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Last Updated: December 22, 2024

ETHINYL ESTRADIOL; NORGESTREL - Generic Drug Details


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Summary for ETHINYL ESTRADIOL; NORGESTREL
US Patents:0
Tradenames:12
Applicants:8
NDAs:11
Finished Product Suppliers / Packagers: 9
Clinical Trials: 5
DailyMed Link:ETHINYL ESTRADIOL; NORGESTREL at DailyMed
Recent Clinical Trials for ETHINYL ESTRADIOL; NORGESTREL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AmgenPhase 1
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Phase 1
National Cancer Institute (NCI)Phase 2

See all ETHINYL ESTRADIOL; NORGESTREL clinical trials

US Patents and Regulatory Information for ETHINYL ESTRADIOL; NORGESTREL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd TURQOZ ethinyl estradiol; norgestrel TABLET;ORAL-28 202980-001 Jul 31, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs OGESTREL 0.5/50-21 ethinyl estradiol; norgestrel TABLET;ORAL-21 075406-001 Dec 15, 1999 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Pharms OVRAL-28 ethinyl estradiol; norgestrel TABLET;ORAL-28 016806-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Pharms OVRAL ethinyl estradiol; norgestrel TABLET;ORAL-21 016672-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Duramed Pharms Barr CRYSELLE ethinyl estradiol; norgestrel TABLET;ORAL-21 075840-001 Nov 30, 2001 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

Expired US Patents for ETHINYL ESTRADIOL; NORGESTREL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms OVRAL-28 ethinyl estradiol; norgestrel TABLET;ORAL-28 016806-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Wyeth Pharms OVRAL ethinyl estradiol; norgestrel TABLET;ORAL-21 016672-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Wyeth Pharms LO/OVRAL-28 ethinyl estradiol; norgestrel TABLET;ORAL-28 017802-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Cadence Health LO/OVRAL ethinyl estradiol; norgestrel TABLET;ORAL-21 017612-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
Wyeth Pharms LO/OVRAL-28 ethinyl estradiol; norgestrel TABLET;ORAL-28 017802-001 Approved Prior to Jan 1, 1982 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

ETHINYL ESTRADIOL; NORGESTREL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethinyl Estradiol and Norgestrel

Introduction

Ethinyl estradiol and norgestrel, commonly used in combination oral contraceptives, have been a cornerstone in reproductive health for decades. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this market segment.

Market Size and Forecast

The global market for ethinyl estradiol and norgestrel has experienced rapid and substantial growth in recent years. According to market research, the ethinyl estradiol and levonorgestrel market (which includes norgestrel as a key component) is expected to continue its upward trend from 2023 to 2031. This growth is driven by increasing demand for oral contraceptives, which are favored for their ease of use and clinical benefits over other contraceptive methods[1][4].

Segmentation and Market Analysis

The market is segmented based on application (hospitals, drug stores), product types (various dosages such as 0.02mg/0.1mg, 0.03mg/0.15mg), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The oral segment, which includes ethinyl estradiol and norgestrel combination pills, dominates the market due to higher adoption rates in both developed and developing countries[1][4].

Geographical Performance

North America holds a significant share of the market, valued at USD 7.27 billion in 2023. This dominance is attributed to high awareness about birth control pills, a growing childbearing population, and favorable healthcare infrastructure. Europe follows closely, driven by an increasing number of women opting for modern contraceptive methods[4].

Drivers of Market Growth

Several factors contribute to the robust growth of the ethinyl estradiol and norgestrel market:

  • Increasing Awareness and Adoption: Public programs aimed at creating awareness about birth control methods have significantly boosted the demand for oral contraceptives[4].
  • Ease of Administration: Oral pills are preferred due to their simplicity and convenience of use[4].
  • Product Approvals: Recent approvals of new contraceptive products, such as Lupin’s Drospirenone tablets, further enhance market growth[4].
  • Online Channels: The rise of online pharmacies and over-the-counter solutions has expanded the distribution channels for these products, making them more accessible[4].

Challenges and Risks

Despite the growth, there are several challenges and risks associated with the use of ethinyl estradiol and norgestrel:

  • Health Risks: The use of combined oral contraceptives is associated with an increased risk of venous thromboembolic and thrombotic diseases. This risk is particularly high for women over 35 years of age who smoke[2][5].
  • Side Effects: Common side effects include nausea, headache, and decreased libido. Unexplained amenorrhea and breakthrough bleeding or spotting can also occur, especially if doses are missed[2][3].

