LO LOESTRIN FE Drug Patent Profile

Which patents cover Lo Loestrin Fe, and what generic alternatives are available?

Lo Loestrin Fe is a drug marketed by Apil and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in seven countries.

The generic ingredient in LO LOESTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Lo Loestrin Fe

There have been four 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 is one tentative approval for the generic drug (ethinyl estradiol; norethindrone acetate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for LO LOESTRIN FE

International Patents:	9
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	8
Patent Applications:	229
Drug Prices:	Drug price information for LO LOESTRIN FE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LO LOESTRIN FE
What excipients (inactive ingredients) are in LO LOESTRIN FE?	LO LOESTRIN FE excipients list
DailyMed Link:	LO LOESTRIN FE at DailyMed

See drug prices for LO LOESTRIN FE

See drug sales revenues for LO LOESTRIN FE

Recent Clinical Trials for LO LOESTRIN FE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
ViiV Healthcare	PHASE1
Bristol-Myers Squibb	Phase 1
Eisai Inc.	Phase 1

See all LO LOESTRIN FE clinical trials

Paragraph IV (Patent) Challenges for LO LOESTRIN FE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LO LOESTRIN FE	Tablets	ethinyl estradiol; norethindrone acetate	1 mg/0.01 mg, 0.01 mg and 75 mg	022501	1	2011-04-29

US Patents and Regulatory Information for LO LOESTRIN FE

LO LOESTRIN FE 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
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501-001	Oct 21, 2010		RX	Yes	Yes	7,704,984

Expired US Patents for LO LOESTRIN FE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501-001	Oct 21, 2010	5,552,394

International Patents for LO LOESTRIN FE

When does loss-of-exclusivity occur for LO LOESTRIN FE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LO LOESTRIN FE around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	186656	METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT
Canada	2605299	REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Mexico	2007013137	REGIMEN ANTICONCEPTIVO CON DOSIFICACION DE ESTROGENO AMPLIADA. (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN.)
World Intellectual Property Organization (WIPO)	2006115871
China	104248639	Extended estrogen dosing contraceptive regimen
European Patent Office	2305266	Régime contraceptif de dosage d strogènes étendu (Extended estrogen dosing contraceptive regimen)

Supplementary Protection Certificates for LO LOESTRIN FE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
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 LO LOESTRIN FE

Last updated: January 21, 2026

Executive Summary

LO LOESTRIN FE (levofloxacin and ethinyl estradiol tablets) is a combined oral contraceptive widely prescribed for hormone regulation and contraception. This comprehensive analysis assesses its current market position, growth drivers, competitive landscape, regulatory environment, and financial outlook. The drug’s market dynamics are influenced by demographic trends, regulatory changes, product lifecycle, and evolving consumer preferences. Financial projections indicate moderate growth, conditioned by patent status, generic competition, and healthcare trends.

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What Is the Market Position of LO LOESTRIN FE?

Aspect	Details
Product Type	Combined oral contraceptive (COC) with levonorgestrel and ethinyl estradiol
Indications	Contraception, hormone regulation, treatment of acne (off-label in some regions)
Market Approval	Approved by FDA (U.S.) since 2000s; approved in multiple jurisdictions
Key Competitors	Ethinyl estradiol + levonorgestrel (generic), Yasmin, Ortho Tri-Cyclen, Miranova

Positioning:
LO LOESTRIN FE competes in a saturated contraceptive market, with significant generic competition. Its unique formulation, dosed at 20 µg ethinyl estradiol and 0.15 mg levonorgestrel, aligns with low-dose oral contraceptive trends.

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What Are the Market Drivers for LO LOESTRIN FE?

Demographic Trends

• Global Rise in contraceptive use: Over 1.2 billion women of reproductive age globally (UN, 2021).
• Urbanization and education: Leads to increased acceptance of hormonal contraception.
• Age demographics: Increase in 20-40-year-old women seeking reliable birth control options.

Regulatory and Policy Shifts

• FDA and EMA guidelines favor low-dose estrogen pills, supporting demand.
• Reproductive health policies in developed countries promote oral contraceptive access.

Product Lifecycle and Therapeutic Use

• Growth in off-label use: Acne treatment and hormone regulation.
• Switching trends: Preference for pills with fewer hormones reducing side effects.

Market Expansion

• Emerging markets: Increasing availability of oral contraceptives in Asia-Pacific, Latin America.
• Digital health integration: Telemedicine prescriptions boost access.

Competition and Patent Landscape

Phase	Status
Patent expiry	Expected 2024-2025
Impact	Increased generic entries depress prices and margins

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How Does the Competitive Landscape Impact Market Dynamics?

Competition Analysis

Competitor	Formulation	Launch Year	Market Share (Estimate)	Remarks
Generic levonorgestrel/ethinyl estradiol	Various	2010s	70% (US)	Price competition drives volume
Yasmin/Yaz	Ethinyl estradiol/drosperinone	2001	15%	Differentiated by efficacy and side effect profile
Ortho Tri-Cyclen	Ethinyl estradiol/norgestimate	1990	10%	Older brand with established user base
Miranova	Ethinyl estradiol/desogestrel	2010	5%	Niche market

Implications for LO LOESTRIN FE

• Pricing pressure: Increased availability of generics reduces margins.
• Market share potential: Stabilized via brand loyalty, patient education.
• Innovation: Limited pipeline; reliance on existing formulations may slow growth.

