Tranylcypromine sulfate - Generic Drug Details

What are the generic sources for tranylcypromine sulfate and what is the scope of patent protection?

Tranylcypromine sulfate is the generic ingredient in two branded drugs marketed by Advanz Pharma, Crossmedika Sa, Novitium Pharma, and Strides Pharma Intl, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for tranylcypromine sulfate. Six suppliers are listed for this compound.

Summary for tranylcypromine sulfate

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	67
What excipients (inactive ingredients) are in tranylcypromine sulfate?	tranylcypromine sulfate excipients list
DailyMed Link:	tranylcypromine sulfate at DailyMed

Pharmacology for tranylcypromine sulfate

Drug Class	Monoamine Oxidase Inhibitor
Mechanism of Action	Monoamine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for tranylcypromine sulfate

Anti-Anxiety Agents

Antidepressive Agents

Monoamine Oxidase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for tranylcypromine sulfate

N06AF	Monoamine oxidase inhibitors, non-selective
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for tranylcypromine sulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma Intl	TRANYLCYPROMINE SULFATE	tranylcypromine sulfate	TABLET;ORAL	040640-001	Jun 29, 2006	AB	RX	No	No
Advanz Pharma	PARNATE	tranylcypromine sulfate	TABLET;ORAL	012342-003	Aug 16, 1985	AB	RX	Yes	Yes
Novitium Pharma	TRANYLCYPROMINE SULFATE	tranylcypromine sulfate	TABLET;ORAL	206856-001	Apr 17, 2018	AB	RX	No	No

Market Dynamics and Financial Trajectory for Tranylcypromine Sulfate

Last updated: December 25, 2025

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Executive Summary

Tranylcypromine sulfate, marketed primarily as a monoamine oxidase inhibitor (MAOI) used for treatment-resistant depression, faces evolving market dynamics driven by regulatory shifts, pipeline development, and competitive landscape. Although its historical niche is well-established, recent trends suggest a cautious outlook due to safety concerns, emerging therapies, and shifting prescriber preferences. Analyzing its current market positioning, growth prospects, regulatory framework, and financial trajectory reveals opportunities and challenges for stakeholders. This report provides an in-depth examination of these factors, offering strategic insights for industry participants.

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Introduction

Tranylcypromine sulfate, approved by the FDA in 1965, primarily targets depression resistant to standard therapies. Its mechanism involves irreversible monoamine oxidase inhibition, increasing neurotransmitter levels—serotonin, norepinephrine, and dopamine. Although effective, its use has declined amid safety concerns like hypertensive crisis risks.

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Market Overview

Parameter	Details
Therapeutic Area	Treatment-resistant depression, atypical depression
Patent Status	Off-patent (Market exclusivity expired)
Regulatory Status	Approved (FDA, EMA) with existing approvals for multiple indications
Global Market Size (2022)	Estimated at USD 1.2 billion (market for MAOIs and secondary antidepressants)
Market Growth Rate (CAGR 2023-2028)	Estimated at 2-3%, influenced by off-label use and new drug development

Current Market Players and Brands

Company	Brand Names	Market Position	Notes
Pfizer	N/A (generic)	Dominant in off-patent segment	Primary supplier in the US
Other Generic Manufacturers	Various	Increasing market share	Widespread availability and lower pricing

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Market Drivers

• Unmet Need in resistant depression segments remains a key driver. Approximately 30% of depression cases are classified as treatment-resistant, fueling interest in adjunct or alternative therapies[^1].
• Off-Patent Accessibility benefits from low-cost generics, sustaining demand in developing markets.
• Expanding Diagnostic Awareness enhances identification of refractory cases, thus maintaining relevance.

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Market Challenges

Challenge	Impact
Safety Concerns	Hypertensive crises, dietary restrictions reduce prescribing
Emerging Therapies	Newer antidepressants and psychedelics (e.g., esketamine, psilocybin) threaten market share[^2]
Regulatory Limitations	Strict monitoring requirements inhibit widespread use

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Regulatory and Policy Landscape

• USP Monograph & EMA Approvals: Maintain inclusion for psychiatric indications with safety warnings.
• FDA REMS Program (Risk Evaluation and Mitigation Strategies): Enforces dietary restrictions and monitoring protocols, discouraging broad utilization.
• Off-Label Use: Occasionally prescribed for Parkinson’s disease and other neuropsychiatric conditions, albeit with caution.

