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Last Updated: December 22, 2024

FLUOXETINE Drug Patent Profile


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When do Fluoxetine patents expire, and when can generic versions of Fluoxetine launch?

Fluoxetine is a drug marketed by Sun Pharm Industries, Watson Labs, Barr, Dr Reddys Labs Ltd, 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, 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, and Twi Pharms. and is included in sixty-nine NDAs.

The generic ingredient in FLUOXETINE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluoxetine

A generic version of FLUOXETINE was approved as fluoxetine hydrochloride by APNAR PHARMA LP on August 2nd, 2001.

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Drug patent expirations by year for FLUOXETINE
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Recent Clinical Trials for FLUOXETINE

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SponsorPhase
Idorsia Pharmaceuticals Ltd.Phase 2
Berry ConsultantsPhase 2
U.S. Army Medical Research and Development CommandPhase 2

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US Patents and Regulatory Information for FLUOXETINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 076001-002 Jan 29, 2002 AB1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Sub Teva Pharms FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 075865-003 Aug 30, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Sub Teva Pharms FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075245-003 Sep 28, 2004 AB 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

FLUOXETINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluoxetine

Market Size and Growth

The fluoxetine market is experiencing steady and significant growth, driven by several key factors. As of 2023, the market size was valued at approximately USD 1,011.63 million, and it is projected to reach USD 1,367.46 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.8% during the forecast period of 2023-2031[1][3].

Drivers of Market Growth

Rising Prevalence of Mental Health Disorders

The increasing prevalence of mental health disorders such as depression, anxiety, obsessive-compulsive disorder (OCD), and bulimia nervosa is a major driver of the fluoxetine market. For instance, in the United States, 19.86% of adults experienced a mental illness in 2022, and approximately 19.1% of U.S. adults are experiencing anxiety disorders[1].

Enhanced Awareness and De-stigmatization

Public awareness campaigns and the increasing discussion of mental health issues on social media platforms have contributed to the de-stigmatization of mental health, leading to more people seeking treatment. This increased awareness has boosted the demand for fluoxetine[3].

Government Initiatives and Funding

Government initiatives and funding for mental health programs have also played a crucial role in the market's growth. These initiatives have led to more facilities, an increase in mental health professionals, and greater awareness, particularly in regions like Asia Pacific[1][3].

Healthcare Expenditure

The rise in healthcare expenditure is another significant factor. Increased healthcare spending enhances the availability and affordability of medications like fluoxetine, leading to better access and adherence for patients[3].

Market Segmentation

Form of the Drug

The fluoxetine market is segmented into various forms, including capsules, tablets, and solutions. In 2022, the capsule segment accounted for the highest market share of 52.50% and is expected to grow at the fastest CAGR due to its convenience and ease of use[1].

Application

Fluoxetine is used to treat a variety of mental health conditions. The depression segment accounted for the highest market share in 2022, while the anxiety disorders segment is expected to grow at the fastest CAGR due to rising awareness of treatment benefits for panic attacks[1].

End Users

The market is categorized into clinics, hospitals, and others. Clinics, being outpatient facilities for non-emergency care, accounted for the highest market share in 2022 and are expected to grow at the fastest CAGR. Mental health clinics offer services such as therapy, medication management, and support groups, which contribute to the demand for fluoxetine[1].

Geographical Analysis

Regional Growth

North America currently dominates the fluoxetine market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure. However, the Asia Pacific region is expected to grow at the fastest CAGR of 4.2% during the forecast period, driven by factors such as increasing economic inequality, age-related mental health disorders, and government initiatives like mental health laws in China[1][4].

Competitive Landscape

The fluoxetine market is highly competitive with several large players and numerous small and medium-sized enterprises. These companies have strong research and development capabilities and a strong presence in the market through their extensive product portfolios and distribution networks. The market is characterized by intense competition, with companies focusing on expanding their product offerings and increasing their market share through mergers, acquisitions, and partnerships[1].

Financial Considerations

Cost of Fluoxetine

The cost of fluoxetine can vary based on several factors, including the treatment plan, insurance coverage, and the pharmacy used. Fluoxetine is available in various forms such as oral tablets, solutions, and capsules, and the cost can differ depending on these factors. Generally, generic fluoxetine tends to be more cost-effective compared to the brand-name version, Prozac[5].

Savings Tips

To reduce the cost of fluoxetine, patients can explore options such as using coupons, getting a 90-day supply if approved by their insurance, and comparing prices across different pharmacies. Generic versions of the drug are also considered safe and effective, offering a more affordable alternative[5].

Research and Development

Advances in diagnostic methods, the rise of telemedicine, and the use of AI and machine learning in drug discovery and development are trends that will positively impact the fluoxetine market. New product launches and strategic collaborations among companies are also expected to provide beneficial opportunities for market growth[3].

Key Statistics

  • Market Size (2023): USD 1,011.63 million[1]
  • Projected Market Size (2031): USD 1,367.46 million[1]
  • CAGR (2023-2031): 3.8%[1]
  • Highest Market Share Segment (2022): Capsule form (52.50%)[1]
  • Fastest Growing Segment: Anxiety disorders[1]
  • Fastest Growing Region: Asia Pacific (CAGR of 4.2%)[1]

Expert Insights

"Fluoxetine has been a cornerstone in the treatment of various mental health disorders. The rising prevalence of these conditions, coupled with increased awareness and government initiatives, is driving the market forward," says Pawan Chasta, author of the Consegic Business Intelligence report[1].

Key Takeaways

  • The fluoxetine market is growing steadily due to the increasing prevalence of mental health disorders.
  • The capsule form of fluoxetine holds the highest market share and is expected to grow at the fastest CAGR.
  • Clinics are the primary end-users and are expected to grow at the fastest CAGR.
  • Asia Pacific is the fastest-growing region due to government initiatives and increasing awareness.
  • The market is highly competitive, with companies focusing on research and development and strategic collaborations.

FAQs

Q: What is the projected market size of fluoxetine by 2031? A: The fluoxetine market is projected to reach USD 1,367.46 million by 2031[1].

Q: Which segment holds the highest market share in the fluoxetine market? A: The capsule segment holds the highest market share and is expected to grow at the fastest CAGR[1].

Q: What are the key drivers of the fluoxetine market growth? A: The key drivers include the rising prevalence of mental health disorders, enhanced awareness and de-stigmatization, government initiatives, and increased healthcare expenditure[1][3].

Q: Which region is expected to grow at the fastest CAGR in the fluoxetine market? A: The Asia Pacific region is expected to grow at the fastest CAGR of 4.2% during the forecast period[1].

Q: How can patients reduce the cost of fluoxetine? A: Patients can reduce the cost by using coupons, getting a 90-day supply if approved by their insurance, and comparing prices across different pharmacies[5].

Cited Sources:

  1. Consegic Business Intelligence - Fluoxetine Market Size, Share & Report Overview 2023-2031
  2. JAMA Network - Benefits From Antidepressants: Synthesis of 6-Week Patient-Level Data
  3. The Business Research Company - Fluoxetine Global Market Report 2024
  4. Data Bridge Market Research - Global Fluoxetine Market - Industry Trends and Forecast to 2029
  5. Medical News Today - Fluoxetine cost 2024: Savings tips and more

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