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Last Updated: December 22, 2024

KAITLIB FE Drug Patent Profile


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When do Kaitlib Fe patents expire, and what generic alternatives are available?

Kaitlib Fe is a drug marketed by Lupin Ltd and is included in one NDA.

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

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Summary for KAITLIB FE
Drug patent expirations by year for KAITLIB FE

US Patents and Regulatory Information for KAITLIB FE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd KAITLIB FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 203448-001 Dec 17, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

KAITLIB FE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Kaitlib Fe

Introduction

Kaitlib Fe, a combination oral contraceptive (COC) containing norethindrone, ethinyl estradiol, and ferrous fumarate, is a significant player in the contraceptive market. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Overview

The contraceptive market is highly competitive, with numerous brands and formulations available. Kaitlib Fe, along with other similar products like Femcon Fe, Generess Fe, and Ovcon 35, competes for market share in the monophasic contraceptive segment[4].

Target Market

Kaitlib Fe is indicated for use by females of reproductive potential to prevent pregnancy. The target market includes women of childbearing age who seek effective and convenient contraception. The product's chewable tablet form may appeal to women who have difficulty swallowing traditional pills[1].

Pricing and Affordability

The pricing of Kaitlib Fe is a critical factor in its market dynamics. As of recent data, the average price for a pack of Kaitlib Fe is around $126.74, which can be influenced by various factors including insurance coverage, coupons, and patient assistance programs[2].

Competition

The contraceptive market is saturated with various brands and generic alternatives. Kaitlib Fe competes with other monophasic contraceptives, each with their own strengths and weaknesses. The competition can drive pricing strategies and influence market share[4].

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of Kaitlib Fe. The product is subject to strict FDA regulations, and any changes in regulatory policies can impact its availability and pricing. For instance, warnings about serious cardiovascular events and liver disease must be clearly communicated to patients[1][4].

Safety and Efficacy

The safety and efficacy of Kaitlib Fe are crucial for its market success. The product has been associated with risks such as thromboembolic events, liver disease, and hypertension, which must be carefully managed and communicated to patients. Efficacy in preventing pregnancy is also a key factor, with studies showing that it is effective for women with a BMI of up to 35 kg/m², although its efficacy in women with a higher BMI has not been evaluated[1][4].

Patient Compliance and Satisfaction

Patient compliance and satisfaction are vital for the long-term success of Kaitlib Fe. Factors such as ease of use (the chewable form), side effects, and the presence of unscheduled bleeding or spotting can influence patient satisfaction. Studies have shown that unscheduled bleeding and spotting are common in the initial cycles of use but tend to decrease over time[1].

Financial Performance

The financial performance of Kaitlib Fe is tied to its market share, pricing, and the overall demand for contraceptives. The product's revenue can be affected by factors such as insurance coverage, government policies, and the introduction of new competitors.

Market Trends

Market trends in the contraceptive sector include a shift towards more convenient and user-friendly products. The chewable form of Kaitlib Fe aligns with this trend, making it more appealing to some users. Additionally, there is an increasing focus on patient education and awareness about the risks and benefits of different contraceptive options[1].

Economic Impact

The economic impact of Kaitlib Fe extends beyond its direct revenue. It contributes to the broader healthcare economy by providing a preventive measure against unintended pregnancies, which can have significant economic and social implications. The cost savings from preventing unwanted pregnancies can be substantial, both for individuals and the healthcare system as a whole.

Resilience in Economic Crises

During economic crises, such as the COVID-19 pandemic, the demand for essential healthcare products like contraceptives can remain relatively stable. However, economic downturns can affect pricing and accessibility due to changes in consumer spending power and healthcare funding. Studies on the resilience of companies during crises, like those analyzing the Bucharest Stock Exchange during the pandemic, highlight the importance of adaptability and strategic management in maintaining market presence[3].

Key Takeaways

  • Market Competition: Kaitlib Fe operates in a highly competitive market with numerous other monophasic contraceptives.
  • Pricing and Affordability: The product's pricing is around $126.74 per pack, influenced by insurance, coupons, and patient assistance programs.
  • Regulatory Environment: Strict FDA regulations and clear communication of risks are essential.
  • Safety and Efficacy: Associated risks include thromboembolic events and liver disease, while efficacy is high for women with a BMI up to 35 kg/m².
  • Patient Compliance: Ease of use and side effects impact patient satisfaction.
  • Financial Performance: Revenue is influenced by market share, pricing, and demand.
  • Market Trends: Shift towards convenient products and increased focus on patient education.

FAQs

  1. What is Kaitlib Fe used for? Kaitlib Fe is used by women to prevent pregnancy. It is a combination oral contraceptive containing norethindrone, ethinyl estradiol, and ferrous fumarate[1].

  2. What are the potential risks associated with Kaitlib Fe? Potential risks include thromboembolic events, liver disease, hypertension, and other cardiovascular events. It is also associated with unscheduled bleeding and spotting, especially in the initial cycles of use[1][4].

  3. How is Kaitlib Fe administered? Kaitlib Fe is taken orally, with 24 active hormone tablets (0.8 mg norethindrone and 0.025 mg ethinyl estradiol) followed by 4 non-hormonal placebo tablets containing 75 mg ferrous fumarate. The tablets should be taken in the order directed on the package[1][5].

  4. Is Kaitlib Fe suitable for all women? Kaitlib Fe is not suitable for all women, particularly those with certain medical conditions such as uncontrolled hypertension, liver disease, or a history of thromboembolic events. Its efficacy in women with a BMI greater than 35 kg/m² has not been evaluated[1][4].

  5. How does Kaitlib Fe impact the broader healthcare economy? By preventing unintended pregnancies, Kaitlib Fe contributes to cost savings for both individuals and the healthcare system. It also plays a role in reducing the economic and social implications associated with unwanted pregnancies.

Sources

  1. Drugs.com - Kaitlib Fe: Package Insert / Prescribing Information
  2. Drugs.com - Kaitlib Fe Prices, Coupons, Copay Cards & Patient Assistance
  3. Tandfonline.com - Assessing the resilience of the financial market
  4. PDR.Net - Kaitlib Fe - Drug Summary
  5. BuzzRx - Kaitlib FE Directions and dosages

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