seasonique Drug Patent Profile

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

Seasonique is a drug marketed by Teva Branded Pharm and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in ten countries.

The generic ingredient in SEASONIQUE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

DrugPatentWatch^® Generic Entry Outlook for Seasonique

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (ethinyl estradiol; levonorgestrel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for seasonique

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	5
Drug Prices:	Drug price information for seasonique
Drug Sales Revenues:	Drug sales revenues for seasonique
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for seasonique
What excipients (inactive ingredients) are in seasonique?	seasonique excipients list
DailyMed Link:	seasonique at DailyMed

See drug prices for seasonique

See drug sales revenues for seasonique

Recent Clinical Trials for seasonique

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

Sponsor	Phase
Duramed Research	Phase 3
Duramed Research	Phase 2

See all seasonique clinical trials

Paragraph IV (Patent) Challenges for SEASONIQUE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg/0.01 mg	021840	1	2008-01-22

US Patents and Regulatory Information for seasonique

seasonique is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006	AB	RX	Yes	Yes

Expired US Patents for seasonique

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006
Teva Branded Pharm	SEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021840-001	May 25, 2006

International Patents for seasonique

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

Country	Patent Number	Title	Estimated Expiration
Brazil	0214716
Japan	2005516913
Russian Federation	2403046	СПОСОБЫ ГОРМОНАЛЬНОГО ЛЕЧЕНИЯ С ПРИМЕНЕНИЕМ КОНТРАЦЕПТИВНЫХ РЕЖИМОВ С НЕПРЕРЫВНЫМ ВВЕДЕНИЕМ ЭСТРОГЕНА (METHOD OF HORMONAL TREATMENT WITH APPLICATION OF CONTRACEPTIVE REGIMENS WITH CONTINUOUS INTRODUCTION OF ESTROGEN)
Poland	213122
China	1599614
Japan	2010180236	ORAL CONTRACEPTIVE TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY
Russian Federation	2351339	ОРАЛЬНЫЕ КОНТРАЦЕПТИВЫ ДЛЯ ПРЕДОТВРАЩЕНИЯ БЕРЕМЕННОСТИ И УМЕНЬШЕНИЯ ПРЕДМЕНСТРУАЛЬНОЙ СИМПТОМАТИКИ (ORAL CONTRACEPTIVES FOR PREVENTION PREGNANCY AND REDUCTION OF PREMENSTRUAL SYMPTOMATOLOGY)

Supplementary Protection Certificates for seasonique

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	C20160011 00192	Estonia		PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015

Market Dynamics and Financial Trajectory for SEASONIQUE

Last updated: July 27, 2025

Introduction

SEASONIQUE, a combination oral contraceptive, has established itself as a significant player within the hormonal contraceptive market, particularly leveraging its extended-cycle regimen. Since its FDA approval in 2006, SEASONIQUE has navigated evolving market forces dictated by regulatory landscapes, consumer preferences, competitive innovation, and healthcare policies. Analyzing its market dynamics and financial trajectory offers critical insights for stakeholders seeking to understand its current positioning and future prospects.

Market Overview and Positioning

SEASONIQUE belongs to the class of extended-cycle combined oral contraceptives (COCs), designed to reduce withdrawal bleeding from 21 days to just four periods annually. Its unique selling proposition is the convenience of fewer menstrual periods, appealing particularly to women seeking reduced bleeding and the associated lifestyle benefits. The global contraceptive market, valued at approximately USD 19.3 billion in 2020 (per MarketWatch), is projected to grow at a CAGR of 6.3% from 2021 to 2028, driven by increasing awareness and demand for safe, effective, and user-friendly contraceptives.

Within this expanding landscape, SEASONIQUE maintains a niche focusing on women prioritizing menstrual reduction. Its positioning is reinforced by its established efficacy, FDA approval, and the backing of its manufacturer, which has actively marketed its benefits. However, competition from a growing array of contraceptive options—including long-acting reversible contraceptives (LARCs), non-hormonal methods, and emerging digital health solutions—has nuance its market share trajectory.

Regulatory and Market Dynamics

Regulatory shifts significantly influence SEASONIQUE's market dynamics. Changes in prescribing guidelines, approval of alternative contraceptives, and patent expirations alter competitive landscapes. Specifically, the introduction of generic formulations following patent lapses reduces price premiums and widens accessibility, fostering broader market penetration. The Food and Drug Administration (FDA)’s approval process has also adapted to accommodate biosimilar and generic entrants, which influences the downstream profitability for original branded versions like SEASONIQUE.

Market penetration is further shaped by healthcare policies and insurance coverage. In several regions, including the United States and Europe, contraceptive coverage is expanded under healthcare mandates, directly impacting sales volume. Conversely, policy shifts restricting reproductive rights could constrain market growth, especially in regions with conservative legislative environments.

Consumer Preferences and Market Trends

Consumer preferences increasingly favor contraceptives that balance efficacy with minimal side effects and lifestyle convenience. The trend toward extended-cycle and continuous-use contraceptives enhances SEASONIQUE’s appeal, provided it maintains a favorable safety profile.

Adherence remains critical; extended-cycle regimens like SEASONIQUE mitigate user compliance challenges associated with traditional 21-day schedules. This attribute fosters higher satisfaction and consistent usage, underpinning sustained market demand.

Digital health platforms also influence consumer engagement, offering education, monitoring, and teleconsultation services that could influence prescribing patterns for products like SEASONIQUE.

