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Last Updated: December 22, 2024

LEVONORGESTREL AND ETHINYL ESTRADIOL Drug Patent Profile


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Which patents cover Levonorgestrel And Ethinyl Estradiol, and what generic alternatives are available?

Levonorgestrel And Ethinyl Estradiol is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Lupin Ltd, Watson Labs, Xiromed, Barr, Dr Reddys Labs Sa, Hetero Labs, and Naari Pte Ltd. and is included in twenty-nine NDAs.

The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

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Summary for LEVONORGESTREL AND ETHINYL ESTRADIOL
US Patents:0
Applicants:9
NDAs:29
Finished Product Suppliers / Packagers: 11
Raw Ingredient (Bulk) Api Vendors: 5
Clinical Trials: 60
What excipients (inactive ingredients) are in LEVONORGESTREL AND ETHINYL ESTRADIOL?LEVONORGESTREL AND ETHINYL ESTRADIOL excipients list
DailyMed Link:LEVONORGESTREL AND ETHINYL ESTRADIOL at DailyMed
Drug patent expirations by year for LEVONORGESTREL AND ETHINYL ESTRADIOL
Recent Clinical Trials for LEVONORGESTREL AND ETHINYL ESTRADIOL

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

SponsorPhase
Alexion Pharmaceuticals, Inc.Phase 1
FHI 360N/A
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)N/A

See all LEVONORGESTREL AND ETHINYL ESTRADIOL clinical trials

Pharmacology for LEVONORGESTREL AND ETHINYL ESTRADIOL

US Patents and Regulatory Information for LEVONORGESTREL AND ETHINYL ESTRADIOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Xiromed LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 205131-001 Dec 14, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiromed LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 200492-001 May 27, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal Pharms LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 203871-001 Nov 13, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Naari Pte Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 207033-001 Oct 9, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Sa LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 078834-001 May 31, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiromed LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 200490-001 Apr 21, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glenmark Pharms Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 203164-001 Jun 12, 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

LEVONORGESTREL AND ETHINYL ESTRADIOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Levonorgestrel and Ethinyl Estradiol

Introduction

Levonorgestrel and ethinyl estradiol are key components of various contraceptive methods, including oral contraceptives, emergency contraception, and transdermal delivery systems. The market for these drugs is driven by several factors, including demographic trends, regulatory environments, and advancements in medical technology.

Market Size and Growth

The global market for levonorgestrel and ethinyl estradiol, as part of the broader contraceptive drugs market, has been experiencing significant growth. As of 2023, the global contraceptive drugs market was valued at USD 16.94 billion and is projected to reach USD 30.06 billion by 2033, growing at a CAGR of 5.9% from 2024 to 2033[3].

Segmentation and Distribution

The market for levonorgestrel and ethinyl estradiol is segmented based on several criteria:

By Product

  • Oral contraceptives, which include various formulations such as 0.02mg/0.1mg, 0.03mg/0.15mg, and 0.01mg/0.15mg of ethinyl estradiol and levonorgestrel, respectively, are a dominant segment. These products are widely used due to their clinical advantages and cost-effectiveness[1][3].
  • Other products include emergency contraception pills, transdermal delivery systems, and extended-cycle oral contraceptives like Seasonale[4].

By Distribution Channel

  • Retail pharmacies account for the largest revenue share due to the high demand for contraceptive pills and favorable regulations. Online distribution channels are also growing rapidly, driven by increased usage of over-the-counter solutions and online discounts[3].

By Geography

  • North America is the largest market, while the Asia-Pacific region is the fastest-growing market due to increasing awareness and acceptance of contraceptive methods[3].

Key Drivers and Restraints

Drivers

  • Increasing Demand for Contraceptives: The number of women using birth control tablets has increased significantly, from approximately 97 million in 1994 to 151 million in 2019. This trend is expected to continue, driven by growing awareness and accessibility of contraceptive methods[3].
  • Advancements in Technology: New products like the reusable silicone vaginal ring (Annovera) and transdermal delivery systems (TWIRLA) are enhancing user convenience and efficacy, contributing to market growth[3][5].

Restraints

  • Regulatory Challenges: The approval process for new contraceptive products can be stringent, and regulatory changes can impact market dynamics. For instance, the FDA approval and subsequent market monopoly for new products can influence competition[5].
  • Cost and Accessibility: While the cost of oral contraceptives is generally lower compared to other modern contraceptive methods, the cost of extended-cycle regimens and new technologies can be higher, potentially limiting access for some users[4].

