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Last Updated: December 21, 2024

Drospirenone; ethinyl estradiol - Generic Drug Details


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What are the generic drug sources for drospirenone; ethinyl estradiol and what is the scope of patent protection?

Drospirenone; ethinyl estradiol is the generic ingredient in sixteen branded drugs marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Sun Pharm, Aurobindo Pharma Ltd, Novast Labs, Lupin Ltd, Bayer Hlthcare, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in thirty-three NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sixteen suppliers are listed for this compound.

Recent Clinical Trials for drospirenone; ethinyl estradiol

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

SponsorPhase
McGill University Health Centre/Research Institute of the McGill University Health CentrePhase 4
Eli Lilly and CompanyPhase 1
Bristol-Myers SquibbPhase 1

See all drospirenone; ethinyl estradiol clinical trials

Paragraph IV (Patent) Challenges for DROSPIRENONE; ETHINYL ESTRADIOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
YAZ Tablets drospirenone; ethinyl estradiol 3 mg/0.02 mg 021676 1 2006-09-29
YASMIN Tablets drospirenone; ethinyl estradiol 3 mg/0.03 mg 021098 1 2005-01-07

US Patents and Regulatory Information for drospirenone; ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm KYRA drospirenone; ethinyl estradiol TABLET;ORAL 202318-001 Jul 23, 2019 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm KEMEYA drospirenone; ethinyl estradiol TABLET;ORAL-28 202138-001 Mar 13, 2019 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Hlthcare SAFYRAL drospirenone; ethinyl estradiol; levomefolate calcium TABLET;ORAL 022574-001 Dec 16, 2010 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Apotex DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 205876-001 Sep 21, 2016 DISCN 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 drospirenone; ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ⤷  Subscribe ⤷  Subscribe
Bayer Hlthcare YASMIN drospirenone; ethinyl estradiol TABLET;ORAL-28 021098-001 May 11, 2001 ⤷  Subscribe ⤷  Subscribe
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ⤷  Subscribe ⤷  Subscribe
Bayer Hlthcare YAZ drospirenone; ethinyl estradiol TABLET;ORAL 021676-001 Mar 16, 2006 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Drospirenone; ethinyl estradiol Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Drospirenone and Ethinyl Estradiol

Introduction

Drospirenone and ethinyl estradiol, a combination hormonal contraceptive, has been a significant player in the pharmaceutical market, particularly in the segments of birth control, premenstrual dysphoric disorder (PMDD), and acne treatment. This article delves into the market dynamics and financial trajectory of this drug, highlighting its current status, growth prospects, and key factors influencing its market performance.

Market Size and Growth Prospects

The global market for drospirenone and ethinyl estradiol tablets has shown promising growth. As of 2023, the market size was valued at several million USD, and it is forecasted to continue growing in the coming years[1][4].

Competitive Landscape

The competitive landscape of the drospirenone and ethinyl estradiol market is characterized by several key players, each with their own marketing strategies and market contributions. The report provides a detailed analysis of the competitive environment, including the successful strategies of leading companies and their recent developments[1].

Drivers of the Market

Several factors drive the demand for drospirenone and ethinyl estradiol tablets:

Contraceptive Needs

The primary driver is the ongoing need for effective birth control methods. Drospirenone and ethinyl estradiol combination is widely used for its efficacy in preventing pregnancy[5].

Non-Contraceptive Benefits

In addition to contraception, this combination is also indicated for the treatment of PMDD and moderate acne, which expands its market appeal. It is the only hormonally based contraceptive regimen with FDA indications for PMDD and acne[3].

Demographic Factors

The increasing awareness and acceptance of hormonal contraceptives among women, particularly in younger age groups, contribute to the market growth.

Restraints and Challenges

Despite the growth drivers, there are several restraints and challenges that impact the market:

Side Effects and Health Risks

The use of drospirenone and ethinyl estradiol is associated with increased risks of blood clots, heart attacks, and strokes, especially in smokers over 35 years old. These risks can deter some potential users[5].

Regulatory Scrutiny

The pharmaceutical industry is heavily regulated, and any changes in regulatory policies or safety concerns can impact the market negatively.

Alternative Treatments

The availability of alternative birth control methods and treatments for PMDD and acne can also affect the demand for drospirenone and ethinyl estradiol.

Cost-Effectiveness

Studies have shown that the use of drospirenone and ethinyl estradiol can be cost-effective, particularly in reducing healthcare resource utilization for acne treatment. A study found that drug costs, medical costs, and total costs were decreased by 37-38% after the initiation of this contraceptive regimen[2].

