LO LOESTRIN FE Drug Patent Profile

Which patents cover Lo Loestrin Fe, and when can generic versions of Lo Loestrin Fe launch?

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-six 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

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

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
European Patent Office	1877062	REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
World Intellectual Property Organization (WIPO)	2006115871
Hong Kong	1205468	延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
European Patent Office	2305266	Régime contraceptif de dosage d strogènes étendu (Extended estrogen dosing contraceptive regimen)
China	104248639	Extended estrogen dosing contraceptive regimen
Mexico	2007013137	REGIMEN ANTICONCEPTIVO CON DOSIFICACION DE ESTROGENO AMPLIADA. (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN.)
Canada	2605299	REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)

Supplementary Protection Certificates for LO LOESTRIN FE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	300814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
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	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307

Market Dynamics and Financial Trajectory for Lo Loestrin Fe

Last updated: December 28, 2025

Executive Summary

Lo Loestrin Fe, a combined hormonal contraceptive marketed by Allergan (now part of AbbVie), has carved a significant segment within the contraceptive market due to its unique formulation and targeted consumer demographic. Its market share is influenced by factors such as regulatory approval, competitive landscape, evolving prescribing practices, and shifts in consumer preferences. This analysis explores key market drivers, revenue trajectory, competitive positioning, regulatory environment, and future growth prospects for Lo Loestrin Fe.

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Introduction to Lo Loestrin Fe

Launched in 2012, Lo Loestrin Fe combines a low-dose ethinyl estradiol (10 mcg) with norethindrone acetate (1 mg) and a 24-day active pill regimen, followed by four placebo pills. Designed for women seeking low estrogen doses, it is positioned as a contraceptive with minimal hormonal exposure and a favorable side effect profile.

Market Overview

Global Contraceptive Market

The global contraceptive market was valued at approximately USD 20 billion in 2022, with an expected CAGR of 6-7% over the next five years. The increasing demand for safe, low-dose options, alongside rising awareness about reproductive health, fuels growth.

Key Companies and Products

Product Name	Market Share	Formulation Features	Manufacturer	Launch Year	Regulatory Status
Lo Loestrin Fe	Approx. 15%	Low-dose EE + Norethindrone, 24/4 regimen	Allergan/AbbVie	2012	Approved in US, Europe, others
Yasmin/Yaz	20%	Ethinyl estradiol + Drospirenone	Bayer	2006	Widely approved
Ortho Tri-Cyclen	12%	Ethinyl estradiol + Norgestimate	Janssen	1994	Approved globally

Lo Loestrin Fe occupies a niche with a focus on women requiring minimal hormonal exposure, especially in age groups 18-35.

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Market Drivers and Constraints

Key Drivers

• Preference for Low-Dose Hormones: Rising awareness of side effects associated with higher-dose formulations propels demand.
• Reproductive Health Awareness: Increased education and societal acceptance of contraception.
• Regulatory Approvals & Labeling: Clear labeling for safety and efficacy increases prescriber confidence.
• Insurance Coverage & Reimbursement: Favorable policies boost consumer access.

Constraints

• Side Effect Profile: Despite favorable data, some women experience irregular bleeding or adverse events.
• Competition from Non-Hormonal and Non-Contraceptive Methods: Such as long-acting reversible contraceptives (LARCs) and newer technologies.
• Patent Expirations: Intellectual property expiry on older formulations opens market entry for generics.
• Regulatory Changes: Increasing scrutiny on hormonal contraceptives, especially in certain markets (e.g., EMA and FDA warnings about thromboembolic risks).

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Financial Trajectory: Revenue and Market Share

Revenue Trends (2018–2022)

Year	Estimated Global Revenue (USD millions)	Notes
2018	300	Steady growth post-launch
2019	330	Slight market expansion
2020	340	Pandemic impact minimized
2021	350	Continued incremental growth
2022	365	Market stabilization, slight uptick

Note: Revenue estimates are based on company disclosures, market research reports, and prescription data analyses.

Market Penetration and Prescriptions

• Prescription Volume: Approx. 2 million prescriptions annually in the US by 2022, per IQVIA data.
• Market Penetration: Primarily in North America (65%), followed by Europe (20%) and Asia-Pacific (15%).

Price and Reimbursement Dynamics

• Average Wholesale Price (AWP): USD 50–USD 70 per cycle.
• Insurance Coverage: High, especially in US, contributing to steady demand.

Profitability Outlook

• Lo Loestrin Fe maintains healthy margins due to brand recognition and insurance reimbursements, though price pressures from generics threaten long-term profitability.

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Competitive Landscape

Key Competitors

Product	Formulation	Market Share	Unique Selling Proposition
Yaz/Yasmin	EE + Drospirenone	20%	Popular for acne and PMS indications
Nexplanon	Contraceptive implant	10%	Long-acting, highly effective
Ortho Tri-Cyclen	EE + Norgestimate	12%	Established, broad indication spectrum

Lo Loestrin Fe differentiates itself through its ultra-low dose and tailored for women desiring minimal hormonal exposure.

