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Last Updated: December 22, 2024

Fluphenazine hydrochloride - Generic Drug Details


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

Fluphenazine hydrochloride is the generic ingredient in three branded drugs marketed by Ani Pharms, Pharm Assoc, Schering, Apothecon, Fresenius Kabi Usa, Ajanta Pharma Ltd, Alembic, Amneal, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Glenmark Pharms Ltd, Lannett Co Inc, MSN, Novitium Pharma, Prasco, Rising, Sandoz, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Watson Labs, and Zydus Lifesciences, and is included in thirty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for fluphenazine hydrochloride. Thirty-one suppliers are listed for this compound.

Summary for fluphenazine hydrochloride
US Patents:0
Tradenames:3
Applicants:25
NDAs:35
Drug Master File Entries: 6
Finished Product Suppliers / Packagers: 31
Raw Ingredient (Bulk) Api Vendors: 145
Clinical Trials: 12
Patent Applications: 2,776
What excipients (inactive ingredients) are in fluphenazine hydrochloride?fluphenazine hydrochloride excipients list
DailyMed Link:fluphenazine hydrochloride at DailyMed
Recent Clinical Trials for fluphenazine hydrochloride

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

SponsorPhase
Janssen Scientific Affairs, LLC
Technische Universität MünchenPhase 4
Hannover Medical SchoolPhase 3

See all fluphenazine hydrochloride clinical trials

Pharmacology for fluphenazine hydrochloride
Drug ClassPhenothiazine
Anatomical Therapeutic Chemical (ATC) Classes for fluphenazine hydrochloride

US Patents and Regulatory Information for fluphenazine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 218173-001 Jul 23, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apothecon PROLIXIN fluphenazine hydrochloride TABLET;ORAL 011751-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Lifesciences FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 214552-001 May 27, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 215674-001 Apr 14, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 089586-003 Oct 16, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apothecon PROLIXIN fluphenazine hydrochloride TABLET;ORAL 011751-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 089586-001 Oct 16, 1987 DISCN 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 hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluphenazine Hydrochloride

Overview of Fluphenazine Hydrochloride

Fluphenazine hydrochloride is a trifluoro-methyl phenothiazine derivative used primarily for the management of schizophrenia and other psychotic disorders. It is known for its long-term antipsychotic therapy benefits and is available in various formulations, including tablets and injectable solutions[4].

Market Size and Growth Projections

The global fluphenazine hydrochloride market has experienced significant growth in recent years and is anticipated to continue this upward trend. As of 2023, the market size was valued at several billion USD, with projections indicating it will reach even higher values by 2031. This growth is driven by increasing demand for antipsychotic medications and the expanding prevalence of psychotic disorders[1].

Segmentation of the Market

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

By Type

  • The market is categorized into different dosage strengths, including 1mg, 2mg, and other formulations. This segmentation helps in understanding the specific demand for each dosage strength and tailoring production and marketing strategies accordingly[1].

By Application

  • The primary applications of fluphenazine hydrochloride are in clinics and hospitals. This segmentation highlights the different settings where the drug is most commonly used, allowing for targeted marketing and distribution strategies[1].

By Geography

  • The market is geographically segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. This segmentation is crucial for understanding regional demand, regulatory environments, and market penetration strategies[1].

Drivers of Market Growth

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

Increasing Prevalence of Psychotic Disorders

  • The rising incidence of schizophrenia and other psychotic disorders globally is a significant driver. As the population grows and mental health awareness increases, the demand for effective antipsychotic medications like fluphenazine hydrochloride is expected to rise[1].

Advancements in Healthcare Infrastructure

  • Improvements in healthcare infrastructure, particularly in developing regions, are enhancing access to psychiatric care and increasing the market for antipsychotic medications[1].

Regulatory Support

  • Favorable regulatory environments and approvals from health authorities such as the FDA contribute to the market's growth by ensuring the drug's safety and efficacy[4].

Restraints and Challenges

Despite the positive growth trajectory, the market faces several challenges:

Side Effects and Adverse Reactions

  • Fluphenazine hydrochloride can have significant side effects, including extrapyramidal symptoms and other adverse reactions, which can limit its adoption and affect patient compliance[4].

Competition from Alternative Treatments

  • The presence of other antipsychotic medications and emerging therapies can pose a competitive threat to fluphenazine hydrochloride. Manufacturers must continuously innovate and demonstrate the drug's efficacy to maintain market share[1].

