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Last Updated: April 6, 2025

DEMULEN 1/35-28 Drug Patent Profile


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When do Demulen 1/35-28 patents expire, and when can generic versions of Demulen 1/35-28 launch?

Demulen 1/35-28 is a drug marketed by Gd Searle Llc and is included in one NDA.

The generic ingredient in DEMULEN 1/35-28 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 1/35-28
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors:6
DailyMed Link:DEMULEN 1/35-28 at DailyMed
Drug patent expirations by year for DEMULEN 1/35-28

US Patents and Regulatory Information for DEMULEN 1/35-28

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Gd Searle Llc DEMULEN 1/35-28 ethinyl estradiol; ethynodiol diacetate TABLET;ORAL-28 018160-001 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

Expired US Patents for DEMULEN 1/35-28

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Gd Searle Llc DEMULEN 1/35-28 ethinyl estradiol; ethynodiol diacetate TABLET;ORAL-28 018160-001 Approved Prior to Jan 1, 1982 3,483,221 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 1 of 1 entries

International Patents for DEMULEN 1/35-28

See the table below for patents covering DEMULEN 1/35-28 around the world.

CountryPatent NumberTitleEstimated Expiration
Finland 45039 ⤷  Try for Free
Sweden 352884 ⤷  Try for Free
Switzerland 476679 Verfahren zur Herstellung neuer ungesättigter Amine ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 3 of 3 entries

Supplementary Protection Certificates for DEMULEN 1/35-28

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0771217 07C0001 France ⤷  Try for Free PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1380301 2009C/007 Belgium ⤷  Try for Free PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0771217 CA 2006 00038 Denmark ⤷  Try for Free PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for DEMULEN 1/35-28

Introduction to DEMULEN 1/35-28

DEMULEN 1/35-28 is a combined oral contraceptive pill that contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol. It is used for the prevention of pregnancy and is part of the broader category of hormonal contraceptives[4].

Market Overview of Oral Contraceptives

The market for oral contraceptives is a significant segment within the pharmaceutical industry. These medications are widely used for birth control and have been a staple in reproductive health for decades. The combined oral contraceptive pill, like DEMULEN 1/35-28, contains both estrogen and progestin, which work together to prevent ovulation and other mechanisms to prevent pregnancy[2].

Competitive Landscape

The oral contraceptive market is highly competitive, with numerous brands and formulations available. DEMULEN 1/35-28 competes with other combined oral contraceptives that vary in their hormonal composition and dosing regimens. The competition is driven by factors such as efficacy, side effect profiles, and patient preference. Manufacturers like Pfizer, which produces DEMULEN, must continually innovate and market their products to maintain market share[1].

Pricing and Cost Considerations

The pricing of DEMULEN 1/35-28 and other oral contraceptives can be influenced by several factors, including production costs, regulatory approvals, and market demand. In recent years, there has been a trend of increasing pharmaceutical expenditures, driven by factors such as new drug approvals, price increases, and changes in utilization patterns. For instance, overall pharmaceutical expenditures in the US grew by 13.6% in 2023 compared to 2022, with a significant portion attributed to increased utilization and new products[3].

Financial Trajectory

Historical Spending Patterns

Historically, the pharmaceutical sector has seen steady growth, with oral contraceptives being a stable segment. However, the financial trajectory of DEMULEN 1/35-28 can be affected by broader industry trends. For example, the rise in prescription drug spending, which is expected to increase by 10.0% to 12.0% in 2024, could impact the financial performance of DEMULEN 1/35-28[3].

Future Projections

For 2024, the pharmaceutical industry is expected to see significant growth, particularly in clinics and hospitals, where spending is anticipated to increase by 11.0% to 13.0%. This growth is driven by increased utilization, new drug approvals, and potential changes in public policy. While DEMULEN 1/35-28 may not be as heavily impacted by these factors as newer or specialty drugs, it will still be influenced by the overall market trends[3].

Regulatory and Policy Influences

Regulatory and policy changes can significantly impact the financial trajectory of pharmaceutical products. For instance, changes in healthcare policies or the approval of new drugs can alter market dynamics. Manufacturers must stay compliant with regulatory requirements and adapt to policy changes to maintain their market position.

Patient and Prescriber Preferences

Patient and prescriber preferences play a crucial role in the market dynamics of DEMULEN 1/35-28. Factors such as side effect profiles, ease of use, and efficacy influence the choice of contraceptive. For example, many women experience spotting or light bleeding during the initial months of using the pill, which can affect patient compliance and prescriber recommendations[1].

Side Effects and Safety Considerations

The safety profile of DEMULEN 1/35-28 is another critical factor in its market dynamics. The pill is associated with several potential side effects, including cardiovascular issues, central nervous system effects, and dermatologic reactions. These side effects can impact patient adherence and prescriber confidence in the product[4].

Marketing and Distribution Strategies

Effective marketing and distribution strategies are essential for maintaining the market position of DEMULEN 1/35-28. This includes educating healthcare providers about the benefits and risks of the product, as well as direct-to-consumer marketing to increase awareness and preference among potential users.

Conclusion

The market dynamics and financial trajectory of DEMULEN 1/35-28 are influenced by a complex interplay of factors including competitive landscape, pricing, regulatory environment, patient and prescriber preferences, and broader industry trends. As the pharmaceutical industry continues to evolve, manufacturers of DEMULEN 1/35-28 must remain adaptable to changes in the market and regulatory landscape to maintain their position.

Key Takeaways

  • Market Competition: DEMULEN 1/35-28 operates in a highly competitive market with numerous other oral contraceptives.
  • Pricing and Cost: The product's pricing is influenced by production costs, regulatory approvals, and market demand.
  • Financial Projections: The pharmaceutical industry is expected to see significant growth in 2024, which could impact DEMULEN 1/35-28.
  • Regulatory Influences: Regulatory and policy changes can significantly affect the product's market dynamics.
  • Patient and Prescriber Preferences: Side effect profiles, ease of use, and efficacy are crucial factors influencing patient and prescriber choices.
  • Safety Considerations: The product's safety profile, including potential side effects, is a critical factor in its market dynamics.

FAQs

Q: What are the active ingredients in DEMULEN 1/35-28? A: DEMULEN 1/35-28 contains 1 mg of ethynodiol diacetate and 35 mcg of ethinyl estradiol[4].

Q: How does DEMULEN 1/35-28 work to prevent pregnancy? A: DEMULEN 1/35-28 works primarily by inhibiting ovulation, and also through alterations in cervical mucus and the endometrium[1].

Q: What are some common side effects of DEMULEN 1/35-28? A: Common side effects include cardiovascular issues, central nervous system effects, and dermatologic reactions[4].

Q: How is DEMULEN 1/35-28 typically prescribed and taken? A: The pill is taken daily for 21 days, followed by a 7-day break or the ingestion of placebo pills[1].

Q: What are the expected growth trends in pharmaceutical spending for 2024? A: Overall prescription drug spending is expected to rise by 10.0% to 12.0%, with clinics and hospitals seeing an 11.0% to 13.0% increase[3].

Sources

  1. Pfizer Canada Inc. - DEMULEN 30 DEMULEN 50 (Ethynodiol Diacetate plus Ethinyl Estradiol Tablets) ORAL CONTRACEPTIVE[1].
  2. Wikipedia - Combined oral contraceptive pill[2].
  3. PubMed - National trends in prescription drug expenditures and projections for 2024[3].
  4. RxList - Demulen (Ethinyl Estradiol and Ethynodiol Diacetate)[4].

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