Amitriptyline hydrochloride - Generic Drug Details

What are the generic sources for amitriptyline hydrochloride and what is the scope of freedom to operate?

Amitriptyline hydrochloride is the generic ingredient in eighteen branded drugs marketed by Roche, Watson Labs, Astrazeneca, Bristol Myers Squibb, Warner Chilcott, Accord Hlthcare, Aiping Pharm Inc, Am Therap, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Copley Pharm, Endo Operations, Halsey, Lederle, Mankind Pharma, Mutual Pharm, Par Pharm, Pliva, Purepac Pharm, Rising, Roxane, Rubicon, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Unichem, Usl Pharma, Vangard, West Ward, Zydus Pharms, Anda Repository, Chartwell Rx, Heritage Pharma, Micro Labs, Mylan Pharms Inc, Schering, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, Sun Pharm Industries, and New River, and is included in one hundred and seventy-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for amitriptyline hydrochloride. Forty-two suppliers are listed for this compound.

Summary for amitriptyline hydrochloride

US Patents:	0
Tradenames:	18
Applicants:	44
NDAs:	179
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	42
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	125
Patent Applications:	4,166
What excipients (inactive ingredients) are in amitriptyline hydrochloride?	amitriptyline hydrochloride excipients list
DailyMed Link:	amitriptyline hydrochloride at DailyMed

Recent Clinical Trials for amitriptyline hydrochloride

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

Sponsor	Phase
Shalamar Institute of Health Sciences	N/A
Beni-Suef University	Phase 2
Patient-Centered Outcomes Research Institute	N/A

See all amitriptyline hydrochloride clinical trials

Pharmacology for amitriptyline hydrochloride

Drug Class

Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for amitriptyline hydrochloride

Adrenergic Uptake Inhibitors

Analgesics, Non-Narcotic

Antidepressive Agents, Tricyclic

Anatomical Therapeutic Chemical (ATC) Classes for amitriptyline hydrochloride

N06AA	Non-selective monoamine reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for amitriptyline hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	AMITID	amitriptyline hydrochloride	TABLET;ORAL	086454-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Mylan	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	071443-005	Nov 10, 1988		RX	No	Yes
Pliva	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	088884-001	Sep 26, 1984		DISCN	No	No
Aiping Pharm Inc	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	212654-003	Sep 29, 2021	AB	RX	No	No
New River	TRIAVIL 2-10	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014715-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Fosun Pharma	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	071063-001	Nov 27, 1987		DISCN	No	No
Endo Operations	AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride	TABLET;ORAL	040218-002	Sep 11, 1997		DISCN	No	No

Expired US Patents for amitriptyline hydrochloride

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
Astrazeneca	ELAVIL	amitriptyline hydrochloride	TABLET;ORAL	012703-001	Approved Prior to Jan 1, 1982	3,428,735

Amitriptyline hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amitriptyline Hydrochloride

Introduction

Amitriptyline hydrochloride, a tricyclic antidepressant, has been a staple in the treatment of mental health disorders such as depression, anxiety, and mood problems. The market for this drug has exhibited significant growth and is expected to continue on this upward trajectory. Here, we delve into the market dynamics and financial outlook for amitriptyline hydrochloride.

Market Size and Growth

The amitriptyline hydrochloride market has experienced rapid and substantial growth in recent years. As of 2023, the market was valued at several billion USD and is anticipated to reach even higher figures by 2031, driven by a robust growth rate throughout the forecast period[1][4].

Segmentation

The market is segmented based on several key factors:

• Type: The drug is available in various dosages, such as 25mg and 10mg tablets.
• Application: It is used to treat a range of conditions including anxiety, depression, agitated depression, and other mental health issues.
• Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1][4].

Market Dynamics

Drivers

Several factors drive the growth of the amitriptyline hydrochloride market:

• Increasing Prevalence of Mental Health Disorders: The rising incidence of depression and other mental health issues globally contributes significantly to the demand for this drug.
• Limited Alternatives: In certain conditions like irritable bowel syndrome (IBS), amitriptyline is often used off-label due to the limited number of approved treatments, further boosting its demand[5].
• Economic Factors: The affordability and efficacy of amitriptyline hydrochloride make it a preferred choice in many regions.

Restraints

Despite the growth, there are several challenges:

• Side Effects: Amitriptyline hydrochloride can cause anticholinergic, cardiac, and antiarrhythmic side effects, which may deter some patients and healthcare providers.
• Regulatory Scrutiny: Strict regulatory environments and the need for continuous safety monitoring can impact market growth.
• Competition from New Therapies: The development of new antidepressants and treatments for related conditions could potentially reduce the market share of amitriptyline hydrochloride[2][4].

