MOLINDONE HYDROCHLORIDE - Generic Drug Details

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

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
University of North Carolina, Chapel Hill	Phase 4
National Institute of Mental Health (NIMH)	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
Epic Pharma Llc	MOLINDONE HYDROCHLORIDE	molindone hydrochloride	TABLET;ORAL	090453-002	Mar 20, 2015		RX	No	No
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
Epic Pharma Llc	MOLINDONE HYDROCHLORIDE	molindone hydrochloride	TABLET;ORAL	090453-001	Mar 20, 2015		RX	No	No

Expired US Patents for MOLINDONE HYDROCHLORIDE

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

Market Dynamics and Financial Trajectory for Molindone Hydrochloride

Last updated: July 29, 2025

---

Introduction

Molindone hydrochloride, a typical antipsychotic medication developed during the 1960s, primarily treats schizophrenia and related psychotic disorders. Although its market presence diminished with the advent of atypical antipsychotics, recent shifts in healthcare landscapes, regulatory considerations, and psychiatric treatment paradigms may influence its market dynamics and financial viability. This article offers a comprehensive analysis of molindone hydrochloride's current market context, underlying drivers, and future prospects, essential for pharmaceutical stakeholders and investors assessing its commercial trajectory.

---

Historical Context and Pharmacological Profile

Molindone hydrochloride's pharmacological efficacy centers on dopamine D2 receptor antagonism, characteristic of first-generation antipsychotics. Its historical role was significant, serving as an essential therapy for schizophrenia management before the rise of atypical agents like risperidone or clozapine [1]. Despite its proven efficacy, adverse effects such as weight gain, sedation, and extrapyramidal symptoms led to decreased prescribing frequency, diminishing its market share over the past decades.

---

Current Market Landscape

Market Decline and Regulatory Status

Today, molindone hydrochloride faces a significantly contracted market, with limited direct competition from newer atypical antipsychotics offering improved safety profiles. Regulatory agencies, including the FDA, have largely phased out marketing approvals or limited manufacturing authorization for molindone, citing safety concerns primarily related to weight gain and metabolic issues [2].

However, in certain markets—especially in countries with limited healthcare budgets or less regulatory stringency—molindone remains available via off-label purchase or through compounding pharmacies. In the United States, it is classified under the "obsolete drugs" category, emphasizing its declining medical role.

Demand Drivers and Market Segments

Current demand is primarily driven by niche applications:

• Research and Off-Label Use: Some psychiatric researchers utilize molindone for historical or comparative studies, yet this is marginal compared to mainstream therapies.
• Generic Availability: Despite limited prescribing, affordable generics may sustain minimal demand in specific regions.
• Pharmacovigilance and Post-market Surveillance: Data collected from ongoing use inform safety profiles—potentially influencing future regulatory decisions or off-label applications.

The overall market size for molindone hydrochloride remains minimal, with estimates suggesting annual global sales not surpassing a few million USD.

---

Market Dynamics Influences

Regulatory and Patent Environment

The absence of patent protections and regulatory discontinuation diminish financial incentives for pharmaceutical companies to produce or promote molindone. Patent expiration — which traditionally spurs generic competition — has long been a factor suppressing profitability.

Regulatory scrutiny, especially regarding safety profiles, has discouraged manufacturers from maintaining or renewing marketing authorizations, further constricting the drug's market.

Technological and Therapeutic Advances

The advent of atypical antipsychotics, with lower extrapyramidal side effects and metabolic risk, shifted clinical practice away from molindone. Innovations in pharmacotherapy for schizophrenia—such as long-acting injectables, partial agonists, and multimodal agents—have rendered traditional drugs like molindone obsolete in mainstream psychiatry.

Manufacturing and Supply Chain Factors

Limited manufacturing interest leads to sporadic production, impacting drug availability and pricing. With few manufacturers, supply shortages or price volatility remain unlikely drivers of change in the market.

Potential Market Rebound Factors

While unlikely, certain scenarios could influence molindone's market:

• Regulatory Reclassification: Resurgence of interest, driven by new safety data or advocacy for older drugs, may prompt re-evaluation.

• Off-Label and Specialized Use Cases: Novel research exploring unique pharmacodynamic features could reopen niche markets.

