LOSEASONIQUE Drug Patent Profile

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

Loseasonique 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 LOSEASONIQUE 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 Loseasonique

There has been one patent litigation case 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 LOSEASONIQUE

International Patents:	22
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Patent Applications:	684
Drug Prices:	Drug price information for LOSEASONIQUE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LOSEASONIQUE
What excipients (inactive ingredients) are in LOSEASONIQUE?	LOSEASONIQUE excipients list
DailyMed Link:	LOSEASONIQUE at DailyMed

See drug prices for LOSEASONIQUE

Paragraph IV (Patent) Challenges for LOSEASONIQUE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOSEASONIQUE	Tablets	ethinyl estradiol; levonorgestrel	0.1 mg/0.02 mg and 0.01 mg	022262	1	2009-11-16

US Patents and Regulatory Information for LOSEASONIQUE

LOSEASONIQUE 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	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008	AB	RX	No	No	7,855,190

Expired US Patents for LOSEASONIQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008	7,615,545
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008	7,858,605

International Patents for LOSEASONIQUE

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

Country	Patent Number	Title	Estimated Expiration
Australia	2002348272
Australia	2008237614
Bulgaria	108736
Brazil	0214716
Brazil	PI0214716	kit, preparos, e uso de estrogênio e progestina na fabricação de um medicamento para uso na prevenção de gravidez

Supplementary Protection Certificates for LOSEASONIQUE

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

LOSEASONIQUE market dynamics and financial trajectory (2026): growth drivers, pricing pressure, and loss of exclusivity risk

Last updated: July 22, 2026

Loseasonique is a branded oral contraceptive (levonorgestrel and ethinyl estradiol) marketed for continuous use schedules (extended-cycle style). Market dynamics across the US depend on (1) how quickly payers tighten on plan formularies for older oral contraceptives, (2) competitive substitution from generics and authorized generics, and (3) any residual exclusivity from Orange Book-listed patents covering the specific product and dosing regimen.

This page compiles the market and financial trajectory drivers that typically determine revenue path for an oral contraceptive brand, with an emphasis on US payer dynamics, launch and coverage effects, and the practical timing of generic entry risks via Orange Book status and Hatch-Waxman exclusivity.

Is Loseasonique a growth brand or a declining brand versus generic oral contraceptives?

Answer: Loseasonique’s commercial trajectory is structurally exposed to the usual oral contraceptive pattern: branded revenue expands or stabilizes mainly when coverage is secured (commercial and managed Medicaid), then compresses quickly as generics/authorized generics take formulary share.

What drives uptake in oral contraceptives after launch

• Plan formulary placement: Preferential tier placement drives script volume. Oral contraceptives are high-substitution products.
• Copay design and rebate economics: Commercial net pricing depends more on rebate and payer contracting than on list price.
• Switching friction: Patient switching to generics is usually low, but discontinuation and restart patterns affect adherence and measured persistence.

What typically triggers revenue compression

• Generic and A/B rated substitution: When branded-to-generic substitution becomes widespread, remaining branded demand shifts to higher willingness-to-pay segments, which is limited.
• Payer tightening: Step edits, prior authorization, and higher copays for non-preferred products usually follow after competitive entry.
• Channel mix: Wholesaler buying surges around new formulary access can reverse when coverage is lost.

How many patents protect Loseasonique and how does that affect its revenue runway?

Answer: The revenue runway for Loseasonique depends on the Orange Book listing tied to the specific NDA product, including active ingredient, dosage form, and any listed formulation or method-of-use patents. Patent expiration and any pediatric exclusivity can extend time before Paragraph IV challenges translate into generic entry.

Patent estate mechanisms that extend sales

• Composition/formulation patents: Cover specific drug substance ratios, dissolution/performance targets, or manufacturing-related formulation features.
• Method-of-use patents: If claims cover the clinical regimen (for example, extended-cycle schedule), they can delay “carve-out” generic switching.
• Timing extensions: 6 months of pediatric exclusivity (if applicable) can push a generic launch window.

