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

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

International Patents for SEASONALE

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

Country	Patent Number	Title	Estimated Expiration
Japan	2007197459	ULTRA LOW DOSE CONTRACEPTIVE WITH LESS MENSTRUAL BLEEDING AND SUSTAINED EFFICACY
Spain	2175650
Canada	2256977	METHODES DE CONTRACEPTION ORALE COMPRENANT UNE UTILISATION PROLONGEE DE L'AGENT CONTRACEPTIF (METHODS OF EXTENDED USE ORAL CONTRACEPTION)
Germany	69804918
Portugal	911029

Supplementary Protection Certificates for SEASONALE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307

SEASONALE Market Analysis and Financial Projection

Last updated: April 25, 2026

SEASONALE (levonorgestrel-ethinyl estradiol) — Investment Scenario and Fundamentals Analysis

What is SEASONALE and how is it positioned commercially?

SEASONALE is an oral contraceptive (OC) combining levonorgestrel (progestin) + ethinyl estradiol (estrogen) in a 21 active days / 7 placebo days regimen, marketed as a continuous 91-day cycle product (extended-cycle dosing vs traditional monthly regimens). It is offered as a brand formulation of a well-established product class: combined oral contraceptives (COCs).

Core commercial dynamic: SEASONALE competes in a mature, high-volume, price-sensitive category where differentiation is typically driven by regimen convenience, brand/formulation, payer placement, and discounting. As a legacy brand with generic entry risk, its investment fundamentals depend on sustained prescription share and ongoing managed-care access rather than on technical differentiation.

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What is the regulatory and IP posture that matters for an investment thesis?

Is SEASONALE protected by new-use or formulation exclusivity that can extend cashflows?

SEASONALE is a legacy branded COC product. For investment decisioning, the key point is that COCs have long-established chemistry and dosing paradigms, and most incremental value from “brand” status generally comes from label lifecycle management (switching, marketing, patient-segment targeting) rather than durable patent landscapes typical of novel therapeutics.

From an IP perspective, SEASONALE’s value trajectory is usually governed by:

• Generic substitution after patent or exclusivity expiry
• Formulary-driven volume erosion
• Brand maintenance through contracting and rebates

(Drug-level patent mapping requires a product-specific dossier and legal status table by jurisdiction; without that mapping, the only accurate conclusion is that SEASONALE belongs to a class where IP durability is typically limited vs first-in-class drugs.)

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How does the market work: demand, pricing, and substitution risk?

What are the demand fundamentals for combined oral contraceptives (COCs)?

COCs are a mature chronic category with:

• Steady baseline demand tied to contraception needs
• Volume shifts driven by guideline preference, switching tolerance, adverse event perception, and pregnancy-prevention adherence
• Ongoing head-to-head and class competition across brands and generics

What is the pricing and reimbursement reality?

In the US, COC pricing is dominated by:

• Wholesale acquisition cost (WAC) vs net price (rebates, discounts, payer contracting)
• Formulary tiering and preferred status
• Switching to generics when formulary pressure increases

For an investment lens, net pricing strength is the swing factor. A legacy brand like SEASONALE typically faces:

• Net price compression after generic entry or formulary change
• Volume retention only if managed-care access remains favorable and patients remain stable on regimen

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What are the competitive forces and share drivers?

How does SEASONALE compete in a saturated OC field?

COCs compete on regimen schedule and brand contracting. SEASONALE’s extended-cycle positioning (fewer withdrawal bleeds vs monthly) targets patients who prefer less frequent cycles.

Competitor set structure typically includes:

• Other extended-cycle COCs
• Monthly COCs
• Generic levonorgestrel/ethinyl estradiol equivalents and related COCs (class substitution)

Implication for fundamentals: SEASONALE’s “moat” is not chemical novelty. It is prescription persistence under payer contracts and patient preference for extended dosing schedules.

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Investment scenario modeling: base case vs downside vs upside

Base case: stable access with modest net-price pressure

A base case for SEASONALE typically assumes:

• Continued availability and predictable prescription volume
• Ongoing net price pressure from competitive contracting
• Incremental volume stability if formulary placement stays intact

Investor signal to monitor: persistence in managed-care coverage and pharmacy benefit tier position.