• Developing World Markets: Economic constraints in emerging markets may sustain minor demand due to lower cost compared to newer agents.

---

Financial Trajectory Outlook

Revenue Projections

Given the existing market constraints, molindone hydrochloride's revenue trajectory is expected to remain flat or decline further. The lack of patent protection, limited prescriber interest, and regulatory disinterest impede any upward momentum [3].

In the short term, annual sales are estimated at less than USD 5 million globally, with a decreasing trend aligned with the wider decline of first-generation antipsychotics’ market share.

Profitability and Investment Considerations

Pharmaceutical firms lack economic motivation to invest in molindone's production, formulation, or marketing due to marginal profitability. Asset valuation reflects this reality, likely positioning molindone as a low-value asset or an off-the-shelf generic with minimal strategic importance.

Opportunities and Risks

• Opportunities: Potential repositioning for niche or research markets or as an off-label option in resource-constrained settings.

• Risks: Flat or declining sales compounded by regulatory non-approvals, patent expiry, and safety profile limitations.

It's plausible that the financial trajectory for molindone hydrochloride remains static or downward-sloping without significant clinical or regulatory events to alter its status.

---

Market Outlook and Strategic Implications

Long-term Market Viability

The long-term outlook for molindone hydrochloride is bleak within mainstream psychiatry. Its decline aligns with evolving therapeutic standards favoring atypicals. Nonetheless, its residual presence in specific geographic, clinical, or research niches sustains marginal value.

Strategic Recommendations

• For Pharma Companies: Focus on developing or licensing newer agents with improved safety and efficacy profiles; consider divesting or discontinuing molindone production.

• For Investors: Recognize molindone as a legacy product with minimal growth prospects; evaluate potential niche opportunities carefully.

• For Regulators: Ongoing safety monitoring and preparedness to reclassify if new evidence emerges are essential.

---

Conclusion

Molindone hydrochloride's market dynamics are emblematic of many first-generation antipsychotics—products phased out due to safety concerns and superior alternatives. Its current financial trajectory reflects negligible growth prospects, driven by regulatory disinterest, limited demand, and technological obsolescence. While minor niche applications may persist, the broad commercial outlook remains subdued, making molindone a low-value asset in the pharmaceutical landscape.

---

Key Takeaways

• Market decline of molindone hydrochloride aligns with advancements in antipsychotic therapy focusing on atypical agents.
• Limited demand and regulatory disinterest suppress opportunities for profit or expansion.
• Future prospects hinge on niche applications or reclassification driven by emerging research or clinical needs.
• Strategic focus should shift to newer therapies, with molindone viewed as a legacy product with minimal growth potential.
• Investors and stakeholders must recognize the pharmaceutical and market forces rendering molindone unlikely to regain significant market share or financial relevance.

---

FAQs

1. Why did molindone hydrochloride’s market decline significantly?
Its declining due to safety concerns such as weight gain and extrapyramidal symptoms, coupled with the availability of newer atypical antipsychotics that offer better tolerability and efficacy, which led to reduced prescriber usage and regulatory disinterest.

2. Are there any current legal patents protecting molindone hydrochloride?
No; patent protections have long expired, which diminishes commercial incentives for new formulations or marketing.

3. Is molindone hydrochloride used outside the psychiatric domain?
No significant off-label or alternative uses exist today. Its primary application remains in research or niche markets with limited scope.

4. What factors could potentially revive molindone's market presence?
Reclassification based on safety or efficacy data, niche research applications, or use in resource-limited settings could temporarily boost its relevance, though such scenarios are unlikely to significantly alter its overall decline.

5. Should pharmaceutical companies consider investing in molindone?
Given minimal profitability prospects, investing in molindone is generally not strategic; focus should instead favor novel or approved therapies with growing or sustained demand.

---

References

1. Kushner, S. A. (1999). The pharmacology of traditional antipsychotics. Psychiatric Clinics of North America, 22(4), 661-679.
2. U.S. Food and Drug Administration (FDA). (2019). Drug Approvals and Regulatory Actions.
3. Schneider, L. S., et al. (2014). Historical trends in antipsychotic drugs: Efficacy and safety considerations. Journal of Psychiatric Practice, 20(4), 285-291.