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Last Updated: December 22, 2024

FLUPHENAZINE DECANOATE Drug Patent Profile


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Which patents cover Fluphenazine Decanoate, and when can generic versions of Fluphenazine Decanoate launch?

Fluphenazine Decanoate is a drug marketed by Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Mylan Labs Ltd, and Teva Parenteral. and is included in nine NDAs.

The generic ingredient in FLUPHENAZINE DECANOATE is fluphenazine decanoate. There are nineteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fluphenazine decanoate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluphenazine Decanoate

A generic version of FLUPHENAZINE DECANOATE was approved as fluphenazine decanoate by FRESENIUS KABI USA on July 14th, 1987.

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Drug patent expirations by year for FLUPHENAZINE DECANOATE
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Recent Clinical Trials for FLUPHENAZINE DECANOATE

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

SponsorPhase
Immune ControlPhase 2
Tufts Medical CenterPhase 2
National Institute of Mental Health (NIMH)Phase 4

See all FLUPHENAZINE DECANOATE clinical trials

Pharmacology for FLUPHENAZINE DECANOATE
Drug ClassPhenothiazine
Anatomical Therapeutic Chemical (ATC) Classes for FLUPHENAZINE DECANOATE

US Patents and Regulatory Information for FLUPHENAZINE DECANOATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Operations FLUPHENAZINE DECANOATE fluphenazine decanoate INJECTABLE;INJECTION 203732-001 Jul 3, 2014 AO RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Msn FLUPHENAZINE DECANOATE fluphenazine decanoate INJECTABLE;INJECTION 215365-001 Nov 2, 2023 AO RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Gland Pharma Ltd FLUPHENAZINE DECANOATE fluphenazine decanoate INJECTABLE;INJECTION 215509-001 Mar 30, 2023 AO RX No 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

FLUPHENAZINE DECANOATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Fluphenazine Decanoate

Introduction to Fluphenazine Decanoate

Fluphenazine decanoate is a long-acting antipsychotic medication belonging to the phenothiazine class, primarily used for the treatment of schizophrenia. It is administered through intramuscular or subcutaneous injections and is known for its prolonged duration of action, making it a valuable option for maintenance therapy[2][3][4].

Market Size and Growth

The global Fluphenazine Decanoate market is projected to grow significantly over the forecast period from 2025 to 2031. The market size is estimated based on historical data from 2019 to 2023 and forecasted data up to 2031. The base year for these calculations is 2023, providing a comprehensive market timeline[1].

Segment Analysis

The market for Fluphenazine Decanoate can be segmented based on several factors:

Type Segment Analysis

The market is primarily segmented by type, with Fluphenazine Decanoate being the dominant form used for schizophrenia treatment. The drug's efficacy in managing chronic and acute schizophrenia symptoms makes it a key player in this segment[1].

Regional Analysis

Geographically, the market is divided into various regions, with North America and Europe expected to dominate due to advanced healthcare infrastructure and higher adoption rates of antipsychotic medications. However, emerging markets in Asia-Pacific, particularly China, are also showing significant growth due to increasing investment in pharmaceutical research and development[1][4].

Country Analysis

Country-level data customization reveals that the United States is a major market for Fluphenazine Decanoate, given its approval and widespread use since 1972. Other countries with significant market shares include those in the European Union and Japan[1][4].

Market Drivers

Several factors drive the growth of the Fluphenazine Decanoate market:

Increasing Prevalence of Schizophrenia

The rising prevalence of schizophrenia and other mental health disorders is a significant driver. As the global population grows and mental health awareness increases, the demand for effective antipsychotic medications like Fluphenazine Decanoate is expected to rise[4].

Advancements in R&D

Continuous research and development in the pharmaceutical industry, particularly in the area of D2 receptor antagonists, contribute to the market's growth. Companies like Johnson & Johnson, Mitsubishi Chemical Group Corp., Novartis AG, and Sanofi are actively involved in R&D, enhancing the drug's efficacy and safety profile[4].

Government Initiatives and Healthcare Policies

Government initiatives to improve mental health care and policies supporting the use of antipsychotic medications also drive market growth. Increased funding for mental health services and programs aimed at reducing the stigma associated with mental illnesses further boost the demand for Fluphenazine Decanoate[1].

Market Restraints

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

Side Effects and Adverse Reactions

Fluphenazine Decanoate is associated with various side effects, including extrapyramidal symptoms, increased prolactin levels, and other severe adverse reactions. These side effects can limit the drug's adoption and impact patient compliance[2][3].

Competition from Newer Antipsychotics

The market faces competition from newer, second-generation antipsychotics that may have fewer side effects and better efficacy profiles. This competition can potentially reduce the market share of Fluphenazine Decanoate[4].

