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Last Updated: March 30, 2025

ENOVID Drug Patent Profile


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

Enovid is a drug marketed by Gd Searle Llc and is included in one NDA.

The generic ingredient in ENOVID is mestranol; norethynodrel. There are eleven drug master file entries for this compound. Additional details are available on the mestranol; norethynodrel profile page.

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Summary for ENOVID
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 18
DailyMed Link:ENOVID at DailyMed
Drug patent expirations by year for ENOVID

US Patents and Regulatory Information for ENOVID

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Gd Searle Llc ENOVID mestranol; norethynodrel TABLET;ORAL-20 010976-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Gd Searle Llc ENOVID mestranol; norethynodrel TABLET;ORAL 010976-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Gd Searle Llc ENOVID-E mestranol; norethynodrel TABLET;ORAL-20 010976-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Gd Searle Llc ENOVID-E 21 mestranol; norethynodrel TABLET;ORAL-21 010976-007 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Gd Searle Llc ENOVID mestranol; norethynodrel TABLET;ORAL 010976-008 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 5 of 5 entries

Market Dynamics and Financial Trajectory of Contraceptive Drugs: A Focus on Enovid and the Broader Market

Introduction

The contraceptive drugs market has been a significant segment within the pharmaceutical industry, driven by increasing awareness and demand for birth control methods. This article will delve into the market dynamics and financial trajectory of contraceptive drugs, with a particular focus on Enovid, the first approved oral contraceptive.

Historical Context of Enovid

Approval and Initial Impact

Enovid, approved by the FDA in 1960, was the first oral contraceptive pill. This approval marked a pivotal moment in reproductive health, offering women a more convenient and effective method of birth control compared to earlier options[4].

Current Market Overview

Global Market Size and Growth

The global contraceptive drugs market was valued at USD 18.57 billion in 2023 and is projected to grow to USD 37.22 billion by 2032, exhibiting a CAGR of 8.2% during the forecast period (2024-2032)[1].

Regional Market Analysis

  • North America: This region dominated the market in 2023, with a market size of USD 7.27 billion. The high awareness about birth control pills and the growing childbearing women population are key factors driving this market[1].
  • Europe: Europe held the second-largest market share, driven by a well-established healthcare infrastructure and an increasing number of women opting for modern contraceptive methods[1].
  • Asia Pacific: This region is expected to register the highest CAGR during the forecast period, driven by government initiatives to expand access to contraceptive drugs and a surge in awareness about birth control pills[1].

Product Segments

Oral Contraceptives

The oral segment accounts for the highest market share, driven by the higher adoption of oral drugs globally. The ease of administration and growing availability of these products in pharmacies and public hospitals are significant factors contributing to this dominance[1].

Injectable and Other Segments

  • Injectable Segment: This segment is expected to witness significant growth due to the lower annual cost compared to oral drugs and patches. The injectable segment offers a cost-effective alternative, making it more appealing to a broader demographic[1].
  • Patches and Other Methods: While these segments are smaller, they still contribute to the overall market growth, particularly in regions with well-established healthcare infrastructures[1].

Distribution Channels

Retail Pharmacy Dominance

The retail pharmacy segment dominated the global market in 2023, driven by the growing demand for over-the-counter (OTC) contraceptive drugs. Countries like Brazil, Mexico, China, and India allow birth control pills to be sold OTC, which has significantly boosted the retail pharmacy segment[1].

Online Channels

Online channels are growing at a higher CAGR than other sub-segments, driven by the rising adoption of OTC solutions and various online offers and discounts. The wide distribution channel and all-time availability of these drugs online are key factors for this growth[1].

Recent Developments in OTC Contraceptives

Opill and Zena

In July 2023, the FDA approved Opill, the first OTC daily oral contraceptive pill, marking a significant shift in the market. Another pharmaceutical company, Cadence, is working towards FDA approval for an OTC version of its combined oral contraceptive pill, Zena[4][5].

Financial Implications

Market Size and Revenue

The U.S. prescription birth control pill market is estimated to be worth about $3 billion annually, with oral contraceptives representing 37% of the $8 billion contraceptive market in the country[5].

Impact of OTC Approval

The approval of OTC birth control pills like Opill is expected to alter the market dynamics. While it is unclear how much revenue will be siphoned away from prescription contraceptives, the increased accessibility is likely to boost overall utilization of oral contraception[5].

Challenges and Opportunities

Regulatory Environment

Favorable regulatory policies, such as the approval of OTC contraceptive pills, are crucial for market growth. However, regulatory hurdles and controversies, as seen with the initial approval of Enovid, can impact market dynamics[4].

Competitive Landscape

Top market players like Johnson & Johnson Services, Inc., AbbVie Inc., and Bayer AG focus on strategic collaborations to gain a competitive advantage. The entry of new OTC products and the expansion of existing product lines are key strategies in this competitive market[1].

Investment Trends in Pharmaceutical R&D

High Costs and Risks

The average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved[3].

Potential Rewards

Despite the challenges, successful drug development can generate significant revenue streams. Blockbuster drugs, like AbbVie's Humira, can generate over $20 billion in annual revenue at their peak[3].

Key Takeaways

  • The global contraceptive drugs market is projected to grow significantly, driven by increasing awareness and demand for birth control methods.
  • Oral contraceptives dominate the market due to their ease of administration and widespread availability.
  • The approval of OTC birth control pills is a significant market shift, expected to increase accessibility and utilization.
  • Regulatory policies and competitive strategies play crucial roles in shaping the market.
  • The pharmaceutical R&D landscape is marked by high costs and risks but offers substantial potential rewards.

FAQs

What was the significance of Enovid in the contraceptive market?

Enovid was the first oral contraceptive pill approved by the FDA in 1960, marking a pivotal moment in reproductive health by offering women a more convenient and effective method of birth control.

How is the global contraceptive drugs market expected to grow?

The global contraceptive drugs market is projected to grow from USD 19.80 billion in 2024 to USD 37.22 billion by 2032, exhibiting a CAGR of 8.2% during the forecast period.

What is the impact of OTC approval on the contraceptive market?

The approval of OTC birth control pills like Opill is expected to increase accessibility and utilization of oral contraception, though the exact financial impact on prescription contraceptives remains unclear.

Which region dominates the contraceptive drugs market?

North America dominated the market in 2023, driven by high awareness about birth control pills and a growing childbearing women population.

What are the key distribution channels for contraceptive drugs?

The retail pharmacy segment dominates the market, followed by online channels which are growing rapidly due to the rising adoption of OTC solutions and online offers.

Sources

  1. Fortune Business Insights: "Contraceptive Drugs Market Size, Share | Global Report, 2032"
  2. Stocktitan: "Invivyd Reports Preliminary Third Quarter 2024 Results, Withdraws Prior Financial Guidance, and Targets Near-Term Profitability"
  3. DrugBank Blog: "Investment Trends in Pharmaceutical Research and Development"
  4. KFF: "Oral Contraceptive Pills: Access and Availability"
  5. BioSpace: "Birth Control Market Evolves as OTC Opill Hits US Stores"

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