What matters for financial trajectory

• Revenue usually declines before legal exclusivity expires because payers anticipate entry and shift to preferred generics.
• If Loseasonique has a limited patent estate or weak blocking patents, the brand’s practical runway can end earlier.

When does Loseasonique lose exclusivity and what generic entry risks exist?

Answer: The generic entry risk is highest once Orange Book exclusivity tied to Loseasonique ends and when any Paragraph IV litigation yields an adverse event for the brand or a settlement that accelerates the launch date.

Paragraph IV risk structure for oral contraceptive brands

• First paragraph IV filer: If a generic applicant is the first to challenge and wins (or settles to enter early), it sets the market’s substitution pace.
• 30-month stay: The FDA approval date can be held off during litigation. If the brand loses or settles, the stay can end and launch follows.
• Authorized generics: Even with litigation, an authorized generic can blunt revenue before true “skinny-label” or label-designated switches.

How this translates into financial trajectory

• Expect a sharp net sales inflection around authorized generic entry or first generic launch.
• After multiple competitors enter, pricing becomes rebate-driven and net revenue per script falls.

What is the Orange Book status of Loseasonique and which patents block generic substitution?

Answer: Orange Book status determines whether generics can launch on Day 1 of eligibility or must wait out blocking patents.

Orange Book entries that matter commercially

• Active ingredient and dosage form coverage: If the listed patents are specific to the exact dosage presentation, substitution risk increases once they expire.
• Use and regimen coverage: If extended-cycle dosing is claimed, label design and method-of-use carve-outs can slow entry.
• Manufacturing and device-adjacent patents: Less common for simple tablets, but if present, they can create process/IP barriers.

Commercial read-through

• If Loseasonique is widely substituted already, the Orange Book may have limited “economic” blocking power.
• If substitution is limited, blocking patents and exclusivity likely still constrain generic design.

What generic or authorized generic competitors threaten Loseasonique’s market share?

Answer: Oral contraceptives face competitive pressure from multiple generic levonorgestrel/ethinyl estradiol extended-cycle/continuous regimen equivalents, plus any authorized generics from the brand owner’s agreements or from generic manufacturers holding supply rights.

Typical competitor classes

• Direct generics: Same active ingredients and regimen schedules.
• Interchangeable oral contraceptives: Different progestin or EE dose can still compete through therapeutically equivalent substitution.
• PBM-preferred alternatives: PBMs often steer toward specific labeled generics that meet their rebate and utilization targets.

Market share implications

• Even if Loseasonique remains on formulary, it can lose share if other products become preferred due to better rebate economics or lower PBM net cost.

How does Loseasonique compare with other oral contraceptives on payer acceptance and net pricing?

Answer: Loseasonique’s payer acceptance is usually determined by contract position with PBMs and by how quickly it falls to non-preferred status after generic entry.

Comparison factors that predict net sales

• Formulary tier: Preferred tier supports volume and retention.
• Copay and patient assistance: Brands often preserve adherence using patient support, but this can erode ROI after generics enter.
• Switching incentives: PBMs use financial levers to move members to lower-cost options.

What tends to separate stronger from weaker brands

• Differentiation that affects adherence or dosing convenience can preserve a niche.
• Brands with broader commercial coverage tend to sustain longer before steep compression.

What patent litigation affects Loseasonique and how do settlements change launch timing?

Answer: For oral contraceptives, litigation outcomes and settlements typically determine whether generics launch at the earliest permissible date, at a delayed date, or enter via authorized generic channels.

Settlement patterns seen in Hatch-Waxman

• “Pay-for-delay” style outcomes: Brand pays to settle, generic launches on a later schedule.
• Design-around: Generic modifies label or dosing approach to avoid method-of-use claims.
• Early entry: Settlement allows launch prior to final exclusivity end, which usually triggers rapid net price compression.

Financial trajectory impacts

• Net sales often fall in phases: (1) anticipation pricing pressure, (2) authorized generic impact, (3) full generic substitution.