Competitive Landscape and Innovation

SEASONIQUE operates in a highly competitive market with key rivals including other combination oral contraceptives, hormonal IUDs, implants, and non-hormonal options. Prominent competitors include brands like Yaz, Seasonale, and manufacturers offering LARCs such as Mirena, which provide longer-lasting, user-controlled contraception.

Recent innovations focus on improving convenience, reducing side effects, and expanding indications. For example, non-pill options like contraceptive patches, vaginal rings, and advanced implants challenge oral contraceptives’ dominance. Digital health integrations, personalized medicine approaches, and research into new hormone combinations further reshape the competitive boundaries.

Financial Trajectory and Revenue Drivers

SEASONIQUE’s financial trajectory is influenced by multiple vectors:

• Market Penetration: Increasing awareness and expanding healthcare access bolster sales volume. Patent protections and exclusivity periods initially provided pricing leverage, but patent expirations have led to the emergence of lower-cost generics, compressing margins.

• Pricing Strategy: Premium branding, coupled with efficacy and convenience factors, enables higher price points, but price competition from generics pressure profitability.

• Regulatory Approvals: New indications or formulations can rejuvenate sales streams. Conversely, regulatory setbacks or safety concerns can dampen financial outlooks.

• Market Expansion: Entry into new geographies, especially emerging markets with rising contraceptive needs, offers revenue growth opportunities. Local regulatory approval and distribution capacity are pivotal.

• Insurance and Reimbursement Policies: Favorable policies that ensure contraceptive coverage enhance sales, whereas restrictions or co-pay increases pose barriers.

In recent years, the overall financial trajectory for branded contraceptive products has seen a stabilization, with some decline in U.S. markets attributable to generic competition. However, niche formulations that address specific consumer needs retain profitability due to premium pricing and brand loyalty.

Future Outlook

Projected financial growth for SEASONIQUE hinges on several factors:

• Continued innovation in formulation and delivery systems to maintain user engagement.
• Strategic expansion into emerging markets, especially where contraceptive awareness is increasing.
• Response to competitive pressures through product differentiation and marketing.
• Navigating regulatory landscapes to ensure continued compliance and market access.

Overall, while the product faces headwinds from generic competition, its unique extended-cycle feature offers a sustained value proposition. Stakeholders should monitor legislative changes, consumer trends, and technological advancements to adapt effectively.

Key Challenges

• Patent Expiry and Generics: Encroachment by generics reduces revenue margins.
• Market Saturation: U.S. and European markets are nearing saturation levels for branded oral contraceptives.
• Regulatory Risks: Potential safety concerns or regulatory restrictions could impede sales.
• Consumer Shift Toward LARCs and Non-Hormonal Options: These alternatives threaten market share.

Key Opportunities

• Global Expansion: Particularly in Asian, African, and Latin American markets with increasing contraceptive demand.
• Product Differentiation: Enhancing formulations with fewer side effects or integrating digital health solutions.
• Partnerships and Licensing: Collaborations for broader distribution and co-marketing.

Conclusion

SEASONIQUE’s market and financial trajectories are emblematic of the broader contraceptive industry’s evolution: a transition from traditional product dominance to a diversified, consumer-centric landscape. While facing challenges from generics and alternative modalities, its unique extended-cycle regimen positions it for continued relevance among niche consumer segments. Strategic initiatives focusing on market expansion, innovation, and regulatory agility hold key potential for sustaining and enhancing its financial performance.

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Key Takeaways

• Market Positioning: SEASONIQUE appeals to women valuing menstrual reduction, constituting a stable niche in the expanding contraceptive market.

• Competitive Dynamics: Patent expirations and the advent of generics challenge pricing power; innovation and differentiation are essential for maintaining profitability.

• Regulatory Environment: Evolving policies and approvals significantly influence market access and revenue streams across different regions.

• Growth Opportunities: Emerging markets and product innovations present avenues for expansion, particularly if tailored to local needs.

• Strategic Imperatives: Stakeholders should focus on patent management, product differentiation, regional expansion, and leveraging digital health tools to fortify market share.

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Frequently Asked Questions (FAQs)

1. How does SEASONIQUE compare with other contraceptives in terms of efficacy?
SEASONIQUE’s efficacy aligns with that of other combined oral contraceptives, boasting a typical-use failure rate of approximately 9%. Its extended-cycle regimen offers the added benefit of reduced menstruation frequency, which can improve user satisfaction without compromising efficacy.

2. What are the main factors impacting SEASONIQUE's market share?
Patent expirations leading to generic competition, the rise of long-acting methods (like IUDs and implants), regulatory shifts, and consumer preferences shifting toward non-pill modalities influence its market share dynamics.

3. What regions present the most growth potential for SEASONIQUE?
Emerging markets in Asia, Africa, and Latin America exhibit significant growth potential due to increasing contraceptive awareness, expanding healthcare infrastructure, and rising demand for women’s health products.

4. How do regulatory changes affect SEASONIQUE’s financial trajectory?
Regulatory approvals or restrictions directly influence market access. Favorable policies can enhance sales, while safety concerns or restrictions can lead to product withdrawals or reduced prescribing.

5. What innovations could sustain SEASONIQUE’s market relevance?
Formulation improvements reducing side effects, digital health integration for adherence support, and combination approaches addressing diverse consumer needs are critical innovation pathways.

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Sources

1. MarketWatch. “Worldwide Contraceptive Market to Reach USD 25 Billion by 2028.” 2021.
2. FDA. “Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).” 2022.
3. Grand View Research. “Contraceptive Market Size, Share & Trends Analysis,” 2021.