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Last Updated: December 22, 2024

NEXESTA FE Drug Patent Profile


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Which patents cover Nexesta Fe, and what generic alternatives are available?

Nexesta Fe is a drug marketed by Aurobindo Pharma and is included in one NDA.

The generic ingredient in NEXESTA 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 NEXESTA FE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:NEXESTA FE at DailyMed
Drug patent expirations by year for NEXESTA FE

US Patents and Regulatory Information for NEXESTA FE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma NEXESTA FE ethinyl estradiol; norethindrone TABLET;ORAL 207535-001 Feb 2, 2017 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

NEXESTA FE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nexesta Fe

Introduction

Nexesta Fe is a combined oral contraceptive (COC) that contains norethindrone and ethinyl estradiol, along with ferrous fumarate tablets. Understanding its market dynamics and financial trajectory involves examining its indications, usage, market position, and the broader pharmaceutical landscape.

Indications and Usage

Nexesta Fe is indicated for use by females of reproductive potential to prevent pregnancy. It consists of 21 active tablets containing 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and 7 non-hormonal placebo tablets containing 75 mg ferrous fumarate[1].

Market Position

In the contraceptive market, Nexesta Fe competes with other COCs and contraceptive methods. The market share of COCs can be influenced by several factors, including prescription rates, patient preferences, and healthcare provider recommendations.

Competitive Landscape

The pharmaceutical market for contraceptives is competitive, with numerous brands and generic options available. Generic medicines, including branded and unbranded generics, represent a significant portion of the market, especially in low and middle-income countries. However, in the context of COCs like Nexesta Fe, the market is more nuanced, with brand loyalty and prescription habits playing crucial roles[3].

Financial Trajectory

To understand the financial trajectory of Nexesta Fe, it is essential to look at the broader financial health of the pharmaceutical companies involved in its production and distribution.

Revenue and Sales

The revenue generated by Nexesta Fe would be part of the overall sales figures for the pharmaceutical company that manufactures it. While specific financial data for Nexesta Fe is not readily available, the sales performance of similar COCs can provide insights. The market for COCs is stable, with a consistent demand driven by reproductive health needs.

Production and Distribution Costs

The costs associated with producing and distributing Nexesta Fe include manufacturing expenses, research and development (R&D) costs, marketing, and distribution. These costs are typically factored into the pricing strategy of the drug.

Pricing Strategy

The pricing of Nexesta Fe is influenced by various factors, including production costs, market competition, and regulatory environments. In many countries, government policies and insurance coverage also impact the pricing and accessibility of contraceptive medications.

Regulatory Environment

Contraindications and Warnings

Nexesta Fe has several contraindications, including a high risk of arterial or venous thrombotic diseases, liver tumors or liver disease, undiagnosed abnormal uterine bleeding, pregnancy, and current or history of breast cancer. These contraindications can affect its market position and usage rates[1].

Safety and Efficacy

The safety and efficacy of Nexesta Fe are closely monitored by regulatory bodies. Any changes in the regulatory environment, such as updates in warnings or contraindications, can impact its market dynamics.

Patient and Provider Preferences

Patient preferences and healthcare provider recommendations significantly influence the market dynamics of Nexesta Fe. Factors such as ease of use, side effect profiles, and effectiveness play crucial roles in determining patient adherence and provider prescribing habits.

Generic and Branded Competition

The entry of generic versions of COCs can impact the market share of branded products like Nexesta Fe. However, the transition from branded to generic is complex and varies by region. In some markets, generic versions may not immediately capture the market share of their branded counterparts[3].

Financial Health of Pharmaceutical Companies

The financial health of the companies producing and distributing Nexesta Fe is crucial for its long-term viability. High debt levels, as seen in some large pharmaceutical companies, can impact their ability to invest in R&D and marketing, which in turn affects the market trajectory of specific products.

Example: Debt-to-Equity Ratio

While the specific financial health of the company producing Nexesta Fe is not detailed here, an example from another industry illustrates the importance of financial health. NextEra Energy, for instance, has a high debt-to-equity ratio of 139%, which can impact its long-term financial stability and ability to invest in new projects[5].

Market Trends and Future Outlook

Follow-On Drugs and Competition

The pharmaceutical industry is characterized by the development of follow-on drugs, which can provide additional therapeutic options and inject price competition into the market. However, the speed of competitive entry has decreased over time, suggesting that the market is becoming more competitive and dynamic[4].

Regulatory Changes

Changes in regulatory policies, such as those related to drug approvals and safety monitoring, can significantly impact the market dynamics of Nexesta Fe. Any updates in prescribing information or contraindications can alter its market position.

Key Takeaways

  • Market Position: Nexesta Fe competes in a competitive contraceptive market influenced by patient preferences, healthcare provider recommendations, and regulatory environments.
  • Financial Trajectory: The financial health of the manufacturing company, production and distribution costs, and pricing strategies are critical for its market performance.
  • Regulatory Environment: Contraindications, warnings, and safety monitoring by regulatory bodies significantly impact its market dynamics.
  • Generic Competition: The transition from branded to generic versions is complex and varies by region.
  • Future Outlook: Market trends, including the development of follow-on drugs and regulatory changes, will continue to shape the market dynamics of Nexesta Fe.

FAQs

  1. What are the active ingredients in Nexesta Fe?

    • Nexesta Fe contains 0.4 mg norethindrone and 0.035 mg ethinyl estradiol in its active tablets[1].
  2. What are the contraindications for Nexesta Fe?

    • Contraindications include a high risk of arterial or venous thrombotic diseases, liver tumors or liver disease, undiagnosed abnormal uterine bleeding, pregnancy, and current or history of breast cancer[1].
  3. How does Nexesta Fe compare to other contraceptive methods?

    • Nexesta Fe is a COC that competes with other hormonal and non-hormonal contraceptive methods, with its market position influenced by patient preferences and healthcare provider recommendations.
  4. What is the impact of generic competition on Nexesta Fe?

    • The entry of generic versions can impact the market share of Nexesta Fe, but the transition is complex and varies by region[3].
  5. How do regulatory changes affect Nexesta Fe?

    • Regulatory changes, such as updates in warnings or contraindications, can significantly impact its market dynamics and usage rates[1].

Sources

  1. Drugs.com: Nexesta Fe: Package Insert / Prescribing Information.
  2. Investor NextEra Energy: Earnings Conference Call - Investor Relations - NextEra Energy.
  3. PubMed: The market dynamics of generic medicines in the private sector of 19 low and middle income countries.
  4. PubMed: The economics of follow-on drug research and development.
  5. Simply Wall St: NextEra Energy (NEE) Balance Sheet & Financial Health Metrics.

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