline market is expected to exhibit a CAGR of 5.6% during the forecast period from 2023 to 2030[1].

3. Which regions dominate the global amitriptyline market? North America and Europe are the dominant regions in the global amitriptyline market[1].

4. What are the primary side effects associated with amitriptyline? The primary side effects include nausea, vomiting, drowsiness, weakness or tiredness, nightmares, headaches, dry mouth, constipation, and changes in sex drive[1].

5. How does amitriptyline compare to other treatments for fibromyalgia? Amitriptyline is associated with higher efficacy and acceptability in improving sleep, fatigue, and health-related quality of life outcomes compared to other treatments like duloxetine and pregabalin[4].

Cited Sources

  1. Coherent Market Insights - Amitriptyline Market Size, Trends and Forecast to 2030
  2. Business Wire - Global Amitriptyline Market to Surpass US$ 762.6 Million by 2027
  3. Yellow Busaba - U.S. Pharmaceutical Statistics
  4. JAMA Network Open - Comparison of Amitriptyline and US Food and Drug Administration–Approved Treatments for Fibromyalgia: A Systematic Review and Network Meta-analysis

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