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Last Updated: December 22, 2024

MOBAN Drug Patent Profile


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Which patents cover Moban, and what generic alternatives are available?

Moban is a drug marketed by Chartwell Rx and Endo Pharms and is included in two NDAs.

The generic ingredient in MOBAN is molindone hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the molindone hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Moban

A generic version of MOBAN was approved as molindone hydrochloride by EPIC PHARMA LLC on March 20th, 2015.

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Summary for MOBAN
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 75
Patent Applications: 1,824
DailyMed Link:MOBAN at DailyMed
Drug patent expirations by year for MOBAN

US Patents and Regulatory Information for MOBAN

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 CAPSULE;ORAL 017111-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx MOBAN molindone hydrochloride TABLET;ORAL 017111-006 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Endo Pharms MOBAN molindone hydrochloride CONCENTRATE;ORAL 017938-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx MOBAN molindone hydrochloride TABLET;ORAL 017111-007 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx MOBAN molindone hydrochloride CAPSULE;ORAL 017111-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx MOBAN molindone hydrochloride CAPSULE;ORAL 017111-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx MOBAN molindone hydrochloride TABLET;ORAL 017111-005 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for MOBAN

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

MOBAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MOBAN (Molindone Hydrochloride)

Introduction to MOBAN

MOBAN, also known as molindone hydrochloride, is an antipsychotic medication used primarily for the management of schizophrenia. It is a dihydroindolone compound, distinct from other antipsychotic classes such as phenothiazines, butyrophenones, and thioxanthenes[4].

Historical Context and Market Reintroduction

MOBAN was initially marketed under the brand name Moban by Endo Pharmaceuticals. However, due to poor sales, Endo Pharmaceuticals announced the discontinuation of its production in 2010. This decision left a gap in the market for this specific type of antipsychotic. In December 2015, Core Pharma relaunched a generic version of molindone, bringing it back into the pharmaceutical market[1].

FDA Indications and Off-Label Uses

MOBAN is FDA-approved for the treatment of schizophrenia. It has also been used off-label for various other conditions, including bipolar disorder, behavioral disturbances, and impulse control disorders. This versatility can contribute to its market demand and financial stability[1][4].

Dosage and Administration

The dosage of MOBAN is typically started at 50-75 mg/day, divided into two to four doses, and can be increased to a maximum of 225 mg/day based on the patient's response. This flexible dosing regimen allows clinicians to tailor the treatment to individual patient needs, which can influence patient compliance and overall market acceptance[1][4].

Side Effects and Safety Profile

MOBAN is known for its intermediate potency, which results in fewer extrapyramidal symptoms (EPS) compared to high-potency antipsychotics and less sedation, orthostasis, and anticholinergic side effects compared to low-potency agents. Common side effects include sedation, EPS, and agitation, while rare but serious side effects can include leukopenia and leukocytosis. This balanced safety profile can make it a preferred option for some clinicians and patients[1][4].

Market Position and Competition

MOBAN operates in a competitive antipsychotic market, which includes both first-generation and second-generation antipsychotics. Its unique pharmacological profile, particularly its ability to reduce weight in some patients, sets it apart from other antipsychotics. This differentiation can help it maintain a niche market share despite the presence of more modern antipsychotic medications[1].

Financial Considerations

Cost and Affordability

MOBAN is a generic medication, which makes it relatively inexpensive compared to brand-name antipsychotics. This affordability is a significant factor in its market appeal, especially in healthcare systems where cost is a critical consideration. The cost-effectiveness of MOBAN can contribute to its financial stability and market presence[1].

Revenue Potential

The antipsychotic market is substantial, driven by the high prevalence of psychiatric disorders. While MOBAN may not be a blockbuster drug, its consistent demand and low production costs can generate steady revenue for the manufacturers. The fact that it is generic and inexpensive also means it can be widely prescribed, contributing to its revenue potential[1][3].

Investment and R&D Landscape

The pharmaceutical industry, including the segment for antipsychotics, is characterized by high development costs and long development timelines. However, the potential rewards for successful drugs are significant. MOBAN, being a well-established medication, does not require extensive R&D investments, which can make it an attractive option for companies looking to maintain a stable product portfolio without the high costs associated with new drug development[3].

Regulatory and Clinical Aspects

MOBAN has undergone extensive clinical studies to establish its efficacy in treating schizophrenia. It is not approved for the treatment of dementia-related psychosis, which is an important regulatory consideration. The lack of routine monitoring requirements unless clinically warranted adds to its practicality and cost-effectiveness in clinical settings[1][4].

Patient and Clinician Preferences

Clinicians often prefer MOBAN for select patients due to its well-tolerated profile and effectiveness. Patient compliance is also higher due to its fewer side effects compared to other antipsychotics. This preference can drive market demand and influence the financial trajectory of the drug[1].

Future Outlook

Given the ongoing need for effective antipsychotic treatments and the unique benefits of MOBAN, it is likely to maintain a stable market presence. The generic status and low cost ensure it remains accessible to a wide range of patients, which can sustain its revenue stream. As the pharmaceutical market continues to grow, driven by increasing global health needs, MOBAN is positioned to remain a viable option within the antipsychotic market segment[1][3].

Key Takeaways

  • Market Reintroduction: MOBAN was reintroduced into the market in 2015 after a brief discontinuation.
  • FDA Indications: Approved for schizophrenia with off-label uses for other psychiatric conditions.
  • Dosage and Administration: Flexible dosing regimen with a maximum dose of 225 mg/day.
  • Side Effects: Intermediate potency with fewer EPS and anticholinergic side effects.
  • Market Position: Niche market share due to its unique pharmacological profile.
  • Financial Considerations: Cost-effective and affordable, contributing to its revenue potential.
  • Regulatory and Clinical Aspects: Established efficacy with no routine monitoring required.
  • Patient and Clinician Preferences: Well-tolerated and effective, leading to higher patient compliance.

FAQs

Q: What is MOBAN used for?

MOBAN is primarily used for the management of schizophrenia. It is also used off-label for conditions such as bipolar disorder, behavioral disturbances, and impulse control disorders.

Q: Why was MOBAN discontinued and then reintroduced?

MOBAN was discontinued by Endo Pharmaceuticals in 2010 due to poor sales. It was reintroduced in 2015 by Core Pharma as a generic medication.

Q: What are the common side effects of MOBAN?

Common side effects include sedation, extrapyramidal symptoms (EPS), and agitation. Rare but serious side effects can include leukopenia and leukocytosis.

Q: How does MOBAN differ from other antipsychotics?

MOBAN has an intermediate potency, resulting in fewer EPS and anticholinergic side effects compared to other antipsychotics. It also has the unique benefit of reducing weight in some patients.

Q: Is MOBAN expensive?

No, MOBAN is a generic medication and is relatively inexpensive compared to brand-name antipsychotics.

Sources

  1. MOLINDONE (Moban) Fact Sheet [G] - The Carlat Report.
  2. Annual Report - Moberg Pharma - Moberg Pharma.
  3. Investment Trends in Pharmaceutical Research - DrugBank Blog.
  4. Moban (Molindone Hydrochloride Tablets) - RxList.
  5. Medincell Publishes Its Consolidated Half-year Financial Results - Business Wire.

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