Trimipramine maleate - Generic Drug Details

What are the generic sources for trimipramine maleate and what is the scope of patent protection?

Trimipramine maleate is the generic ingredient in two branded drugs marketed by Odyssey Pharms, Breckenridge, Elite Labs Inc, and Usl Pharma, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for trimipramine maleate. Three suppliers are listed for this compound.

Summary for trimipramine maleate

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	59
Patent Applications:	1,004
Drug Prices:	Drug price trends for trimipramine maleate
What excipients (inactive ingredients) are in trimipramine maleate?	trimipramine maleate excipients list
DailyMed Link:	trimipramine maleate at DailyMed

See drug prices for trimipramine maleate

Pharmacology for trimipramine maleate

Drug Class

Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for trimipramine maleate

Adrenergic Uptake Inhibitors

Antidepressive Agents, Tricyclic

Anatomical Therapeutic Chemical (ATC) Classes for trimipramine maleate

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

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

US Patents and Regulatory Information for trimipramine maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Usl Pharma	TRIMIPRAMINE MALEATE	trimipramine maleate	CAPSULE;ORAL	071285-001	Dec 8, 1987		DISCN	No	No
Elite Labs Inc	TRIMIPRAMINE MALEATE	trimipramine maleate	CAPSULE;ORAL	077361-002	Aug 2, 2006	AB	RX	No	No
Usl Pharma	TRIMIPRAMINE MALEATE	trimipramine maleate	CAPSULE;ORAL	071284-001	Dec 8, 1987		DISCN	No	No
Odyssey Pharms	SURMONTIL	trimipramine maleate	CAPSULE;ORAL	016792-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Breckenridge	TRIMIPRAMINE MALEATE	trimipramine maleate	CAPSULE;ORAL	208127-003	Apr 15, 2016	AB	RX	No	No

Trimipramine maleate Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Trimipramine Maleate

Introduction

Trimipramine maleate, marketed under the brand name Surmontil among others, is a tricyclic antidepressant (TCA) with a diverse range of therapeutic applications, including the treatment of depression, insomnia, anxiety disorders, and psychosis. This article delves into the market dynamics and financial trajectory of trimipramine maleate, exploring its clinical use, market position, and financial aspects.

Clinical Use and Therapeutic Applications

Trimipramine maleate is distinguished by its atypical profile within the TCA class, characterized by weak monoamine reuptake inhibition but strong receptor antagonism, particularly against histamine H1, serotonin 5-HT2A, and α1-adrenergic receptors[1][4].

• Depression: It is primarily used to treat major depressive disorder (MDD), with therapeutic concentrations between 0.5 and 1.2 μM[1].
• Insomnia and Anxiety: Trimipramine has significant sedative and anxiolytic effects, making it useful for treating insomnia and anxiety disorders[1][2].
• Other Uses: It also exhibits weak antipsychotic effects and is used in the management of psychosis.

Market Position

Competitive Landscape

The market for antidepressants is highly competitive, with various classes of drugs including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and atypical antidepressants. Trimipramine maleate, as a TCA, faces competition from newer, often better-tolerated antidepressants. However, its unique pharmacological profile and efficacy in certain conditions maintain its niche in the market.

Patient Population

The patient population for trimipramine maleate includes individuals with major depressive disorder, insomnia, anxiety disorders, and psychosis. The drug's use is particularly notable in cases where other antidepressants have failed or are not suitable due to side effect profiles or specific patient needs.

Financial Trajectory

Revenue and Sales

The financial performance of trimipramine maleate is influenced by several factors, including prescription rates, competition from generic versions, and the overall demand for antidepressants.

• Generic Competition: Since the patent for trimipramine maleate has expired, generic versions are available, which can reduce the revenue generated by the branded product. However, the drug still maintains a significant market presence due to its established use and patient loyalty.
• Prescription Trends: The prescription trends for TCAs have generally declined with the advent of newer antidepressants. However, trimipramine maleate's unique therapeutic profile ensures it remains a viable option for certain patient groups.

Pricing and Accessibility

The pricing of trimipramine maleate varies by region and is influenced by factors such as healthcare policies, insurance coverage, and competition from generic alternatives.

• Cost-Effectiveness: Compared to newer antidepressants, trimipramine maleate can be more cost-effective, especially for patients who require long-term treatment. This cost-effectiveness can contribute to its continued use despite the availability of newer drugs.

Regulatory and Safety Considerations

Suicidality Risk

Trimipramine maleate, like other antidepressants, carries a risk of suicidality, particularly in children, adolescents, and young adults. This risk necessitates careful monitoring and caution in prescribing the drug to these patient groups[2][5].

Side Effects and Contraindications

The drug has a range of side effects, including sedation, anticholinergic effects, weight gain, and sexual dysfunction. These side effects can impact patient compliance and influence the drug's market position. Additionally, contraindications such as urinary retention, hyperthyroidism, and seizure disorders further limit its use in certain patient populations[1][2].

Market Trends and Future Outlook

Growing Demand for Mental Health Treatments

The increasing awareness and recognition of mental health issues have led to a growing demand for effective treatments. While newer classes of antidepressants dominate the market, the unique profile of trimipramine maleate ensures it remains relevant.

Generic Market Expansion

The availability of generic versions of trimipramine maleate has expanded its reach, making it more accessible to a broader patient population. This expansion is expected to continue, influencing the drug's financial trajectory.

Research and Development

There is ongoing research into the pharmacological properties of TCAs, including trimipramine maleate. New insights into its mechanism of action and potential new indications could revitalize interest and impact its market dynamics.

Key Takeaways

• Unique Therapeutic Profile: Trimipramine maleate's atypical TCA profile, with strong receptor antagonism and weak monoamine reuptake inhibition, maintains its niche in the market.
• Competitive Landscape: The drug faces competition from newer antidepressants but remains viable due to its efficacy in specific conditions.
• Financial Performance: Revenue is influenced by generic competition, prescription trends, and cost-effectiveness.
• Regulatory and Safety Considerations: The drug carries risks such as suicidality and side effects, which must be carefully managed.
• Future Outlook: Growing demand for mental health treatments and the expansion of the generic market are key factors in its future financial trajectory.

FAQs

1. What is the primary use of trimipramine maleate? Trimipramine maleate is primarily used to treat major depressive disorder (MDD), but it is also used for its sedative, anxiolytic, and weak antipsychotic effects in treating insomnia, anxiety disorders, and psychosis.

2. How does trimipramine maleate differ from other TCAs? Trimipramine maleate is an atypical TCA due to its weak monoamine reuptake inhibition and strong receptor antagonism, particularly against histamine H1, serotonin 5-HT2A, and α1-adrenergic receptors.

3. What are the common side effects of trimipramine maleate? Common side effects include sedation, anticholinergic effects (such as dry mouth, blurred vision, constipation), weight gain, orthostatic hypotension, sexual dysfunction, and others.

4. Does trimipramine maleate carry a risk of suicidality? Yes, like other antidepressants, trimipramine maleate carries a risk of suicidality, particularly in children, adolescents, and young adults.

5. How has the availability of generic versions impacted the market for trimipramine maleate? The availability of generic versions has expanded the drug's reach, making it more accessible and influencing its financial trajectory by increasing competition for the branded product.

Sources

1. Wikipedia: Trimipramine - Wikipedia
2. FDA: SURMONTIL (Trimipramine Maleate) DESCRIPTION
3. NCBI: Development of Visible Spectrophotometric Methods for the ...
4. Apexbt: Trimipramine (maleate) potent antagonist of histamine H1 receptor
5. Drugs.com: Trimipramine Monograph for Professionals - Drugs.com