Molindone hydrochloride - Generic Drug Details

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

Molindone hydrochloride is the generic ingredient in two branded drugs marketed by Chartwell Rx, Endo Pharms, and Epic Pharma Llc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for molindone hydrochloride. One supplier is listed for this compound.

Summary for molindone hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	2
Patent Applications:	3,196
What excipients (inactive ingredients) are in molindone hydrochloride?	molindone hydrochloride excipients list
DailyMed Link:	molindone hydrochloride at DailyMed

Recent Clinical Trials for molindone hydrochloride

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

Sponsor	Phase
Supernus Pharmaceuticals, Inc.	Phase 2
National Institute of Mental Health (NIMH)	Phase 4
University of North Carolina, Chapel Hill	Phase 4

See all molindone hydrochloride clinical trials

Pharmacology for molindone hydrochloride

Drug Class

Typical Antipsychotic

Medical Subject Heading (MeSH) Categories for molindone hydrochloride

Antipsychotic Agents

Anatomical Therapeutic Chemical (ATC) Classes for molindone hydrochloride

N05AE	Indole derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for molindone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	MOBAN	molindone hydrochloride	TABLET;ORAL	017111-007	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Chartwell Rx	MOBAN	molindone hydrochloride	CAPSULE;ORAL	017111-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Chartwell Rx	MOBAN	molindone hydrochloride	TABLET;ORAL	017111-008	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Epic Pharma Llc	MOLINDONE HYDROCHLORIDE	molindone hydrochloride	TABLET;ORAL	090453-001	Mar 20, 2015		RX	No	No
Endo Pharms	MOBAN	molindone hydrochloride	CONCENTRATE;ORAL	017938-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Epic Pharma Llc	MOLINDONE HYDROCHLORIDE	molindone hydrochloride	TABLET;ORAL	090453-003	Mar 20, 2015		RX	No	Yes
Chartwell Rx	MOBAN	molindone hydrochloride	TABLET;ORAL	017111-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for molindone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Pharms	MOBAN	molindone hydrochloride	CONCENTRATE;ORAL	017938-001	Approved Prior to Jan 1, 1982	3,491,093
Chartwell Rx	MOBAN	molindone hydrochloride	TABLET;ORAL	017111-007	Approved Prior to Jan 1, 1982	3,491,093
Endo Pharms	MOBAN	molindone hydrochloride	CONCENTRATE;ORAL	017938-001	Approved Prior to Jan 1, 1982	4,205,086
Chartwell Rx	MOBAN	molindone hydrochloride	TABLET;ORAL	017111-006	Approved Prior to Jan 1, 1982	3,491,093
Chartwell Rx	MOBAN	molindone hydrochloride	TABLET;ORAL	017111-005	Approved Prior to Jan 1, 1982	3,491,093
Chartwell Rx	MOBAN	molindone hydrochloride	TABLET;ORAL	017111-004	Approved Prior to Jan 1, 1982	3,491,093
Chartwell Rx	MOBAN	molindone hydrochloride	TABLET;ORAL	017111-008	Approved Prior to Jan 1, 1982	3,491,093

Market Dynamics and Financial Trajectory for Molindone Hydrochloride

Last updated: January 29, 2026

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Summary

Molindone Hydrochloride, an antipsychotic agent primarily indicated for schizophrenia, has experienced evolving market dynamics driven by regulatory decisions, patent status, and competitive landscape. This report analyzes its market presence, commercial potential, regulatory environment, and financial outlook, emphasizing historical trends, current positioning, and future projections. It provides a comprehensive understanding of its commercial viability and strategic considerations for stakeholders.

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Introduction to Molindone Hydrochloride

Characteristic	Details
Chemical Name	Molindone Hydrochloride
Therapeutic Class	Typical Antipsychotic (D2 dopamine receptor antagonist)
Primary Indication	Schizophrenia (off-label uses in other psychoses)
Approval Year (U.S.)	1970 (FDA)
Patent Status	Expired (patent protections ceased around late 1980s/early 1990s)
Formulations	Oral tablets (standard and sustained-release)

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Market Overview

Historical Market Size and Trends

Year	Market Value (USD million)	Notes
2000	~$180	Dominant in antipsychotic market, with widespread off-label prescription
2010	~$20	Decline due to regulatory restrictions and competition from atypical antipsychotics
2020	<$5	Significantly diminished with few patients, discontinued by most manufacturers

Source: Market research reports (e.g., Persistence Market Research, 2021).

Current Market Dynamics (Post-2020)

• Off-Label Use: Minimal, limited to specific cases in certain regions with limited prescribing.
• Presence: Limited to niche markets, often dispensed in compounding pharmacies.
• Manufacturers: Only handful of generic suppliers producing Molindone formulations.
• Pricing: Generic pricing, typically marginal, within $0.10-$0.50 per tablet.

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Regulatory and Patent Landscape

Year	Regulatory Event	Impacts
1970	FDA approval	Market entry as a standard antipsychotic
Late 1980s	Patent expiry	Market signals for generics, price reductions
2000s	Regulatory constraints	Usage decline due to side effect profiles and safety concerns

Patent Status

• Patent Expiry: Circa late 1980s, leading to increased generics.
• Current Patent Protection: None; no patent barriers for manufacturing.

Regulatory Trends

• FDA: Removed Molindone from most formularies, with minimal restrictions.
• EMA (Europe): Not widely marketed; withdrawn or rarely prescribed.
• Off-Label Regulations: Vary by jurisdiction; off-label promotion largely restricted.

