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:	75
Clinical Trials:	2
Patent Applications:	3,340
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
Endo Pharms	MOBAN	molindone hydrochloride	CONCENTRATE;ORAL	017938-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Chartwell Rx	MOBAN	molindone hydrochloride	TABLET;ORAL	017111-004	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	017111-006	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	090453-003	Mar 20, 2015		RX	No	Yes

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
Chartwell Rx	MOBAN	molindone hydrochloride	TABLET;ORAL	017111-005	Approved Prior to Jan 1, 1982
Chartwell Rx	MOBAN	molindone hydrochloride	TABLET;ORAL	017111-004	Approved Prior to Jan 1, 1982

MOLINDONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Molindone Hydrochloride

Introduction

Molindone hydrochloride, marketed under the brand name Moban, is a first-generation antipsychotic medication primarily used to treat schizophrenia and other psychiatric disorders. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global molindone hydrochloride market has experienced significant growth in recent years. As of 2023, the market size was valued at approximately USD 0.9 billion and is projected to reach USD 1.5 billion by 2032[5].

Market Segmentation

The molindone hydrochloride market is segmented based on several key factors:

• Type: The market is categorized into products with purity levels above 98% and above 99%[2].
• Application: The primary applications include pharmaceutical, chemical, and other industries[2].
• Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[2].

Market Drivers

Several factors are driving the growth of the molindone hydrochloride market:

• Increasing Demand for Antipsychotic Medications: The rising prevalence of psychiatric disorders, such as schizophrenia and bipolar disorder, is driving the demand for effective antipsychotic medications like molindone hydrochloride[3].
• Reintroduction and Generic Availability: After being discontinued by Endo Pharmaceuticals in 2010, molindone hydrochloride was reintroduced by Core Pharma in 2015 as a generic version, making it more accessible and affordable[3].
• Favorable Clinical Profile: Molindone hydrochloride is known for its intermediate potency, which results in fewer extrapyramidal symptoms (EPS) and less sedation compared to other antipsychotics, making it a preferred choice for some clinicians[3].

Market Restraints

Despite the growth, there are several restraints affecting the market:

• Side Effects and Safety Concerns: Molindone hydrochloride is associated with side effects such as sedation, EPS, and rare but serious conditions like leukopenia and leukocytosis. These safety concerns can limit its adoption[3].
• Limited Clinical Data: There is limited data on the use of molindone hydrochloride in pregnant and breastfeeding women, which can restrict its prescription in these populations[3].

Competitive Landscape

The molindone hydrochloride market is characterized by the presence of several key players:

• VEGSCI
• Chemos
• Ningbo Inno Pharmchem
• Finetech Industry
• Shenzhen Topbatt Chemical

These companies are profiled based on their product offerings and market-related factors, providing a comprehensive overview of the competitive landscape[2].

Financial Outlook

The financial trajectory of the molindone hydrochloride market is promising:

• Revenue Projections: The market is expected to exhibit robust growth rates from 2023 to 2031, with the global market size anticipated to reach USD 1.5 billion by 2032[5].
• Cost-Effectiveness: Molindone hydrochloride, being a generic medication, is relatively inexpensive, which contributes to its financial attractiveness in the market[3].

Market Opportunities and Challenges

Opportunities

• Expanding Applications: The potential for off-label uses in conditions like bipolar disorder, behavioral disturbances, and impulse control disorders presents opportunities for market expansion[3].
• Emerging Markets: Growing healthcare infrastructure and increasing awareness of psychiatric disorders in emerging markets offer new avenues for growth[2].

Challenges

• Regulatory Scrutiny: The need for continuous monitoring and adherence to regulatory standards can pose challenges for manufacturers[4].
• Competition from Newer Antipsychotics: The introduction of second-generation antipsychotics with potentially better safety profiles could challenge the market share of molindone hydrochloride[4].

Pharmacological and Clinical Aspects

Molindone hydrochloride has a distinct pharmacological profile:

• Mechanism of Action: It acts as a dopamine D2 antagonist, which is crucial for its antipsychotic effects[3].
• Pharmacokinetics: It is metabolized primarily through CYP2D6, with a half-life of approximately 1.5 hours[3].
• Clinical Efficacy: It is effective in managing schizophrenia without significant muscle-relaxing or anticholinergic effects[1].

Key Takeaways

• The molindone hydrochloride market is experiencing significant growth driven by increasing demand and the reintroduction of the drug as a generic version.
• The market is segmented by type, application, and geography, with key players contributing to its competitive landscape.
• Despite side effects and safety concerns, molindone hydrochloride remains a cost-effective and clinically favorable option for treating psychiatric disorders.
• The financial outlook is positive, with projected revenue growth and expanding applications in emerging markets.

FAQs

Q: What is the primary use of molindone hydrochloride? A: Molindone hydrochloride is primarily used to treat schizophrenia and other psychiatric disorders.

Q: Why was molindone hydrochloride reintroduced into the market? A: It was reintroduced by Core Pharma in 2015 as a generic version after being discontinued by Endo Pharmaceuticals in 2010 due to poor sales.

Q: What are the common side effects of molindone hydrochloride? A: Common side effects include sedation, extrapyramidal symptoms (EPS), and agitation, with rare but serious conditions like leukopenia and leukocytosis.

Q: How does molindone hydrochloride compare to other antipsychotics? A: It has an intermediate potency, resulting in fewer EPS and less sedation compared to high-potency agents and fewer anticholinergic side effects compared to low-potency agents.

Q: What is the projected market size of molindone hydrochloride by 2032? A: The global market size is projected to reach approximately USD 1.5 billion by 2032.

Cited Sources:

1. FDA Label for Moban - Accessdata.fda.gov
2. Global Molindone Hydrochloride Market Report - Market Research Intellect
3. Molindone (Moban) Fact Sheet - The Carlat Report
4. AHRQ Comparative Effectiveness Review Surveillance Program - Effective Healthcare
5. Molindone Hydrochloride Market Research Report - Dataintelo