You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

DESOGESTREL; ETHINYL ESTRADIOL - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Desogestrel; ethinyl estradiol is the generic ingredient in seventeen branded drugs marketed by Organon Usa Inc, Duramed Pharms Barr, Janssen Pharms, Lupin Ltd, Aspen Global Inc, Dr Reddys Labs Sa, Naari Pte Ltd, Novast Labs, Watson Labs, Xiromed, Endo Operations, Aurobindo Pharma, Barr, Teva Branded Pharm, and Glenmark Pharms Ltd, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound.

Summary for DESOGESTREL; ETHINYL ESTRADIOL
Recent Clinical Trials for DESOGESTREL; ETHINYL ESTRADIOL

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

SponsorPhase
Laboratorios Andromaco S.A.Phase 1
University of PennsylvaniaPhase 3
Milton S. Hershey Medical CenterPhase 3

See all DESOGESTREL; ETHINYL ESTRADIOL clinical trials

US Patents and Regulatory Information for DESOGESTREL; 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 DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 202085-001 May 20, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Xiromed DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 202296-001 Aug 30, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd BEKYREE desogestrel; ethinyl estradiol TABLET;ORAL-28 202226-001 Aug 12, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Endo Operations KIMIDESS desogestrel; ethinyl estradiol TABLET;ORAL-28 076681-001 Apr 30, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs DESOGESTREL AND ETHINYL ESTRADIOL desogestrel; ethinyl estradiol TABLET;ORAL-28 076915-001 Jul 29, 2005 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Duramed Pharms Barr VELIVET desogestrel; ethinyl estradiol TABLET;ORAL-28 076455-001 Feb 24, 2004 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 DESOGESTREL; ETHINYL ESTRADIOL

DESOGESTREL; ETHINYL ESTRADIOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Desogestrel and Ethinyl Estradiol

Market Overview

The market for Desogestrel and Ethinyl Estradiol tablets, a combined hormonal contraceptive (CHC), is experiencing significant growth and is poised for continued expansion. Here are the key aspects of its market dynamics and financial trajectory.

Market Size and Growth Projections

The Desogestrel and Ethinyl Estradiol Tablets Market has reached substantial value and is anticipated to continue growing significantly. By 2023, the market had already achieved a notable value, and projections indicate it will attain even higher values by 2031. This growth is driven by increasing demand for effective and reliable contraceptive methods, as well as the drug's additional benefits such as treating moderate acne and hypoestrogenic conditions[1].

Segmentation

The market is segmented based on type (short-acting contraceptives, long-acting contraceptives), application (hospital, clinic), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse market needs and trends across different regions and applications[1].

Drivers of Growth

Several factors are driving the growth of the Desogestrel and Ethinyl Estradiol market:

  • Increasing Demand for Contraceptives: The global need for effective and safe contraceptive methods is on the rise, particularly among younger populations.
  • Additional Health Benefits: The drug's efficacy in treating moderate acne and other conditions like hypoestrogenism adds to its market appeal[4].
  • Advancements in Pharmaceutical Technology: Improvements in drug formulation and delivery systems enhance the drug's bioavailability and user compliance[2][5].

Restraints and Challenges

Despite the growth, there are several challenges and restraints:

  • Health Risks: Combined hormonal contraceptives like Desogestrel and Ethinyl Estradiol are associated with increased risks of venous and arterial thromboembolism, particularly in smokers and older users. This includes risks of deep venous thrombosis, pulmonary embolism, and cerebrovascular events[4].
  • Regulatory Scrutiny: The pharmaceutical industry is heavily regulated, and any adverse event reports or changes in regulatory policies can impact market dynamics[3].

Opportunities

The market presents several opportunities:

  • Expanding into New Markets: Growing healthcare infrastructure and increasing awareness about family planning in emerging economies offer significant opportunities for market expansion.
  • Innovation and R&D: Continuous research and development in the field of hormonal contraceptives can lead to new formulations and delivery methods, enhancing the drug's efficacy and safety profile[3].

Competitive Landscape

The competitive landscape of the Desogestrel and Ethinyl Estradiol market is characterized by the presence of several key players:

  • Major Players: Companies like Cipla, Bayer, Merck, Teva Pharmaceutical, Allergan, Pfizer, Reckitt Benckiser, Mankind Pharma, Janssen Pharmaceutical, HLL Lifecare, and Mithra Pharmaceuticals are prominent in the market. These companies are involved in various activities such as new product releases, collaborations, mergers, and acquisitions[1].

