SARAFEM Drug Patent Profile

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

Sarafem is a drug marketed by Eli Lilly And Co and Apil and is included in two NDAs.

The generic ingredient in SARAFEM 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 Sarafem

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

Summary for SARAFEM

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	10
Patent Applications:	5,914
Drug Prices:	Drug price information for SARAFEM
What excipients (inactive ingredients) are in SARAFEM?	SARAFEM excipients list
DailyMed Link:	SARAFEM at DailyMed

See drug prices for SARAFEM

See drug sales revenues for SARAFEM

Recent Clinical Trials for SARAFEM

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

Sponsor	Phase
Bogachan Sahin	Phase 2
Torrent Pharmaceuticals Limited	Phase 1
Eli Lilly and Company	Phase 3

See all SARAFEM clinical trials

Pharmacology for SARAFEM

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

US Patents and Regulatory Information for SARAFEM

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	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-007	Jul 6, 2000		DISCN	Yes	No
Apil	SARAFEM	fluoxetine hydrochloride	TABLET;ORAL	021860-002	May 19, 2006		DISCN	Yes	No
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-008	Jul 6, 2000		DISCN	Yes	No
Apil	SARAFEM	fluoxetine hydrochloride	TABLET;ORAL	021860-001	May 19, 2006		DISCN	Yes	No
Apil	SARAFEM	fluoxetine hydrochloride	TABLET;ORAL	021860-003	May 19, 2006		DISCN	Yes	No

Expired US Patents for SARAFEM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-008	Jul 6, 2000
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-007	Jul 6, 2000
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-008	Jul 6, 2000
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-008	Jul 6, 2000
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-007	Jul 6, 2000
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-007	Jul 6, 2000

International Patents for SARAFEM

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

Country	Patent Number	Title	Estimated Expiration
Germany	3856295
Japan	S59193821	USE OF FLUOXETIN AS ANTIANXIETY
Australia	4008699
Malaysia	127938	COMBINATIN THERAPY FOR TREATMENT OF PARTIAL RESPONDERS OR REFRACTORY DEPRESSION
China	1154496
Canada	1051034	ARYLOXYPHENYLPROPYLAMINES (ARYLOXYPHENYLPROPYLAMINES)

SARAFEM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sarafem

Introduction

Sarafem, known chemically as fluoxetine hydrochloride, is a medication that has made significant impacts in the pharmaceutical industry, particularly in the treatment of premenstrual dysphoric disorder (PMDD) and other conditions. Here, we delve into the market dynamics and financial trajectory of Sarafem, exploring its approval, market performance, and the factors influencing its success.

Approval and Initial Market Impact

Sarafem was approved by the US Food and Drug Administration (FDA) on July 6, 2000, for the treatment of PMDD, a severe form of premenstrual syndrome (PMS) that affects 3 to 5 percent of menstruating women in the United States[4].

Clinical Significance

The approval was based on studies that showed Sarafem to be significantly more effective than a placebo in alleviating mood, physical, and social impairment symptoms associated with PMDD. This marked a significant milestone in the treatment of PMDD, offering a targeted therapeutic option for women suffering from this condition.

Market Positioning

Sarafem is essentially a rebranded version of Prozac, another well-known antidepressant developed by Eli Lilly and Co. This rebranding strategy allowed Eli Lilly to differentiate Sarafem from Prozac, which is primarily used for depression, obsessive-compulsive disorder, and bulimia.

Branding Strategy

The use of a new trademark, Sarafem, enabled Eli Lilly to launch a public education campaign highlighting the differences between depression and PMDD. This strategy helped in targeting a specific demographic and raising awareness about PMDD, thereby expanding the market for Sarafem[4].

Financial Performance

The financial trajectory of Sarafem is closely tied to the overall performance of Prozac, given that they are chemically identical.

Sales Performance

In the early 2000s, Prozac, and by extension Sarafem, experienced significant sales. However, as the patent for Prozac expired, sales began to decline. For instance, combined sales of Prozac, Prozac Weekly, and Sarafem decreased by 66 percent in one quarter, reflecting the impact of generic competition[2].

Impact on Eli Lilly's Financials

The decline in Prozac sales had a notable impact on Eli Lilly's financials. The company reported a 25 percent decrease in operating income and a 24 percent decrease in earnings per share during the fourth quarter of 2000, largely due to the decline in Prozac sales[2].

Market Trends and Competition

The antidepressant market, including drugs like Sarafem, is subject to various market trends and competitive forces.

Generic Competition

The entry of generic versions of SSRIs and SNRIs, including fluoxetine, has significantly impacted the market. Generic drugs have lower prices, leading to a shift in utilization from brand-name drugs to generics. This trend has been observed in Medicaid spending, where generic substitutions have been a key cost-containment strategy[1].

Market Growth

Despite the challenges posed by generic competition, the antidepressant market is growing. The global antidepressants market is projected to grow at a CAGR of 7.90% from 2023 to 2032, reaching USD 36.41 billion by 2032. North America, where Sarafem is primarily marketed, remains the largest market for antidepressants[3].

Regulatory and Patent Considerations

The regulatory and patent landscape plays a crucial role in the market dynamics of Sarafem.

Patent and Licensing

MIT licensed the use of serotonin uptake blockers like Prozac for treating PMS/PMDD to Interneuron, which subsequently sublicensed this patent to Eli Lilly. This licensing arrangement allowed Eli Lilly to market Sarafem specifically for PMDD, while also ensuring royalty payments to MIT[4].

Consumer Awareness and Stigma

The growth of the antidepressant market, including Sarafem, is influenced by consumer awareness and the reduction of stigma associated with mental health conditions.

Reduced Stigma

Growing awareness and reduced stigma around mental health issues are driving the demand for antidepressants. As more people seek treatment for conditions like PMDD, the market for targeted therapies like Sarafem is expected to expand[3].

Key Takeaways

• Approval and Market Impact: Sarafem was approved for PMDD in 2000, offering a targeted treatment option.
• Financial Performance: Sales of Sarafem were affected by the decline in Prozac sales due to generic competition.
• Market Trends: The antidepressant market is growing, driven by increasing awareness and reduced stigma.
• Regulatory Considerations: Licensing agreements and patent expirations have influenced the market trajectory of Sarafem.
• Consumer Awareness: Growing awareness about PMDD and mental health is driving the demand for antidepressants like Sarafem.

FAQs

What is Sarafem used for?

Sarafem is used for the treatment of premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome (PMS).

How was Sarafem approved?

Sarafem was approved by the FDA in 2000 based on studies showing its efficacy in alleviating symptoms of PMDD.

What is the relationship between Sarafem and Prozac?

Sarafem is chemically identical to Prozac (fluoxetine hydrochloride) but is marketed specifically for PMDD.

How has generic competition affected Sarafem sales?

The entry of generic versions of fluoxetine has led to a decline in sales of brand-name Sarafem, as generics offer a cheaper alternative.

What are the future prospects for the antidepressant market?

The global antidepressant market is expected to grow at a CAGR of 7.90% from 2023 to 2032, driven by increasing awareness and reduced stigma around mental health conditions.

Sources

1. Drug Expenditure, Price, and Utilization in the U.S. Medicaid - PubMed
2. Lilly Announces Fourth-Quarter Earnings per Share of $.60 ... - Eli Lilly Investor
3. Antidepressants Drugs Market Size & Share, Analysis Report 2032 - The Brainy Insights
4. MIT-patented treatment approved by FDA for severe form of PMS - MIT News
5. Form 10-Q - Eli Lilly Investors - Eli Lilly Investor