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-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
Purdue Pharma LP	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
China	104248639	Extended estrogen dosing contraceptive regimen
Canada	2605299	REGIME CONTRACEPTIF DE DOSAGE D'ESTROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)
Israel	186656	METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT
Mexico	2007013137	REGIMEN ANTICONCEPTIVO CON DOSIFICACION DE ESTROGENO AMPLIADA. (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN.)

Supplementary Protection Certificates for LO LOESTRIN FE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
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	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129

Market Dynamics and Financial Trajectory for LO LOESTRIN FE

Last updated: July 27, 2025

Introduction

LO LOESTRIN FE, a combined oral contraceptive pill produced by Teva Pharmaceuticals, holds a significant position within the global reproductive health market. Its formulation, which combines ethinyl estradiol and norethindrone, delivers hormonal contraception along with the benefit of low-dose estrogen, appealing to a broad demographic. This analysis explores the current market dynamics, competitive landscape, regulatory environment, and the anticipated financial trajectory of LO LOESTRIN FE, aiming to inform stakeholders and decision-makers within the pharmaceutical industry.

Market Overview

The global oral contraceptive market, valued at approximately $8.7 billion in 2022, is projected to expand at a compound annual growth rate (CAGR) of around 5.2% through 2030 [1]. This growth reflects increasing demand driven by rising awareness of reproductive health, improvements in healthcare infrastructure, and expanding markets in developing economies. LO LOESTRIN FE occupies a notable segment within this market, primarily targeting women seeking reliable, low-dose oral contraceptive options with fewer side effects.

Market Drivers

Several fundamental drivers underpin the growth of LO LOESTRIN FE and similar products:

• Health and Wellness Trends: Rising awareness of family planning and women's health contributes to sustained demand for effective contraceptives.
• Product Differentiation: The low estrogen dose of LO LOESTRIN FE reduces typical estrogen-related side effects, appealing to health-conscious consumers and healthcare providers.
• Regulatory Approvals: Regulatory bodies such as the FDA and EMA have streamlined approval processes for established formulations, facilitating continued market access.
• Market Penetration in Emerging Economies: Expanding healthcare infrastructure in Asia, Latin America, and Africa broadens access to contraceptive products, including LO LOESTRIN FE.

Competitive Landscape

LO LOESTRIN FE faces competition from a wide array of oral contraceptives, including both generic and branded formulations:

• Brand Competitors: Yaz, LoSeasonique, and Ortho Tri-Cyclen are well-established oral contraceptives with differentiated features.
• Generics Market: As patents expire, generic formulations from companies such as Mylan, Teva itself, and others have increased price competition.
• Innovative Alternatives: Long-acting reversible contraceptives (LARCs), such as intrauterine devices (IUDs), challenge oral contraceptive market share, especially in developed markets.

Teva's position relies on competitive pricing, established manufacturing capabilities, and a broad distribution network. Continued innovation and positioning as a cost-effective, reliable option bolster its market share.

Regulatory Environment

Regulatory landscapes significantly influence LO LOESTRIN FE's market trajectory. Stringent quality and safety standards in developed markets underpin consumer trust, while emerging markets may face varying levels of regulation and oversight. Recent regulatory trends driving the market include:

• Increased Focus on Safety Profiles: Post-market surveillance and safety updates may impact formulations and marketing.
• Patent Expiry and GENERIC APPROVALs: Expiration of key patents enables generic manufacturing, intensifying price competition.
• Regulatory Approvals for New Indications: Expansion into supplementary uses could create additional revenue streams.

Financial Trajectory Analysis

Forecasting LO LOESTRIN FE’s financial trajectory involves analyzing market demand, competitive pressures, pricing strategies, and regulatory impacts:

• Revenue Growth: Given the global expansion of contraceptive markets, LO LOESTRIN FE is expected to maintain a steady CAGR of approximately 4-6% over the next five years.
• Pricing Dynamics: Price erosion due to generic competition may exert downward pressure on margins; however, volume growth could offset reduced per-unit revenues.
• Market Penetration: Increased adoption in emerging markets and expanded insurance coverage in developed economies may drive revenues.
• R&D and Portfolio Diversification: Innovation in formulation or new indications—such as menstrual regulation or hormonal therapy—could open additional revenue streams.
• Patent and Exclusivity Challenges: The upcoming expiration of key formulations potentially ushers in rapid generic penetration, impacting profitability.

Risks and Opportunities

Risks:

• Patent Expiry: The imminent patent cliff threatens revenue erosion through generics.
• Market Competition: Price competition and alternative contraceptive methods could diminish market share.
• Regulatory Delays: Slower-than-anticipated approvals or adverse safety findings could impede growth.
• Market Access: Variability in healthcare infrastructure and affordability in developing countries may limit penetration.

Opportunities:

• Market Expansion: Growing contraceptive awareness can facilitate entry into underserved markets.
• Product Line Extension: Developing new formulations or delivery systems (e.g., extended-cycle pills) can attract new users.
• Strategic Partnerships: Collaborations with healthcare providers and NGOs improve distribution and acceptance.
• Digital and Telehealth Integration: Leveraging telemedicine to promote access and adherence increases consumer base.

Conclusion

LO LOESTRIN FE stands poised to sustain moderate growth within the global contraceptive market, supported by demographic trends, consumer preferences for safety-efficient formulations, and expanding global health initiatives. While patent expiries and intensifying competition pose challenges, strategic product positioning, innovation, and market expansion will be crucial to capitalize on emerging opportunities. Stakeholders must closely monitor regulatory developments and pricing strategies to navigate the evolving landscape effectively.

---

Key Takeaways

• The global oral contraceptive market is projected to grow at a CAGR of approximately 5.2%, favoring established products like LO LOESTRIN FE.
• Market dynamics are driven by rising awareness, product differentiation through low-dose formulations, and expanding geographic access.
• Patent expiries and generic competition pose significant risks, necessitating strategic focus on innovation and market penetration.
• Expansion into emerging markets and product line extensions represent critical growth opportunities.
• A balanced approach addressing regulatory changes, market competition, and consumer preferences will determine LO LOESTRIN FE’s financial success in the coming years.

---

FAQs

1. How does LO LOESTRIN FE differentiate itself from other oral contraceptives?
LO LOESTRIN FE offers a low-dose estrogen formulation combined with progestin, reducing estrogen-related side effects and improving tolerability. Its formulation suits women seeking reliable contraception with minimized hormonal side effects.

2. What are the primary factors influencing LO LOESTRIN FE’s market share?
Key factors include patent status, competitive pricing, endorsement by healthcare providers, consumer awareness, and regulatory approval in target markets.

3. How will patent expirations impact LO LOESTRIN FE’s financial performance?
Patent expirations typically lead to increased generic competition, which can diminish revenue margins and overall market share unless compensated by volume growth or product diversification.

4. Are there emerging markets with significant growth potential for LO LOESTRIN FE?
Yes, countries in Asia, Latin America, and Africa are witnessing expanding contraceptive needs, offering substantial growth prospects as healthcare infrastructure improves and awareness increases.

5. What strategic actions can Teva take to sustain LO LOESTRIN FE’s market leadership?
Teva can innovate through new formulations, expand into untapped markets, foster partnerships, enhance educational campaigns, and optimize cost structures to remain competitive.

---

Sources

[1] MarketResearch.com, "Global Contraceptive Market Size & Trends," 2022.