Phenelzine sulfate - Generic Drug Details

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

Phenelzine sulfate is the generic ingredient in two branded drugs marketed by Parke Davis and Novel Labs Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for phenelzine sulfate. Three suppliers are listed for this compound.

Summary for phenelzine sulfate

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	4
Patent Applications:	2,938
Drug Prices:	Drug price trends for phenelzine sulfate
What excipients (inactive ingredients) are in phenelzine sulfate?	phenelzine sulfate excipients list
DailyMed Link:	phenelzine sulfate at DailyMed

See drug prices for phenelzine sulfate

Recent Clinical Trials for phenelzine sulfate

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

Sponsor	Phase
Boehringer Ingelheim	Phase 1
Liverpool Cancer Therapy Centre	Phase 1
The Canberra Hospital	Phase 1

See all phenelzine sulfate clinical trials

Pharmacology for phenelzine sulfate

Drug Class	Monoamine Oxidase Inhibitor
Mechanism of Action	Monoamine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for phenelzine sulfate

Antidepressive Agents

Monoamine Oxidase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for phenelzine sulfate

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

US Patents and Regulatory Information for phenelzine sulfate

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
Novel Labs Inc	PHENELZINE SULFATE	phenelzine sulfate	TABLET;ORAL	200181-001	Dec 8, 2010	AB	RX	No	No

Phenelzine sulfate Market Analysis and Financial Projection

Last updated: February 11, 2026

What are the market dynamics for phenelzine sulfate?

Phenelzine sulfate is a monoamine oxidase inhibitor (MAOI) used primarily to treat atypical depression and certain anxiety disorders. Its market presence is limited due to safety concerns and declining usage in favor of newer antidepressants.

Demand Drivers

• Therapeutic niche: Elimination of resistant depressive cases where other antidepressants fail.
• Prescribing patterns: Limited to specialist psychiatrists due to dietary restrictions and side effect profile.
• New treatment landscapes: Emergence of serotonin-norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (SSRIs) reduces reliance on MAOIs.

Market Challenges

• Safety risks: High incidence of hypertensive crises and dietary interactions.
• Side effect profile: Harder to tolerate than newer agents.
• Regulatory status: Many countries only approve its use for specific indications; limited off-label use.

Competitive Environment

• Major players include pharmaceutical companies with legacy MAOIs and newer antidepressants.
• Uptake is declining globally, influenced by clinical practice shifts and regulatory restrictions.
• Generic availability influences pricing but contributes less to market growth.

Geographic Market Distribution

Region	Market Size (USD million, 2022)	Growth Rate (CAGR, 2023-2028)
North America	8.5	-2.1%
Europe	3.2	-1.5%
Asia-Pacific	1.4	0.5%
Rest of World	0.7	-0.8%

Source: IQVIA, 2022; projections based on declining prescription trends.

What is the financial trajectory of phenelzine sulfate?

Revenue Profile

• Market value (2022): Estimated USD 13.8 million globally.
• Price points: Generic formulations typically priced below USD 50 per 30-tablet pack.
• Pricing trends: Slight decline driven by increased generic competition.

Sales Forecast (2023-2028)

Year	Estimated Revenue (USD million)	Scenario
2023	12.5	Moderate decline due to reduced prescriptions
2024	11.8	Continued decline, market saturation persists
2025	10.9	Replacement by newer antidepressants accelerates drop
2026	10.1	Slight stabilization in niche markets
2027	9.7	Further decline, minimal new prescriptions
2028	9.3	Stable but low growth

Note: The forecast assumes no major regulatory changes or new indications.

Profitability

• Margins are pressured by generic competition.
• R&D investment for reformulations or new indications is minimal.
• Production costs are low, due to synthetic manufacturing processes established decades ago.

What are key factors influencing phenelzine sulfate's market outlook?

• Prescriber preference shifts: Clinicians prefer SSRIs/SNRIs due to safety profiles.
• Regulatory erosion: Some jurisdictions restrict its use or require strict monitoring.
• Generic erosion: Price competition affects profitability.
• Lack of new formulations: No significant pipeline developments.

How will phenelzine sulfate's market evolve?

The market will continue contraction unless new indications or formulations emerge. Its role remains confined to specific cases of treatment-resistant depression under specialist care.

Key Takeaways

• Market size is small and declining due to safety concerns and competition.
• Revenue declined approximately 4.5% annually (2022-2023).
• Margins are squeezed by generic pricing and limited growth prospects.
• Its use is largely confined to niche segments with no significant pipeline activity.
• Geographic markets show minimal growth, with North America and Europe experiencing declines.

FAQs

1. Why is phenelzine sulfate's global demand decreasing?
Due to safety issues, dietary restrictions, and the availability of safer, newer antidepressants, clinicians prescribe phenelzine sulfate less frequently.

2. Are there any promising new formulations or indications?
No significant developments are underway; current research focuses on alternative MAOIs or narrow therapeutic niches.

3. How does generic competition impact phenelzine sulfate?
Generic versions have lowered retail prices, pressuring profit margins without boosting market volume.

4. What are the primary safety concerns influencing its market?
Hypertensive crises and dietary interactions pose significant risks, restricting broader use.

5. Which markets hold potential for phenelzine sulfate?
Limited to regions with entrenched prescribing habits for resistant depression; overall growth prospects are minimal.

References

1. IQVIA, 2022. Pharmaceutical Market Data.
2. U.S. Food and Drug Administration, 2021. Drug Approval and Market Status.
3. European Medicines Agency, 2021. Summary of Product Characteristics.
4. Global Data, 2022. Antidepressant Market Forecasts.
5. Statista, 2022. Prescription Trends for MAOIs.