Nefazodone hydrochloride - Generic Drug Details

What are the generic drug sources for nefazodone hydrochloride and what is the scope of patent protection?

Nefazodone hydrochloride is the generic ingredient in two branded drugs marketed by Ani Pharms, Aurobindo Pharma Usa, Chartwell Rx, Dr Reddys Labs Inc, Ivax Sub Teva Pharms, Roxane, Sun Pharm Inds Ltd, Teva, Watson Labs, and Bristol Myers Squibb, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for nefazodone hydrochloride. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for nefazodone hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	1,932
What excipients (inactive ingredients) are in nefazodone hydrochloride?	nefazodone hydrochloride excipients list
DailyMed Link:	nefazodone hydrochloride at DailyMed

Recent Clinical Trials for nefazodone hydrochloride

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

Sponsor	Phase
Laboratorios Grossman, S.A.	Phase 3
Instituto Nacional de Salud Publica, Mexico	Phase 3
James J. Peters Veterans Affairs Medical Center	Phase 2

See all nefazodone hydrochloride clinical trials

Generic filers with tentative approvals for NEFAZODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		250MG	TABLET;ORAL
		200MG	TABLET;ORAL
		150MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for nefazodone hydrochloride

Drug Class

Serotonin Reuptake Inhibitor

Anatomical Therapeutic Chemical (ATC) Classes for nefazodone hydrochloride

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for nefazodone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076037-003	Sep 16, 2003		RX	No	No
Aurobindo Pharma Usa	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076129-003	Sep 16, 2003		DISCN	No	No
Sun Pharm Inds Ltd	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076409-002	Sep 16, 2003		DISCN	No	No
Sun Pharm Inds Ltd	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076409-005	Sep 16, 2003		DISCN	No	No
Sun Pharm Inds Ltd	NEFAZODONE HYDROCHLORIDE	nefazodone hydrochloride	TABLET;ORAL	076409-001	Sep 16, 2003		DISCN	No	No

Expired US Patents for nefazodone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-006	Dec 22, 1994	5,256,664*PED
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-001	Dec 22, 1994	4,338,317*PED
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-005	Dec 22, 1994	5,256,664*PED
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-003	Dec 22, 1994	5,256,664*PED
Bristol Myers Squibb	SERZONE	nefazodone hydrochloride	TABLET;ORAL	020152-005	Dec 22, 1994	4,338,317*PED

Market Dynamics and Financial Trajectory for Nefazodone Hydrochloride

Last updated: February 19, 2026

Nefazodone hydrochloride, marketed historically as Serzone, is an antidepressant originally approved by the U.S. Food and Drug Administration (FDA) in 1994. It functions as a serotonin antagonist and reuptake inhibitor (SARI). Its market presence has declined markedly due to safety concerns, notably hepatotoxicity, leading to voluntary removal from many markets by its manufacturer. Current market activity is limited, with minimal sales and little R&D investment, but historical and potential future factors influence its financial trajectory.

Historical Market and Regulatory Context

Year	Development & Approval	Market Status	Regulatory Actions
1994	FDA approval	Flourishing sales as antidepressant	Initial approval for treatment of major depressive disorder (MDD)
2000s	Increasing prescriptions	Leading alternative to SSRIs	Known for efficacy, but also reports of hepatotoxicity
2004	FDA safety warning	Rising safety concerns	Warnings on hepatotoxicity; label revisions emphasizing liver monitoring
2004	Market withdrawal	Decline in sales	Manufacturer Elan Pharmaceuticals ceased marketing in the U.S.
2007	Product discontinuation	Market withdrawal globally	Eliminated from most markets, with limited remaining supplies

Current Market Landscape

Nefazodone hydrochloride is no longer marketed in the United States, Europe, or other major markets. It retains limited, niche use where prescribed informally or off-label, and certain compounding pharmacies supply it in some regions.

Global Market Size

• Sales volume: Estimated at less than USD 10 million annually (pre-2004 peak), with current actual sales near negligible.
• Market share: Virtually zero in current therapeutic options.

Key Drivers and Barriers

Drivers:

• Historical efficacy as an antidepressant
• Alternative for patients intolerant of SSRIs or SNRIs

Barriers:

• Hepatotoxicity risk leading to regulatory restrictions
• Safety profile concerns resulting in market withdrawal
• Lack of recent clinical trials and R&D

R&D Landscape and Patent Status

Nefazodone’s patent expired decades ago, with no recent formulation patent protections. The absence of new formulations or combinations limits innovation prospects.

Financial Trajectory Analysis

Period	Sales (USD million)	Growth/Decline	Key Factors
1994-2004	USD 150-200	Growth	Rising prescriptions, market acceptance
2004-2007	Decline to near zero	Sharp decline	Safety warnings, regulatory actions
2008-present	Minimal (~USD 1-5 annually)	Stable/declining	Limited, off-label use, compounding availability

Projected sales over the next five years remain flat or decline further, with negligible market activity expected absent new approvals or formulations. Any market resurgence would require extensive safety data and regulatory approval, unlikely given current safety concerns.

Investment and R&D Outlook

Investments in nefazodone hydrochloride are dead. Companies focus on newer, safer antidepressants with fewer adverse effects. No active clinical trials or licensing agreements exist. Developers in psychiatric therapeutics have pivoted to agents with better safety profiles.

Competitive Landscape

• Major competitors: SSRIs, SNRIs, atypical antidepressants
• Market trends: Increased focus on safety, tolerability, personalized medicine
• Nefazodone’s future: Limited to historical context and potential niche off-label use

Regulatory Environment Impact

The safety concerns around nefazodone hydrochloride have resulted in:

• Removal from the market in key jurisdictions
• Strict prescribing restrictions where permitted
• Absence of regulatory pathways for approval of generics or new formulations

Conclusion

Nefazodone hydrochloride’s market is effectively dormant post-2007. Its financial trajectory remains stagnant, with negligible sales and no active R&D. Regulatory and safety barriers prevent revival. Any future market activity hinges on new safety data, innovation, or revised regulatory approvals, which are unlikely absent significant breakthroughs.

Key Takeaways

• Nefazodone hydrochloride peaked in sales in the late 1990s, then declined sharply after safety warnings in 2004.
• Presently, no commercial market exists for nefazodone, with minimal sales driven by residual, informal, or compounding pharmacy activity.
• The drug's patent expired long ago, with no active R&D or clinical development.
• Regulatory and safety concerns substantially limit future market potential.
• No near-term prospects for market resurgence or investment opportunities.

FAQs

1. Is nefazodone hydrochloride available in any form today?
Limited supplies may exist via compounding pharmacies in some regions, but it is not officially marketed or approved elsewhere.

2. Are there ongoing clinical trials involving nefazodone?
No. The last relevant clinical studies ended before 2010, with no active trials registered currently.

3. Can nefazodone be prescribed legally today?
In most markets, prescribing is restricted or prohibited due to safety concerns. Some regions may permit off-label use, but this is rare.

4. What safety issues are linked to nefazodone?
Hepatotoxicity remains the primary concern, leading to warnings and market withdrawal.

5. What are the alternative antidepressants replacing nefazodone?
SSRIs (e.g., sertraline, escitalopram), SNRIs (e.g., venlafaxine, duloxetine), and newer agents with improved safety profiles.

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References

[1] Food and Drug Administration. (2004). Serzone (nefazodone): Drug safety information. FDA.
[2] Elan Pharmaceuticals. (2007). Market withdrawal notice for nefazodone. Public statement.
[3] IMS Health. (2004). Antidepressant market sales data.
[4] U.S. Patent and Trademark Office. (2022). Patent expiry records for nefazodone.