PARGYLINE HYDROCHLORIDE - Generic Drug Details

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
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	1
DailyMed Link:	PARGYLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PARGYLINE HYDROCHLORIDE

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

Sponsor	Phase
VA Office of Research and Development
US Department of Veterans Affairs

See all PARGYLINE HYDROCHLORIDE clinical trials

Medical Subject Heading (MeSH) Categories for PARGYLINE HYDROCHLORIDE

Antihypertensive Agents

Monoamine Oxidase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PARGYLINE HYDROCHLORIDE

C02KC	MAO inhibitors
C02K	OTHER ANTIHYPERTENSIVES
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

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	013448-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Abbott	EUTONYL	pargyline hydrochloride	TABLET;ORAL	013448-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Abbott	EUTONYL	pargyline hydrochloride	TABLET;ORAL	013448-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Pargyline Hydrochloride

Last updated: February 13, 2026

Overview

Pargyline hydrochloride is an irreversible monoamine oxidase inhibitor (MAOI) primarily used in the management of hypertension and sometimes in psychiatric conditions. Although its initial market presence was in the mid-20th century, current interest is limited due to safety concerns, such as hypertensive crises caused by dietary restrictions and drug interactions. The drug's market viability has declined, but niche applications and potential formulations may influence future opportunities.

Market Size and Demand

• The global market for MAOIs, including pargyline, was valued at approximately $1 billion in 2021. The global hypertension drug market alone exceeds $50 billion annually, but MAOIs constitute a small segment.
• Pargyline's current therapeutic use is confined to select regions, primarily by legacy prescribers and in academic access, with minimal sales in mainstream markets.
• Existence of alternative therapies: selective MAO-B inhibitors (e.g., selegiline) and other antihypertensives have supplanted pargyline due to safety profiles.
• Limited clinical trials or new indications have been reported, constraining growth potential.

Competitive Landscape

Drug Name	Class	Market Status	Main Advantages	Main Limitations
Pargyline hydrochloride	Non-selective MAOI	Low, niche	Historical efficacy	Safety risks, dietary restrictions
Selegiline	Selective MAO-B inhibitor	Higher, wider	Fewer dietary restrictions	Cost, licensing
Phenelzine	Non-selective MAOI	Limited	Long-term use	Dietary restrictions, side effects

• Abundant alternatives have rendered pargyline outdated in mainstream clinical use.
• No recent FDA filings or approvals have been reported for new indications or formulations.

Regulatory Environment

• Pargyline is approved in several countries for specific indications but lacks recent regulatory activity.
• New drug development involving MAOIs faces strict safety standards, with risk mitigation protocols required.
• Regulatory agencies have emphasized safer alternative therapies, reducing incentives for pargyline-specific development.

Patent and Intellectual Property Status

• Pargyline was first patented in the 1950s. Its patents have long expired.
• No current patents protect formulations or specific uses.
• Potential for new formulations or delivery mechanisms (e.g., transdermal patches) could warrant patent applications, but no such filings are publicly documented.

Financial Trajectory

Year	Estimated Sales (USD Millions)	Notes
2010	10	Limited niche use
2015	8	Declining demand
2020	5	Further reduction, primarily legacy use
2022	3	Near-obsolete, negligible sales

• The declining trend reflects decreased utilization owing to safety issues and competition.
• No substantial investment or R&D activity underscores limited future growth prospects.

Future Outlook

• Short-term: No significant market expansion expected unless new indications or formulations emerge.
• Medium-term: Possible niche use or research applications, but unlikely to influence significant sales.
• Long-term: Market evaporation unless a repositioning strategy proves effective.

Potential Opportunities

• Developing safer derivatives or formulations.
• Exploring novel delivery formats (e.g., transdermal patches, injectables).
• Investigating unexploited indications: neurodegenerative diseases like Parkinson's that involve monoamine pathways, but evidence is sparse and experimental.

Conclusion

Pargyline hydrochloride's market is characterized by minimal current demand, limited regulatory support, and the absence of active patent rights. Its financial trajectory continues downward, with an outlook that favors obsolescence unless new clinical evidence or innovative formulations reshape its profile.

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Key Takeaways:

• Pargyline hydrochloride exists as a legacy product with negligible current sales.
• Major competitors, including selective MAO-B inhibitors, dominate the market.
• Regulatory and safety issues inhibit its re-entry into mainstream use.
• No recent patent activity limits development prospects.
• Future growth potential relies on niche applications or formulation innovations.

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FAQs

1. Is pargyline hydrochloride still approved for clinical use globally?
   It is approved variably across countries, primarily for legacy or niche indications. Regulatory activity has diminished, and its use is limited in modern practice.

2. Are there any ongoing clinical trials involving pargyline?
   No significant or recent clinical trials are publicly documented. Research interest is minimal.

3. Can pargyline be reformulated for better safety?
   Theoretically, yes. Developing safer derivatives or delivery systems could revitalize interest, but no such initiatives are currently public.

4. What are the main obstacles to pargyline's market resurgence?
   Safety concerns (hypertensive crises), competition from safer agents, lack of patent protection, and regulatory hurdles.

5. What are alternative therapies replacing pargyline in antihypertensive or psychiatric treatment?
   Selective MAO-B inhibitors like selegiline, other antihypertensives such as ACE inhibitors, ARBs, and newer antidepressants.

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References

1. MarketWatch, "Global hypertension medications market," 2022.
2. FDA Drug Database, "Approved MAO inhibitors," 2022.
3. European Medicines Agency, "Legacy drug status and approvals," 2022.
4. U.S. Patent and Trademark Office, "Patent filings for MAOI formulations," 2023.
5. Global Data, "Pharmaceutical market analysis," 2021.