Opportunities

The market presents several opportunities:

• Emerging Markets: Growing healthcare infrastructure and increasing awareness of mental health in emerging economies offer significant growth potential.
• Drug Delivery Innovations: Research into new drug delivery systems, such as gemini surfactants, could enhance the bioavailability and efficacy of amitriptyline hydrochloride, making it more attractive to patients and healthcare providers[2].

Challenges

• Research and Development: Continuous investment in research is necessary to address the side effects and improve the drug's delivery mechanisms.
• Regulatory Hurdles: Navigating complex regulatory landscapes to ensure compliance and approval is a significant challenge.

Financial Trajectory

The financial outlook for the amitriptyline hydrochloride market is promising:

• Revenue Growth: The market is expected to generate substantial revenue throughout the forecast period from 2023 to 2031, with a notable compound annual growth rate (CAGR)[1][4].
• Regional Performance: The North American market, in particular, is expected to contribute significantly to the overall revenue, with a projected CAGR from 2023 to 2030[3].

Key Players and Market Share

The market is dominated by several key players who have established themselves through their product offerings and distribution networks. These companies are continually investing in research and development to improve the efficacy and safety of amitriptyline hydrochloride. The global market share and ranking of these players are closely monitored, with reports providing detailed insights into their overall sales and demand forecasts[3].

Consumer Behavior and Economic Landscape

Consumer behavior plays a crucial role in the market dynamics of amitriptyline hydrochloride. Increasing awareness of mental health issues and the willingness to seek medical help are driving factors. Economically, the affordability of the drug and the healthcare policies in various regions influence its adoption. The economic, political, and social landscapes of countries also impact the market, with factors such as government subsidies and insurance coverage affecting demand[1][4].

Technological Advancements

Technological advancements, particularly in drug delivery systems, are enhancing the market for amitriptyline hydrochloride. For instance, the use of gemini surfactants has shown potential in improving the bioavailability of the drug, making it more effective and reducing side effects.

"A significant interaction between AMT and 14-E2-14 was detected by tensiometric study as the critical micelle concentration (cmc) of AMT+14-E2-14 is reduced upon an increase of mole fraction (α 1) of 14-E2-14. The decrease in cmc indicates the nonideality of studied mixtures of different compositions."[2]

Conclusion

The amitriptyline hydrochloride market is poised for significant growth driven by increasing demand for mental health treatments, technological advancements in drug delivery, and favorable economic conditions. However, it must navigate challenges such as side effects, regulatory scrutiny, and competition from new therapies.

Key Takeaways

• Rapid Market Growth: The market is expected to grow substantially from 2023 to 2031.
• Segmentation: The market is segmented by type, application, and geographical regions.
• Drivers: Increasing prevalence of mental health disorders, limited alternatives, and economic factors drive growth.
• Restraints: Side effects, regulatory scrutiny, and competition from new therapies are significant challenges.
• Opportunities: Emerging markets and drug delivery innovations offer growth potential.
• Financial Trajectory: The market is expected to generate significant revenue with a notable CAGR.

FAQs

Q: What are the primary applications of amitriptyline hydrochloride? A: Amitriptyline hydrochloride is primarily used to treat anxiety, depression, agitated depression, and other mental health issues.

Q: How is the amitriptyline hydrochloride market segmented? A: The market is segmented based on type (dosage), application (mental health conditions), and geographical regions.

Q: What are the key drivers of the amitriptyline hydrochloride market? A: The key drivers include the increasing prevalence of mental health disorders, limited alternatives for certain conditions, and favorable economic factors.

Q: What are the potential restraints on the market growth of amitriptyline hydrochloride? A: Side effects, regulatory scrutiny, and competition from new therapies are significant restraints.

Q: How does technological advancement impact the amitriptyline hydrochloride market? A: Technological advancements, such as the use of gemini surfactants, can improve the bioavailability and efficacy of the drug, enhancing its market potential.

Sources

1. Market Research Intellect: Amitriptyline Hydrochloride Market Size, Scope And Forecast Report.
2. PLoS ONE: Investigation of micellar and interfacial phenomenon of amitriptyline hydrochloride with cationic ester-bonded gemini surfactant mixture in different solvent media.
3. Market Research Reports: Amitriptyline Hydrochloride Tablets - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
4. Market Research Intellect: Global Amitriptyline HCL Market Size, Trends and Projections.
5. Mayo Clinic: Current and future treatments for irritable bowel syndrome associated with diarrhea.