Fluphenazine decanoate - Generic Drug Details

What are the generic sources for fluphenazine decanoate and what is the scope of patent protection?

Fluphenazine decanoate is the generic ingredient in two branded drugs marketed by Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Mylan Labs Ltd, Teva Parenteral, and Bristol Myers Squibb, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for fluphenazine decanoate. Eight suppliers are listed for this compound.

Summary for fluphenazine decanoate

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	2
Patent Applications:	3,187
Drug Prices:	Drug price trends for fluphenazine decanoate
What excipients (inactive ingredients) are in fluphenazine decanoate?	fluphenazine decanoate excipients list
DailyMed Link:	fluphenazine decanoate at DailyMed

See drug prices for fluphenazine decanoate

Recent Clinical Trials for fluphenazine decanoate

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

Sponsor	Phase
Immune Control	Phase 2
Tufts Medical Center	Phase 2
National Institute of Mental Health (NIMH)	Phase 4

See all fluphenazine decanoate clinical trials

Pharmacology for fluphenazine decanoate

Drug Class

Phenothiazine

Anatomical Therapeutic Chemical (ATC) Classes for fluphenazine decanoate

N05AB	Phenothiazines with piperazine structure
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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
Gland Pharma Ltd	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	215509-001	Mar 30, 2023	AO	RX	No	No
Hikma	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	074531-001	Aug 30, 1996	AO	RX	No	No
Endo Operations	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	203732-001	Jul 3, 2014	AO	RX	No	No
Msn	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	215365-001	Nov 2, 2023	AO	RX	No	No
Teva Parenteral	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	074795-001	Sep 10, 1996		DISCN	No	No
Fresenius Kabi Usa	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	071413-001	Jul 14, 1987	AO	RX	No	Yes
Hospira	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	074966-001	Apr 16, 1998		DISCN	No	No

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]