Financial Trajectory

Revenue Projections

  • The ethinyl estradiol and levonorgestrel market is expected to continue its rapid growth from 2023 to 2031, with forecasts indicating significant expansion. The market size is projected to increase substantially, driven by the positive momentum in market dynamics and sustained expansion[1].

Cost and Pricing

  • The average monthly cost of ethinyl estradiol and levonorgestrel formulations varies. For example, combination oral contraceptives can cost around $35 to $41 per month, while extended-cycle regimens like Seasonale can cost approximately $120.57 for a 91-day cycle[2][4].

Competitive Landscape

The market for levonorgestrel and ethinyl estradiol is highly competitive, with several key players:

  • Teva, Pfizer, Aurobindo Pharma, Laboratorios Leon Farma, Glenmark, Allergan, Avion Pharmaceuticals, LUPIN, Mayne Pharma, Novast, Mylan, and Amneal Pharmaceuticals are prominent companies in this market[1].

Emerging Trends

Extended-Cycle Regimens

  • Products like Seasonale, which offer extended-cycle regimens, are gaining popularity due to their convenience and reduced frequency of menstrual cycles. These regimens involve taking active hormone tablets for 84 consecutive days followed by 7 days of hormone-free tablets[4].

Transdermal Delivery Systems

  • Transdermal delivery systems like TWIRLA, which avoid the need for daily pill-taking, are becoming more popular. These systems deliver levonorgestrel and ethinyl estradiol over a 28-day cycle with application and replacement every 7 days[5].

Consumer Behavior and Preferences

  • Consumers are increasingly turning to retail pharmacies and online channels for contraceptive products due to convenience and cost-effectiveness. The ease of use and long product life cycle of new technologies, such as vaginal rings and transdermal systems, are also driving consumer preferences[3].

Regulatory Environment

  • Regulatory approvals and guidelines play a crucial role in the market dynamics. For instance, the FDA approval of new products like Annovera and TWIRLA has expanded the range of available contraceptive options[3][5].

Conclusion

The market for levonorgestrel and ethinyl estradiol is poised for significant growth, driven by increasing demand for contraceptives, advancements in technology, and favorable regulatory environments. As the market continues to evolve, it is expected to be shaped by emerging trends such as extended-cycle regimens and transdermal delivery systems.

Key Takeaways

  • The global contraceptive drugs market, including levonorgestrel and ethinyl estradiol, is projected to grow significantly from 2023 to 2033.
  • The market is segmented by product, distribution channel, and geography, with oral contraceptives and retail pharmacies being dominant segments.
  • Key drivers include increasing demand for contraceptives and technological advancements.
  • Restraints include regulatory challenges and cost accessibility issues.
  • The competitive landscape is highly competitive with several key players.
  • Emerging trends include extended-cycle regimens and transdermal delivery systems.

FAQs

What is the projected growth rate of the global contraceptive drugs market from 2024 to 2033?

The global contraceptive drugs market is expected to grow at a CAGR of 5.9% from 2024 to 2033[3].

Which region is the largest market for levonorgestrel and ethinyl estradiol?

North America is the largest market for levonorgestrel and ethinyl estradiol, while the Asia-Pacific region is the fastest-growing market[3].

What are the key drivers of the levonorgestrel and ethinyl estradiol market?

Key drivers include increasing demand for contraceptives and advancements in technology, such as new product introductions and improved delivery systems[3].

How do extended-cycle regimens like Seasonale differ from conventional oral contraceptives?

Extended-cycle regimens like Seasonale involve taking active hormone tablets for 84 consecutive days followed by 7 days of hormone-free tablets, resulting in fewer menstrual cycles compared to conventional oral contraceptives[4].

What is the role of regulatory approvals in the market for levonorgestrel and ethinyl estradiol?

Regulatory approvals, such as those from the FDA, are crucial for the introduction of new products and influence market dynamics by ensuring safety and efficacy standards are met[5].

Sources

  1. Market Research Intellect: Global Ethinyl Estradiol And Levonorgestrel Market Size And Forecast.
  2. American Academy of Family Physicians: Emergency Contraception.
  3. Precedence Research: Contraceptive Drugs Market Size, Report 2024-2033.
  4. American Academy of Family Physicians: Ethinyl Estradiol/Levonorgestrel (Seasonale) for Oral Contraception.
  5. PLoS ONE: Extended regimen of a levonorgestrel/ethinyl estradiol transdermal delivery system: Predicted serum hormone levels using a population pharmacokinetic model.

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