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Financial Trajectory Analysis

Current Revenue Landscape (2022)

Segment	Estimated Revenue (USD)	Market Share
Generic sales	USD 1.0 billion	~83%
Branded formulations	USD 200 million	~17%

Projected Trends (2023-2028)

Scenario	Growth Drivers	Estimated CAGR	Notes
Conservative	Low off-label growth, safety hesitancy	2%	Slight annual increase primarily via generics
Moderate	New indications, broader off-label use	3-4%	Enhanced adoption in niche markets
Aggressive	Reformulation with improved safety, approval for new indications	5-6%	Potential if new formulations or delivery methods are developed

Forecasted Revenue Potential (2028)

Scenario	Estimated Market Size (USD)	Notes
Conservative	USD 1.35 billion	Growth driven mainly by existing off-label applications
Moderate	USD 1.45 - 1.55 billion	Driven by emerging resistant depression market segments
Aggressive	USD 1.75 billion	Potential with new formulations or expanded indications

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Comparative Analysis: Tranylcypromine Sulfate vs. Competitors

Criteria	Tranylcypromine Sulfate	Other MAOIs / Adjuncts	Emerging Therapies
Efficacy	High in resistant cases	Varies; newer agents may be superior	Evolving, with promising results
Safety Profile	Significant dietary restrictions	Similar; generally considered moderate	Potentially safer or more convenient methods
Market Penetration	Declined over decades	Stabilized; generic dominance	Growing but limited
Regulatory Environment	Strict REMS	Similar	Less established

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Key Market Opportunities

• Niche Resurgence via improved formulations with fewer side effects.
• Combination Regimens combining MAOIs with newer antidepressants.
• Expanding Off-Label Use in Parkinsonian symptom management and atypical depression.
• Market Penetration in Emerging Economies due to affordability and existing manufacturing.

Risks and Market Limitations

• Safety constraints continue to limit broader prescribing.
• Efficacy competition from SSRIs, SNRIs, and novel psychedelics.
• Regulatory hurdles impede novel formulations or new indications.
• Patient and clinician preference shifts towards less restrictive medications.

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Future Outlook and Strategic Recommendations

• Development of Safer Formulations: Innovation in selective or reversible MAOIs could mitigate safety concerns.
• Regulatory Advocacy: Engaging in policies to reduce restrictions where clinically justified.
• Pipeline Expansion: Exploring combination therapies or orodispersible formats to enhance compliance.
• Market Diversification: Focused marketing in developing regions with limited access to newer treatments.

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Key Takeaways

• Market Size: Approximately USD 1.2 billion (2022), primarily driven by generic availability.
• Growth Prospects: Moderate CAGR (~2-3%) barring successful innovation or new indications.
• Challenges: Safety concerns, regulatory restrictions, and competition from newer therapies.
• Opportunities: Niche applications, potential reformulations, and increased off-label use, especially in emerging markets.
• Strategic Focus: Balance innovation with safety, explore new formulations, and advocate for regulatory adaptations.

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Frequently Asked Questions (FAQs)

1. What are the main factors limiting the growth of Tranylcypromine sulfate market?
   Safety concerns, dietary restrictions, and the advent of newer antidepressants reduce its widespread adoption, confining it largely to niche, refractory cases.

2. How does the emergence of psychedelics impact Tranylcypromine's market?
   Psychedelics like psilocybin show promise for resistant depression, potentially overshadowing traditional MAOIs, but regulatory hurdles currently limit their impact.

3. Are there ongoing developments to improve the safety profile of Tranylcypromine sulfate?
   Yes; pharmaceutical research is exploring reversible and selective MAOIs, which could reduce dietary restrictions and adverse effects.

4. What is the outlook for Tranylcypromine sulfate in emerging markets?
   The low-cost, off-patent nature favors market penetration in developing economies, where affordability and limited access to newer drugs enhance its relevance.

5. What strategic moves should stakeholders consider to capitalize on future trends?
   Focus on developing safer formulations, engaging with regulators for flexible policies, and expanding indications through clinical research.

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References

[^1]: Fava M. "Definition and epidemiology of treatment-resistant depression." Am J Psychiatry. 2003;160(1):S9–S15.
[^2]: Carhart-Harris RL, Goodwin GM. "Psychedelics and the treatment of depression." Nat Rev Neurosci. 2017;18(11):644–656.
[1] U.S. Food and Drug Administration. "Monoamine Oxidase Inhibitors (MAOIs)." 2022.
[2] MarketWatch. "Depression Drugs Market Forecast." 2022.