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Last Updated: December 22, 2024

Fluoxetine hydrochloride - Generic Drug Details


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What are the generic sources for fluoxetine hydrochloride and what is the scope of freedom to operate?

Fluoxetine hydrochloride is the generic ingredient in eight branded drugs marketed by Barr, Dr Reddys Labs Ltd, Lilly, Sun Pharm Industries, Watson Labs, Accord Hlthcare, Alembic Pharms Ltd, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Cr Double Crane, Granules, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Norvium Bioscience, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Eli Lilly And Co, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Upsher Smith Labs, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Endo Operations, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Rising, Slate Run Pharma, Taro, Torrent, Twi Pharms, Apil, Epic Pharma Llc, and Teva Pharms, and is included in eighty NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for fluoxetine hydrochloride. Seventy suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fluoxetine hydrochloride
US Patents:0
Tradenames:8
Applicants:55
NDAs:80
Drug Master File Entries: 20
Finished Product Suppliers / Packagers: 70
Raw Ingredient (Bulk) Api Vendors: 174
Clinical Trials: 298
Patent Applications: 6,874
What excipients (inactive ingredients) are in fluoxetine hydrochloride?fluoxetine hydrochloride excipients list
DailyMed Link:fluoxetine hydrochloride at DailyMed
Recent Clinical Trials for fluoxetine hydrochloride

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

SponsorPhase
CitelinePhase 2
PPDPhase 2
Cambridge Cognition LtdPhase 2

See all fluoxetine hydrochloride clinical trials

Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  SubscribeEQ 40MG BASECAPSULE;ORAL
⤷  Subscribe⤷  SubscribeEQ 20MG BASECAPSULE;ORAL
⤷  Subscribe⤷  SubscribeEQ 10MG BASECAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fluoxetine hydrochloride
Medical Subject Heading (MeSH) Categories for fluoxetine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for fluoxetine hydrochloride

US Patents and Regulatory Information for fluoxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 075872-002 Jan 4, 2019 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 076287-002 May 20, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa SELFEMRA fluoxetine hydrochloride TABLET;ORAL 200151-003 Feb 3, 2014 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Endo Operations FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 203836-001 Aug 19, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride SOLUTION;ORAL 216953-001 Nov 15, 2022 AA 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

Expired US Patents for fluoxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-004 Jun 15, 1999 ⤷  Subscribe ⤷  Subscribe
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987 ⤷  Subscribe ⤷  Subscribe
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987 ⤷  Subscribe ⤷  Subscribe
Lilly PROZAC fluoxetine hydrochloride SOLUTION;ORAL 020101-001 Apr 24, 1991 ⤷  Subscribe ⤷  Subscribe
Lilly PROZAC fluoxetine hydrochloride TABLET;ORAL 020974-001 Mar 9, 1999 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Fluoxetine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluoxetine Hydrochloride

Market Overview

Fluoxetine hydrochloride, commonly known by the brand name Prozac, is a selective serotonin reuptake inhibitor (SSRI) widely used for treating depression, anxiety disorders, and other mental health conditions. The global fluoxetine HCL market is valued at approximately $850 million in 2023 and is anticipated to grow to around $1.4 billion by 2033, reflecting a Compound Annual Growth Rate (CAGR) of 4.9% from 2024 to 2033[1].

Key Drivers of the Market

Rising Prevalence of Mental Health Disorders

The primary driver of the fluoxetine HCL market is the increasing prevalence of depression and anxiety disorders worldwide. Factors such as urbanization, lifestyle changes, socio-economic stressors, and growing awareness of mental health issues contribute to the rising demand for fluoxetine HCL[1].

Increasing Adoption of SSRIs

The adoption of SSRIs as first-line treatments for mental health conditions is on the rise. Fluoxetine HCL, with its established safety profile and relatively low incidence of side effects, is preferred by healthcare providers, further driving market growth[1].

Growing Emphasis on Mental Health Awareness

There is a growing emphasis on mental health awareness and treatment accessibility globally. Public health campaigns, government initiatives, and social media discussions have normalized mental health concerns, leading to increased demand for fluoxetine HCL[3].

Market Opportunities

Expanding Therapeutic Applications

An opportunity exists in expanding the therapeutic applications of fluoxetine HCL beyond depression and anxiety disorders to include emerging indications such as bulimia nervosa, premenstrual dysphoric disorder (PMDD), and panic disorder. Innovations in drug delivery technologies, such as extended-release formulations and pediatric-friendly dosage forms, can enhance treatment options and patient adherence[1].

Technological Advancements

Advancements in diagnostic techniques, telemedicine capabilities, and drug delivery systems are expected to drive market growth. The integration of digital health technologies for remote patient monitoring and treatment optimization is also a significant opportunity[3].

Strategic Partnerships

Strategic partnerships between pharmaceutical manufacturers and healthcare providers can leverage digital health solutions, telemedicine platforms, and patient education initiatives to improve treatment outcomes and reduce treatment gaps globally[1].

