PROZAC WEEKLY Drug Patent Profile

When do Prozac Weekly patents expire, and what generic alternatives are available?

Prozac Weekly is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in PROZAC WEEKLY 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 Prozac Weekly

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

Summary for PROZAC WEEKLY

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	110
Patent Applications:	5,914
DailyMed Link:	PROZAC WEEKLY at DailyMed

Recent Clinical Trials for PROZAC WEEKLY

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

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

See all PROZAC WEEKLY clinical trials

US Patents and Regulatory Information for PROZAC WEEKLY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001		DISCN	Yes	No

Expired US Patents for PROZAC WEEKLY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001	5,910,319*PED
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001	RE39030
Lilly	PROZAC WEEKLY	fluoxetine hydrochloride	CAPSULE, DELAYED REL PELLETS;ORAL	021235-001	Feb 26, 2001	5,985,322*PED

International Patents for PROZAC WEEKLY

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

Country	Patent Number	Title	Estimated Expiration
Colombia	4940407	GRANULOS ENTERICOS DE FLUOXETINA
South Africa	9803173
Taiwan	I239838
China	1285189
Australia	6904898
Spain	2161574	GRANULOS ENTERICOS DE FLUOXETINA.
China	1212834

PROZAC WEEKLY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prozac Weekly

Introduction

Prozac Weekly, a once-weekly formulation of fluoxetine, has been a significant player in the antidepressant market since its approval. Here, we will delve into the market dynamics and financial trajectory of Prozac Weekly, highlighting its performance, challenges, and future prospects.

Approval and Clinical Use

Prozac Weekly was approved by the FDA for patients with stabilized symptoms of depression, allowing for a convenient once-weekly dosing regimen. This formulation is recommended to be initiated 7 days after the last daily dose of Prozac, ensuring a seamless transition for patients[1][5].

Market Performance Pre-Generic Competition

Before the introduction of generic competition, Prozac and its variants, including Prozac Weekly and Sarafem, were highly successful. In the early 2000s, these products were among the top performers for Eli Lilly, contributing significantly to the company's revenue[2].

Impact of Generic Competition

The introduction of generic fluoxetine in August 2001 marked a significant turning point. Prozac sales in the U.S. plummeted by 84%, and combined sales of Prozac, Prozac Weekly, and Sarafem decreased by 66% in the fourth quarter of 2001. This decline had a substantial impact on Eli Lilly's financial performance, leading to a 25% decrease in operating income and a 24% decrease in diluted earnings per share for the fourth quarter of 2001[2].

Global Sales and Market Share

Despite the decline in U.S. sales, Prozac and its variants continued to generate revenue globally. In 2001, worldwide combined sales of Prozac, Prozac Weekly, and Sarafem were $1.990 billion, although this represented a 23% decrease from the previous year. The international market, particularly outside the U.S., saw a slight increase in sales, mitigating some of the losses[2].

Current Market Trends

The global fluoxetine market, including Prozac Weekly, is expected to grow at a CAGR of 4.10% from 2022 to 2029. Key drivers include the rising prevalence of depression, bulimia nervosa, and obsessive-compulsive disorder, as well as increasing geriatric populations and healthcare expenditures. However, the market faces challenges such as high drug costs, side effects, and intense competition among market players[4].

Regional Market Dynamics

North America, with its well-developed healthcare infrastructure and high disposable income, dominates the fluoxetine market. However, the Asia-Pacific region is expected to grow significantly during the forecast period due to increasing research and development activities and growing government support[4].

Competitive Landscape

The fluoxetine market is highly competitive, with several key players. Companies are engaging in strategic collaborations, mergers, and acquisitions to enhance their market presence. The competitive landscape is further complicated by the presence of generic alternatives, which continue to erode the market share of branded products like Prozac Weekly[3][4].

Financial Trajectory

The financial performance of Prozac Weekly has been significantly impacted by the introduction of generic competition. While the product still generates revenue, its contribution to Eli Lilly's overall financial health has diminished. The company has shifted its focus to other growth products such as Zyprexa, Gemzar, and Evista, which have driven sales growth in recent years[2].

Challenges and Opportunities

Despite the challenges posed by generic competition and side effects associated with fluoxetine, there are opportunities for growth. Increasing awareness and government initiatives, particularly in regions with growing healthcare infrastructure, can drive demand. Additionally, ongoing research and development activities and new product launches could provide beneficial opportunities for the fluoxetine market[4].

Patient Epidemiology and Market Impact

The prevalence, incidence, and mortality rates of depression and other related disorders significantly impact the market growth of fluoxetine. Detailed patient epidemiology analysis helps in forecasting the market and understanding the direct or indirect impact of these factors on market dynamics[4].

Key Takeaways

• Generic Competition: The introduction of generic fluoxetine significantly impacted Prozac Weekly's sales and market share.
• Global Market: The global fluoxetine market is expected to grow, driven by increasing prevalence of related disorders and healthcare expenditures.
• Regional Dynamics: North America dominates the market, but the Asia-Pacific region is expected to grow significantly.
• Competitive Landscape: The market is highly competitive, with companies engaging in various strategies to maintain market presence.
• Financial Trajectory: Prozac Weekly's financial contribution has diminished but still generates revenue, albeit at a lower level.

FAQs

Q: What was the impact of generic competition on Prozac Weekly sales? A: The introduction of generic fluoxetine in August 2001 led to an 84% decrease in Prozac sales in the U.S. and a 66% decrease in combined sales of Prozac, Prozac Weekly, and Sarafem for the fourth quarter of 2001[2].

Q: What are the key drivers of the global fluoxetine market? A: The key drivers include the rising prevalence of depression, bulimia nervosa, and obsessive-compulsive disorder, as well as increasing geriatric populations and healthcare expenditures[4].

Q: Which region dominates the fluoxetine market? A: North America dominates the fluoxetine market due to its well-developed healthcare infrastructure and high disposable income[4].

Q: What are the challenges facing the fluoxetine market? A: The market faces challenges such as high drug costs, side effects, and intense competition among market players[4].

Q: How is Eli Lilly addressing the decline in Prozac sales? A: Eli Lilly has shifted its focus to other growth products such as Zyprexa, Gemzar, and Evista, which have driven sales growth in recent years[2].

Sources

1. Prozac and Prozac Weekly (fluoxetine HCl) - accessdata.fda.gov
2. Lilly Announces Fourth-Quarter Earnings per Share of $.60 ... - investor.lilly.com
3. Fluoxetine Market Share, Industry Growth, Trend, Drivers ... - BioSpace
4. Global Fluoxetine Market - Industry Trends and Forecast to 2029 - databridgemarketresearch.com
5. Once-weekly Prozac - Managed Healthcare Executive