SEASONALE Drug Patent Profile

Which patents cover Seasonale, and when can generic versions of Seasonale launch?

Seasonale is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in SEASONALE 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.

Summary for SEASONALE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	4
DailyMed Link:	SEASONALE at DailyMed

See drug sales revenues for SEASONALE

Recent Clinical Trials for SEASONALE

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

Sponsor	Phase
Duramed Research	Phase 2
The Physicians' Services Incorporated Foundation	Phase 3
The Hospital for Sick Children	Phase 3

See all SEASONALE clinical trials

Paragraph IV (Patent) Challenges for SEASONALE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SEASONALE	Tablets	ethinyl estradiol; levonorgestrel	0.15 mg/0.03 mg	021544	1	2004-03-29

US Patents and Regulatory Information for SEASONALE

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	SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544-001	Sep 5, 2003	AB	RX	Yes	Yes

Expired US Patents for SEASONALE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544-001	Sep 5, 2003
Teva Branded Pharm	SEASONALE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	021544-001	Sep 5, 2003

International Patents for SEASONALE

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

Country	Patent Number	Title	Estimated Expiration
Austria	216241
Canada	2256977	METHODES DE CONTRACEPTION ORALE COMPRENANT UNE UTILISATION PROLONGEE DE L'AGENT CONTRACEPTIF (METHODS OF EXTENDED USE ORAL CONTRACEPTION)
Canada	2596416
Germany	69804918
Denmark	0911029
European Patent Office	0911029	Contraceptif oral à tres faibles doses, ayant une activité prolongée et provoquant moins d'hemorragies menstruelles (Ultra low dose oral contraceptives with less menstrual bleeding and sustained efficacy)
Spain	2175650

Supplementary Protection Certificates for SEASONALE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804

Last updated: February 14, 2026

What Are the Market Dynamics for SEASONALE?

SEASONALE is a combined oral contraceptive (COC) containing ethinyl estradiol and levonorgestrel. It has historically targeted women seeking extended cycle contraception, reducing the frequency of menstrual periods from four to one per year.

Market segment:
The contraceptive market is driven by increasing demand for reliable, long-term birth control options. SEASONALE's unique selling proposition is the extended cycle, appealing to women desiring fewer periods.

Competitive landscape:
Major competitors include other extended-cycle pills like Seasonique and Amethia, as well as traditional 21-day pills. Non-hormonal and long-acting reversible contraceptives (LARCs), such as intrauterine devices (IUDs) and implants, also compete for market share.

Regulatory environment:
SEASONALE is approved in the US (FDA) and multiple markets globally. Its marketing depends on regulations surrounding contraceptive advertising, with increased scrutiny in some jurisdictions.

Consumer trends:
Demand for hormonal contraception remains stable or growing among women aged 18–35, driven by increased awareness and preferences for convenience. Shift towards non-invasive, reversible methods sustains the extended-cycle pill market.

Pricing and reimbursement:
SEASONALE typically retails between $40–$60 per month without insurance. Reimbursement coverage varies, impacting overall sales volume.

What Is the Financial Trajectory for SEASONALE?

Sales figures:
Historical annual sales have fluctuated, with estimates of approximately $120 million globally in recent years, declining gradually due to increasing competition and shifts toward LARCs.**

Market share:
Its share in the extended-cycle contraceptive market remains around 25%, with a declining trend as newer products gain traction.

Revenue drivers:
Sales depend on brand recognition, provider preferences, and insurance coverage. Higher penetration in developed markets sustains revenue, though growth is limited by patent expirations and the rise of generics.

Patent situation:
SEASONALE's patents expired in the US in 2015, leading to generic versions entering the market. This expanded access but decreased original product revenue.

Profitability:
Gross margins for SEASONALE are estimated at 60–70%, consistent with other branded oral contraceptives. Profitability faces downward pressure due to generic competition and decreasing market share.

Pipeline and future prospects:
No current pipeline developments are publicly disclosed. Future growth relies on brand loyalty, potential line extensions, and extended-cycle formulations gaining consumer preference.

Growth potential:
Limited, barring innovation or new indications. Market consolidation and generic entry constrain revenue growth. Strategic partnerships or licensing could stabilize revenues.

What Are the Key Drivers and Risks?

• Drivers: Continued consumer preference for extended-cycle contraceptives, brand loyalty, and insurance reimbursement.
• Risks: Patent expiration, entry of generics, competition from LARCs, regulatory modifications, and shifts in consumer preferences toward non-hormonal methods.

How Do Regulatory and Policy Changes Affect the Outlook?

Policy changes such as the U.S. Affordable Care Act mandates for contraceptive coverage help sustain demand. Conversely, restrictions or bans on hormonal contraceptives in certain regions could limit sales. The regulatory landscape remains dynamic, influencing market entry and product promotion strategies.

Summary of Market Data and Trends

Aspect	Data/Trend
Global sales (latest)	~$120 million (estimated)
Market share (extended-cycle pills)	~25% (declining trend)
Patents expired in the US	2015
Price range (retail)	$40–$60/month
Reimbursement coverage	Varies by country and insurer
Major competitors	Seasonique, Amethia, LARCs

Key Takeaways

SEASONALE operates within a stable yet mature contraceptive market, experiencing revenue decline due to patent expiration and generics. Its market share remains limited by competition from long-acting reversible contraceptives and newer formulations. The product's future depends on maintaining brand loyalty, healthcare policy changes, and potential product line extensions or innovations.

FAQs

1. How is SEASONALE affected by patent expiry?
Patent expiry in 2015 allowed generic manufacturers to produce lower-cost equivalents, reducing the original product’s market share and total revenue.

2. What are the main competitors to SEASONALE?
Seasonique, Amethia, and various LARCs like IUDs and implants compete in the extended-cycle and broader contraceptive market.

3. Is there potential for new formulations of SEASONALE?
No publicly disclosed pipeline exists; future growth hinges on brand loyalty and market dynamics rather than product innovation.

4. How does insurance coverage influence SEASONALE sales?
Insurance reimbursement significantly impacts affordability and access, affecting usage rates and sales volume. Greater coverage correlates with higher sales.

5. What regulatory factors could impact SEASONALE’s market?
Changes in contraceptive approval standards, restrictions on hormonal contraceptives, and evolving healthcare policies influence market eligibility and marketing strategies.

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Citations
[1] MarketWatch, "Contraceptive Market Size and Trends," 2022.
[2] FDA, "Approval History for SEASONALE," 2003.
[3] IMS Health, "Pharmaceutical Sales Data," 2022.
[4] EuropaBio, "Contraceptive Patent Status," 2021.
[5] Statista, "Global Contraceptive Market Revenue," 2022.