Financial Performance

The financial performance of the Desogestrel and Ethinyl Estradiol market is robust, with significant revenue projections:

  • Revenue Growth: The market is expected to see substantial revenue growth from 2023 to 2031, driven by increasing demand and expanding market reach.
  • Pricing Strategies: The pricing of these tablets is influenced by factors such as production costs, market competition, and regulatory environments. Companies often employ dynamic pricing strategies to maintain market share and profitability[1][3].

Regional Analysis

The market is geographically diverse, with different regions exhibiting unique trends:

  • North America and Europe: These regions have a well-established market with high demand due to advanced healthcare systems and high awareness about family planning.
  • Asia-Pacific: This region is expected to show rapid growth due to increasing healthcare infrastructure and a large population base[1].

Economic Implications

The economic implications of the Desogestrel and Ethinyl Estradiol market are significant:

  • R&D Investments: The shift towards precision medicines and innovative drug formulations requires substantial investments in research and development, which can impact the overall cost structure and pricing policies of pharmaceutical companies[3].
  • Government Incentives: Government policies and incentives play a crucial role in shaping the market. Support for family planning programs and subsidies for contraceptive drugs can enhance market growth[3].

User Efficacy and Safety

The user efficacy of Desogestrel and Ethinyl Estradiol tablets is high, with a typical user-efficacy pregnancy rate of 1.12 per 100 women-years. However, the drug comes with certain safety concerns, such as increased risks of thromboembolic events and cerebrovascular diseases, especially in smokers and older users[2][4].

Contraindications and Precautions

The drug is contraindicated in females with certain conditions, including known or suspected pregnancy, thrombophlebitis or thromboembolic disorders, liver disease, and breast cancer. Precautions include monitoring blood pressure and discontinuing the drug if significant elevation occurs[4].

Conclusion

The Desogestrel and Ethinyl Estradiol market is poised for significant growth driven by increasing demand, additional health benefits, and advancements in pharmaceutical technology. However, it faces challenges such as health risks and regulatory scrutiny. Understanding these market dynamics is crucial for pharmaceutical companies to navigate the competitive landscape effectively.

Key Takeaways

  • Growing Market Demand: Increasing need for effective and safe contraceptive methods.
  • Additional Health Benefits: Efficacy in treating moderate acne and hypoestrogenic conditions.
  • Health Risks: Associated with increased risks of thromboembolic and cerebrovascular events.
  • Regulatory Scrutiny: Heavily regulated industry with potential impacts from adverse event reports or policy changes.
  • Competitive Landscape: Dominated by key players like Cipla, Bayer, and Merck.
  • Financial Performance: Robust revenue growth projections from 2023 to 2031.

FAQs

Q: What are the primary uses of Desogestrel and Ethinyl Estradiol tablets? A: The primary uses include contraception, treatment of moderate acne vulgaris, and management of hypoestrogenic conditions[4].

Q: What are the key health risks associated with Desogestrel and Ethinyl Estradiol? A: The key health risks include increased risks of venous and arterial thromboembolism, cerebrovascular events, and hypertension[4].

Q: Which companies are major players in the Desogestrel and Ethinyl Estradiol market? A: Major players include Cipla, Bayer, Merck, Teva Pharmaceutical, Allergan, Pfizer, Reckitt Benckiser, Mankind Pharma, Janssen Pharmaceutical, HLL Lifecare, and Mithra Pharmaceuticals[1].

Q: How is the market segmented? A: The market is segmented by type (short-acting, long-acting contraceptives), application (hospital, clinic), and geographical regions[1].

Q: What is the expected market growth for Desogestrel and Ethinyl Estradiol tablets from 2023 to 2031? A: The market is expected to see substantial growth, driven by increasing demand and expanding market reach, with significant revenue projections[1].

Sources

  1. Market Research Intellect: Desogestrel and Ethinyl Estradiol Tablets Market Size, Scope And Forecast 2023-2031.
  2. DailyMed: Desogestrel and Ethinyl Estradiol Tablets USP 0.15 mg/0.03 mg Rx Only.
  3. National Bureau of Economic Research: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
  4. Elsevier Health: Desogestrel; Ethinyl Estradiol.
  5. FDA: DESOGEN Tablets Label.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.