Economic Factors

  • Economic fluctuations and changes in healthcare policies can impact the affordability and accessibility of the drug, particularly in regions with limited healthcare resources[1].

Key Players and Market Competition

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

Major Manufacturers

  • Companies such as Mysun Pharma, AA Pharma, Aristopharma, TWi Pharma, and others are prominent in the market. These companies are involved in the production, distribution, and marketing of fluphenazine hydrochloride in various formulations[1].

Competitive Landscape

  • The market is competitive, with companies competing on factors such as product quality, pricing, and market penetration. Strategic partnerships, mergers, and acquisitions are common strategies used to gain a competitive edge[1].

Financial Performance and Projections

Revenue Growth

  • The market is expected to achieve significant revenue growth from 2023 to 2031, driven by the increasing demand for antipsychotic medications and the expanding patient base[1].

Pricing Analysis

  • The pricing of fluphenazine hydrochloride varies based on the dosage strength and formulation. For instance, the cost of fluphenazine tablets can range from $2.38 for a 5mg tablet to $3.1 for a 10mg tablet. This pricing strategy is crucial for maintaining profitability while ensuring affordability for patients[4].

Market Outlook

  • The comprehensive market outlook includes an analysis of Porter's 5 Forces Framework, macroeconomic assessments, and a detailed pricing analysis. These components help in understanding the current market scenario and predicting future trends[1].

Regional Market Analysis

North America

  • North America is a significant market for fluphenazine hydrochloride due to the high prevalence of psychotic disorders and well-developed healthcare infrastructure. The region is expected to continue driving market growth[1].

Europe

  • Europe also represents a substantial market, with a strong focus on mental health care and a high demand for antipsychotic medications. Regulatory support and favorable healthcare policies contribute to the market's growth in this region[1].

Asia-Pacific

  • The Asia-Pacific region is emerging as a key market due to its large population and increasing awareness of mental health issues. Improving healthcare infrastructure and economic growth are expected to drive the demand for fluphenazine hydrochloride in this region[1].

Opportunities and Challenges

Opportunities

  • Expanding into Emerging Markets: There is a significant opportunity for growth in emerging markets where mental health care is becoming more prominent. Companies can leverage this by expanding their distribution networks and marketing efforts[1].

  • Innovative Formulations: Developing new formulations or delivery systems for fluphenazine hydrochloride can enhance patient compliance and open up new market segments[1].

Challenges

  • Regulatory Hurdles: Navigating regulatory requirements in different regions can be challenging. Companies must ensure compliance with local health authorities to maintain market presence[1].

  • Public Awareness and Stigma: Mental health stigma and lack of awareness can affect the adoption of antipsychotic medications. Public education campaigns and collaborations with mental health organizations can help address these issues[1].

Key Takeaways

  • The fluphenazine hydrochloride market is poised for significant growth driven by increasing demand for antipsychotic medications.
  • The market is segmented by type, application, and geography, with key players competing on product quality, pricing, and market penetration.
  • Regulatory support, advancements in healthcare infrastructure, and expanding into emerging markets are key opportunities.
  • Challenges include side effects, competition from alternative treatments, and economic factors.

FAQs

Q: What is fluphenazine hydrochloride used for?

A: Fluphenazine hydrochloride is used for the management of schizophrenia and other psychotic disorders, providing long-term antipsychotic therapy[4].

Q: What are the common side effects of fluphenazine hydrochloride?

A: Common side effects include extrapyramidal symptoms, such as tremors and rigidity, as well as other adverse reactions like drowsiness and dry mouth[4].

Q: Who are the key players in the fluphenazine hydrochloride market?

A: Key players include Mysun Pharma, AA Pharma, Aristopharma, TWi Pharma, and others involved in the production and distribution of the drug[1].

Q: What are the main drivers of the fluphenazine hydrochloride market growth?

A: The main drivers include the increasing prevalence of psychotic disorders, advancements in healthcare infrastructure, and favorable regulatory environments[1].

Q: How is the fluphenazine hydrochloride market segmented?

A: The market is segmented by type (dosage strength), application (clinics and hospitals), and geography (North America, Europe, Asia-Pacific, etc.)[1].

Sources

  1. Market Research Intellect: "FLuphenazine Hydrochloride Market Size, Scope And Forecast Report"
  2. FDA: "PROLIXIN® (fluphenazine hydrochloride) tablets"
  3. Ken Research: "Global Fluphenazine Hydrochloride Market: Ken Research"
  4. DrugBank: "Fluphenazine: Uses, Interactions, Mechanism of Action"

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