AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE - Generic Drug Details

What are the generic drug sources for amitriptyline hydrochloride; perphenazine and what is the scope of patent protection?

Amitriptyline hydrochloride; perphenazine is the generic ingredient in ten branded drugs marketed by Schering, Chartwell Rx, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, Par Pharm, Sun Pharm Industries, Watson Labs, and New River, and is included in thirty-seven NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

US Patents:	0
Tradenames:	10
Applicants:	9
NDAs:	37
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	1
Patent Applications:	58
DailyMed Link:	AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE at DailyMed

Recent Clinical Trials for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

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

Sponsor	Phase
Hospital Civil de Guadalajara	Phase 2
University of Guadalajara	Phase 2
Institute of Experimental and Clinical Therapeutics	Phase 2

See all AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE clinical trials

Pharmacology for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Drug Class

Phenothiazine Tricyclic Antidepressant

Anatomical Therapeutic Chemical (ATC) Classes for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

N05AB	Phenothiazines with piperazine structure
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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

US Patents and Regulatory Information for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fosun Pharma	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	071862-001	Dec 21, 1987		DISCN	No	No
Par Pharm	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	070621-001	Sep 11, 1986		DISCN	No	No
Mylan	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	071443-004	Nov 10, 1988		RX	No	Yes

Expired US Patents for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
New River	TRIAVIL 4-25	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014715-005	Approved Prior to Jan 1, 1982
Schering	ETRAFON 2-10	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014713-007	Approved Prior to Jan 1, 1982
New River	TRIAVIL 4-10	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014715-003	Approved Prior to Jan 1, 1982

AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Amitriptyline Hydrochloride and Perphenazine

Introduction

Amitriptyline hydrochloride and perphenazine are medications with a long history of use in treating various psychiatric and neurological conditions. Understanding the market dynamics and financial trajectory of these drugs is crucial for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

Market Size and Growth

The amitriptyline hydrochloride market has experienced significant growth in recent years and is expected to continue this trend. By 2031, the market is anticipated to reach substantial revenue, driven by increasing demand for psychiatric and neurological treatments[1][4].

Forecast Period

The forecast period from 2023 to 2031 indicates robust growth rates for the amitriptyline hydrochloride market. This growth is attributed to the positive momentum in market dynamics, including increasing prevalence of mental health disorders and the need for effective treatments[1][4].

Market Segmentation

The market for amitriptyline hydrochloride is segmented based on several factors:

Type

The market is categorized into different dosage forms, such as 25mg/tablet and 10mg/tablet. Each dosage form has its specific market share and growth prospects[1].

Application

Amitriptyline hydrochloride is used for various applications, including anxiety, depression, agitated depression, and other conditions. The demand for the drug varies across these applications, influencing market dynamics[1].

Geographical Regions

The market is analyzed across different geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own growth trajectory and market size[1].

Drivers of Market Growth

Several factors drive the growth of the amitriptyline hydrochloride market:

Increasing Prevalence of Mental Health Disorders

The rising incidence of depression, anxiety, and other mental health conditions drives the demand for effective treatments like amitriptyline hydrochloride[1][4].

Off-Label Uses

Amitriptyline hydrochloride is also used off-label for conditions such as chronic pain syndrome, insomnia, and post-traumatic stress disorder, expanding its market reach[2].

Combination Therapies

The use of amitriptyline hydrochloride in combination with other medications, such as perphenazine, enhances its therapeutic efficacy and market appeal[3].

Restraints and Challenges

Despite the growth potential, the market faces several restraints and challenges:

Side Effects and Safety Concerns

Amitriptyline hydrochloride has a significant side effect profile, including anticholinergic, antihistaminic, and alpha-adrenergic blocking effects. These side effects can limit its use, especially in certain patient populations[2].

Regulatory Warnings

The FDA has issued black box warnings regarding the use of amitriptyline hydrochloride in adolescents and young adults due to the risk of suicidal ideation and behavior[2].

Metabolic Variability

The metabolism of amitriptyline hydrochloride varies significantly among individuals, particularly those with CYP2D6 and CYP2C19 polymorphisms, which can affect its efficacy and safety[2].

Perphenazine and Amitriptyline Hydrochloride Combination

Perphenazine, a phenothiazine derivative, is often combined with amitriptyline hydrochloride to manage mixed syndromes of anxiety and depression.

Therapeutic Benefits

This combination offers a broad spectrum of therapeutic benefits, including alleviating symptoms of anxiety, tension, and psychomotor excitement. It is particularly useful for patients with various degrees of mental illness intensity[3].

Dosage Flexibility

The combination is available in multiple dosage forms, providing flexibility for optimal management of patients with different needs[3].

Financial Trajectory

The financial trajectory of the amitriptyline hydrochloride market is promising, with significant revenue growth expected during the forecast period.

Revenue Projections

The market is anticipated to generate substantial revenue by 2031, driven by the increasing demand for psychiatric treatments and the expanding use of amitriptyline hydrochloride in various applications[1][4].

Investment Opportunities

The robust growth prospects of the amitriptyline hydrochloride market present attractive investment opportunities for pharmaceutical companies and investors. However, it is crucial to consider the challenges and restraints associated with this market[1][4].

Conclusion

The market for amitriptyline hydrochloride is poised for significant growth, driven by increasing demand for effective psychiatric and neurological treatments. While the combination with perphenazine enhances therapeutic efficacy, the market faces challenges related to side effects, regulatory warnings, and metabolic variability. Understanding these dynamics is essential for stakeholders to make informed decisions.

Key Takeaways

• The amitriptyline hydrochloride market is expected to grow significantly from 2023 to 2031.
• The market is segmented by type, application, and geographical region.
• Increasing prevalence of mental health disorders and off-label uses drive market growth.
• Side effects, safety concerns, and metabolic variability are key restraints.
• The combination with perphenazine offers therapeutic benefits and dosage flexibility.
• The financial trajectory indicates substantial revenue growth and investment opportunities.

FAQs

What are the primary applications of amitriptyline hydrochloride?

Amitriptyline hydrochloride is primarily used to treat depression in adults. It is also used off-label for anxiety, post-traumatic stress disorder, chronic pain syndrome, and insomnia[2].

What are the common side effects of amitriptyline hydrochloride?

Common side effects include weight gain, gastrointestinal symptoms, dizziness, headache, somnolence, anticholinergic effects, and antihistaminic effects[2].

How does the combination of perphenazine and amitriptyline hydrochloride work?

This combination is used to manage mixed syndromes of anxiety and depression, offering a broad spectrum of therapeutic benefits and dosage flexibility[3].

What are the regulatory warnings associated with amitriptyline hydrochloride?

The FDA has issued a black box warning regarding the increased risk of suicidal ideation and behavior in adolescents and young adults using amitriptyline hydrochloride[2].

How does metabolic variability affect the use of amitriptyline hydrochloride?

Metabolic variability, particularly in individuals with CYP2D6 and CYP2C19 polymorphisms, can affect the efficacy and safety of amitriptyline hydrochloride, requiring careful monitoring and dose adjustments[2].

Sources

1. Market Research Intellect: Amitriptyline Hydrochloride Market Size, Scope And Forecast Report.
2. NCBI Bookshelf: Amitriptyline - StatPearls.
3. FDA: PERPHENAZINE and AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP.
4. Market Research Intellect: Global Amitriptyline HCL Market Size, Trends and Projections.