seasonique Drug Patent Profile

Which patents cover Seasonique, 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
South Africa	200404249	ORAL CONTRACEPTIVES TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY
China	101001631	Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration
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)

Supplementary Protection Certificates for seasonique

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C20160011 00192	Estonia		PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414

SEASONIQUE (levonorgestrel/ethinyl estradiol extended-cycle) — Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is SEASONIQUE and how is it positioned in the market?

SEASONIQUE is an extended-cycle combined oral contraceptive (COC) containing levonorgestrel and ethinyl estradiol administered on a 21-day active/7-day low-dose or placebo-free interval schedule (product-specific regimen). It sits in the U.S. women’s health market category of oral contraception brands with substitution pressure from generics and from longer-acting contraceptive methods.

Market positioning is shaped by four forces:

1. Formulation and schedule differentiation
   Extended-cycle COC regimens compete on convenience (fewer withdrawal bleeds) and adherence, not on novelty of mechanism. That limits pricing power versus branded “standard” 28-day products and versus non-oral long-acting contraceptives.

2. Generic substitution and statutory competition
   As COCs transition from brand exclusivity into generic entry, pricing typically collapses toward AWP-discounted generic benchmarks. SEASONIQUE’s long-run trajectory is therefore dominated by the date of generic approvals and subsequent channel switching.

3. Channel mix (pharmacy vs managed care)
   Contraceptive buyers increasingly pay through formulary management. Where payers list generics as preferred, SEASONIQUE’s market share compresses unless it holds a non-preferred or specialty niche (limited in this category).

4. Therapeutic adjacency to other hormonal options
   Loss of share can occur not only to generic COCs but also to competing hormonal formats (patch, vaginal ring) and to long-acting reversible contraception (IUDs, implants).

How have market dynamics evolved for SEASONIQUE (pricing, share, and competitive landscape)?

SEASONIQUE is widely treated as a mature COC product in the market. The category’s competitive dynamics follow a repeatable pattern:

• Early brand premium: during patent/exclusivity windows, branded COCs price higher and gain channel traction via detailing and payer coverage.
• Generic-driven repricing: once ANDA entrants launch, net price and revenue typically decline as prescribers and patients move to lower-cost alternatives.
• Consolidation and reduced SKU value: mature COC portfolios shrink in perceived differentiation. Prescription switching increasingly depends on payer formularies, copays, and pharmacy inventory.

For SEASONIQUE, that category structure implies that its financial trajectory is governed less by incremental clinical differentiation and more by:

• timing of generic competition,
• payer formulary decisions,
• and the durability of any “extended-cycle” preference relative to standard 21/7 or 24/4 regimens.

What is the product’s financial trajectory: sales direction and revenue drivers?

A COC’s financial trajectory in the U.S. typically breaks into three segments:

1. Pre-generic plateau
   Branded sales hold while exclusivity remains. Growth comes from share gains and continued prescriber adoption rather than market expansion.

2. Generic price compression and share erosion
   After generic entry, two things happen simultaneously:

   • net pricing declines sharply (discounting and payer reimbursement adjustments),
   • and prescription volume shifts to lower-cost equivalents.

3. Post-erosion stabilization
   Revenues often stabilize at a lower level driven by remaining brand scripts, patients with prior-use preference, and managed care lists that still allow some branded utilization.

For SEASONIQUE, the same macro pattern applies: the long-run revenue curve in a mature COC class follows generic entry and payer substitution dynamics rather than innovation-led reacceleration.

What are the key market drivers that determine SEASONIQUE’s near-to-medium term financial outlook?

1) Payer formularies and cost sharing

COCs are highly sensitive to:

• preferred formulary status (generic-first policies),
• member copay tiers (brand copay penalties),
• and plan utilization management (prior authorization is less common for contraception but tiering is frequent).

2) Supply and switching behavior in retail channels

Once generics become widely stocked, pharmacies push lower-cost equivalents through:

• automatic substitution rules,
• inventory availability,
• and patient counseling at pickup.

3) Competitive pressure from non-oral contraception

Even where oral COCs retain volume, long-acting methods can dilute the overall contraceptive pill market. That reduces ceiling growth even if generic pricing stabilizes.

4) Clinical and regimen preference

Extended-cycle regimens can preserve a subsegment. But in mature markets, preference is usually not enough to sustain premium pricing after generic saturation.

What is the competitive benchmark for SEASONIQUE within the COC class?

SEASONIQUE competes against:

• generic levonorgestrel/ethinyl estradiol extended-cycle and related dose schedules, and
• other brand or differentiated extended-cycle COCs, where present.

The category’s benchmark for performance is usually measured by:

• script share trends at the pharmacy counter,
• net price trajectories post-generic,
• and formulary persistence across payer tiers.

Because SEASONIQUE’s mechanism is shared across many entrants, the product’s relative performance depends on whether it retains coverage despite generic availability, and whether it maintains patient-prescriber loyalty tied to extended-cycle convenience.

How does regulatory and intellectual property posture affect market dynamics?

SEASONIQUE’s market behavior is consistent with a product that has moved beyond the high-exclusivity phase typical for brand COCs, leading to:

• generic entry,
• and pricing pressure.

IP posture in COC portfolios generally matters most during the final years of exclusivity and patent life. After that, the market becomes primarily a function of channel substitution and payer economics.

Key takeaways

• SEASONIQUE’s market dynamics follow mature COC patterns: generic substitution and payer tiering drive net price erosion and share compression.
• The financial trajectory is expected to show decline after generic entry, then stabilization at a lower revenue base based on residual brand preference and formulary allowance.
• Forward performance depends on formulary persistence and extended-cycle regimen retention, but those advantages typically do not offset sustained generic and non-oral contraceptive competition.

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FAQs

1) What ultimately drives SEASONIQUE revenue in the U.S.?

Generic availability, payer formulary placement, and retail switching behavior are the dominant revenue drivers for mature COCs.

2) Does SEASONIQUE’s extended-cycle schedule protect it from generic erosion?

It can support residual demand, but extended-cycle convenience usually does not prevent net price and share compression once generics are established.

3) Is SEASONIQUE more threatened by other pills or long-acting contraception?

Both. Generic COCs pressure share within oral contraception, while long-acting methods dilute the overall contraceptive mix.

4) What matters most for near-term profitability?

Net pricing and channel mix under managed care contracts, which typically worsen after generic entry.

5) Can SEASONIQUE regain growth through clinical re-positioning?

COC growth in mature markets rarely reaccelerates without meaningful differentiation that changes payer and generic substitution economics.

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References

[1] FDA. “Drug Trials Snapshots: SEASONIQUE (levonorgestrel and ethinyl estradiol).” U.S. Food and Drug Administration.
[2] DailyMed. “SEASONIQUE (levonorgestrel and ethinyl estradiol) tablet, film coated.” U.S. National Library of Medicine.
[3] IMS Health / IQVIA. U.S. prescription and market trend reporting for oral contraceptives (industry category-level benchmarks).