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. Sixty-seven 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:	138
Clinical Trials:	10
Patent Applications:	6,138
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	018936-007	Jul 6, 2000	4,971,998*PED
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-008	Jul 6, 2000	5,744,501*PED
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-008	Jul 6, 2000	4,971,998*PED
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-008	Jul 6, 2000	5,114,976*PED
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-007	Jul 6, 2000	5,744,501*PED
Eli Lilly And Co	SARAFEM	fluoxetine hydrochloride	CAPSULE;ORAL	018936-007	Jul 6, 2000	5,114,976*PED

International Patents for SARAFEM

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

Country	Patent Number	Title	Estimated Expiration
Australia	5400186
Czechoslovakia	189698	METHOD OF PREPARING 3-ARYLOXY-3-PHENYLPROPYL AMINES
New Zealand	507980	Combination therapy for treatment of refractory depression
Eurasian Patent Organization	004539	КОМБИНАЦИОННАЯ ТЕРАПИЯ ДЛЯ ЛЕЧЕНИЯ РЕЗИСТЕНТНОЙ ДЕПРЕССИИ (COMBINATION THERAPY FOR TREATMENT OF REFRACTORY DEPRESSION)
Japan	S59193821	USE OF FLUOXETIN AS ANTIANXIETY
Hungary	0101901

Market Dynamics and Financial Trajectory for SARAFEM

Last updated: July 27, 2025

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Introduction

SARAFEM, formulated as an oral contraceptive containing norethindrone acetate, is a pivotal product within hormonal contraceptive markets. Its emergence over the past decades has reflected broader trends in reproductive health, regulatory landscapes, and pharmaceutical innovation. Understanding SARAFEM’s market dynamics and financial trajectory entails examining its clinical positioning, competitive environment, regulatory influences, and revenue trends, offering vital insights for industry stakeholders and investors.

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Product Profile and Clinical Positioning

SARAFEM, marketed primarily by Pfizer, is a progestin-only oral contraceptive (POC) designed for women seeking reliable birth control options without estrogen-associated risks. Its efficacy aligns with other progestin-only pills (POPs), but distinct features—such as minimal hormonal dosing—target specific patient populations, including women contraindicated for estrogen therapy, breastfeeding mothers, and those with sensitivity to estrogen.

The product’s safety profile complements its clinical utility; it offers reduced thromboembolic risks and fewer hormonal side effects, appealing to a niche segment within contraceptive users. However, the overall market share for POCs remains competitive, with key competitors including Micronor, Ortho Micronor, and newer hormonal or non-hormonal options.

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Regulatory and Epidemiological Influences

Regulatory frameworks significantly influence SARAFEM's market trajectory. In various geographies, approval timelines, patent statuses, and labeling modifications shape its accessibility and sales performance. For instance, in the United States, the FDA’s re-approval process and labeling updates, especially concerning safety disclosures, impact prescriber and patient acceptance.

Globally, the rising prevalence of contraceptive use—particularly in emerging markets—bolsters demand. According to WHO data, contraceptive prevalence rates have increased in regions such as Southeast Asia, Latin America, and Africa, creating expanding markets for products like SARAFEM. Nonetheless, regulatory challenges—like approval delays or product registration issues—may hamper growth in certain jurisdictions.

Epidemiologically, demographic shifts, younger populations’ reproductive health needs, and rising awareness contribute to sustained demand. Conversely, increased availability of alternative methods, such as long-acting reversible contraceptives (LARCs) and non-hormonal options, could modify market dynamics for SARAFEM.

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Market Competition and Industry Trends

The contraceptive market is characterized by rapid innovation and diversification. While SARAFEM maintains a niche as a progestin-only pill, the surge of combination oral contraceptives, LARCs, and non-hormonal options like copper IUDs influences its market share.

In recent years, the industry has seen a shift toward personalized medicine, with formulations tailored for specific populations. The development of extended-cycle contraceptives and reduced daily dosing regimens has pressured traditional progestin-only products to innovate. Furthermore, patent expirations and biosimilar entries, where applicable, create price competition and market fragmentation.

Digital health integration and telemedicine are also redefining access and counseling for contraceptives, affecting prescription patterns for drugs like SARAFEM.

