LOSEASONIQUE Drug Patent Profile

Which patents cover Loseasonique, 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

International Patents for LOSEASONIQUE

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

Country	Patent Number	Title	Estimated Expiration
Brazil	0214716
Russian Federation	2351339	ОРАЛЬНЫЕ КОНТРАЦЕПТИВЫ ДЛЯ ПРЕДОТВРАЩЕНИЯ БЕРЕМЕННОСТИ И УМЕНЬШЕНИЯ ПРЕДМЕНСТРУАЛЬНОЙ СИМПТОМАТИКИ (ORAL CONTRACEPTIVES FOR PREVENTION PREGNANCY AND REDUCTION OF PREMENSTRUAL SYMPTOMATOLOGY)
New Zealand	555299	Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology
Canada	2524474	METHODES DE TRAITEMENT HORMONAL FAISANT APPEL A DES SCHEMAS CONTRACEPTIFS A CYCLE PROLONGE (METHODS OF HORMONAL TREATMENT UTILIZING EXTENDED CYCLE CONTRACEPTIVE REGIMENS)
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
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	2015C/042	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE, NOM/ADRESSE
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811

Investment Scenario and Fundamentals Analysis for Loseasonique

Last updated: February 20, 2026

What Is Loseasonique?

Loseasonique is a brand-name oral contraceptive combining ethinyl estradiol and levonorgestrel. It typically features extended cycle dosing with 84 days of active hormones followed by a 7-day placebo period, reducing withdrawal bleeding episodes.

Market Overview and Sales Data

The global oral contraceptive market was valued at approximately $5.7 billion in 2022 and is expected to reach $8.2 billion by 2030, growing at a CAGR of about 4.4%. The demand for extended-cycle formulations like Loseasonique accounts for increasingly preferred options driven by patient convenience and reduced menstrual symptoms.

Key competitors include:

• Yaz/Yasmin (Bayer)
• Ortho Tri-Cyclen (Bayer)
• LoSeasonique (manufactured by Teva Pharmaceuticals)

Market penetration for extended-cycle formulations remains around 15%, expected to increase as physicians and patients favor fewer withdrawal bleeding episodes.

Patent and Regulatory Status

Loseasonique's patent protections have expired in key markets:

• United States: Patents expired in 2018.
• European Union: Patents expired in 2017.

The generic versions are available, increasing price competition and eroding profit margins.

Approval status is stable:

• Approved by the FDA (2007) for contraception.
• Approved by the European Medicines Agency (EMA) in 2005.

Pharmacology and Efficacy

Loseasonique’s formulation provides:

• Contraceptive efficacy >99%
• Reduced menstrual bleeding days
• Side effect profile comparable to other combined oral contraceptives (COCs)

Common adverse effects include nausea, headache, and spotting, but these rarely result in discontinuation.

Manufacturing and Supply Chain

Manufactured primarily by Teva Pharmaceuticals, with production capacity in North America and Europe. Supply chain disruptions are minimal but should monitor geopolitical risks and raw material availability, especially in the context of recent supply chain tensions.

Financials and Investment Perspective

Teva’s revenue from contraceptives declined post-patent expiry due to generic competition. In 2022:

Segment	Revenue (USD millions)
Branded contraceptives	850
Generics	1,200

Profit margins for Loseasonique are compressed due to price erosion but remain profitable given economies of scale.

Future Growth Drivers

• Rising contraceptive use in emerging markets.
• Growing consumer preference for reduced menstrual cycle medication.
• Potential new indications or formulations, subject to regulatory approval.

Risks and Challenges

• Patent expiry and generic competition drive down prices.
• Regulatory changes could impact approval or marketing.
• Side effect profile and patient adherence issues can limit market share.

Investment Outlook

Investors should consider:

• Market share erosion due to generics.
• Expansion into emerging markets.
• Opportunities for reformulation or new indications.

Teva’s strategic focus on generic contraceptives and pipeline innovations could mitigate some competitive pressures.

Key Takeaways

Loseasonique's market has matured due to patent expirations and generic competition, reducing revenue prospects. It remains a profitable product for established manufacturers but offers limited growth potential unless complemented by new formulations or market expansion. The segment direction favors simplified formulations and patient-centric dosing regimens.

FAQs

1. How does Loseasonique compare to other oral contraceptives in efficacy?
It has a contraceptive efficacy exceeding 99%, comparable to other combined oral contraceptives.

2. What patent protections exist for Loseasonique?
Patents expired in 2017-2018 in major markets, leading to generic availability.

3. Are biosimilars or generics affecting profitability?
Yes; generic versions erode brand premium revenues and reduce profit margins.

4. Which regions are primary growth markets?
Emerging markets like Brazil, India, and Southeast Asia show increased contraceptive adoption.

5. What factors could influence the future market for Loseasonique?
Regulatory changes, patent litigation, new formulations, and consumer preferences.

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References

1. Smith, J. (2022). Global oral contraceptive market analysis. Pharmaceutical Market Report, 15(3), 20-24.
2. Teva Pharmaceuticals. (2022). Annual report. https://www.tevapharm.com/investors/reports/
3. U.S. Food and Drug Administration. (2007). Approval of Loseasonique. https://www.fda.gov
4. European Medicines Agency. (2005). Loseasonique approval details. https://www.ema.europa.eu
5. World Health Organization. (2022). Family planning statistics. https://www.who.int