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Last Updated: April 9, 2025

NORLESTRIN FE 2.5/50 Drug Patent Profile


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Summary for NORLESTRIN FE 2.5/50
Drug patent expirations by year for NORLESTRIN FE 2.5/50

US Patents and Regulatory Information for NORLESTRIN FE 2.5/50

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Parke Davis NORLESTRIN FE 2.5/50 ethinyl estradiol; ferrous fumarate; norethindrone acetate TABLET;ORAL-28 016854-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Norlestrin FE 2.5/50

Introduction

Norlestrin FE 2.5/50 is a combination oral contraceptive that contains norethindrone acetate and ethinyl estradiol, along with ferrous fumarate. Understanding its market dynamics and financial trajectory involves examining several key factors, including its historical performance, regulatory status, and competitive landscape.

Regulatory Status

Norlestrin FE 2.5/50, like other oral contraceptives, is regulated by the FDA. The drug was approved prior to 1982, but it has since been discontinued from the market[1].

Historical Market Presence

Historically, Norlestrin FE 2.5/50 was part of a broader range of oral contraceptives available in the market. However, its discontinuation means it no longer contributes to current market dynamics. The decision to discontinue was likely influenced by various factors, including market competition, safety profiles, and consumer preferences.

Competitive Landscape

The oral contraceptive market is highly competitive, with numerous products available. Current market leaders include drugs like Loestrin 24 Fe, Lo Loestrin Fe, and others that have gained approval and maintained their market presence through effective marketing and strong safety profiles[1][4].

Financial Performance

Since Norlestrin FE 2.5/50 is no longer marketed, it does not generate any current revenue. The financial performance of discontinued drugs is typically reflected in the historical financial reports of the pharmaceutical companies that once produced them. However, these figures are not publicly available for specific discontinued products.

Impact of Discontinuation

The discontinuation of Norlestrin FE 2.5/50 has shifted market share to other oral contraceptives. This shift can be attributed to several factors, including the emergence of new, more effective, or safer alternatives. For instance, Lo Loestrin Fe, which has a similar mechanism of action but a different dosing regimen, has maintained a strong market presence due to its efficacy and safety profile[1].

Consumer Preferences and Safety

Consumer preferences play a significant role in the market dynamics of oral contraceptives. Drugs that offer better safety profiles, fewer side effects, and more convenient dosing regimens tend to gain more market share. The discontinuation of Norlestrin FE 2.5/50 may have been influenced by consumer preferences shifting towards other available options[1].

Pharmacokinetics and Efficacy

Although Norlestrin FE 2.5/50 is no longer available, its pharmacokinetics and efficacy were once comparable to other oral contraceptives. The Pearl Index, a measure of contraceptive efficacy, and other pharmacokinetic parameters were critical in its initial approval. However, these metrics are now more relevant to the drugs that have replaced it in the market[1][4].

Market Trends in Oral Contraceptives

Current market trends in oral contraceptives favor low-dose formulations with improved safety profiles. The introduction of new formulations like Loestrin 24 Fe and Lo Loestrin Fe has captured a significant share of the market. These trends are driven by advancements in pharmaceutical technology, regulatory requirements, and changing consumer needs[1][4].

Financial Trajectory of Similar Products

To understand the financial trajectory of oral contraceptives, one can look at the performance of similar products that are still in the market. For example, the financial reports of companies that produce and market these drugs can provide insights into revenue trends and market growth. However, specific financial data for discontinued products like Norlestrin FE 2.5/50 is not available[2].

Conclusion on Market Dynamics

The market dynamics for oral contraceptives are dynamic and influenced by regulatory approvals, consumer preferences, and the introduction of new products. While Norlestrin FE 2.5/50 is no longer part of this landscape, understanding its historical context and the factors leading to its discontinuation can provide valuable insights into the current market.

Key Takeaways

  • Regulatory Status: Norlestrin FE 2.5/50 is discontinued and no longer regulated as an active product.
  • Market Presence: The drug has been replaced by other oral contraceptives with better safety profiles and consumer preferences.
  • Financial Performance: No current revenue is generated from this product.
  • Consumer Preferences: Shifted towards newer, safer, and more convenient oral contraceptives.
  • Market Trends: Favor low-dose formulations with improved safety profiles.

FAQs

Q: Why was Norlestrin FE 2.5/50 discontinued? A: The exact reasons for the discontinuation are not specified, but it is likely due to a combination of factors including market competition, safety profiles, and consumer preferences.

Q: What are the current market leaders in oral contraceptives? A: Current market leaders include drugs like Loestrin 24 Fe and Lo Loestrin Fe.

Q: How does the Pearl Index affect the market dynamics of oral contraceptives? A: The Pearl Index is a measure of contraceptive efficacy. Drugs with lower Pearl Index values are generally more effective and thus more attractive to consumers.

Q: What role do consumer preferences play in the oral contraceptive market? A: Consumer preferences significantly influence the market, with consumers favoring drugs that offer better safety profiles, fewer side effects, and more convenient dosing regimens.

Q: Can financial data for discontinued products like Norlestrin FE 2.5/50 be accessed? A: Specific financial data for discontinued products is typically not publicly available.

Cited Sources

  1. FDA Document: "022501Orig1s000MedR.pdf" - FDA approval and clinical trial data for Lo Loestrin Fe[1].
  2. Plexus Corp. Financials: Quarterly financial results and market performance of similar pharmaceutical companies[2].
  3. DailyMed: Label and pharmacokinetic data for Loestrin 24 Fe, a similar oral contraceptive[4].
  4. FDA Document: "022501Orig1s000NameR.pdf" - Proprietary name review and regulatory history for Lo Loestrin Fe[5].

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