Downside case: formulary erosion triggers faster generic substitution

Downside typically occurs when:

• A major payer downgrades the brand
• Preferred generic alternatives widen access
• Patient persistence falls due to switches driven by cost

Investor signal to monitor: share loss acceleration and increased claims migration to generics.

Upside case: contracting strength and extended-cycle preference support resilience

Upside is possible when:

• SEASONALE maintains preferential coverage relative to category peers
• Extended-cycle dosing preference supports persistence
• Competitive set shifts create temporary brand retention benefits

Investor signal to monitor: claims growth or stable-to-improving prescription share despite industry net price compression.

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Fundamentals checklist for SEASONALE (what matters for an investment memo)

1) Revenue resilience is access-driven

For a legacy COC, the fundamental driver is managed-care access and retention rather than new clinical differentiation.

Operational metrics to track:

• Prescription volumes and Rx share in target geographies
• PBM formulary status and tier changes
• Patient persistence by time on therapy (switch rates)

2) Profitability is margin-and-mix sensitive

COC category economics are strongly influenced by:

• Net-to-gross conversion (rebates/discounting)
• Supply chain stability
• Contract structure with wholesalers, PBMs, and health plans

Investor signal: margin stability relative to category-wide net price movement.

3) Category-level policy and safety communications influence switching

COCs can experience shifts from:

• Safety communication cycles
• Label updates and risk messaging
• Guideline changes that affect the relative attractiveness of extended-cycle vs monthly regimens

Investor signal: changes in utilization patterns across OC subtypes.

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Why SEASONALE can still be investable despite “mature drug” status

Is there a workable thesis even without novel IP?

Yes, but only under an “access and persistence” thesis. In matured product categories, the investment decision turns on:

• Whether brand placement persists
• Whether net price compression is gradual enough to preserve cash generation
• Whether switching dynamics are favorable (patient persistence on extended-cycle dosing)

A legacy OC brand can produce reliable cash flows when payer access holds, even if growth is limited.

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Key diligence actions for an investor (transaction-grade items)

What diligence should determine whether the thesis holds?

A rigorous diligence pack for SEASONALE should cover:

• Managed-care coverage map by PBM and major plan groups
• Claims-based performance: Rx volume, share, and switching rates
• Net price and rebate structure drivers (net realization over WAC)
• Generic competitive impact timing: which entry waves coincide with volume loss
• Channel mix: retail vs mail vs specialty-like pharmacy pathways (for OCs, retail/mail primarily)

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Key Takeaways

• SEASONALE is a mature combined oral contraceptive; its investment fundamentals are driven by managed-care access and patient persistence, not by technical innovation.
• The primary risk is net price compression and formulary-driven substitution, typical in legacy OC brands.
• The most actionable upside lever is staying preferred on formularies and maintaining Rx persistence for extended-cycle regimens.
• A viable investment thesis for SEASONALE is an access-resilience model with monitoring of claims, PBM tiering, and switching dynamics.

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FAQs

1) What product category is SEASONALE in?

SEASONALE is a combined oral contraceptive containing levonorgestrel and ethinyl estradiol delivered in an extended-cycle schedule.

2) What determines SEASONALE’s financial performance most?

Its performance is primarily determined by formulary placement, net pricing (rebates/discounts), and prescription persistence.

3) What is the biggest competitive threat to SEASONALE?

Generic substitution and formulary downgrades that accelerate switching to lower-cost alternatives.

4) Does SEASONALE rely on new scientific differentiation?

No. Its differentiator is extended-cycle dosing convenience rather than novel mechanism or clinical breakthroughs.

5) What diligence metric best predicts downside?

A rapid change in Rx share and switching rates after payer tier adjustments.

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References

[1] FDA. (n.d.). SEASONALE (levonorgestrel and ethinyl estradiol) prescribing information. U.S. Food and Drug Administration.
[2] FDA. (n.d.). Drug label database. U.S. Food and Drug Administration.