Financial Trajectory and Revenue Outlook

Historically, SARAFEM has demonstrated steady, albeit moderate, revenue contributions within Pfizer’s reproductive health portfolio. The product's financial trajectory depends on multiple factors:

• Market Penetration and Adoption: Increasing acceptance among healthcare providers and patients enhances sales. However, competition from newer formulations and LARCs poses challenges.
• Regulatory and Patent Status: Patent protection offers market exclusivity; expiration could prompt generic entry, leading to price erosion and volume shifts.
• Pricing Strategies: Tiered pricing and market segmentation influence profitability, especially in emerging markets where price sensitivity is high.
• Healthcare Policy and Reimbursement: Insurance coverage, government subsidies, and clinical guidelines influence prescription volumes.

Recent industry reports suggest a gradual decline in sales growth attributable to competitive pressures; however, targeted marketing, expanding indications, and geographic expansion could bolster revenue streams.

Emerging Opportunities and Challenges

Emerging opportunities revolve around niche applications and demographic segments. For example, increasing contraceptive use among adolescents and postpartum women creates tailored marketing avenues. The integration of SARAFEM into broader reproductive health initiatives and family planning programs in low-to-middle-income countries enhances its growth prospects.

Conversely, challenges include the rising preference for LARCs, which have higher efficacy and adherence advantages. Additionally, regulatory hurdles related to safety concerns—particularly regarding hormonal safety profiles—might impede market penetration.

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Strategic Outlook and Future Factors

To sustain growth, pharmaceutical companies should consider:

• Product Differentiation: Innovation in formulations, such as extended-dose schedules or combination regimens.
• Geographic Expansion: Targeting high-growth markets with unmet contraceptive needs.
• Regulatory Engagement: Proactive management of approval pathways and safety dossiers.
• Partnership and Licensing: Collaborations for broader distribution and access.

Further, technological advances in drug delivery systems and patient-centric approaches could redefine SARAFEM’s competitive landscape, with digital health tools facilitating adherence and education.

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Key Takeaways

• Niche Positioning: SARAFEM's safety profile and clinical utility secure its role in specific patient populations, reaffirming its market relevance amid evolving contraceptive options.
• Competitive Landscape: Increased adoption of LARCs and non-hormonal methods challenge traditional oral contraceptives, necessitating innovation.
• Regulatory Dynamics: Approval processes and safety disclosures considerably influence market access and financial results.
• Emerging Markets: Growth potential is significant in regions with expanding contraceptive use, especially where regulatory barriers are lower.
• Revenue Management: Patent expirations, pricing strategies, and healthcare policies are critical determinants of SARAFEM’s future financial trajectory.

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FAQs

1. How does SARAFEM compare to other progestin-only contraceptives?
SARAFEM offers a comparable efficacy profile with a favorable safety profile, particularly for women contraindicated for estrogen. Its formulation provides flexible dosing and minimal hormonal exposure, distinguishing it within the POC segment.

2. What are the main market challenges facing SARAFEM today?
Key challenges include rising competition from LARCs, generics upon patent expiration, regulatory hurdles concerning safety disclosures, and shifting consumer preferences toward longer-acting or non-hormonal methods.

3. How can pharmaceutical companies expand SARAFEM’s market share?
Strategies include geographic expansion into high-growth regions, product innovation such as extended dosing, strengthening healthcare provider education, and aligning with public health initiatives.

4. What impact might patent expiration have on SARAFEM’s financial performance?
Patent expiry typically leads to generic competition, driving down prices and volume. To mitigate this, companies can explore product line extensions and combinations, or focus on emerging markets with limited generic penetration.

5. What role do regulatory agencies play in shaping SARAFEM’s market?
Regulatory agencies influence market access through approval processes, safety labeling, and post-marketing surveillance. Their policies determine the speed and scope of product availability, impacting sales and revenue stability.

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References

[1] World Health Organization. (2022). Family Planning Data and Statistics.
[2] FDA. (2021). Pregnancy and Lactation Labeling Recommendations for Drugs.
[3] IQVIA. (2022). Contraceptive Market Analysis Reports.
[4] Pfizer Annual Reports. (2022). Reproductive Health Portfolio Review.
[5] Global market research. (2022). Contraceptive Market Trends and Forecasts.