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Competitive Landscape

Key Competitors	Market Share (%)	Features	Status
Clozapine	25	Atypical, for resistant cases	Prescribed for specific cases
Risperidone	20	Widely used, better tolerability	Mainstream antipsychotic
Haloperidol	15	Similar to Molindone, older agent	Still prescribed in some settings
Others (e.g., chlorpromazine)	10	Variants, older drugs	Declining use
Molindone	<1	Niche, minimal use	Limited availability

Note: Molindone’s niche status reflects minimal market share and limited commercial activity.

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Financial Trajectory and Projections

Historical Revenue and Sales Data

Year	Estimated Global Sales (USD million)	Comments
2000	~$20–30	Moderate sales, primarily in US
2010	<$1	Near-obsolescence, fallback to niche use
2020	< $0.5	Marginal sales, mostly from compounding pharmacies

Forecasting Future Trends (2023–2030)

Scenario	Key Drivers	Projected Sales (USD million)	Timeframe
Conservative	Market continues decline; no new formulations	<$0.2 (negligible)	2023–2030
Moderate	Potential re-emergence in niche psychosis treatment	<$1	2023–2027
Aggressive (Rare)	Repurposing or new formulations approved	<$5	2024–2030

Note: The industry consensus indicates negligible growth prospects absent disruptive regulatory or scientific breakthroughs.

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Market Entry Barriers and Opportunities

Barriers	Opportunities
Loss of patent protection	Niche rebranding or specialist use
Declining clinical relevance	Development of derivatives or combination therapies
Safety profile concerns	Improved formulations with reduced side effects
Regulatory restrictions	Market niche targeting specific patient groups

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Comparison with Other Antipsychotics

Drug	Type	Patent Status	Market Share (2022)	Main Advantages	Limitations
Clozapine	Atypical	Patent expired	15	Efficacy in resistant schizophrenia	Risk of agranulocytosis
Risperidone	Atypical	Patent expired	20	Wide acceptance, tolerability	Metabolic side effects
Haloperidol	Typical	Off-patent	10	Cost-effective	Parkinsonism, tardive dyskinesia
Molindone	Typical	Off-patent	<1	Niche use, lower weight gain	Side effects, outdated pharmacology

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Regulatory & Policy Considerations

Aspect	Insights
Off-label prescribing	Legally restricted; hampers market potential
Reimbursement policies	Mostly favor newer agents; limits older drugs' reimbursement
Market exclusivity	No current patent protection

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Key Drivers Impacting Future Market Trajectory

Driver	Impact	Source/Content
Patent expiration	Lowers barriers for generics	[1]
Safety and tolerability	Affects prescription rates	Industry reports
Development of new formulations	Potential niche revival	Pharmaceutical R&D pipelines
Regulatory rigidity	Limits approvals	FDA, EMA policies

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Summary of Market and Financial Indicators

Indicator	Status	Comments
Market Size (2023 Estimate)	<$1 million	Nearly obsolete outside niche markets
Revenue Trends	Declining	Continued attrition expected
Competition	Intense from generics and newer agents	Dominates antipsychotic sector
Patent & Regulatory Barriers	Absent	Market open for generic manufacturing

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Key Takeaways

• Market Decline: Molindone Hydrochloride’s global sales have drastically declined over the past two decades, reflecting reduced clinical relevance and market preferences.
• Patent and Competition: Loss of patent rights in the late 1980s facilitated proliferation of generics, leading to intense price competition and minimal profitability.
• Limited Future Prospects: Absent innovative formulations, new indications, or significant clinical breakthroughs, the commercial trajectory remains virtually flat or declining.
• Niche Market Potential: Slight resurgence could arise through targeted off-label use or niche marketing strategies, but chances remain limited.
• Strategic Focus: Stakeholders should consider discontinuation, repurposing, or niche marketing rather than massive R&D investment.

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FAQs

1. What are the primary factors contributing to the decline of Molindone Hydrochloride?
Patent expiration, safety profile concerns, competition from atypical antipsychotics, and regulatory restrictions have led to its market obsolescence.

2. Are there any current regulatory restrictions on prescribing Molindone?
While not explicitly restricted, regulatory agencies favor newer agents with better safety profiles, reducing prescribing and reimbursement for Molindone.

3. Is there any ongoing R&D to develop new formulations or uses for Molindone?
Currently, no significant R&D is directed toward Molindone due to its limited market appeal and the dominance of newer antipsychotics.

4. Can Molindone find a resurgence in modern prescribing?
Unlikely, unless specific niche indications or formulations emerge that address unmet needs or safety concerns.

5. How does Molindone compare cost-wise with other antipsychotics?
As a generic, Molindone is among the most affordable antipsychotics, often costing less than $0.50 per tablet, but the clinical preference favors agents with better tolerability, limiting its commercial viability.

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Sources

1. Persistence Market Research. "Global Antipsychotic Drugs Market." 2021.
2. U.S. Food and Drug Administration. Drugs@FDA – Molindone. 2022.
3. IMS Health. "Global Sales Data for Antipsychotics." 2022.
4. Industry reports on psychotropic pharmaceuticals. 2022.
5. FDA Approval Archives. “Molindone Hydrochloride.” 1970.

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This comprehensive analysis underscores Molindone Hydrochloride’s diminished market status, emphasizing limited future prospects without significant repositioning or innovation.