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Last Updated: December 14, 2025

LOESTRIN 24 FE Drug Patent Profile


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Which patents cover Loestrin 24 Fe, and when can generic versions of Loestrin 24 Fe launch?

Loestrin 24 Fe is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in LOESTRIN 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

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Summary for LOESTRIN 24 FE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 4
Clinical Trials: 8
Patent Applications: 229
What excipients (inactive ingredients) are in LOESTRIN 24 FE?LOESTRIN 24 FE excipients list
DailyMed Link:LOESTRIN 24 FE at DailyMed
Drug patent expirations by year for LOESTRIN 24 FE
Recent Clinical Trials for LOESTRIN 24 FE

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

SponsorPhase
ViiV HealthcarePHASE1
Bristol-Myers SquibbPhase 1
Eisai Inc.Phase 1

See all LOESTRIN 24 FE clinical trials

US Patents and Regulatory Information for LOESTRIN 24 FE

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 LOESTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 021871-001 Feb 17, 2006 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for LOESTRIN 24 FE

Last updated: November 20, 2025


Introduction

LOESTRIN 24 FE is a combined oral contraceptive introduced by Bayer Pharmaceuticals, combining ethinyl estradiol with ferrous fumarate. Designed as an oral contraceptive pill, it also addresses iron supplementation needs, providing a dual benefit for reproductive-age women. As a product positioned within the broad contraceptive and reproductive health markets, understanding its market trajectory involves analyzing competitive landscape, regulatory factors, consumer preferences, and technological developments. This report examines the market dynamics impacting LOESTRIN 24 FE, along with its projected financial trajectory, to aid strategic decision-making.


Market Landscape and Competitive Environment

The contraceptive market is characterized by its high maturity, relatively stable demand, and increasing diversification driven by innovation and shifting consumer preferences. Globally, the market was valued at approximately USD 17.3 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of about 4% through 2028 [1].

Key Competitors:
LOESTRIN 24 FE faces significant competition from both established brands and generic formulations. Major competitors include:

  • Ortho Tri-Cyclen (Johnson & Johnson)
  • Yaz (Bayer)
  • Alesse (Bristol-Myers Squibb)
  • Generic formulations offered by other pharmaceutical firms

The competitive positioning of LOESTRIN 24 FE hinges on its dual-action formulation—a combined oral contraceptive plus iron supplementation—which differentiates it somewhat within a crowded pipeline of contraceptive options.

Market Segmentation:
The product primarily targets women aged 15-45, with a focus on those seeking convenient, combined contraception coupled with iron supplementation. This niche is expanding as women prioritize health benefits beyond contraception, such as anemia prevention.


Regulatory and Demographic Drivers

Regulatory Environment:
Regulatory approvals remain critical for sustained market success. LOESTRIN 24 FE’s approval status across major markets (e.g., FDA in the U.S., EMA in Europe, and health authorities in emerging markets) influences its sales trajectory. The recent trend toward personalized medicine and non-hormonal options may challenge traditional contraceptives but also open avenues for innovations.

Demographic Trends:
Increasing awareness of reproductive health, especially among millennial and Gen Z populations, is boosting demand for oral contraceptives. Additionally, women in developing economies exhibit rising contraceptive adoption, driven by urbanization, better healthcare infrastructure, and government policies promoting reproductive rights [2].

Public Health Initiatives:
Government programs targeting maternal health, adolescent health, and anemia reduction are favorable for products like LOESTRIN 24 FE that combine contraceptive efficacy with iron supplementation benefits.


Technological and Innovation Trends

Advances in contraceptive technology include the development of non-hormonal options, long-acting reversible contraceptives (LARCs), and biodegradable implants. Despite these developments, oral combined pills like LOESTRIN 24 FE retain their dominance, especially in regions where ease of use and familiarity influence choice.

Innovations such as digital health monitoring and targeted drug delivery could potentially impact future formulations, though their adoption in current products remains limited.


Market Dynamics Impacting Financial Trajectory

Revenue Drivers:

  • Market Penetration and Brand Loyalty: LOESTRIN 24 FE benefits from Bayer’s established presence and extensive distribution networks. Continuous brand loyalty and physician recommendations are key revenue drivers.
  • Pricing Strategies: Competitive pricing, especially against generics, influences sales volume. A premium positioning may be sustainable if brand differentiation is convincible.
  • Market Expansion: Entry into emerging markets offers growth potential, although regulatory and reimbursement hurdles may pose challenges.

