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Last Updated: March 26, 2026

NARDIL Drug Patent Profile


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

Nardil is a drug marketed by Parke Davis and is included in one NDA.

The generic ingredient in NARDIL is phenelzine sulfate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the phenelzine sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Nardil

A generic version of NARDIL was approved as phenelzine sulfate by NOVEL LABS INC on December 8th, 2010.

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Summary for NARDIL
Drug patent expirations by year for NARDIL
Drug Prices for NARDIL

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Recent Clinical Trials for NARDIL

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

SponsorPhase
Boehringer IngelheimPhase 1
Liverpool Cancer Therapy CentrePhase 1
The Canberra HospitalPhase 1

See all NARDIL clinical trials

Pharmacology for NARDIL

US Patents and Regulatory Information for NARDIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis NARDIL phenelzine sulfate TABLET;ORAL 011909-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 NARDIL

Last updated: February 10, 2026

NARDIL (phenelzine) is a monoamine oxidase inhibitor (MAOI) used primarily for treatment-resistant depression. Its market dynamics and financial outlook hinge on factors including clinical efficacy, competitive landscape, regulatory status, and shifting prescriber practices.


What is the current market status of NARDIL?

NARDIL is a branded drug marketed by Pfizer. It remains available in several markets, notably the U.S. and parts of Europe, through specialty pharmacies. However, its use has declined over the past decades due to safety concerns, alternative antidepressants, and evolving clinical guidelines.

  • Market share: NARDIL's share in antidepressant prescriptions is minimal. It has been largely supplanted by SSRIs, SNRIs, and atypical antidepressants.
  • Pricing: As a legacy product, NARDIL's pricing is moderate but constrained by limited demand and formulary restrictions.
  • Market size: The global antidepressant market was valued at approximately $15 billion in 2022, with MAOIs accounting for less than 1% of prescriptions.

What are the market drivers and barriers?

Drivers

  • Treatment-resistant depression: NARDIL remains one of the few options for patients unresponsive to SSRIs or SNRIs.
  • Unique efficacy profile: For certain patients, phenelzine offers benefits where other antidepressants fail.
  • Off-label uses: Some clinicians prescribe NARDIL for atypical depression and panic disorders, although these are not FDA-approved indications.

Barriers

  • Safety profile: Dietary restrictions, drug interactions, and side effects impair compliance.
  • Limited prescriber familiarity: Many clinicians avoid MAOIs due to complexity and side effects.
  • Regulatory and formulary restrictions: Insurance coverage is inconsistent, further limiting access.

How does NARDIL’s competitive landscape influence its market projection?

Key competitors

  • SSRIs: Fluoxetine, sertraline, escitalopram dominate due to safety and ease of use.
  • SNRIs and atypicals: Venlafaxine, duloxetine, mirtazapine offer alternative mechanisms with improved tolerability.
  • Emerging agents: Rapid-acting antidepressants like ketamine and esketamine focus on treatment-resistant cases, potentially reducing reliance on older drugs like NARDIL.

Competitive challenges

  • Safety concerns curb widespread adoption.
  • Newer agents with faster onset and fewer restrictions replace legacy drugs in treatment protocols.

What are the regulatory and reimbursement considerations?

  • Regulatory status: NARDIL remains approved in select jurisdictions; however, updates or relabeling are infrequent.
  • Reimbursement: Coverage varies; in the U.S., NARDIL is often classified as a specialty drug with high copayments.
  • Off-label use relies heavily on clinician discretion rather than formal approval, limiting formal market expansion.

What is the financial trajectory outlook for NARDIL?

Revenue trends

  • NARDIL's revenue declined steadily through the 2000s and stabilized at a low level.
  • In the U.S., annual sales are estimated below $5 million, primarily driven by niche prescribing.

Future projections

Scenario Assumptions Estimated impact
Status quo Prescriber familiarity remains low, no new indications Continued decline or stable very low sales
Enhanced advocacy Targeted marketing for treatment-resistant depression Potential slight increase, but unlikely significant gains
Market decline Introduction of better-tolerated alternatives (ketamine, esketamine) Accelerated decline, further restricting niche demand

Market potential

The niche demand for NARDIL may sustain small-scale use over the next 5-10 years but is unlikely to generate substantial revenue growth unless new formulations or indications emerge.


Key difference from other antidepressants

Aspect NARDIL SSRIs/SNRIs Ketamine/Esketamine
Mechanism MAOI Selective serotonin reuptake inhibitors NMDA receptor antagonists
Tolerability Lower Higher Variable (rapid onset)
Safety concerns High Low Variable

Summary of implications

  • NARDIL’s market remains niche and declining.
  • Limited growth prospects driven by safety concerns, competition, and prescriber preferences.
  • Future revenue hinges on niche use cases, off-label prescribing, and potential new formulations.

Key Takeaways

  • NARDIL stays available but is a marginal player in depression therapy.
  • Market drivers include treatment-resistant depression; barriers include safety and prescriber familiarity.
  • Competitive landscape features newer agents with improved tolerability and quicker onset.
  • Revenue prospects remain limited with potential for niche stability but no significant growth.
  • Policy, safety profiles, and evolving treatment guidelines will shape future market potential.

FAQs

1. Can NARDIL be prescribed outside of its approved indications?
Yes, clinicians may prescribe NARDIL off-label for treatment-resistant depression or atypical depression, but coverage and reimbursement are inconsistent.

2. What safety concerns limit NARDIL’s use?
Dietary restrictions to prevent hypertensive crisis, interactions with other serotonergic drugs, and side effects such as dizziness and weight gain limit usage.

3. Will NARDIL gain market share with new formulations?
Unlikely, unless new formulations significantly reduce adverse effects or ease prescribing challenges.

4. How does NARDIL compare to ketamine in treating resistant depression?
Ketamine acts rapidly and has fewer dietary restrictions, making it more suitable for acute cases. NARDIL’s efficacy in resistant depression is less immediate but well-documented.

5. Is there potential for NARDIL in emerging markets?
Potential exists due to limited alternatives, but local regulatory and safety infrastructures influence adoption.


Sources:

[1] EvaluatePharma. "World Pharmaceutical Market 2022."
[2] Pfizer. "NARDIL Prescribing Information."
[3] MarketResearch.com. "Antidepressant Market Trends 2022."
[4] FDA. “Drug Approvals and Labeling.”
[5] IQVIA. “Prescription Data Analysis, 2022.”

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