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Last Updated: April 9, 2025

DEMULEN 1/50-21 Drug Patent Profile


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When do Demulen 1/50-21 patents expire, and when can generic versions of Demulen 1/50-21 launch?

Demulen 1/50-21 is a drug marketed by Gd Searle Llc and is included in one NDA.

The generic ingredient in DEMULEN 1/50-21 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 1/50-21
Drug patent expirations by year for DEMULEN 1/50-21

US Patents and Regulatory Information for DEMULEN 1/50-21

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Gd Searle Llc DEMULEN 1/50-21 ethinyl estradiol; ethynodiol diacetate TABLET;ORAL-21 016927-001 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 1/50-21

Introduction to Demulen 1/50-21

Demulen 1/50-21 is a combination hormonal contraceptive pill, containing ethinylestradiol (an estrogen) and norethindrone (a progestin). This medication is used primarily to prevent pregnancy and is part of a broader category of combined oral contraceptive pills (COCPs)[2][5].

Market Overview of Combined Oral Contraceptives

The market for combined oral contraceptives is substantial and continues to grow due to increasing demand for effective and convenient birth control methods. The global contraceptive market, which includes COCPs, is driven by factors such as rising awareness about family planning, government initiatives to promote contraceptive use, and advancements in pharmaceutical technology.

Product Positioning and Competition

Demulen 1/50-21 competes in a crowded market with numerous other COCPs, each offering slightly different formulations and benefits. The product is positioned as a reliable and effective contraceptive option, with a specific dosage strength of 50 mcg of ethinylestradiol and 1 mg of norethindrone. This positioning helps it stand out among other similar products, such as Alesse, Ortho Tri-cyclen, and others[1][5].

Pricing and Revenue

The pricing of Demulen 1/50-21 is influenced by several factors, including production costs, market competition, and regulatory environments. Generally, COCPs are priced competitively, with generic and branded versions available. The revenue generated from Demulen 1/50-21 is part of the larger pharmaceutical market, which was estimated to be over $400 billion in 2024, with a projected compound annual growth rate (CAGR) of 7.56% between 2024 and 2029[3].

Economic Implications of Drug Development

The development and pricing of Demulen 1/50-21 are impacted by broader economic trends in the pharmaceutical industry. The shift towards precision medicines and the increasing focus on rare diseases have significant economic implications. For instance, the ability to develop drugs for small patient populations can lead to higher prices due to the high value created for these individuals, which justifies the research and development investments[4].

Regulatory Landscape

The regulatory environment plays a crucial role in the market dynamics of Demulen 1/50-21. Regulatory frameworks are evolving to keep pace with innovation, which can affect the approval process, marketing, and pricing of pharmaceutical products. In 2025, it is expected that regulatory bodies will continue to adapt to new technologies and study designs, potentially streamlining the approval process for new and existing drugs[3].

Clinical Trial Designs and Innovation

The future of Demulen 1/50-21 and similar products will be influenced by advancements in clinical trial designs. Accelerated and innovative study designs are becoming more prevalent, aiming to reduce the time and cost associated with drug development. These changes can lead to more efficient timelines and better patient outcomes, which in turn can impact the market positioning and financial performance of the product[3].

Patient-Centered Care and Precision Medicine

There is a growing trend towards patient-centered care and precision medicine in the pharmaceutical industry. This shift could influence the development of new contraceptive products, including potential variations of Demulen 1/50-21, tailored to specific patient needs. Precision medicine can lead to more effective treatments and better patient outcomes, which can drive market demand and revenue[3][4].

Market Size and Growth Projections

The biopharma and biotech markets, which include contraceptive medications, are experiencing significant growth. The biotech market size was nearly $500 billion in 2020, with an estimated CAGR of 9.4% between 2021 and 2027. This growth is driven by technological advancements, evolving regulatory frameworks, and a focus on patient-centered care. Demulen 1/50-21, as part of this larger market, is likely to benefit from these trends[3].

Consumer Behavior and Awareness

Consumer behavior and awareness about contraceptive options play a crucial role in the market dynamics of Demulen 1/50-21. Increasing awareness about family planning and the availability of various contraceptive methods can drive demand for products like Demulen. Educational campaigns and healthcare provider recommendations also influence consumer choices, impacting the product's market share[2].

Financial Performance and Projections

The financial performance of Demulen 1/50-21 is tied to the overall performance of the pharmaceutical company and the broader market trends. With the projected growth in the biopharma and biotech sectors, it is likely that Demulen 1/50-21 will continue to generate significant revenue. However, the exact financial projections would depend on various factors including market competition, pricing strategies, and regulatory changes.

Key Takeaways

  • Market Positioning: Demulen 1/50-21 competes in a crowded market of combined oral contraceptives, distinguished by its specific formulation.
  • Pricing and Revenue: The product's pricing is influenced by market competition, production costs, and regulatory environments.
  • Regulatory Landscape: Evolving regulatory frameworks will impact the approval, marketing, and pricing of Demulen 1/50-21.
  • Innovation and Clinical Trials: Advances in clinical trial designs and precision medicine will shape the future of the product.
  • Market Growth: The product benefits from the growing biopharma and biotech markets.
  • Consumer Behavior: Awareness and educational campaigns influence consumer choices and demand.

FAQs

1. What are the active ingredients in Demulen 1/50-21? Demulen 1/50-21 contains ethinylestradiol (an estrogen) and norethindrone (a progestin)[5].

2. How is Demulen 1/50-21 used? It is taken orally once daily, with the user picking a consistent time of day to ensure compliance[5].

3. What is the market size of the biopharma and biotech industries? The biopharma market size was over $400 billion in 2024, with a projected CAGR of 7.56% between 2024 and 2029. The biotech market size was nearly $500 billion in 2020, with an estimated CAGR of 9.4% between 2021 and 2027[3].

4. How do regulatory changes impact Demulen 1/50-21? Regulatory changes can affect the approval process, marketing, and pricing of Demulen 1/50-21, potentially streamlining the development and approval of new and existing drugs[3].

5. What are the future trends in the development of contraceptive medications like Demulen 1/50-21? Future trends include accelerated clinical trial designs, a focus on precision medicine, and patient-centered care, which can lead to more effective and tailored contraceptive options[3][4].

Sources

  1. DrugBank: Ethinylestradiol: Uses, Interactions, Mechanism of Action.
  2. Wikipedia: Combined oral contraceptive pill.
  3. TFS CRO: 5 Predictions for the Biopharma and Biotech Industries in 2025.
  4. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market.
  5. WebMD: Demulen 1/50 (28) Tablet - Uses, Side Effects, and More.

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