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Last Updated: December 31, 2025

PARNATE Drug Patent Profile


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Which patents cover Parnate, and what generic alternatives are available?

Parnate is a drug marketed by Advanz Pharma and is included in one NDA.

The generic ingredient in PARNATE is tranylcypromine sulfate. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tranylcypromine sulfate profile page.

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Summary for PARNATE
Drug patent expirations by year for PARNATE
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Recent Clinical Trials for PARNATE

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SponsorPhase
Sheppard Pratt Health SystemN/A
Central Michigan UniversityN/A
National Institute of Mental Health (NIMH)Phase 4

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Pharmacology for PARNATE

US Patents and Regulatory Information for PARNATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Advanz Pharma PARNATE tranylcypromine sulfate TABLET;ORAL 012342-003 Aug 16, 1985 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PARNATE

Last updated: July 29, 2025


Introduction

PARNATE (tranylcypromine sulfate) is a monoamine oxidase inhibitor (MAOI) developed by Parke-Davis, now a part of Pfizer. It is primarily prescribed for major depressive disorder (MDD), treatment-resistant depression, and certain anxiety disorders. Despite its long-standing presence in psychiatric treatment, PARNATE occupies a niche in a landscape dominated by newer antidepressants, influencing its market dynamics and financial trajectory.

This analysis explores the current market environment, competitive landscape, regulatory considerations, and revenue prospects for PARNATE. It concludes with strategic insights relevant to stakeholders navigating its evolving commercial potential.


Market Overview and Demand Drivers

Historical Context and Clinical Utility

Introduced in the 1950s, PARNATE remains one of the earliest antidepressants. Its efficacy for treatment-resistant depression is well-documented, especially for patients unresponsive to selective serotonin reuptake inhibitors (SSRIs) and other modern therapies. Its mechanism of action—irreversible inhibition of monoamine oxidase A and B—facilitates increased levels of neurotransmitters like serotonin, norepinephrine, and dopamine, providing a potent treatment option where others fail [1].

Demographic and Epidemiological Factors

The global prevalence of depression underscores the therapeutic demand. According to WHO, over 280 million people suffer from depression worldwide, with treatment-resistant cases comprising approximately 15-30% of this population [2]. The aging global population further amplifies demand due to increased depression comorbidity.

Prescriber and Patient Trends

Despite its clinical efficacy, PARNATE’s use is limited by safety concerns and dietary restrictions. Nonetheless, its role persists in specialized psychiatric settings, particularly where patients have failed other treatments. The patient population suitable for PARNATE thus remains relatively stable but niche.


Market Dynamics Influencing PARNATE

Competitive Landscape

The psychiatric drug market is highly competitive, dominated by SSRIs, SNRIs, atypical antipsychotics, and novel modalities such as ketamine and psychedelics. Newer agents often offer favorable tolerability profiles and minimal dietary restrictions, reducing PARNATE’s appeal outside specialized settings.

Key competitors include:

  • SSRIs (e.g., sertraline, escitalopram)
  • SNRIs (e.g., venlafaxine, duloxetine)
  • Atypical antidepressants (e.g., bupropion, mirtazapine)
  • Novel agents (e.g., esketamine, digital therapeutics)

PARNATE’s market positioning remains primarily within treatment-resistant subgroups, where alternative options are limited.

Regulatory Environment

PARNATE is approved by the FDA, with a longstanding status. However, regulatory challenges include safety warnings related to hypertensive crises, dietary restrictions, and drug interactions. These factors influence prescriber willingness and reimbursement policies, affecting volume and revenue potential.

Pricing and Reimbursement

As a generic drug, PARNATE’s pricing is relatively low. Limited formularies and reimbursement constraints further constrain revenue streams. However, cost savings in long-term treatment-resistant cases and its niche positioning sustain some demand.

Supply Chain and Manufacturing Considerations

Manufacturing shifts, such as shortages of active pharmaceutical ingredients (APIs) or regulatory manufacturing hurdles, can impact availability, influencing market dynamics.


Financial Trajectory and Revenue Outlook

Historical Revenue Performance

PARNATE’s historical revenues have declined from peaks in the late 20th century due to decreased prescribing and market saturation of newer agents. Exact figures are not publicly detailed but are estimated to be modest relative to blockbuster antidepressants.

Current Revenue Estimates

In the current landscape, PARNATE's revenue is primarily derived from specialized psychiatric providers and niche markets. The total global market for MAOIs is estimated to be several hundred million dollars, with PARNATE accounting for a fraction due to its limited use.

Forecasting Future Growth

Factors potentially influencing future revenues include:

  • Increased recognition of treatment-resistant depression: Growing awareness may broaden PARNATE’s off-label or specialized prescribing.
  • Developments in precision psychiatry: As personalized treatments advance, PARNATE may serve specific genetic or biomarker-defined subgroups.
  • Regulatory initiatives: Potential for expanded indications or combination therapies could improve sales.

Conversely, barriers such as safety concerns, stiff competition, and declining physician preference for older agents challenge growth prospects.

Projected trajectory: PARNATE’s revenues are expected to remain stable but modest over the next 5-10 years, with potential marginal increases if niche applications expand or if new formulations reduce side effects.


Strategic Considerations

  • Market Differentiation: Emphasizing PARNATE's efficacy in treatment-resistant cases and developing educational programs targeting psychiatrists.
  • Formulation Innovation: Developing newer formulations with fewer dietary restrictions or improved safety profiles could rekindle interest.
  • Regulatory Engagement: Securing expanded indications or safety approvals to boost confidence and usage.
  • Partnerships and Access: Collaborations with mental health organizations could expand awareness and access.

Conclusion

PARNATE’s market environment is defined by its clinical niche within treatment-resistant depression, constrained by safety considerations, competition, and regulatory factors. Its financial trajectory depicts a stable but limited revenue stream resilient to significant growth unless strategic innovations or market expansions occur.


Key Takeaways

  • PARNATE holds a niche position in the depression treatment landscape, primarily serving treatment-resistant cases.
  • Market dynamics are influenced by safety concerns, competition from newer agents, and regulatory scrutiny.
  • Its revenue potential remains modest but steady, with limited growth prospects unless new formulations or indications are developed.
  • Strategic initiatives focusing on education, safety profile improvements, and targeted marketing could optimize its market share.
  • Continuous monitoring of psychiatric treatment trends, regulatory changes, and healthcare policies is essential for stakeholders.

FAQs

1. What are the main challenges facing PARNATE in today’s market?
Safety concerns, dietary restrictions, competition from newer antidepressants, and limited prescriber familiarity restrict broader adoption and growth.

2. Can PARNATE be used for conditions beyond depression?
Currently approved primarily for depression, off-label uses exist in certain anxiety disorders or atypical cases, but regulatory approval is limited to depression.

3. Are there efforts to reformulate PARNATE to improve tolerability?
Research into new formulations that mitigate side effects or dietary limitations is ongoing but not widespread; such efforts could enhance its appeal.

4. How does PARNATE compare price-wise to newer antidepressants?
Being a generic, PARNATE’s cost is significantly lower than brand-name SSRIs and SNRIs, but its limited use diminishes its volume-based revenue potential.

5. What is the outlook for PARNATE’s role in psychiatric treatment?
Its role is expected to remain niche, primarily for specialists treating treatment-resistant depression, unless innovations expand its safety profile or alternative applications.


References

[1] Stahl, SM. Stahl’s Essential Psychopharmacology. 4th Edition. Cambridge University Press, 2013.
[2] World Health Organization. Depression Fact Sheet. 2021.

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