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
European Patent Office	2305229
Japan	2010180236	ORAL CONTRACEPTIVE TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY
Japan	2007534622
Hungary	S1800033
World Intellectual Property Organization (WIPO)	03049744
Russian Federation	2006101214	СПОСОБЫ ГОРМОНАЛЬНОГО ЛЕЧЕНИЯ С ПРИМЕНЕНИЕМ КОНТРАЦЕПТИВНЫХ РЕЖИМОВ С НЕПРЕРЫВНЫМ ВВЕДЕНИЕМ ЭСТРОГЕНА

Supplementary Protection Certificates for LOSEASONIQUE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
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
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521	2015C/042	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE, NOM/ADRESSE
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON

Market Dynamics and Financial Trajectory for LOSEASONIQUE

Last updated: July 27, 2025

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Introduction

LOSEASONIQUE, a combination oral contraceptive (COC) marketed primarily for contraceptive efficacy and menstrual regulation, has carved out a niche within reproductive health. Its unique formulation and positioning influence its market dynamics and financial trajectory. This report examines the factors shaping LOSEASONIQUE’s market environment, competitive positioning, growth prospects, and financial outlook, providing insights for industry stakeholders and investors.

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Product Profile and Therapeutic Positioning

LOSEASONIQUE is a monophasic COC containing ethinyl estradiol and levonorgestrel, designed primarily for contraception and menstrual cycle regulation with extended cycle dosing. Its differentiation lies in its extended-use regimen, which reduces the frequency of withdrawal bleeding, potentially significantly improving patient compliance and convenience (source: manufacturer’s prescribing information).

This formulation appeals to women seeking less frequent bleeding episodes, aligning with trends toward more patient-centric contraceptive options. Its tolerability profile, combined with a well-established safety record, maintains its relevance in the contraceptive market segment.

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Market Dynamics

1. Global Contraceptive Market Growth

The global contraceptive market has experienced steady growth driven by increased awareness, rising female workforce participation, and expanding healthcare infrastructure in emerging markets. In 2022, the market was valued at approximately USD 20 billion, with forecasts projecting a compound annual growth rate (CAGR) of around 7% through 2030 (source: Grand View Research).

As a key segment, oral contraceptives account for a significant share, with both branded and generic options competing fiercely. LOSEASONIQUE, positioned as a premium, extended-cycle product, benefits from consumer preferences favoring reduced bleeding episodes.

2. Competitive Landscape

The competitive environment comprises major pharmaceutical corporations, generic drug manufacturers, and specialty biotech firms. Notable competitors include brands like Ortho Tri-Cyclen Lo, Yaz, and various generic equivalents.

Loseasonique’s distinct extended-cycle regimen offers a competitive advantage by addressing the unmet need for fewer menstrual periods, a growing consumer demand. However, generic competition and potential patent expirations pose risks to its revenue streams.

3. Regulatory and Reimbursement Environment

Regulatory approvals from agencies such as the FDA, EMA, and other regional authorities influence product accessibility. Reimbursement policies significantly impact consumer adoption, especially in healthcare systems emphasizing cost-effectiveness.

In developed markets, insurance coverage and physician preferences influence prescribing patterns favorably towards LOSEASONIQUE’s convenience. Conversely, high out-of-pocket costs may hinder penetration in certain regions.

4. Demographic and Socioeconomic Factors

Increasing urbanization, higher health literacy, and evolving social attitudes toward family planning fuel demand for effective, user-friendly contraceptives such as LOSEASONIQUE. Moreover, partnerships with healthcare providers and advocacy groups further enhance market penetration.

5. Patent and Patent Expirations

While LOSEASONIQUE’s patent protection extends until the mid-2020s, upcoming expirations threaten to increase generic competition. The entry of generics typically exerts downward pressure on prices, impacting revenue and margins.

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Financial Trajectory

1. Revenue Projections

Estimates suggest that LOSEASONIQUE’s annual global sales could be in the vicinity of USD 300–500 million (assuming current market share and growth trends). In mature markets, growth stabilizes, with incremental rises driven by increased demand for extended-cycle contraceptives.

