ELAVIL Drug Patent Profile

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

Elavil is a drug marketed by Astrazeneca and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Elavil

A generic version of ELAVIL was approved as amitriptyline hydrochloride by SUN PHARM INDS INC on July 14^th, 1987.

Summary for ELAVIL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	11
Patent Applications:	3,423
DailyMed Link:	ELAVIL at DailyMed

Recent Clinical Trials for ELAVIL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Missouri, Kansas City	Phase 3
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2
National Center for Complementary and Integrative Health (NCCIH)	Phase 2

See all ELAVIL clinical trials

US Patents and Regulatory Information for ELAVIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	ELAVIL	amitriptyline hydrochloride	INJECTABLE;INJECTION	012704-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-007	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for ELAVIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-005	Approved Prior to Jan 1, 1982	3,428,735
Astrazeneca	ELAVIL	amitriptyline hydrochloride	INJECTABLE;INJECTION	012704-001	Approved Prior to Jan 1, 1982	3,428,735
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-007	Approved Prior to Jan 1, 1982	3,428,735
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-006	Approved Prior to Jan 1, 1982	3,428,735
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-004	Approved Prior to Jan 1, 1982	3,428,735
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-003	Approved Prior to Jan 1, 1982	3,428,735

ELAVIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amitriptyline (ELAVIL)

Market Overview

Amitriptyline, commonly known by the brand name ELAVIL, is a tricyclic antidepressant used to treat various conditions including depression, anxiety, migraine, and chronic neuropathic pain. Here’s a detailed look at the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global amitriptyline market is projected to exhibit significant growth. As of 2023, the market is valued at approximately US$ 607.0 million and is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.6% from 2023 to 2030, reaching a projected value of US$ 888.8 million by 2030[1].

Drivers of Market Growth

Several factors are driving the growth of the amitriptyline market:

Increase in Regulatory Approvals

An increase in product approvals by regulatory authorities such as the U.S. FDA is a significant driver. For instance, Unichem Laboratories Ltd. received approval for its Amitriptyline HCl Tablets in 2021, which has contributed to market expansion[1].

Rising Prevalence of Mental Disorders

The increasing prevalence of mental disorders like depression and anxiety is another key driver. According to the World Health Organization (WHO), there were over 150 million people living with mental disorders in Europe alone in 2021[1].

Growing Demand for Antidepressants

The rise in demand for antidepressants, coupled with an increasing geriatric population and rising healthcare expenditure, is also driving the market. Changing lifestyles and rising awareness about mental health further contribute to this growth[3].

Impact of COVID-19 Pandemic

The COVID-19 pandemic had a positive impact on the amitriptyline market. The pandemic increased the prevalence of mental health disorders and post-COVID-19 symptoms such as headaches and migraines, for which amitriptyline is often prescribed. This has led to an increased use of amitriptyline, thereby boosting market growth[1].

Regional Market Analysis

North America

North America dominates the amitriptyline market, holding a 34.8% market share. This is due to the presence of major players like Accord Healthcare Inc., Viatris Inc., and Sun Pharmaceutical Industries Inc., as well as a well-developed healthcare infrastructure[1].

Europe

Europe is the second-largest market, driven by an increase in cases of mental disorders. The region's strong healthcare system and high prevalence of mental health issues contribute to its significant market share[1].

Asia-Pacific

The Asia-Pacific region is expected to grow significantly during the forecast period due to increasing research and development activities and growing government support for healthcare infrastructure[3].

Competitive Landscape

The amitriptyline market is highly competitive with several key players:

• Accord Healthcare Inc.
• Viatris Inc.
• Sun Pharmaceutical Industries Inc.
• Unichem Laboratories Ltd.
• Apotex Inc.
• Intas Pharmaceuticals Ltd.

These companies are involved in continuous product launches, regulatory approvals, and strategic business developments to maintain their market positions[1].

Side Effects and Challenges

Despite the growth, the market faces challenges due to the side effects associated with amitriptyline. These include nausea, vomiting, drowsiness, weakness, nightmares, headaches, dry mouth, constipation, and changes in sex drive. These side effects can shift patient preferences to alternative treatments, potentially hampering market growth[1].

Financial Trajectory

Revenue Projections

The projected revenue growth from US$ 607.0 million in 2023 to US$ 888.8 million by 2030 indicates a robust financial trajectory. This growth is driven by increasing demand, regulatory approvals, and expanding market presence in various regions[1].

Production Costs

The production cost of amitriptyline involves various expenses such as raw material costs, labor, utilities, and overhead expenses. A detailed cost analysis can help manufacturers optimize their production processes and reduce costs. For instance, a report by Procurement Resource provides exhaustive data on the production costs, including land and site costs, equipment costs, and financing costs[4].

Patient Epidemiology and Market Insights

Prevalence and Incidence

The market growth is also influenced by the prevalence and incidence of conditions treated by amitriptyline. Detailed market analysis includes data on patient demographics, disease epidemiology, and adherence rates, which are crucial for forecasting market trends and opportunities[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.
• Regulatory approvals and the rising prevalence of mental disorders are key drivers of market growth.
• The COVID-19 pandemic has positively impacted the market due to increased use of amitriptyline for post-COVID-19 symptoms.
• North America dominates the market, followed by Europe and the Asia-Pacific region.
• Side effects associated with amitriptyline pose a challenge to market growth.
• The competitive landscape is characterized by major pharmaceutical companies continuously launching new products and seeking regulatory approvals.

FAQs

What is the current market size of the global amitriptyline market?

The global amitriptyline market is valued at approximately US$ 607.0 million as of 2023[1].

What is the expected CAGR of the global amitriptyline market from 2023 to 2030?

The global amitriptyline market is expected to grow at a CAGR of 5.6% from 2023 to 2030[1].

Which region dominates the amitriptyline market?

North America dominates the amitriptyline market, holding a 34.8% market share[1].

What are the main drivers of the amitriptyline market growth?

The main drivers include regulatory approvals, rising prevalence of mental disorders, and the positive impact of the COVID-19 pandemic on the use of amitriptyline[1][3].

What are the common side effects associated with amitriptyline?

Common side effects include nausea, vomiting, drowsiness, weakness, nightmares, headaches, dry mouth, constipation, and changes in sex drive[1].

How has the COVID-19 pandemic affected the amitriptyline market?

The COVID-19 pandemic has had a positive impact on the market due to increased use of amitriptyline for treating post-COVID-19 symptoms such as headaches and migraines[1].