Market Challenges:

  • Generic Competition: Price erosion effects from generics threaten margins, requiring Bayer to innovate or differentiate further.
  • Evolving Consumer Preferences: Increasing preference for non-hormonal methods or long-acting options could diminish demand.
  • Healthcare Policy Changes: Restrictions on hormonal contraceptives in some jurisdictions may alter market size projections.

Financial Outcomes:
Given these factors, LOESTRIN 24 FE’s revenues are expected to experience moderate growth driven by expanding markets and sustained demand within established regions. However, profit margins may face pressure from price competition and regulatory constraints.

Based on industry reports and Bayer’s historical performance, revenues for LOESTRIN 24 FE could see a CAGR of approximately 3-4% over the next five years, consistent with broader contraceptive market trends [1].


Strategic Opportunities and Risks

Opportunities:

  • Market Diversification: Targeting niche segments such as women with anemia risk or specific health concerns.
  • Product Line Extension: Developing new formulations combining contraception with other health benefits.
  • Digital Initiatives: Utilizing digital health data to improve patient adherence and personalized care.

Risks:

  • Regulatory Delays: Slower approvals or restrictions could hinder market access.
  • Competitor Innovation: Superior non-hormonal options or longer-acting devices could diminish oral contraceptive sales.
  • Market Saturation: High penetration in developed markets limits further growth potential.

Conclusion: Financial Trajectory Outlook

LOESTRIN 24 FE’s market and financial trajectory appear cautiously optimistic. Its dual-benefit formulation positions it favorably within the contraceptive market niche, especially in regions where iron deficiency anemia is prevalent. Bayer’s strategic focus on reproductive health and extending product life cycles through innovation will influence revenue stability.

While the product’s growth potential is constrained by fierce competition and evolving preferences, targeted expansion, strategic marketing, and product differentiation could foster a CAGR of 3-4% over the next five years. This aligns with the broader global contraceptive market, which continues to expand steadily, driven by demographic and public health trends.


Key Takeaways

  • Market stability combined with moderate growth potential characterizes LOESTRIN 24 FE’s outlook, driven by demographic trends and public health initiatives.
  • Competitive pressures from generics underscore the importance of brand loyalty and product differentiation.
  • Emerging markets present significant growth opportunities, despite regulatory hurdles.
  • Innovation in contraceptive options could pose long-term challenges but also open avenues for product line extensions.
  • Strategic positioning focusing on dual benefits—contraception plus iron supplementation—differentiates LOESTRIN 24 FE, supporting its future financial sustainability.

FAQs

  1. How does LOESTRIN 24 FE compare to other combined oral contraceptives?
    LOESTRIN 24 FE combines estrogen-progestin therapy with iron supplementation, which is unique. It offers a dual benefit, potentially increasing adherence among women at risk of iron deficiency, setting it apart from traditional contraceptives that do not address anemia.

  2. What are the main regulatory considerations for LOESTRIN 24 FE?
    Approval depends on regional regulatory bodies like the FDA and EMA. The product must demonstrate safety, efficacy, and quality. Ongoing post-market surveillance and adherence to local regulations influence its availability and continued market presence.

  3. Can LOESTRIN 24 FE expand into new markets?
    Yes, especially in emerging economies with rising contraceptive adoption and anemia prevalence. However, market entry requires navigating regulatory pathways, establishing distribution channels, and localized marketing strategies.

  4. What are the main challenges facing LOESTRIN 24 FE’s market growth?
    Key challenges include generic competition, shifts toward long-acting reversible contraceptives (LARCs), regulatory restrictions, and changing consumer preferences toward non-hormonal methods.

  5. What future innovations could impact LOESTRIN 24 FE’s market?
    Advances in non-hormonal contraceptives, long-acting devices, and personalized medicine could reduce demand for oral contraceptives. Conversely, innovations integrating digital health monitoring may enhance adherence and product appeal.


References

[1] ResearchandMarkets, "Global Contraceptive Market," 2022.
[2] World Health Organization, "Reproductive health and rights," 2021.

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