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Last Updated: April 9, 2025

DEMULEN 1/50-28 Drug Patent Profile


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Which patents cover Demulen 1/50-28, and what generic alternatives are available?

Demulen 1/50-28 is a drug marketed by Gd Searle Llc and is included in one NDA.

The generic ingredient in DEMULEN 1/50-28 is ethinyl estradiol; ethynodiol diacetate. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.

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Summary for DEMULEN 1/50-28
Drug patent expirations by year for DEMULEN 1/50-28

US Patents and Regulatory Information for DEMULEN 1/50-28

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Gd Searle Llc DEMULEN 1/50-28 ethinyl estradiol; ethynodiol diacetate TABLET;ORAL-28 016936-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Demulen 1/50-28

Introduction to Demulen 1/50-28

Demulen 1/50-28 is a combined oral contraceptive that contains two types of hormones: ethinyl estradiol and ethynodiol diacetate. This medication was used to prevent pregnancy and was available under several brand names, including Demulen 1/50, Kelnor, and Zovia[5].

Historical Context and Discontinuation

The Demulen 1/50 brand has been discontinued in the U.S., although generic versions may still be available if approved by the FDA. This discontinuation is part of a broader trend in the pharmaceutical industry where older drugs are often phased out in favor of newer, more advanced treatments or due to changes in market demand and regulatory environments.

Market Trends in Contraceptives

The market for oral contraceptives is highly competitive and subject to various trends and regulatory changes. Here are some key points:

Evolving Consumer Preferences

Consumers are increasingly looking for more convenient and safer contraceptive options. This has led to the development of newer contraceptives with improved side effect profiles and easier administration methods, such as patches, rings, and injectables[1].

Regulatory Environment

The pharmaceutical industry is heavily regulated, and changes in regulations can significantly impact the market dynamics of drugs like Demulen 1/50-28. For instance, stricter safety guidelines and increased scrutiny over side effects can influence the availability and popularity of certain drugs[5].

Financial Trajectory of Oral Contraceptives

Declining Economic Returns

The overall financial returns from new prescription drugs, including contraceptives, have been declining over the past few decades. A study analyzing the economic returns of new prescription drugs launched in the U.S. found that the average present values of lifetime net economic returns have fallen sharply since the early 2000s. This decline suggests that the rewards for innovation in the pharmaceutical sector may not be sufficient to maintain historical rates of investment in R&D[4].

Cost and Revenue Considerations

The development and marketing of oral contraceptives are costly endeavors. Pharmaceutical companies must balance the costs of research, development, and marketing with the potential revenue from sales. For drugs like Demulen 1/50-28, which have been discontinued, the financial trajectory would likely show a decline in revenue over time as the product is phased out and replaced by newer alternatives.

Impact of Technological Advancements

AI and Data-Driven Innovation

The pharmaceutical industry is increasingly leveraging AI, data analytics, and digital tools to drive innovation and reduce costs. While Demulen 1/50-28 itself may not benefit from these advancements, the broader contraceptive market is likely to see new products and improved versions developed using these technologies. For example, AI can help in identifying new targets for contraceptive drugs and optimizing clinical trial processes, potentially leading to more effective and safer treatments[3].

Supply Chain Resilience

Pharmaceutical companies are focusing on optimizing their supply chains and building resilience using technology. This includes investments in smart manufacturing and data-driven tools to ensure continuous supply and mitigate risks associated with global economic dynamics. While this does not directly impact Demulen 1/50-28, it reflects the industry's broader strategy to maintain and improve the supply of essential medications[3].

Consumer Health and Safety Considerations

Side Effects and Risks

Oral contraceptives like Demulen 1/50-28 come with potential side effects and risks, such as nausea, vomiting, headache, and increased risk of cardiovascular events, especially in smokers over 35 years old. These factors can influence consumer choice and market demand, with many opting for alternatives that offer better safety profiles[2][5].

Competitive Landscape

The contraceptive market is highly competitive, with numerous brands and types of contraceptives available. The discontinuation of Demulen 1/50-28 has likely led to a shift in market share towards other available options. Pharmaceutical companies are continually innovating and expanding their portfolios to capture market share and meet evolving consumer needs[1].

Future Outlook

Innovation in Contraceptives

The future of contraceptives is likely to be shaped by advancements in technology, changing consumer preferences, and the need for safer and more effective treatments. Pharmaceutical companies are investing in novel modalities and mechanisms of action, which could lead to the development of new, more appealing contraceptive options[3].

Market Adaptation

The pharmaceutical industry must adapt to changing market dynamics, regulatory environments, and technological advancements. Companies that fail to innovate and diversify their portfolios risk being left behind in a competitive market.

Key Takeaways

  • Discontinuation and Market Impact: Demulen 1/50-28 has been discontinued, reflecting broader trends in the pharmaceutical industry.
  • Declining Economic Returns: The financial returns from new prescription drugs, including contraceptives, have been declining.
  • Technological Advancements: AI, data analytics, and digital tools are driving innovation and cost reduction in the pharmaceutical sector.
  • Consumer Health and Safety: Side effects and risks associated with oral contraceptives influence consumer choice and market demand.
  • Competitive Landscape: The contraceptive market is highly competitive, with continuous innovation and expansion of portfolios.

Frequently Asked Questions

1. Why was Demulen 1/50-28 discontinued?

Demulen 1/50-28 was discontinued likely due to a combination of factors including market demand, regulatory changes, and the availability of newer, more advanced contraceptive options.

2. What are the common side effects of oral contraceptives like Demulen 1/50-28?

Common side effects include nausea, vomiting, headache, and an increased risk of cardiovascular events, especially in smokers over 35 years old[2].

3. How is technology impacting the development of new contraceptives?

Technology, including AI and data analytics, is being used to identify new targets, optimize clinical trials, and develop safer and more effective treatments[3].

4. What are the financial challenges facing the pharmaceutical industry in developing new drugs?

The industry faces declining economic returns from new prescription drugs, making it challenging to maintain historical rates of investment in R&D[4].

5. How are pharmaceutical companies adapting to changing market dynamics?

Companies are focusing on evolving their portfolios based on scientific and technological breakthroughs, accelerating R&D with data and AI, and optimizing supply chains for sustainability and resilience[3].

Sources:

  1. DrugBank - Norethisterone: Uses, Interactions, Mechanism of Action.
  2. Drugs.com - Demulen 1/50 Side Effects: Common, Severe, Long Term.
  3. ZS - Exploring 2025 pharma industry trends, outlook and strategies.
  4. PubMed - Decline in economic returns from new drugs raises concerns.
  5. Drugs.com - Demulen 1/50 Advanced Patient Information.

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