You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 14, 2025

LARIN FE 1.5/30 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Larin Fe 1.5/30, and what generic alternatives are available?

Larin Fe 1.5/30 is a drug marketed by Novast Labs and is included in one NDA.

The generic ingredient in LARIN FE 1.5/30 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.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for LARIN FE 1.5/30?
  • What are the global sales for LARIN FE 1.5/30?
  • What is Average Wholesale Price for LARIN FE 1.5/30?
Summary for LARIN FE 1.5/30
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers:4
DailyMed Link:LARIN FE 1.5/30 at DailyMed
Drug patent expirations by year for LARIN FE 1.5/30

US Patents and Regulatory Information for LARIN 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
Novast Labs LARIN FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 091453-001 Aug 23, 2013 AB RX 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 LARIN FE 1.5/30

Last updated: July 28, 2025

Introduction

LARIN FE 1.5/30, a combined oral contraceptive, embodies a significant segment of the global hormonal contraceptive market. Comprising levonorgestrel (1.5 mg) and ethinyl estradiol (30 µg), this formulation aligns with market preferences for effective, predictable, and user-friendly contraceptive options. Its trajectory is shaped by evolving market dynamics, regulatory pathways, competitive landscape, and demographic trends, offering compelling insights into its future financial prospects.

Market Overview and Demand Drivers

The global contraceptive market has experienced steady growth, projected to expand at a compound annual growth rate (CAGR) of approximately 4-6% through 2030 [1]. The rising acceptance of hormonal contraceptives, especially among women of reproductive age, underpins this growth. Factors such as increasing awareness, improved access to healthcare, and expanding female workforce participation intensify demand.

LARIN FE 1.5/30 specifically targets a mature segment comprising combination oral contraceptives (COCs), estimated to hold over 60% of the global hormonal birth control market. Its appeal stems from proven efficacy, safety profile, and widespread familiarity among physicians and patients.

Regulatory and Market Access Factors

The regulatory landscape heavily influences LARIN FE 1.5/30’s market penetration. Stringent approval processes in North America and Europe—mandating rigorous clinical trial data, safety, and efficacy—set high barriers but also present opportunities for proven, well-documented products. The drug’s approval status in key markets will shape launch timelines and initial sales trajectories.

Market access strategies—including pricing, reimbursement, and healthcare provider education—determine eventual uptake. Countries with robust healthcare systems, such as Germany, the U.S., and Japan, present lucrative opportunities for premium pricing, supported by demand for safe, convenient contraception.

Competitive Landscape

LARIN FE 1.5/30 operates within an intensely competitive arena. Major players include Bayer (Yasmin, Yaz), Teva (Levonorgestrel formulations), and generic manufacturers. While branded options often command higher prices, generics dominate in volume and price competition.

Differentiation hinges on safety profiles, side effect profiles, convenience, and marketing strategies. LARIN FE 1.5/30’s unique formulation or delivery benefits could carve niche advantages, especially if supported by clinical data emphasizing lower breakthrough bleeding or reduced side effects.

Economic and Demographic Influences

Demographic trends dictate market potential. The global reproductive-age female population, approximately 1.9 billion, continues to expand, with increased adoption rates in emerging economies driven by urbanization and increased health literacy [2].

Economic development influences contraceptive affordability and access. In countries like India, Brazil, and Indonesia, government initiatives and NGO programs expanding access to family planning services amplify demand for affordable options like LARIN FE 1.5/30—and generic equivalents.

Pricing Strategy and Revenue Projections

Pricing will be influenced by market maturity, competitive positioning, and regulatory conditions. In developed markets, premium pricing can be justified through safety and reliability, translating to higher margins. Conversely, in price-sensitive markets, volume-driven revenues from generics dominate.

Projected revenues depend on market penetration rates, which are estimated to reach 10-15% in mature markets within five years, assuming successful approval and launch. In a hypothetical scenario, with a conservative market share of 10% of the contraceptive segment, annual sales could approach $200-300 million globally within five years, considering the size of the global oral contraceptive market (~$7 billion in 2021) [1].

Emerging Trends and Innovation

The future trajectory of LARIN FE 1.5/30 will also be shaped by trends such as:

  • Extended-cycle formulations: Increasing preference for 84/7 or 91/7 regimens for menstrual regularity.
  • Reduced estrogen doses: To minimize side effects, aligning with regulatory guidance.
  • Digital health integration: Telemedicine and adherence tracking enhance consumer engagement.
  • New delivery platforms: Such as contraceptive patches or vaginal rings, providing alternate options.

Regulatory and Patent Outlook

Patent protection duration influences exclusivity and pricing strategies. While LARIN FE 1.5/30’s patent status will vary by jurisdiction, patent expirations can invite generic competition, pressure prices downward, and impact revenue streams. Strategic patent filing, formulation patents, and market exclusivity periods are critical components of financial planning.

Impact of External Factors

  • Regulatory shifts: Tightening of safety evaluations or contraindications could impact sales.
  • Healthcare policy: Inclusion in national formularies and family planning programs bolsters sales.
  • Market disruptions: COVID-19 slowed some launch timelines but also increased telemedicine adoption.

Conclusion

LARIN FE 1.5/30 stands poised for sustained growth within the global contraceptive market. Its financial trajectory hinges on regulatory approvals, competitive differentiation, demographic trends, and strategic market entry—especially in emerging economies. While facing competition from generics and new modalities, its established efficacy and safety profile provide a strong foundation for revenue generation. Milling regulatory, demographic, and technological shifts will define its future positioning.


Key Takeaways

  • The global contraceptive market is projected for steady growth, with hormonal formulations maintaining dominant share.
  • LARIN FE 1.5/30’s prospects depend on successful regulatory approval, strategic market access, and competitive differentiation.
  • Emerging markets and demographic shifts provide substantial growth opportunities, especially through affordable generics.
  • Innovation trends like extended-cycle formulations and digital health integration could influence its market position.
  • Patent expirations and regulatory changes require vigilant strategic planning to sustain profitability.

FAQs

  1. What factors influence the pricing strategy for LARIN FE 1.5/30 in different markets?
    Pricing depends on market maturity, competitive landscape, regulatory requirements, and healthcare reimbursement policies. Premium pricing applies in developed markets with high safety standards, while volume-based generic pricing dominates in emerging markets.

  2. How does patent protection impact the financial outlook for LARIN FE 1.5/30?
    Patent protection secures market exclusivity, enabling premium pricing and higher margins. Expirations open opportunities for generic competition, typically resulting in price declines and revenue reduction.

  3. What demographic trends are most favorable for the growth of LARIN FE 1.5/30?
    Growth correlates with increasing reproductive-age female populations, rising awareness about contraception, and policies expanding access in emerging economies.

  4. Which regulatory developments could most significantly impact LARIN FE 1.5/30’s market deployment?
    Stringent safety evaluations, contraindication updates, and approval delays could impede market entry or expansion, whereas supportive policies and inclusion in family planning programs accelerate growth.

  5. What role do technological innovations play in the future success of LARIN FE 1.5/30?
    Innovations like digital adherence tools and alternative delivery systems can enhance user experience, improve compliance, and expand market reach.


References

[1] Research and Markets. “Global Contraceptive Market Report 2022.”
[2] UN Department of Economic and Social Affairs. “World Population Prospects 2022.”

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.