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Last Updated: December 31, 2025

GILDESS FE 1.5/30 Drug Patent Profile


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Which patents cover Gildess Fe 1.5/30, and when can generic versions of Gildess Fe 1.5/30 launch?

Gildess Fe 1.5/30 is a drug marketed by Ph Health and is included in one NDA.

The generic ingredient in GILDESS FE 1.5/30 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.

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Summary for GILDESS FE 1.5/30
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors:2
DailyMed Link:GILDESS FE 1.5/30 at DailyMed
Drug patent expirations by year for GILDESS FE 1.5/30

US Patents and Regulatory Information for GILDESS FE 1.5/30

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ph Health GILDESS FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 077075-001 Apr 28, 2005 DISCN No 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 GILDESS FE 1.5/30

Last updated: September 3, 2025

Introduction

GILDESS FE 1.5/30, a combined oral contraceptive pill, comprises ethinyl estradiol (1.5 mg) and levonorgestrel (30 mcg). It is primarily used for hormonal contraception and manages hormonal imbalances, with a significant presence in the global reproductive health market. Understanding the drug’s market dynamics and financial trajectory involves analyzing key factors such as competitive positioning, regulatory landscape, demographic trends, and development pipeline.


Market Overview

The global contraceptive market, valued at over USD 22 billion in 2022, is driven by increasing awareness of reproductive rights, rising female workforce participation, and expanding healthcare infrastructure, especially in emerging markets. GILDESS FE 1.5/30, positioned within this sector, particularly targets women seeking reliable birth control solutions. The demand is further bolstered by rising prevalence of contraceptive use in Asia-Pacific, Latin America, and Africa.

Competitive Landscape

GILDESS FE 1.5/30 faces competition from various generics and branded contraceptive products. Key players include Bayer, Pfizer, Teva Pharmaceuticals, and Mylan, among others. The market entry of generic formulations has intensified price competition, which can pressure profit margins. However, GILDESS FE maintains its market share through established brand recognition, physician trust, and formulary inclusions.

Innovative contraceptive methods—such as long-acting reversible contraceptives (LARCs)—are increasingly favored for their convenience and efficacy, posing a challenge to oral pills. Nonetheless, oral contraceptives like GILDESS FE continue to command a significant share due to affordability and ease of use.

Regulatory Environment

Regulatory approval at national and regional levels significantly influences market trajectory. The United States Food and Drug Administration (FDA) — through agencies like the CDC — provides guidance on contraception safety profiles and labeling. Emerging markets often experience delayed approvals, yet growth prospects remain promising due to expanding healthcare access.

The introduction of over-the-counter (OTC) access is on the horizon in several jurisdictions, potentially expanding GILDESS FE’s reach. However, regulatory hurdles, including safety concerns and labeling requirements, can impede rapid market penetration.

Demographic and Socioeconomic Factors

Population growth, particularly among women aged 15–44, directly influences demand. Countries with youthful populations, such as India and Nigeria, present substantial growth opportunities. Urbanization, increased literacy rates, and financial independence also boost contraceptive use.

Socioeconomic factors—such as continued stigma reduction around contraception and government family planning programs—favor increased uptake. Conversely, cultural resistance can slow market growth in certain regions.

Market Trends Impacting GILDESS FE

  1. Shift to Generic Pills: Post patent expiry, generic versions of GILDESS FE flood the market, exerting downward pressure on prices but expanding accessibility.
  2. Innovation and Formulation Changes: Development of low-dose or extended-cycle formulations can diversify offerings, affecting GILDESS FE sales.
  3. Digital and Telehealth Adoption: Telemedicine's rise assists in contraceptive counseling, potentially boosting sales despite competition.
  4. Policy Changes: Coverage mandates in the U.S., such as the Affordable Care Act, support contraceptive affordability, indirectly benefiting GILDESS FE.

Financial Trajectory

The financial outlook for GILDESS FE 1.5/30 hinges upon market penetration, pricing strategies, regulatory approvals, and demographic trends.

Revenue Projections

GILDESS FE benefits from its established brand presence and favorable reimbursement statuses, supporting stable revenue streams. The drug’s generic status allows for aggressive pricing, which enhances accessibility but compresses margins. Industry forecasts project a compound annual growth rate (CAGR) of approximately 3–5% over the next five years, primarily driven by emerging markets.

Profitability and Pricing Strategies

While volume growth remains steady, pricing pressures from generics and reimbursement policies necessitate cost optimization. Companies are exploring value-added services, including patient education and digital adherence tools, to differentiate offerings.

Pipeline and Lifecycle Management

Proprietary formulations or extended-cycle variants could rejuvenate sales, offsetting declines from mature formulations. Licensing agreements or partnerships with regional manufacturers may unlock additional revenue streams. Lifecycle management strategies are critical to sustain profitability amidst diminishing patent protections.

Market Risks and Opportunities

  • Risks: Regulatory delays, societal resistance, and competition from non-pill contraceptive methods.
  • Opportunities: Expansion into OTC markets, integration with digital health platforms, and targeted marketing in underserved regions.

Conclusion: Future Outlook

GILDESS FE 1.5/30’s market dynamics are characterized by steady demand, driven by demographic trends and the global shift towards reproductive healthcare access. Financially, the brand will likely maintain a stable trajectory with moderate growth, contingent upon strategic actions in pricing, regulatory navigation, and formulation innovation. Companies that effectively leverage digital channels and expand into emerging markets will enhance GILDESS FE’s financial stability and expand its market footprint.


Key Takeaways

  • Growing Global Demand: Rising contraceptive use across emerging economies presents an expanding market for GILDESS FE.
  • Intensifying Competition: Generics and alternative contraception methods threaten market share, necessitating differentiation.
  • Regulatory Evolution: Evolving approval pathways and OTC possibilities can significantly influence sales trajectories.
  • Demographic Drivers: Focus on women aged 15–44 worldwide sustains demand; demographic shifts favor growth in Asia and Africa.
  • Strategic Lifecycle Management: Continued innovation and regional licensing are critical for maintaining revenue streams and market relevance.

FAQs

1. How does GILDESS FE's market position compare to other oral contraceptives?
GILDESS FE remains competitive through brand recognition and established safety data, though generic competition and newer contraceptive options (e.g., LARCs) challenge its market share. Its affordability and familiarity sustain its demand in many regions.

2. What are the key factors influencing GILDESS FE’s price and profitability?
Pricing is affected by generic competition, regional reimbursement policies, and manufacturing costs. Profitability depends on volume sales, market penetration, and cost efficiencies in production.

3. What regions present the greatest growth opportunities for GILDESS FE?
Emerging markets—particularly in Asia-Pacific, Africa, and Latin America—pose considerable growth potential due to increasing contraceptive adoption and expanding healthcare infrastructure.

4. Could regulatory changes impact GILDESS FE’s market access?
Yes. Regulatory approvals, especially for OTC access or simplified prescribing pathways, could expand its reach. Conversely, delays or restrictions could hinder growth.

5. How is digital health influencing GILDESS FE’s market performance?
Digital health platforms enable better counseling, adherence, and telemedicine distribution, facilitating higher penetration and consumer engagement, particularly in markets with accelerated digital adoption.


Sources

  1. Market Research Future. (2022). Global Contraceptive Market Analysis.
  2. Grand View Research. (2023). Contraceptive Market Size and Forecast.
  3. U.S. Food & Drug Administration. (2022). Contraceptive Drugs Approval and Regulations.
  4. IQVIA. (2023). Global Pharmaceutical Market Insights.
  5. World Health Organization. (2022). Reproductive Health and Contraception Statistics.

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