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Last Updated: December 22, 2024

DROSPIRENONE AND ETHINYL ESTRADIOL Drug Patent Profile


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Which patents cover Drospirenone And Ethinyl Estradiol, and when can generic versions of Drospirenone And Ethinyl Estradiol launch?

Drospirenone And Ethinyl Estradiol is a drug marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Apotex, Dr Reddys Labs Sa, Lupin Ltd, and Naari Pte Ltd. and is included in sixteen NDAs.

The generic ingredient in DROSPIRENONE AND ETHINYL ESTRADIOL is drospirenone; ethinyl estradiol. There are eleven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Drospirenone And Ethinyl Estradiol

A generic version of DROSPIRENONE AND ETHINYL ESTRADIOL was approved as drospirenone; ethinyl estradiol by DR REDDYS LABS SA on September 7th, 2010.

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Summary for DROSPIRENONE AND ETHINYL ESTRADIOL
Drug patent expirations by year for DROSPIRENONE AND ETHINYL ESTRADIOL
Recent Clinical Trials for DROSPIRENONE AND ETHINYL ESTRADIOL

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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 AND ETHINYL ESTRADIOL clinical trials

US Patents and Regulatory Information for DROSPIRENONE 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
Barr DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 078515-001 Mar 30, 2009 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiromed DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 202594-001 Oct 22, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hlthcare DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 203291-001 Jul 18, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hetero Labs DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 213034-001 Jan 24, 2020 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

DROSPIRENONE AND 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 of synthetic estrogen and progesterone, is widely used as an oral contraceptive and for the treatment of acne and premenstrual dysphoric disorder (PMDD). This article delves into the market dynamics and financial trajectory of this drug, highlighting key trends, drivers, and forecasts.

Market Size and Growth

The global market for drospirenone and ethinyl estradiol tablets is anticipated to experience significant growth. The market size is expected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent from 2023 to 2031, driven by increasing demand for effective oral contraceptives and treatments for acne and PMDD[1][4].

Segmentation

The market is segmented based on several factors, including:

  • Application: Pharmacy, Hospital, Clinic, and Online Store.
  • Product: Different dosages such as 3mg/0.03mg and 3mg/0.02mg.
  • Geographical Regions: North America, Europe, Asia-Pacific, South America, and Middle-East and Africa[1][4].

Drivers of Growth

Several factors are driving the growth of this market:

  • Increasing Demand for Oral Contraceptives: The need for effective and convenient birth control methods continues to rise, contributing to the market's expansion.
  • Therapeutic Benefits: The drug's efficacy in treating acne and PMDD adds to its demand, making it a versatile product in the pharmaceutical market[5].
  • Consumer Behavior: Changes in consumer behavior, particularly among women seeking comprehensive healthcare solutions, have boosted the market's growth[4].

Key Players

The market is dominated by several key players, including:

  • Bayer AG
  • Camber Pharmaceuticals
  • Morningside Pharmaceuticals
  • Lupin Pharmaceuticals
  • Xiromed
  • Sun Pharmaceutical
  • Hetero Drugs
  • Jubilant Cadista
  • Mylan
  • Glenmark Pharmaceuticals

These companies are actively involved in product development, mergers and acquisitions, and research to maintain their market share and drive innovation[4].

Financial Impact

The use of drospirenone and ethinyl estradiol has significant financial implications:

  • Cost Savings: Studies have shown that the use of this drug can lead to substantial reductions in healthcare costs. For example, a study found that drug costs, medical costs, and total costs were decreased by 38%, 37%, and 37%, respectively, among women using this medication for acne treatment[3].
  • Market Revenue: The market revenue is projected to increase significantly over the forecast period, driven by the growing demand and expanding product penetration in various regions[1][4].

Pharmacokinetics and Efficacy

Understanding the pharmacokinetics of drospirenone and ethinyl estradiol is crucial for its market success:

  • Bioavailability: The absolute bioavailability of drospirenone is about 76%, while that of ethinyl estradiol is approximately 40%. The drug reaches peak serum concentrations within 1-2 hours after administration[2].
  • Therapeutic Effects: The combination of drospirenone and ethinyl estradiol is highly effective in preventing pregnancy, treating acne, and managing PMDD, which enhances its market appeal[5].

Geographical Analysis

The market is geographically diverse, with significant presence in:

  • North America: A major market due to high demand for oral contraceptives and acne treatments.
  • Europe: Another significant region with a strong pharmaceutical market.
  • Asia-Pacific: Rapidly growing due to increasing healthcare awareness and access to pharmaceuticals.
  • South America and Middle-East & Africa: Emerging markets with growing potential[1][4].

Challenges and Opportunities

Despite the positive growth trajectory, the market faces several challenges:

  • Regulatory Environment: Strict regulatory requirements and varying healthcare policies across regions can impact market growth.
  • Competition: The presence of other oral contraceptives and acne treatments poses competitive challenges.
  • COVID-19 Impact: The pandemic has altered consumer behavior and healthcare priorities, requiring market players to adapt their strategies[4].

SWOT Analysis

A SWOT analysis highlights the market's strengths, weaknesses, opportunities, and threats:

  • Strengths: Effective therapeutic benefits, strong brand presence, and growing demand.
  • Weaknesses: High competition, regulatory challenges, and potential side effects.
  • Opportunities: Expanding into emerging markets, developing new formulations, and leveraging digital healthcare platforms.
  • Threats: Economic downturns, changes in healthcare policies, and the emergence of alternative treatments[4].

Conclusion

The market for drospirenone and ethinyl estradiol tablets is poised for significant growth, driven by its therapeutic efficacy, increasing demand, and strategic market positioning by key players. As the market continues to evolve, understanding the dynamics and financial trajectory will be crucial for stakeholders to make informed decisions.

Key Takeaways

  • The market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
  • Key drivers include increasing demand for oral contraceptives and treatments for acne and PMDD.
  • Major players are investing in product development and market expansion.
  • The market faces challenges such as regulatory hurdles and competition but offers opportunities for growth in emerging markets.

Frequently Asked Questions (FAQs)

Q: What are the primary uses of drospirenone and ethinyl estradiol tablets? A: These tablets are primarily used for the prevention of pregnancy, treatment of acne, and management of premenstrual dysphoric disorder (PMDD)[5].

Q: Which regions are expected to drive the market growth? A: North America, Europe, and the Asia-Pacific region are anticipated to be key drivers of market growth due to high demand and expanding healthcare access[1][4].

Q: How do drospirenone and ethinyl estradiol affect healthcare costs? A: Studies have shown that the use of this medication can lead to significant reductions in healthcare costs, including drug costs, medical costs, and total costs[3].

Q: What are the major challenges facing the market? A: The market faces challenges such as regulatory requirements, competition from other treatments, and the impact of the COVID-19 pandemic on consumer behavior and healthcare priorities[4].

Q: Who are the key players in the drospirenone and ethinyl estradiol market? A: Key players include Bayer AG, Camber Pharmaceuticals, Morningside Pharmaceuticals, Lupin Pharmaceuticals, and several others[4].

Cited Sources:

  1. Marketresearchintellect - Drospirenone And Ethinyl Estradiol Tablets Market Size And Forecast
  2. FDA - YAZ (drospirenone and ethinyl estradiol) Tablets PHYSICIAN LABEL
  3. PubMed - Use of drospirenone/ethinyl estradiol (DRSP/EE) among women
  4. Pharmiweb - Global Drospirenone and Ethinyl Estradiol Tablets Market Scope, Share and Size Estimation with Forecast 2021 to 2026
  5. Cleveland Clinic - Drospirenone; Ethinyl Estradiol Tablets

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