How strong is the patent estate for Loseasonique compared with typical oral contraceptive products?

Answer: For oral contraceptives, patent estates are often thinner than for biologics or complex small molecules because core compositions have been stable for years. Economic strength depends on whether patents cover the specific extended-cycle regimen, formulation performance, or uniquely constrained manufacturing steps.

What a “strong” estate means in practice

• Claims that block generic label designs or prevent narrow carve-outs.
• Multiple active patents extending beyond core composition protection.
• Weak generic ability to design around without changing regimen labeling.

What a “weak” estate implies

• Generic entry at or near first allowable date.
• Faster payer substitution and steeper net price erosion.

What are the FDA regulatory milestones for Loseasonique that shape market adoption?

Answer: FDA approvals for oral contraceptives typically do not drive short-term revenue beyond initial launch and label updates. Post-approval regulatory signals that matter are often tied to generic entry eligibility and any labeling restrictions.

Key milestones that influence commercial performance

• Initial NDA approval and label: Determines ability to claim regimen benefits.
• CBE supplements or label updates: Can affect prescriber confidence and payer coverage.
• Switch readiness: FDA approval of generic products triggers formulary and dispensing shifts.

Which formulation patents or dosing-regimen patents matter for Loseasonique?

Answer: In oral contraceptives, formulation patents matter mainly when they protect specific product performance or manufacturing characteristics that a generic cannot easily replicate. Dosing regimen patents matter if they restrict how the product can be indicated or used.

Formulation-risk implications

• If formulation claims are narrow or easily design-around, generics can launch with equivalent tablets.
• If regimen claims are enforceable, label carve-outs can slow substitution despite AB-rated active ingredient equivalence.

Manufacturing and IP barriers: does process IP slow generic competition for Loseasonique?

Answer: For tablets, manufacturing process IP can delay competition only if the generic must replicate a protected process step or if process details are required to satisfy regulatory comparability with the protected product performance.

What to look for in competition

• Whether generic applicants cite manufacturing equivalence without copying protected methods.
• Whether the brand has successfully enforced process claims in prior cases.

Revenue exposure model: what portion of Loseasonique sales is at risk from generic entry?

Answer: Oral contraceptive brands typically face a high percentage of revenue exposure to generic entry because substitution is clinically straightforward and reimbursement is cost-sensitive.

How exposure usually manifests

• Pre-launch: PBMs adjust preferred status ahead of date of generic entry.
• At launch: Share shifts quickly because generic pricing anchors net costs.
• Post-launch: Net sales per script declines as rebate intensity changes and competitors underbid.

Practical financial indicators

• Declining prescription share after formulary shifts.
• Net price compression even if volumes initially stabilize.

Key Takeaways

• Loseasonique’s financial trajectory is likely governed less by patient demand and more by payer formulary placement, rebate economics, and the timing of generic/authorized generic entry.
• The Orange Book and patent estate strength directly translate into the practical revenue runway: even before legal expiration, payers anticipate entry.
• Paragraph IV litigation outcomes and settlements typically determine whether compression is gradual (delayed entry) or abrupt (accelerated authorized generic or early launch).
• In oral contraceptives, revenue exposure to generic competition is high because substitution is routine and reimbursement favors the lowest net-cost option.

FAQs

1. What Orange Book patents and exclusivities determine when Loseasonique generics can launch?
2. How do authorized generics for levonorgestrel/ethinyl estradiol products affect Loseasonique net sales before full generic entry?
3. Do method-of-use or regimen patents delay substitution for extended-cycle oral contraceptives like Loseasonique?
4. What typically happens to a branded oral contraceptive’s formulary status and net pricing after the first Paragraph IV launch?
5. How do copay support and rebate contracting change once Loseasonique faces multiple generic competitors?

References (APA)

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. (Accessed 2026).
2. FDA. Hatch-Waxman Amendments and Paragraph IV Abbreviated New Drug Applications: Overview of exclusivity and litigation framework. US Food and Drug Administration. (Accessed 2026).