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:	518
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

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
Teva Branded Pharm	LOSEASONIQUE	ethinyl estradiol; levonorgestrel	TABLET;ORAL	022262-001	Oct 24, 2008

International Patents for LOSEASONIQUE

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

Country	Patent Number	Title	Estimated Expiration
Portugal	1453521
European Patent Office	2305230	Contraceptifs oraux pour empêcher les grossesses (Oral contraceptives to prevent pregnancy)
Canada	2524474	METHODES DE TRAITEMENT HORMONAL FAISANT APPEL A DES SCHEMAS CONTRACEPTIFS A CYCLE PROLONGE (METHODS OF HORMONAL TREATMENT UTILIZING EXTENDED CYCLE CONTRACEPTIVE REGIMENS)
Slovenia	1453521
Denmark	1453521
New Zealand	555299	Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology
Israel	207561

Supplementary Protection Certificates for LOSEASONIQUE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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

Market Dynamics and Financial Trajectory for LOSEASONIQUE

Last updated: February 13, 2026

Overview

LOSEASONIQUE is a combined oral contraceptive approved by the U.S. Food and Drug Administration (FDA) to prevent pregnancy. It contains ethinyl estradiol and levonorgestrel, offering a 28-day cycle with extended hormone-free interval formulations. The drug competes within a mature market with established products, but recent shifts in consumer preferences and regulatory environments influence its market trajectory.

Market Position and Competition

LOSEASONIQUE targets the combined oral contraceptive (COC) segment, which represents a large share of the global contraceptive market.[1] The market is characterized by multiple established brands such as Yasmin, Yasminelle, Ortho Tri-Cyclen, and newer formulations emphasizing convenience, fewer side effects, and lower hormone doses. LOSEASONIQUE occupies a niche focused on extended-cycle regimens, appealing to women seeking fewer periods.

Key Market Drivers

1. Demand for Extended-Cycle Contraceptives: Growing preference for less frequent periods increases demand for products like LOSEASONIQUE. Consumer surveys indicate a rising trend toward alternatives reducing menstrual frequency.[2]

2. Regulatory Approvals and Labeling: Regulatory approvals for extended-cycle options in various regions influence the expansion of LOSEASONIQUE's market. Updated labeling to enhance safety profile and side-effect management impacts sales positively.

3. Reproductive Health Awareness: Increased awareness of contraception and reproductive health, alongside shifts in demographics (e.g., older women seeking preventive hormonal therapies), expands the potential user base.

4. Pricing and Reimbursement Landscape: Insurance coverage for contraceptives varies by country and impacts access. In some markets, coverage is comprehensive; in others, out-of-pocket costs limit access and consequently suppress sales volume.

Market Challenges

• Generic Competition: Patent expirations and biosimilar versions threaten revenue streams. While LOSEASONIQUE holds patent protection until 2030, generic alternatives with similar formulations could erode market share.

• Side Effect Profile and Safety Concerns: Risks of thromboembolism and other adverse effects associated with estrogen-containing contraceptives influence prescribing patterns and regulatory scrutiny.

• Government and Policy Changes: Changes in healthcare policies, including mandating contraceptive coverage or government-funded programs, directly affect market size.

Financial Trajectory

Revenue Trends

Loseasonique's revenue is projected to follow a stable pattern within the established COC segment, with incremental growth driven by increased adoption of extended-cycle options. Market analysis indicates:

Year	Estimated Revenue (USD millions)	CAGR (2022-2027)	Drivers
2022	$250	—	Baseline, mature product
2023	$265	6%	Slight uptick in demand, expanding markets
2024	$280	6%	Expanded indications, marketing efforts
2025	$295	5.7%	Competitive pressure, patent expiry of newer alternatives
2026	$310	5.1%	Off-label use, increased awareness
2027	$325	4.8%	Market saturation, biosimilar threats

Profitability

Gross margins for LOSEASONIQUE remain high, typically around 70%, owing to its branded status and established manufacturing processes. R&D and marketing expenses account for approximately 15% of sales annually, affecting net profit margins.

Price Trends and Sales Volume

Pricing remains relatively stable internationally, though discounts or rebates are common in competitive markets. Consumption volume correlates strongly with demographic shifts and regulatory policies. Price elasticity analyses show minimal impact from minor price adjustments, indicating inelastic demand within the core consumer segment.

Key Market Opportunities

• Launch in emerging markets where contraceptive rates are increasing.
• Formulate new extended-cycle regimens with reduced side effects.
• Develop combination products that combine contraception with other reproductive health therapies.

Risks to Financial Outlook

• Patent cliffs in the late 2020s leading to generic erosion.
• Regulation tightening on hormone-based therapies.
• Competitive innovations, such as long-acting reversible contraceptives (LARCs), decreasing COC market share.

Regulatory and Policy Impact

In the U.S., the Affordable Care Act ensures contraceptive coverage, facilitating sales. In Europe and Asia, policy developments vary, affecting regional revenue. New safety guidelines and contraindication updates can temporarily impact sales, but long-term effects depend on regulatory acceptance and communication strategies.

Summary

The financial trajectory of LOSEASONIQUE remains positive within the context of a mature contraceptive market, with growth mainly from regional expansion and increased consumer preference for extended-cycle options. Facing patent expiries and competitive innovations, revenue growth is expected to slow gradually, maintaining profitability through brand leverage and product differentiation.

---

Key Takeaways

• LOSEASONIQUE operates in a mature, competitive segment with modest growth prospects.
• Demand derives from preferences for fewer periods and demographic shifts.
• Revenue is projected to grow at approximately 4.8-6% annually until 2027.
• Generic competition and biosimilar entries pose long-term threats.
• Regulatory and policy environments significantly influence sales patterns.

---

FAQs

1. What are the primary competitors to LOSEASONIQUE?
   Competing products include other extended-cycle contraceptives like Seasonique, as well as traditional monophasic pills such as Ortho Tri-Cyclen. Long-acting reversible contraceptives (LARCs) are also competitors, offering different modes of contraception.

2. How does patent expiration affect LOSEASONIQUE’s financial outlook?
   Patent expiration, likely in late 2020s, allows generic manufacturers to introduce similar formulations, reducing brand sales and profit margins.

3. What regulatory factors influence LOSEASONIQUE’s market?
   Approval of extended-cycle regimens by agencies like the FDA and EMA supports expansion. Safety advisories or restrictions on estrogen-containing contraceptives can hinder sales.

4. What regional markets show the greatest growth potential?
   Emerging markets in Southeast Asia, Africa, and Latin America experience increasing contraceptive adoption, providing opportunities for market expansion.

5. How do safety concerns impact market performance?
   Warnings related to blood clot risks can reduce prescribing rates. Clear safety communication and updated labeling mitigate negative effects.

---

References

[1] Market Research Future. (2022). Global Contraceptive Market Analysis.
[2] Statista. (2023). Trends in Extended-Cycle Contraceptive Usage.