TRIMIPRAMINE MALEATE - Generic Drug Details

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

Trimipramine maleate is the generic ingredient in two branded drugs marketed by Teva Womens, 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:	67
Patent Applications:	1,086
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
Teva Womens	SURMONTIL	trimipramine maleate	CAPSULE;ORAL	016792-003	Sep 15, 1982		DISCN	Yes	No
Breckenridge	TRIMIPRAMINE MALEATE	trimipramine maleate	CAPSULE;ORAL	208127-001	Apr 15, 2016	AB	RX	No	No
Elite Labs Inc	TRIMIPRAMINE MALEATE	trimipramine maleate	CAPSULE;ORAL	077361-002	Aug 2, 2006	AB	RX	No	No

Market Dynamics and Financial Trajectory for Trimipramine Maleate

Last updated: July 27, 2025

Introduction

Trimipramine maleate, a tricyclic antidepressant (TCA), has historically served as a pharmacological treatment for depression, anxiety, and sleep disorders. Despite the advent of newer antidepressants, trimipramine’s unique pharmacological profile and specific clinical applications sustain its relevance in certain markets. Analyzing the current market landscape, future growth drivers, challenges, and financial outlook provides critical insights for stakeholders ranging from pharmaceutical companies to investors.

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Pharmacological Profile and Clinical Use

Trimipramine maleate operates primarily as a sedative and antidepressant by modulating neurotransmitter pathways, notably inhibiting the reuptake of norepinephrine and serotonin. Its unique sedative properties distinguish it from other TCAs, often making it a preferred choice in cases where sleep disturbances are prominent alongside depression.

Clinically, trimipramine remains prescribed for:

• Major depressive disorder,
• Anxiety disorders,
• Insomnia associated with depression,

partly due to its tolerability profile relative to older TCAs. However, its usage has declined in regions where SSRIs and newer antidepressants dominate prescribing habits.

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Current Market Landscape

Global Market Size & Segmentation

The global antidepressant market was valued at approximately USD 16 billion in 2022, with a compound annual growth rate (CAGR) of around 2.4% from 2023-2030 [1]. Within this, TCAs—once the mainstay—have seen their market share diminish, but specific niches persist for drugs like trimipramine.

Regional Market Dynamics

• North America: Despite the availability of newer agents, trimipramine maintains a niche role owing to its sedative properties and an aging population with comorbid sleep disorders.
• Europe: Usage is decreasing but persists in certain countries owing to clinical familiarity and regulatory legacy.
• Asia-Pacific: Growth potential is significant due to expanding mental health awareness, rising depression prevalence, and limited access to newer antidepressants in some markets.

Market Constraints

• Declining prescriptions driven by safety concerns, particularly cardiotoxicity risks associated with TCAs.
• Stringent regulatory restrictions limiting new formulations or broader indications.
• Competition from SSRIs, SNRIs, and atypical antidepressants, which are perceived as safer and easier to tolerate.

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Driving Factors for Market Dynamics

1. Changing Prescribing Patterns and Drug Preferences

The shift towards selective serotonergic agents has resulted in a contraction of TCA markets globally. Nonetheless, trimipramine’s sedative effects make it suitable in a subset of patients resistant to other treatments or with sleep disturbance predominant symptoms.

2. Regulatory Environment and Patent Status

Trimipramine is an off-patent, generic drug in most markets, impacting pricing strategies and R&D investments. Regulatory bodies, such as the FDA and EMA, maintain rigorous standards for safety, which influence market entry and continuation.

3. Unmet Clinical Needs

Subgroups of patients with treatment-resistant depression, comorbid insomnia, or medication intolerances can benefit from trimipramine’s unique profile. These niche markets bolster its steady if modest demand.

4. Increasing Focus on Mental Health

A rising global mental health awareness campaign and expanded diagnosis rates are potentially expanding market segments, especially in emerging economies.

5. Production and Supply Chain Considerations

Manufacturing of trimipramine benefits from straightforward synthesis pathways, but supply chain disruptions or raw material availability could influence pricing and availability.

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Financial Trajectory and Future Outlook

Market Valuation & Revenue Projections

Given the current landscape, the global market for trimipramine per se remains limited—comparable to a niche pharmaceutical product—estimated at USD 50-100 million annually. Its revenues are projected to decline modestly at a CAGR of -1% to -2% over the next five years, primarily due to dwindling prescriptions.

Emerging Opportunities

• Formulation Innovation: Development of sustained-release formulations could improve patient compliance and expand indications.
• Combination Therapies: Co-prescribing with newer agents may sustain demand in therapeutic niches.
• Market Expansion: Entry into underserved regions with limited access to newer antidepressants could stabilize revenues.

Risk Factors

• Regulatory Risks: Changes in safety standards could restrict usage.
• Market Substitution: The shift toward SSRIs and SNRIs continues to threaten market share.
• Competitive Landscape: Introduction of novel agents with better safety profiles could further diminish trimipramine’s relevance.

R&D Investment and Patent Landscape

As an off-patent drug, trimipramine lacks exclusive market rights, limiting incentives for innovation which impacts future revenue potential. However, pharmaceutical companies might explore reformulation or combination approaches to create differentiation.

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Strategic Considerations for Stakeholders

1. Reaffirm Niche Position: Focus on patient populations with specific needs, such as those requiring sedative antidepressants.
2. Develop Novel Formulations: Invest in research for improved delivery systems and extended-release options.
3. Market Expansion: Leverage emerging markets with less access to newer antidepressants to sustain minimal revenues.
4. Regulatory Engagement: Collaborate with authorities for indication expansions or safety profile enhancements.
5. Lifecycle Management: Consider licensing or partnership opportunities to maximize returns in select markets.

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Key Takeaways

• Market Decline but Niche Persistence: Despite a shrinking market due to evolving treatment guidelines, trimipramine maleate maintains clinical relevance for specific patient segments.
• Limited Growth Potential: The global outlook suggests a modest decline driven by competitive dynamics and safety concerns.
• Opportunity in Specialized Use Cases: Developing formulations or exploring unique therapeutic niches can prolong its market trajectory.
• Regional Variability Matters: Emerging markets offer growth potential amid limited competition and unmet needs.
• Investment in Innovation is Crucial: To sustain relevance, stakeholders should consider reformulation and strategic partnerships.

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FAQs

1. Why has the prescription of trimipramine maleate declined globally?
The decline stems from safety concerns associated with TCAs, particularly cardiotoxicity, and the preference for newer antidepressants like SSRIs and SNRIs, which offer improved safety and tolerability profiles.

2. Are there any recent regulatory approvals or indications for trimipramine?
No recent major approvals have expanded its indications. Most markets consider it an off-label or legacy medication, with regulatory focus on safety monitoring.

3. Can trimipramine maleate find new therapeutic uses?
Research exploring its sedative and anxiolytic properties suggests potential for niche applications, but widespread new indications are limited without significant clinical trials.

4. What is the outlook for innovative formulations of trimipramine?
Sustained-release and combination formulations could extend its therapeutic utility, but such developments require investment and regulatory approval, which are currently limited.

5. How do regional differences influence the market for trimipramine maleate?
Emerging markets with limited access to newer therapies may sustain or slightly grow demand, whereas developed regions show declining prescriptions due to availability of safer alternatives.

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References

[1] IQVIA, "Global Outlook on the Antidepressant Market," 2022.