seasonique Drug Patent Profile

When do Seasonique patents expire, and when can generic versions of Seasonique launch?

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
Spain	2428118
Bulgaria	108736
New Zealand	545130	Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration
Mexico	PA04005445	ANTICONCEPTIVOS ORALES PARA PREVENIR EL EMBARAZO Y DISMINUIR LA SINTOMATOLOGIA PREMENSTRUAL. (ORAL CONTRACEPTIVES TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY.)
Japan	2007534622
Brazil	PI0214716	kit, preparos, e uso de estrogênio e progestina na fabricação de um medicamento para uso na prevenção de gravidez
Portugal	1453521

Supplementary Protection Certificates for seasonique

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1214076	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
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
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: December 28, 2025

Executive Summary
Seasonique, a hormonal contraceptive branded by Teva Pharmaceuticals, has historically occupied a niche within the extended-cycle oral contraceptive market. The drug's unique formulation offers quarterly periods with reduced bleeding, appealing to specific demographic segments. This analysis explores the current market landscape, competitive forces, regulatory developments, and financial trends shaping Seasonique's trajectory. It underscores evolving consumer preferences, patent and patent expirations, pricing strategies, and potential growth opportunities within the contraceptive segment.

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What Are the Core Market Dynamics Influencing Seasonique?

1. Market Size and Segmentation

• The global contraceptive market was valued at approximately $21.9 billion in 2021 and is projected to reach $30.2 billion by 2027, with a compound annual growth rate (CAGR) of 6.1% (1).
• Within this, oral contraceptives account for roughly 30-40% of total revenue, driven predominantly by combined formulations like Seasonique.
• Women aged 15–49 constitute the primary consumer segment, with preferences split among pills, IUDs, implants, and other methods.

Key Market Segments for Seasonique:

Segment	Market Share	Characteristics
Extended-cycle oral contraceptives	~15%	Popular among women seeking fewer periods
Traditional 28-day pills	~60%	Standard, fixed cycle, widely used
Long-acting reversible contraceptives (LARCs)	~25%	Increasing due to efficacy and compliance

2. Competitive Landscape

Major Players and Market Share:

Company	Key Products	Estimated Market Share	Notes
Teva Pharmaceuticals	Seasonique, LoSeasonique	~20%	Pioneered extended-cycle formulations
Bayer AG	Yasmin, Yaz, Beyaz	~25%	Focus on combination pills, expanding portfolio
Mithra Pharmaceuticals	Estelle, Estarylla	Growing	Newer entrants with extended-cycle options
Others	Numerous generics and niche brands	Remaining	Increasing competition from generics

Key Competitive Factors:

• Efficacy and safety profile
• Patient adherence & convenience
• Insurance coverage and formulary positioning
• Price competitiveness

3. Regulatory and Patent Landscape

• Patent expirations: Teva’s primary patent for Seasonique expired in 2014, but exclusivity was maintained through formulations and manufacturing processes until generic entry gained momentum between 2014-2016.
• FDA approvals: Continual approval of generic and biosimilar versions impacts market share.
• Regulatory shifts: Increased focus on over-the-counter (OTC) access could threaten prescription-based sales in the long term (2).

4. Consumer Preferences and Trends

• Fewer Menstrual Bleeds: Growing demand for extended- and continuous-cycle contraceptives to reduce menstrual periods, driven by convenience and lifestyle preferences.
• Safety and Side Effects: Concerns over hormonal risks have prompted shifts toward more natural or lower-dose formulations.
• Accessibility & Cost: Insurance coverage influences consumer choices considerably.

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Financial Trajectory Analysis: Past, Present, and Future

1. Historical Financial Performance of Seasonique

• Launch and Initial Market Penetration (2003-2014):
  Teva introduced Seasonique to target women seeking extended-cycle options, capturing significant share via aggressive marketing and insurance coverage strategies.

• Post-Patent Expiry (2014 onward): Substantial decline in sales due to patent expiration and arrival of generics:	Year	Estimated Sales (USD Millions)	Market Share Impact
  2013	~$250	Monopoly period
  2015	~$120	Generic entries reduce sales
  2020	~$90	Continued erosion

Sources: Company annual reports and IMS Health data.

2. Current Market Revenue & Sales Channels

• Estimated Global Sales (2022):

  • Approximately $75–$100 million for Seasonique, with the majority from North America.
  • Growth driven by switching patients to extended-cycle formulations as generics saturate the market.

• Distribution Channels:

  • Hospitals, clinics, and pharmacies, with increasing online/e-prescription sales.

3. Projected Financial Trends

Year	Forecasted Global Sales	Key Drivers	Risks
2023	~$80 million	Patent cliff stabilization, increased demand for fewer periods	Competition from generics, pricing pressures
2025	~$100–$120 million	Possible introduction of improved formulations or line extensions	Regulatory hurdles, market saturation
2030	Potential resurgence with innovation	Bi-modal formulations, OTC transition, new indications	Regulatory delays, shift to non-oral contraceptives

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What Are the Factors Reshaping the Market Trajectory of Seasonique?