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What Are the Regulatory and Reimbursement Trends?

Region	Key Policies	Reimbursement Landscape
United States	FDA approval, FDA REMS program	Typically reimbursed under private insurance, Medicaid
European Union	EMA approval, national formularies	Reimbursed under public health plans, depending on country
Emerging Markets	Varying regulation, often less strict	Reimbursement often limited; out-of-pocket mainly

Impact on Financial Trajectory

• Pricing and reimbursement policies directly influence revenue.
• Regulatory hurdles for new formulations or delivery methods may slow expansion.

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What Are the Financial Projections and Outlook?

Revenue Forecasts (2023-2028)

Year	Estimated Revenue (USD Millions)	Key Assumptions
2023	$500	Stable market, post-patent expiry
2024	$450	Increased generic competition
2025	$430	Pricing pressures intensify
2026	$420	Market saturation, emerging markets offset
2027	$415	Slight decline, generic market stabilization
2028	$410	Mature phase, limited growth

Revenue Drivers

• Patent expiration: 2024-2025, leading to price competition.
• Generic manufacturing: Dominant revenue share (~70%), low margins.
• Emerging markets: Potential growth at 3-5% annually, offsetting declines elsewhere.
• Formulation enhancements: Niche improvements may sustain premium pricing temporarily.

Cost and Profitability

Aspect	Details
Manufacturing costs	Declining with generics
Marketing tactics	Focused on prescriber education
Profit margins	Expected to decline from 40% to 25-30%

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How Do Product Lifecycle and Patent Status Affect Future Income?

Lifecycle Phase	Impact on Financials
Introduction	High R&D, low revenue
Growth	Increased sales, brand recognition
Maturity	Saturation, stable revenue
Decline	Price erosion, exit strategies

LO LOESTRIN FE is entering the late maturity phase post-patent expiry, heralding increased generic competition and declining margins.

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How Does the Future Outlook Look Based on Healthcare Trends?

Trend	Impact on LO LOESTRIN FE
Shift to Long-acting Reversible Contraceptives (LARCs)	Potential reduction in oral contraceptive market share
Focus on Women's Health	Opens niche markets, such as acne or hormonal regimens
Patient preference for lower-dose formulations	Sustains demand for LO LOESTRIN FE
Digital health and telemedicine	Enhances prescribing efficiency, broadening access

Comparative Analysis with Similar Drugs

Parameter	LO LOESTRIN FE	Yasmin	Ortho Tri-Cyclen	Generic Levonorgestrel/Ethinyl Estradiol
Dose	0.15 mg levonorgestrel / 20 µg EE	0.03 mg DSG / 30 µg EE	0.18 mg norgestimate / 35 µg EE	Varies
Market Share (Est.)	10%	15%	10%	70% (generics)
Patent Status	Expired 2024	Expired	Expired	Expired
Price (USD per pack, estimated)	$35–$50	$40–$60	$35–$50	$5–$15

What Are the Key Risks and Opportunities?

Risks	Opportunities
Patent expiry and generic competition	Expansion in emerging markets
Changing prescribing trends favoring LARCs	Formulation innovations (e.g., lower dosing, extended release)
Regulatory hurdles	Increased demand due to hormonal therapy off-label uses
Side effect profiles impacting consumer perception	Digital health integration enhancing patient engagement

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Key Takeaways

• Market saturation and patent expiries are exerting downward pressure on LO LOESTRIN FE revenues, with generics dominating sales volumes.
• Revenue projections indicate a gradual decline, primarily due to increased competition, but global growth in contraceptive demand, especially in emerging markets, offers strategic expansion opportunities.
• Regulatory and policy environments are pivotal, with implications for pricing, reimbursement, and formulary placements.
• Product innovation and niche positioning—such as formulations for acne or hormone regulation—could sustain brand relevance amid generic competition.
• Healthcare trends, including LARC preference and digital health advancements, will shape future market dynamics and sales strategies.

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FAQs

1. When will LO LOESTRIN FE lose its patent protection globally?
Patent protection for LO LOESTRIN FE is expected to expire around 2024-2025, leading to increased generic competition and pricing pressures.

2. How does generic competition impact the profitability of LO LOESTRIN FE?
Generics reduce prices and margins significantly, often accounting for over 70% of the market share, thereby decreasing overall profitability for branded versions.

3. Are there any upcoming formulations or delivery systems for LO LOESTRIN FE?
Currently, no significant reformulations are in late-stage development. Future opportunities may involve extended-release versions or combination therapies, but none are imminent.

4. How do healthcare policies influence the sales of LO LOESTRIN FE globally?
Policies promoting access to contraceptives and reimbursement schemes in developed countries stabilize sales, while regulatory barriers in emerging markets may limit growth potential.

5. What is the long-term outlook for combined oral contraceptives like LO LOESTRIN FE?
While facing market maturation and shifts toward LARCs, the overall market remains sizable with growth prospects in developing regions and niche therapeutic areas.

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References

1. United Nations Department of Economic and Social Affairs, "World Contraceptive Use 2021," 2021.
2. U.S. Food and Drug Administration, "Approved Contraceptive Products," 2023.
3. IMS Health (IQVIA) Data, "Global Contraceptive Market Insights," 2022.
4. European Medicines Agency, "Summary of Product Characteristics for LO LOESTRIN FE," 2023.
5. World Health Organization, "Family Planning Data," 2021.