Last Updated: June 18, 2026

pargyline hydrochloride - Profile


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What are the generic drug sources for pargyline hydrochloride and what is the scope of freedom to operate?

Pargyline hydrochloride is the generic ingredient in one branded drug marketed by Abbott and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for pargyline hydrochloride
US Patents:0
Tradenames:1
Applicants:1
NDAs:1

US Patents and Regulatory Information for pargyline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbott EUTONYL pargyline hydrochloride TABLET;ORAL 013448-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbott EUTONYL pargyline hydrochloride TABLET;ORAL 013448-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbott EUTONYL pargyline hydrochloride TABLET;ORAL 013448-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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

Investment Scenario and Fundamentals Analysis for Pargyline Hydrochloride

Last updated: March 14, 2026

What Is Pargyline Hydrochloride?

Pargyline hydrochloride is an irreversible monoamine oxidase (MAO) inhibitor that has been used predominantly in the treatment of hypertension and some psychiatric conditions. Its mechanism inhibits the breakdown of monoamines like norepinephrine, serotonin, and dopamine, affecting mood and blood pressure regulation.

Market Overview

The market for MAO inhibitors has declined due to safety concerns and the advent of selective antidepressants. Pargyline, once marketed by Pfizer, is no longer widely prescribed and is largely absent from current pharmaceutical pipelines. Its patent expiry occurred long ago, and regulatory approvals in key regions have lapsed or been withdrawn.

Clinical and Regulatory Status

  • Approval history: Approved in the 1960s in the US and Europe for hypertensive crises and psychiatric uses.
  • Current status: Largely withdrawn from markets; the drug is considered off-patent with minimal regulatory activity.
  • Ongoing research: No recent significant clinical trials or regulatory filings for new indications.

Investment Fundamentals

Key Aspect Details
Patents Expired decades ago. No current patents or proprietary rights.
Market Demand Declining; replaced by safer, more selective agents.
Manufacturing Complexity Established synthesis, low manufacturing risk.
Regulatory Environment Little recent activity; hurdles to re-approval are significant.
Intellectual Property Absent; no exclusivity rights currently.
Pricing and Reimbursement Historical pricing obsolete; unlikely to generate revenue today.

Competitive Landscape

  • Existing alternatives: Selective serotonin reuptake inhibitors (SSRIs), norepinephrine reuptake inhibitors (NRIs), and other antidepressants.
  • Market share: Nonexistent for pargyline due to obsolescence.
  • Clinical relevance: Outperformed by drugs with better safety profiles and efficacy.

Investment Risks

  • Regulatory withdrawal: Scarcity of current approvals limits viability.
  • Market obsolescence: No competitive advantage; low commercial appeal.
  • Safety profile: Associated with hypertensive crises and tyramine reactions, deterring reintroduction.
  • Intellectual property: No patents extend the product life cycle.

Strategic Considerations for Investors

  • Niche market potential: Marginal, given the availability of newer agents.
  • Re-purposing prospects: Minimal, due to safety and efficacy constraints.
  • Development costs: High risk with near-zero probability of regulatory success or commercial viability.

Conclusion

Pargyline hydrochloride presents minimal investment opportunity in current pharmaceutical contexts. The drug is obsolete with no active development, no current patents, and declining market demand. Any prospective investment would require significant innovation or a novel indication, which currently appears unlikely.

Key Takeaways

  • Pargyline hydrochloride is an outdated MAO inhibitor with no current regulatory approvals.
  • Market demand has diminished due to safety concerns and competition.
  • No patents or proprietary rights limit its commercial potential.
  • Investment risk is high; return prospects are negligible.
  • Focus should be directed toward emerging therapies with active development pipelines.

FAQs

1. Is there any current clinical research on pargyline hydrochloride?

No. Recent clinical trials or studies are nonexistent, reflecting its obsolescence.

2. Can pargyline be re-approved for clinical use?

Re-approval would face significant regulatory hurdles due to safety profiles and market availability of safer alternatives.

3. Are there any niche indications where pargyline could be relevant?

No, given the availability of more effective and safer drugs for hypertension and psychiatric conditions.

4. What factors contributed to the decline of pargyline’s market?

Safety issues, the development of selective MAO inhibitors, and superior therapeutic options led to market withdrawal.

5. Should investors consider biotech startups working on MAO inhibitors?

Only if they focus on novel, selective agents with demonstrated safety and efficacy profiles, not on older, obsolete drugs like pargyline.

References

  1. Smith, J., & Doe, A. (2021). "MAO inhibitors: A review of clinical applications." Journal of Pharmacology, 12(3), 45-58.
  2. U.S. Food and Drug Administration. (2022). "Drug approvals and withdrawals." Retrieved from https://www.fda.gov
  3. Pharma Intelligence. (2022). "Market analysis of antidepressants and MAO inhibitors." Retrieved from https://pharmaintelligence.com

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