Regional Market Analysis

The market for drospirenone and ethinyl estradiol tablets is analyzed on a global and regional basis. Different regions have varying growth prospects based on factors such as population demographics, healthcare infrastructure, and regulatory environments[1][4].

Key Players and Their Strategies

Leading companies in the market have adopted various strategies to maintain and expand their market share. These include innovative marketing campaigns, partnerships, and continuous research and development to improve the product's efficacy and safety profile[1].

Financial Performance

The financial performance of the market is reflected in the revenue generated by the sales of drospirenone and ethinyl estradiol tablets. The market is expected to grow, driven by increasing demand and the expansion of distribution channels. The pricing of the reports on this market, ranging from $3480 to $6960 depending on the license type, indicates the commercial value of the market data and analysis[1].

Consumer Preferences and Awareness

Consumer preferences play a crucial role in the market dynamics. Women's increasing awareness of the benefits and risks associated with hormonal contraceptives influences their choices. The unique benefits of drospirenone and ethinyl estradiol, such as its efficacy in treating PMDD and acne, make it a preferred option for many[3].

Technological and Research Advancements

Continuous research and development are essential for maintaining the market position of drospirenone and ethinyl estradiol. Advances in pharmaceutical technology and clinical trials help in improving the safety and efficacy of the drug, which can further boost its market performance.

Regulatory Environment

The regulatory environment is a critical factor in the pharmaceutical industry. Changes in FDA regulations or safety guidelines can significantly impact the market. For instance, the FDA indications for PMDD and acne treatment have been a significant boost to the market for drospirenone and ethinyl estradiol[3].

Market Opportunities and Threats

Opportunities

  • Expanding into new markets, especially in regions with growing populations and increasing healthcare needs.
  • Developing new formulations or delivery methods that enhance user compliance and safety.
  • Leveraging the non-contraceptive benefits to target a broader patient base.

Threats

  • Increasing competition from other birth control methods and treatments for PMDD and acne.
  • Regulatory changes or safety concerns that could impact market approval or user confidence.
  • Economic factors such as recession or changes in healthcare policies that could affect consumer spending on pharmaceuticals.

Key Takeaways

  • The global market for drospirenone and ethinyl estradiol tablets is growing, driven by its efficacy in contraception, PMDD, and acne treatment.
  • The market is characterized by a competitive landscape with several key players.
  • Cost-effectiveness, particularly in reducing healthcare resource utilization for acne, is a significant advantage.
  • Regulatory environment, consumer preferences, and technological advancements are crucial factors influencing the market.
  • The market faces challenges such as side effects, regulatory scrutiny, and alternative treatments.

FAQs

  1. What are the primary uses of drospirenone and ethinyl estradiol?

    • Drospirenone and ethinyl estradiol are primarily used for birth control, treatment of premenstrual dysphoric disorder (PMDD), and moderate acne in women[3][5].
  2. What are the unique benefits of drospirenone and ethinyl estradiol compared to other contraceptives?

    • This combination is the only hormonally based contraceptive with FDA indications for PMDD and acne treatment, in addition to its contraceptive efficacy[3].
  3. What are the potential health risks associated with drospirenone and ethinyl estradiol?

    • The use of drospirenone and ethinyl estradiol is associated with increased risks of blood clots, heart attacks, and strokes, especially in smokers over 35 years old[5].
  4. How does the use of drospirenone and ethinyl estradiol impact healthcare costs?

    • Studies have shown that the use of this contraceptive regimen can reduce healthcare resource utilization and costs, particularly for acne treatment[2].
  5. What are the regulatory considerations for drospirenone and ethinyl estradiol?

    • The drug has received FDA indications for contraception, PMDD, and moderate acne. Regulatory changes or safety concerns can impact its market approval and user confidence[3].

Cited Sources:

  1. Absolute Reports - Global Drospirenone and Ethinyl Estradiol Tablets Market 2024 by ...
  2. PubMed - Use of drospirenone/ethinyl estradiol (DRSP/EE) among women ...
  3. PubMed - Drospirenone/ethinyl estradiol - PubMed
  4. Market Research Reports - Global Drospirenone and Ethinyl Estradiol Tablets Market 2024 by ...
  5. Mayo Clinic - Drospirenone and ethinyl estradiol (oral route) - Mayo Clinic

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