PROZAC Drug Patent Profile

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

Prozac is a drug marketed by Eli Lilly And Co and Lilly and is included in four NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prozac

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

Summary for PROZAC

US Patents:	0
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	110
Patent Applications:	3,864
Drug Prices:	Drug price information for PROZAC
Drug Sales Revenues:	Drug sales revenues for PROZAC
What excipients (inactive ingredients) are in PROZAC?	PROZAC excipients list
DailyMed Link:	PROZAC at DailyMed

See drug prices for PROZAC

See drug sales revenues for PROZAC

Recent Clinical Trials for PROZAC

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

Sponsor	Phase
Stanford University	Phase 2
Avy L. & Roberta L. Miller Foundation	Phase 2
Milton S. Hershey Medical Center	Early Phase 1

See all PROZAC clinical trials

Pharmacology for PROZAC

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

US Patents and Regulatory Information for PROZAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	AB1	RX	Yes	No
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-004	Jun 15, 1999		DISCN	No	No
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-006	Dec 23, 1992	AB1	RX	Yes	No
Lilly	PROZAC	fluoxetine hydrochloride	TABLET;ORAL	020974-002	Mar 9, 1999		DISCN	Yes	No
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001		DISCN	Yes	No

Expired US Patents for PROZAC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	4,683,235
Lilly	PROZAC	fluoxetine hydrochloride	SOLUTION;ORAL	020101-001	Apr 24, 1991	4,018,895
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	4,590,213
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-006	Dec 23, 1992	4,018,895
Eli Lilly And Co	PROZAC	fluoxetine hydrochloride	CAPSULE;ORAL	018936-001	Dec 29, 1987	4,314,081*PED

International Patents for PROZAC

See the table below for patents covering PROZAC around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	113284
Ireland	912826
Mexico	4983
Netherlands	181654
Sweden	7500215

Market Dynamics and Financial Trajectory of Prozac (Fluoxetine)

Introduction

Prozac, known generically as fluoxetine, is a selective serotonin reuptake inhibitor (SSRI) widely used for treating various mental health conditions, including depression, obsessive-compulsive disorder (OCD), bulimia nervosa, and panic disorders. Here, we delve into the market dynamics and financial trajectory of this influential drug.

Historical Context of Prozac

Prozac was first introduced by Eli Lilly and Company in the late 1980s and quickly gained popularity due to its efficacy and relatively favorable side effect profile compared to older antidepressants. By the early 2000s, it had become one of the best-selling drugs in the world[2].

Market Size and Growth

The fluoxetine market is projected to grow significantly over the coming years. According to recent reports, the market size is expected to reach USD 1,367.46 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.8% from 2023 to 2031. In 2022, the market size was valued at USD 980.47 million, indicating a steady increase driven by the rising prevalence of mental health disorders[1][4].

Regional Market Dynamics

The fluoxetine market is segmented into several regions, with North America currently holding the largest market share. In 2022, North America accounted for 38.15% of the market, valued at USD 374.05 million. The U.S. dominates this region, with a significant share due to the high prevalence of mental health disorders and well-developed healthcare infrastructure[1][4].

However, the Asia-Pacific region is expected to grow at the fastest CAGR of 4.2% during the forecast period. This growth is attributed to increasing economic inequality, age-related mental health disorders, and government initiatives to improve mental health care in countries like China[1][4].

Form and Application Segments

The fluoxetine market is segmented by form into capsules, tablets, and solutions. Capsules accounted for the highest market share of 52.50% in 2022 and are expected to grow at the fastest CAGR due to their convenience and ease of use[1].

In terms of application, the depression segment holds the highest market share. The rising prevalence of depression and other mental health disorders is a major driver for the demand for fluoxetine[1].

Competitive Landscape

The fluoxetine market is highly competitive, with several large players such as Aurobindo Pharma, Alembic Pharmaceuticals Limited, Cadila Pharmaceuticals, Teva Pharmaceuticals USA, Inc., and Eli Lilly and Company. These companies invest heavily in research and development and expand their market share through mergers, acquisitions, and partnerships[1].

Impact of Generic Competition

The introduction of generic versions of fluoxetine has significantly impacted the market. After the patent for Prozac expired in 2001, generic competition led to a decline in Eli Lilly's sales. For instance, in the fourth quarter of 2001, Prozac sales declined due to generic competition in the U.S., resulting in a 5% decrease in worldwide sales for Eli Lilly[2].

Financial Performance

Historically, Prozac was a financial powerhouse for Eli Lilly. However, with the introduction of generic competition, the company saw a decline in Prozac sales. In 2001, the decline in Prozac sales led to a 25% decrease in operating income and a 24% decrease in diluted earnings per share for Eli Lilly[2].

Despite this, the company has managed to offset the decline through the growth of other products such as Zyprexa, Gemzar, Evista, and diabetes care products. The company's strategic focus on new product launches and expanding its product portfolio has helped maintain its financial stability[2].

Drivers of Market Growth

Several factors are driving the growth of the fluoxetine market:

• Rising Prevalence of Mental Health Disorders: The increasing prevalence of depression, anxiety disorders, and other mental health conditions is a significant driver. For example, in 2022, 19.86% of adults in the United States experienced a mental illness[1].
• Government Initiatives: Government support and initiatives to improve mental health care, especially in regions like Asia-Pacific, are boosting the market[1][4].
• Research and Development: Continuous research and development activities and new product launches are providing opportunities for market growth[4].

Challenges and Opportunities

Despite the growth potential, the fluoxetine market faces several challenges:

• Generic Competition: The presence of generic versions continues to impact the market share of branded products like Prozac[2].
• Regulatory Environment: Strict regulatory requirements and the need for continuous innovation to stay competitive are significant challenges[4].

However, opportunities abound in regions with growing government support and increasing awareness about mental health. Strategic collaborations and new product launches can also drive market expansion[4].

Key Takeaways

• The fluoxetine market is projected to reach USD 1,367.46 million by 2031, growing at a CAGR of 3.8%.
• North America currently dominates the market, but the Asia-Pacific region is expected to grow at the fastest CAGR.
• Capsules are the most popular form of fluoxetine due to their convenience.
• The depression segment holds the highest market share in terms of application.
• Generic competition has significantly impacted the sales of branded products like Prozac.
• Government initiatives and increasing awareness about mental health are key drivers of market growth.

FAQs

What is the projected market size of fluoxetine by 2031?

The fluoxetine market is expected to reach USD 1,367.46 million by 2031, growing at a CAGR of 3.8% from 2023 to 2031[1].

Which region dominates the fluoxetine market?

North America currently holds the largest market share, with the U.S. being the major contributor within this region[1][4].

What is the impact of generic competition on the fluoxetine market?

The introduction of generic versions has led to a decline in sales of branded products like Prozac, as seen in the significant drop in Eli Lilly's sales post-2001[2].

What are the key drivers of the fluoxetine market growth?

The rising prevalence of mental health disorders, government initiatives, and continuous research and development activities are major drivers of market growth[1][4].

Which form of fluoxetine is most popular and why?

Capsules are the most popular form of fluoxetine, accounting for 52.50% of the market share in 2022, due to their convenience and ease of use[1].

Sources

1. Consegic Business Intelligence - Fluoxetine Market Size, Share & Report Overview 2023-2031
2. Eli Lilly and Company - Lilly Announces Fourth-Quarter Earnings per Share of $.60 ...
3. ResearchGate - Pricing dynamics and product quality: The case of antidepressant drugs
4. Data Bridge Market Research - Global Fluoxetine Market - Industry Trends and Forecast to 2029