Emerging markets present an attractive growth avenue, with pharma companies investing in market access strategies. A conservative growth estimate anticipates a CAGR of 4-5% over the next five years, factoring in increased penetration and demographic shifts.

2. Pricing and Reimbursement Impact

Pricing strategies are influenced by competitive pressures and reimbursement environments. Premium positioning may command higher prices in some markets, but price erosion due to generics will likely pressure margins over time.

Negotiations with payers and expanding formulary inclusion are crucial for sustaining revenue streams. Effective commercialization strategies can help offset the impact of patent expirations.

3. Cost Structure and Margins

Manufacturing costs for LOSEASONIQUE are relatively stable given the mature production processes. R&D investments are primarily focused on life-cycle management and line extensions rather than initial product development.

Gross margins are expected to remain stable in the short-term but may compress over time due to increased generic competition and pricing pressures.

4. Strategic Initiatives and Growth Drivers

Pharmaceutical companies are exploring new indications and formulations for extended-cycle contraceptives, which could diversify revenue sources. Digital health partnerships and educational campaigns targeting healthcare providers could also enhance market share.

Partnerships with regional distributors and tailored marketing for emerging markets are pivotal growth strategies poised to influence the financial trajectory positively.

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Risks and Challenges

• Patent Expires: Loss of exclusivity could lead to generic erosion, reducing revenues.
• Regulatory Changes: Stringent guidelines or restrictions on hormone-based contraceptives may impact market access.
• Market Penetration: Consumer preferences shifting towards non-hormonal or innovative contraceptive methods could diminish demand.
• Pricing Pressures: Increasing reimbursement scrutiny may pressure prices, affecting profitability.

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Conclusion

Loseasonique’s market dynamics are shaped by its extended-cycle formulation aligning with current consumer trends, competitive pressures from generics, and regional regulatory landscapes. While near-term revenues are supported by its established safety and convenience profile, its long-term financial success hinges on effective lifecycle management, diversification, and regional expansion.

Significant growth prospects exist in emerging markets, but the upcoming patent expirations and evolving healthcare policies necessitate proactive strategies. A balanced approach incorporating innovation, market access, and cost management will be essential in securing its financial trajectory.

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Key Takeaways

• Market Positioning: Loseasonique’s unique extended-cycle design appeals to consumer demand but faces advanced competition once patent protections expire.
• Growth Opportunities: Emerging markets and new formulation extensions offer substantial upside, provided regulatory and reimbursement hurdles are addressed.
• Revenue Outlook: Estimated global sales of USD 300-500 million with modest CAGR driven by increased adoption and regional expansion.
• Threats: Patent cliffs, generics, and changing consumer preferences pose significant challenges.
• Strategic Focus: Emphasize lifecycle management, regional market access, and innovation to maintain revenue streams amidst competitive and regulatory pressures.

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FAQs

1. When does LOSEASONIQUE’s patent protection expire?
Patent protection for LOSEASONIQUE is anticipated to expire in the mid-2020s, opening the market to generic competitors and potentially impacting sales.

2. How does LOSEASONIQUE compare to other extended-cycle contraceptives?
Loseasonique offers a favorable safety profile and user convenience through its extended-use regimen, aligning with trends toward less frequent bleeding, but faces similar competition from other extended-cycle formulations and generics.

3. What are the key growth strategies for LOSEASONIQUE?
Focus areas include expanding into emerging markets, developing new formulations or indications, strengthening healthcare provider partnerships, and navigating patent expirations with lifecycle management.

4. What are the primary risks to LOSEASONIQUE’s financial performance?
Patent expirations leading to generic competition, regulatory changes restricting hormone use, shifts in consumer preferences, and pricing pressures are major risks.

5. How does reimbursement influence LOSEASONIQUE’s market success?
Reimbursement policies determine accessibility; favorable coverage in developed markets enhances sales, whereas high out-of-pocket costs limit adoption in some regions.

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Sources
[1] Grand View Research. "Contraceptive Market Size & Trends." 2022.
[2] Manufacturer’s prescribing information. LOSEASONIQUE product label.
[3] Industry reports on pharmaceutical patent expirations and generics.
[4] Regulatory agency publications (FDA, EMA).