Financial Trajectory

The global contraceptive drugs market, which includes ethinyl estradiol and norgestrel, was valued at USD 18.57 billion in 2023 and is projected to reach USD 37.22 billion by 2032. This growth is expected to occur at a Compound Annual Growth Rate (CAGR) of 8.2% from 2024 to 2032[4].

Key Players

Major players in the contraceptive drugs market include Johnson & Johnson Services, Inc., AbbVie Inc., and Bayer AG. These companies play a significant role in driving innovation and expanding the market through new product launches and strategic marketing efforts[4].

Market Opportunities

The market presents several opportunities for growth:

  • Emerging Markets: There is a significant potential for growth in emerging markets where awareness about modern contraceptive methods is increasing[4].
  • Product Innovation: Continuous innovation in contraceptive products, such as the development of new formulations and delivery systems, can further drive market growth[4].

Consumer Behavior and Preferences

Consumer behavior is a crucial factor in the market dynamics of ethinyl estradiol and norgestrel. Women increasingly prefer oral contraceptives due to their ease of use and the wide availability of these products in pharmacies and online channels. Public programs and increasing insurance coverage also influence consumer preferences, making these products more accessible and affordable[4].

Regulatory Environment

The regulatory environment plays a vital role in shaping the market. Recent approvals by regulatory bodies such as the U.S. FDA for new contraceptive products have been instrumental in driving market growth. Compliance with regulatory standards is essential for manufacturers to ensure the safety and efficacy of their products[4].

Clinical Benefits and Efficacy

Ethinyl estradiol and norgestrel combination pills are highly effective in preventing pregnancy. They work by suppressing gonadotropins, inhibiting ovulation, and altering cervical mucus and the endometrium to prevent sperm entry and implantation. Studies have shown that these pills are highly effective, even in cases where doses are occasionally missed[2][3].

"Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation)"[2].

Conclusion

The market for ethinyl estradiol and norgestrel is poised for significant growth driven by increasing demand, ease of use, and expanding distribution channels. However, it is crucial to address the associated health risks and side effects through proper counseling and medical supervision. As the market continues to evolve, innovation and regulatory compliance will remain key factors in its financial trajectory.

Key Takeaways

  • The ethinyl estradiol and norgestrel market is expected to grow substantially from 2023 to 2031.
  • North America and Europe are the dominant regions in this market.
  • The oral segment leads the market due to its ease of use and wide availability.
  • Health risks associated with smoking and age over 35 are significant concerns.
  • Innovation and regulatory approvals are driving market growth.
  • Emerging markets and product innovation present significant opportunities.

FAQs

What are the primary mechanisms through which ethinyl estradiol and norgestrel prevent pregnancy?

Ethinyl estradiol and norgestrel prevent pregnancy by suppressing gonadotropins, inhibiting ovulation, and altering cervical mucus and the endometrium to prevent sperm entry and implantation[2].

What are the health risks associated with the use of ethinyl estradiol and norgestrel?

The use of these combined oral contraceptives is associated with an increased risk of venous thromboembolic and thrombotic diseases, particularly for women over 35 years of age who smoke[2][5].

Which regions dominate the market for ethinyl estradiol and norgestrel?

North America and Europe are the dominant regions in this market, driven by high awareness and favorable healthcare infrastructure[4].

What is the projected growth rate of the global contraceptive drugs market?

The global contraceptive drugs market is expected to grow at a CAGR of 8.2% from 2024 to 2032[4].

What are the key drivers of the market growth for ethinyl estradiol and norgestrel?

Key drivers include increasing awareness, ease of administration, product approvals, and the rise of online channels for distribution[4].

Sources

  1. Market Research Intellect: Global Ethinyl Estradiol And Levonorgestrel Market Size And Forecast.
  2. Drugs.com: Norgestrel and Ethinyl Estradiol: Package Insert / Prescribing Info.
  3. PubMed: Norgestrel and ethynyl estradiol: a new low-dosage oral agent for contraception.
  4. Fortune Business Insights: Contraceptive Drugs Market Size, Share | Global Report, 2032.
  5. Mayo Clinic: Ethinyl estradiol and norgestrel (oral route) - Mayo Clinic.

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