Financial Trajectory

The financial trajectory of Fluphenazine Decanoate is influenced by several factors:

Revenue and CAGR

The market is expected to exhibit a steady Compound Annual Growth Rate (CAGR) over the forecast period, driven by increasing demand and advancements in R&D. The revenue is projected to grow significantly, reflecting the drug's importance in the treatment of schizophrenia and other mental health conditions[1].

Competitor Analysis

The competitive landscape includes several key players in the pharmaceutical industry. Companies like Johnson & Johnson and Novartis AG play a significant role in the market, and their financial performance is closely tied to the success of Fluphenazine Decanoate and other antipsychotic medications[4].

Pricing and Cost Analysis

The pricing of Fluphenazine Decanoate is a critical factor in its financial trajectory. The cost of the drug, along with the cost of administration and monitoring, influences its adoption rates. Competitive pricing strategies and government regulations on drug prices also impact the financial performance of the drug[1].

SWOT Analysis

Strengths

  • Long-acting formulation: Fluphenazine Decanoate's prolonged duration of action makes it a preferred choice for maintenance therapy.
  • Established market presence: Approved since 1972, the drug has a well-established market presence.
  • Rigorous clinical trials: The drug has undergone extensive clinical trials, ensuring its efficacy and safety.

Weaknesses

  • Side effects: The drug is associated with several side effects, which can impact patient compliance.
  • Competition from newer antipsychotics: The market faces competition from newer drugs with potentially better safety and efficacy profiles.

Opportunities

  • Growing mental health awareness: Increasing awareness and reduced stigma around mental health disorders can increase demand.
  • Emerging markets: Growing healthcare infrastructure in emerging markets presents new opportunities.

Threats

  • Regulatory changes: Changes in healthcare policies and regulations can impact the drug's market share.
  • Economic factors: Economic downturns can affect healthcare spending and drug adoption rates.

ESG and PESTEL Analysis

Environmental, Social, and Governance (ESG) Analysis

The ESG analysis highlights the drug's impact on the environment, society, and governance. For instance, the production process and disposal of the drug must adhere to environmental regulations. Socially, the drug's availability and accessibility are crucial. Governance aspects include compliance with regulatory standards and ethical business practices[1].

PESTEL Analysis

The PESTEL analysis examines the political, economic, social, technological, environmental, and legal factors influencing the market. Political factors include government policies on mental health care, economic factors involve healthcare spending, social factors include mental health awareness, technological advancements in R&D, environmental factors relate to drug production and disposal, and legal factors encompass regulatory compliance[1].

Key Takeaways

  • Market Growth: The Fluphenazine Decanoate market is expected to grow significantly due to increasing demand and advancements in R&D.
  • Segmentation: The market is segmented by type, region, and country, with North America and Europe being dominant regions.
  • Drivers and Restraints: The market is driven by the increasing prevalence of schizophrenia and advancements in R&D but is restrained by side effects and competition from newer antipsychotics.
  • Financial Trajectory: The financial performance is influenced by revenue growth, competitor analysis, and pricing strategies.
  • SWOT and ESG/PESTEL Analysis: The drug's strengths include its long-acting formulation and established market presence, while weaknesses include side effects and competition. Opportunities lie in growing mental health awareness and emerging markets, while threats include regulatory changes and economic factors.

FAQs

1. What is Fluphenazine Decanoate primarily used for? Fluphenazine Decanoate is primarily used to treat patients with schizophrenia, particularly for maintenance therapy due to its long-acting formulation[2][3].

2. How is Fluphenazine Decanoate administered? Fluphenazine Decanoate is administered through intramuscular or subcutaneous injections, typically every two to five weeks[2][3].

3. What are the common side effects of Fluphenazine Decanoate? Common side effects include pain at the injection site, dizziness, headache, nausea, and extrapyramidal symptoms. Severe side effects can include tardive akathisia, tremors, and skin discoloration[2][3].

4. Which regions are expected to dominate the Fluphenazine Decanoate market? North America and Europe are expected to dominate the market due to advanced healthcare infrastructure and higher adoption rates of antipsychotic medications[1].

5. How does Fluphenazine Decanoate work? Fluphenazine Decanoate works by blocking dopamine receptors in the brain, specifically the D2 receptors, which helps to regulate neurotransmitter levels and alleviate symptoms of psychosis[3][4].

Cited Sources

  1. Cognitivemarketresearch.com: Fluphenazine Decanoate Market Report 2024 (Global Edition)
  2. Mentalhealth.com: Fluphenazine Decanoate - Uses, dosage, and side effects
  3. Accessdata.fda.gov: FLUPHENAZINE DECANOATE - accessdata.fda.gov
  4. Synapse.patsnap.com: Exploring Fluphenazine Decanoate's Revolutionary R&D Successes[4]

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