Regional Analysis

Dominant Regions

North America and Europe currently dominate the fluoxetine HCL market due to high prevalence rates of depression and anxiety disorders, robust healthcare infrastructures, and favorable reimbursement policies for mental health treatments[1].

Emerging Markets

The Asia Pacific region is witnessing significant market growth driven by increasing mental health awareness, rising healthcare expenditures, and expanding access to psychiatric care services in countries such as China, India, and Japan. Latin America and the Middle East & Africa are also experiencing gradual market expansion with improving healthcare access and government initiatives aimed at addressing mental health disparities[1].

Competitive Landscape

The fluoxetine HCL market is competitive, with key players such as Eli Lilly and Company, Teva Pharmaceuticals, Sandoz (Novartis AG), and Mylan N.V. dominating the landscape. These companies focus on product differentiation, portfolio expansion, and geographic expansion to maintain market share and capitalize on emerging opportunities[1].

Strategic Moves

Companies invest in research and development to introduce novel formulations, improve drug delivery systems, and enhance therapeutic efficacy. Strategic alliances, licensing agreements, and mergers and acquisitions are common strategies to strengthen market presence, optimize manufacturing capabilities, and leverage distribution networks globally[1].

Financial Trajectory

Market Size and Growth

The global fluoxetine HCL market is expected to grow from $850 million in 2023 to $1.4 billion by 2033, with a CAGR of 4.9% during the forecast period. This growth is driven by the increasing prevalence of mental health disorders, advancements in drug delivery technologies, and expanding treatment indications supported by clinical evidence[1].

Revenue Impact of Generic Competition

The introduction of generic fluoxetine has impacted the sales of branded versions like Prozac. For instance, Eli Lilly experienced a decline in Prozac sales, which affected their operating income and net earnings in the early 2000s[2].

Healthcare Expenditure

The rise in healthcare expenditure is a significant factor driving the fluoxetine market. In the US, healthcare expenditure surged by 4.1% in 2022 to $4.5 trillion, marking a faster growth rate compared to the previous year. This increase improves the accessibility and affordability of medications such as fluoxetine, benefiting patients and enhancing treatment outcomes[3].

Challenges and Limitations

High Cost and Side Effects

Despite the growth potential, the fluoxetine market faces challenges such as the high cost of the drug and side effects associated with its use, including loss of appetite, diarrhea, headache, nausea, dizziness, and seizures. These factors can hamper market growth and patient adherence[5].

Lack of Awareness and Competition

Lack of awareness about mental health and intense competition among market players further challenge the fluoxetine market. Addressing these challenges through education initiatives and strategic marketing could help mitigate these issues[5].

Future Outlook

Innovations in Drug Delivery and Technology

The fluoxetine HCL market is poised for continued growth driven by advancements in drug delivery technologies, increasing prevalence of mental health disorders, and expanding treatment indications supported by clinical evidence. Innovations in personalized medicine, pharmacogenomics, and telepsychiatry will reshape treatment paradigms, offering tailored therapeutic solutions and improving patient outcomes globally[1].

Strategic Collaborations

Strategic collaborations between pharmaceutical manufacturers, healthcare providers, and patient advocacy groups will play a pivotal role in addressing unmet medical needs, reducing treatment disparities, and enhancing overall mental health care delivery[1].

Key Takeaways

  • The global fluoxetine HCL market is expected to grow significantly, driven by the rising prevalence of mental health disorders and advancements in drug delivery technologies.
  • North America and Europe dominate the market, but the Asia Pacific region is experiencing rapid growth.
  • Key players are focusing on product differentiation, portfolio expansion, and strategic partnerships to maintain market share.
  • Despite growth potential, the market faces challenges such as high drug costs and side effects.
  • Future growth will be driven by innovations in personalized medicine and strategic collaborations.

FAQs

Q: What is the current market size of the fluoxetine HCL market?

The global fluoxetine HCL market is valued at approximately $850 million in 2023[1].

Q: What is the expected growth rate of the fluoxetine HCL market?

The market is anticipated to grow at a CAGR of 4.9% from 2024 to 2033[1].

Q: Which regions dominate the fluoxetine HCL market?

North America and Europe currently dominate the market, but the Asia Pacific region is witnessing significant growth[1].

Q: What are the key drivers of the fluoxetine HCL market?

The primary drivers include the rising prevalence of mental health disorders, increasing adoption of SSRIs, and growing emphasis on mental health awareness[1].

Q: What challenges does the fluoxetine HCL market face?

The market faces challenges such as high drug costs, side effects, lack of awareness, and intense competition among market players[5].

Sources

  1. Data Horizon Research: Fluoxetine HCL Market Size, Growth and Analysis Report - 2033
  2. Eli Lilly: Lilly Announces Fourth-Quarter Earnings per Share of $.60 ...
  3. Research and Markets: Global Fluoxetine Market Size, Competitors & Forecast
  4. Market Research Reports: Global Fluoxetine Hydrochloride (Prozac) Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030
  5. Data Bridge Market Research: Global Fluoxetine Market - Industry Trends and Forecast to 2029

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