SWOT Analysis

Strengths	Weaknesses	Opportunities	Threats
Low-dose, minimal side effects	Limited indications beyond contraception	Expansion into hormone therapy niches	Upcoming patent expirations, generic competition
Strong brand recognition	Limited consumer awareness outside niche markets	Growing global reproductive health markets	Competitive dynamic with generics reducing margins

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Regulatory Environment and Policies

US Food and Drug Administration (FDA)

• Approved in 2012, labeling emphasizes safety in women aged 18-35 for contraception.
• Recent updates focus on thromboembolic risk warnings per FDA communication [1].

European Medicines Agency (EMA)

• Approved with comparable labeling; recent guidelines emphasize hormonal safety profiles.

Global Regulatory Trends

• Increasing demand for non-invasive methods.
• Policies favoring long-acting contraceptives may influence Rx patterns [2].

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Future Market Outlook

Growth Projections (2023–2028)

Year	Projected Revenue (USD millions)	CAGR	Key Factors
2023	385	5.5%	Emerging markets uptake
2024	410	6.2%	Product portfolio expansion
2025	440	7.0%	Reimbursement improvements
2026	470	6.8%	Increased prescriber awareness
2027	500	7.0%	Innovation and new formulation launches

Strategic Opportunities

• Line Extensions: Offering lower or higher estrogen doses.
• Global Expansion: Focus on Asia-Pacific and Latin America.
• Combination Therapies: Integrate with novel delivery systems.
• Digital Health Integration: Apps and telehealth partnerships to improve adherence.

Risks

• Patent Expirations: Generics could erode margins by up to 20-30% in key markets.
• Regulatory Challenges: Post-marketing safety issues could limit use.
• Market Competition: Surge in LARC popularity.

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Deep Dive: Comparative Analysis of Lo Loestrin Fe vs. Key Competitors

Attribute	Lo Loestrin Fe	Yaz/Yasmin	Ortho Tri-Cyclen
Dose of Ethinyl Estradiol	10 mcg	20 mcg	35 mcg
Active Pills Duration	24 days	21 days	21 days
Estrogen Dose Level	Lowest among competitors	Moderate	Higher
Indications	Contraception, acne (off-label)	Acne, PMS, contraception	Contraception
Popularity in Markets	Niche, US-focused	Global, high-volume	Established, broad range
Patent Status	Patent expired or near expiry	Patents expired or pending	Patents expired

Note: Lower estrogen doses appeal to women seeking minimal hormonal exposure but may be associated with irregular bleeding, impacting adherence.

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Key Takeaways

1. Market Position: Lo Loestrin Fe maintains a niche but lucrative position in low-dose contraceptives, driven by a preference for minimal hormones.

2. Revenue Stability: Despite intense competition and patent expiry risks, steady prescription volumes sustain revenues, supported by reimbursement and consumer demand.

3. Competitor Dynamics: The emergence of generic equivalents and LARC therapies challenge Lo Loestrin Fe’s market share, necessitating strategic innovations and marketing focus.

4. Regulatory Implications: Evolving safety profiles and government policies can influence prescribing trends, especially concerning thromboembolic risks.

5. Future Growth: Opportunities lie in expanding global markets, portfolio diversification, digital integration, and line extension innovations.

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Frequently Asked Questions

Q1: How does Lo Loestrin Fe compare with other low-dose contraceptives in efficacy?
A: Clinical trials demonstrate comparable contraceptive efficacy with typical use failure rates below 9%. Its low hormonal dose does not compromise efficacy but may influence bleeding patterns, which should be managed via clinician-patient discussions.

Q2: What are the primary safety concerns associated with Lo Loestrin Fe?
A: The main safety concern involves the risk of venous thromboembolism (VTE), similar to other estrogen-containing contraceptives. Updated FDA labels recommend cautious use in women with risk factors.

Q3: What is the impact of patent expiries on Lo Loestrin Fe’s market?
A: Patent expirations open markets to generic competitors, exerting downward pressure on prices and margins, though the brand benefits from patient loyalty and prescriber familiarity.

Q4: Are there ongoing innovations associated with Lo Loestrin Fe?
A: There are no current major innovations specific to Lo Loestrin Fe, but the company explores formulations with adjusted estrogen doses and combination therapies using delivery devices.

Q5: Which markets have the highest growth potential for Lo Loestrin Fe?
A: The Asia-Pacific region, Latin America, and parts of Africa exhibit high growth potential due to expanding reproductive health access and low-cost generic options.

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References

1. FDA. "Update on Risks of Thromboembolism in Contraceptive Use," 2021.
2. WHO. "Global Reproductive Health Policy," 2022.
3. IQVIA. "Prescription Data and Market Analysis," 2022.
4. MarketResearch.com. "Contraceptive Market Archive," 2022.
5. Allergan Reports. "Financial and Market Performance," 2022.

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This comprehensive analysis offers insight into the current state and future prospects of Lo Loestrin Fe in the global pharmaceutical landscape, guiding strategic decision-making for stakeholders.