1. Impact of Generic Competition

• The entry of multiple generics post-2014 eroded Seasonique’s pricing power, leading to revenue declines.
• Innovative formulations or delivery methods could help Teva recover market share.

2. Regulatory Developments and Patent Strategies

• Recent moves by regulators to promote OTC access could undermine prescription-based sales.
• Patent strategies, including method-of-use and formulation patents, remain critical barriers for generics.

3. Innovation and Line Extensions

• Introduction of formulations with lower hormone doses or reduced side effects can reignite consumer interest.
• Potential for combination with other hormonal agents to broaden indications.

4. Market Trends Towards LARCs and Natural Methods

• Despite growth in LARCs, oral contraceptives like Seasonique retain relevance among women preferring oral options.
• Consumer-led demand for minimal bleeding and convenience remains a key differentiator.

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Comparison: Seasonique vs. Competitors

Feature	Seasonique	Yasmin/Yaz (Bayer)	LARCs (e.g., IUDs, Implants)	Over-the-counter options (e.g., condoms)
Administration Mode	Oral, Extended-cycle	Oral, 28-day with active pills	Long-acting, 3-10 years duration	Condom, male and female
Efficacy	~99% in perfect use	~99% in perfect use	99%+ in perfect use	Variable, ~85-98%
Side Effect Profile	Minimal breakthrough bleeding, hormonal risks	Thromboembolism, side effects	Rare, but risk of perforation or expulsion	Minimal, but limited protection against STI
Market Position	Niche for women seeking fewer periods	Popular due to efficacy and convenience	Growing segment, but higher upfront cost	Widely accessible and cost-effective

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Key Market Drivers and Challenges for Seasonique

Drivers	Challenges
Increasing demand for extended-cycle pills	Entry of new generics compresses margins
Consumer preference for convenience and fewer periods	Regulatory push towards OTC availability
Insurance coverage facilitating access	Patent and formulation patent expirations limiting exclusivity
Evolving safety profiles and lower-dose formulations	Competition from LARCs and non-hormonal methods

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Conclusion: The Financial and Market Outlook for Seasonique

The future of Seasonique hinges on innovative differentiation, strategic patent protection, and evolving healthcare policies. While generic competition has historically challenged the brand’s profitability, there remains a niche of consumers prioritizing convenience and fewer periods, which Teva can target through clinical research, line extensions, and strategic marketing. Advancements in hormonal safety profiles and potential regulatory shifts toward OTC access could further influence sales trajectories.

Teva’s ability to innovate and adapt to regulatory and consumer trends will determine whether Seasonique sustains its market presence or becomes a niche relic amid more dominant competitors.

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Key Takeaways

• The global contraceptive market is growing, with oral contraceptives representing a significant segment poised for innovation-driven growth.
• Seasonique’s revenue has declined post-patent expiry but stabilizes due to niche consumer demand.
• Competition from generics, LARCs, and regulatory shifts pose ongoing challenges.
• Future growth opportunities include formulation improvements, line extensions, and potential OTC access.
• Strategic patent protection and aligning with consumer health trends are critical for profitability preservation.

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FAQs

1. How does patent expiration affect Seasonique’s market sales?
Patent expiration typically leads to increased generic competition, reducing prices and sales margins. For Seasonique, the primary patent expired in 2014, resulting in significant sales erosion due to the entry of generics.

2. Can regulatory shifts toward OTC availability threaten Seasonique?
Yes. If regulatory agencies approve switch-over to OTC status, prescription-based sales could decline sharply, affecting exclusivity and profitability.

3. What are the growth prospects for Seasonique beyond 2023?
Opportunities depend on formulation innovations, line extensions targeting safety and convenience, and possibly transitioning some formulations to OTC access, which could expand the consumer base.

4. How does consumer preference influence Seasonique’s market trajectory?
Women increasingly prefer fewer periods and lower hormonal side effects, incentivizing demand for extended-cycle formulations like Seasonique.

5. What competitive advantages does Seasonique hold amid generic competition?
Brand loyalty, established safety profile, insurance coverage, and consumer preference for specific dosing schedules serve as competitive advantages if effectively leveraged.

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References

1. ResearchandMarkets. "Global Contraceptive Market Forecast," 2022.
2. U.S. Food and Drug Administration. "Regulations and Policies on OTC Contraceptives," 2021.
3. Teva Pharmaceuticals Annual Reports, 2013–2022.
4. IMS Health. "Pharmaceutical Market Data Reports," 2020–2022.
5. MarketWatch. "Contraceptive Market Trends," 2023.

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Note: This comprehensive analysis synthesizes the latest available data and trends as of early 2023 to assist business professionals in making informed strategic decisions regarding Seasonique’s market position and financial trajectory.