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Last Updated: March 14, 2025

Diethylstilbestrol diphosphate - Generic Drug Details


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What are the generic drug sources for diethylstilbestrol diphosphate and what is the scope of patent protection?

Diethylstilbestrol diphosphate is the generic ingredient in one branded drug marketed by Bayer Pharms and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for diethylstilbestrol diphosphate

US Patents and Regulatory Information for diethylstilbestrol diphosphate

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bayer Pharms STILPHOSTROL diethylstilbestrol diphosphate INJECTABLE;INJECTION 010010-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bayer Pharms STILPHOSTROL diethylstilbestrol diphosphate TABLET;ORAL 010010-002 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
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Market Dynamics and Financial Trajectory of Diethylstilbestrol Diphosphate

Introduction

Diethylstilbestrol diphosphate (DESdP), a derivative of diethylstilbestrol (DES), has a complex history marked by various medical applications and significant regulatory changes. This article will delve into the market dynamics and financial trajectory of DESdP, highlighting its production, usage, and the economic factors influencing its market presence.

Historical Production and Usage

DES, including its diphosphate form, was first produced in the early 1940s and gained widespread use in the medical field for several decades. In the United States, production of DES was reported as early as 1941, with multiple companies involved in its manufacture until the 1970s. By 1976, only one U.S. company was producing DES, and by the early 2000s, U.S. pharmaceutical companies had ceased its production[1].

Medical Applications

DESdP was used for various medical purposes, including the treatment of prostate cancer, breast cancer, and as a hormone replacement therapy. It was also administered to prevent miscarriages, although this use was later found to be ineffective and harmful[5].

Prostate Cancer Treatment

DESdP was particularly effective in treating advanced prostate cancer by suppressing androgen production and inducing apoptosis in cancer cells. Studies have shown that DES and DESdP have direct cytotoxic effects on prostate cancer cells, independent of estrogen receptors, making them valuable agents against androgen-insensitive prostate neoplasms[4].

Breast Cancer Treatment

While DESdP was used in the treatment of breast cancer, its use has been largely supplanted by bioidentical estrogens like estradiol due to the lower risk of cardiovascular toxicity associated with these alternatives[5].

Market Dynamics

Regulatory Changes

The market for DESdP has been significantly impacted by regulatory changes. In 1979, the use of DES as a growth promoter in livestock was banned, and its production for human use has been strictly regulated. The Environmental Protection Agency (EPA) has listed DES as a hazardous waste, and its reportable quantity is set at 1 lb[1].

Decline in Usage

The decline in the use of DESdP can be attributed to several factors, including the discovery of its harmful effects, particularly on pregnant women and their offspring. Studies have linked DES exposure to various health issues such as infertility, miscarriage, and increased risks of certain cancers[5].

Current Market Status

Although DES is no longer manufactured by U.S. pharmaceutical companies, it is still available from some suppliers. The annual U.S. imports of DES, including its diphosphate form, have significantly decreased from the 1970s to the 1980s, reflecting the decline in its medical use[1].

Financial Trajectory

Production Costs and Revenue

The financial trajectory of DESdP is closely tied to its production costs and the revenue generated from its sale. With the decline in demand due to regulatory changes and the discovery of adverse health effects, the revenue from DESdP has decreased substantially. The production costs, however, have remained relatively stable, although the scale of production has reduced significantly[1].

Impact of Alternative Treatments

The introduction of alternative treatments, such as bioidentical estrogens, has further eroded the market share of DESdP. These alternatives offer similar therapeutic benefits with lower risks, making them more attractive to both patients and healthcare providers. This shift has resulted in a decline in the financial performance of DESdP[5].

Economic Factors

Healthcare Costs and Reimbursement

The economic viability of DESdP is also influenced by healthcare costs and reimbursement policies. With the increased awareness of its adverse effects, many healthcare systems have reduced or eliminated reimbursement for DESdP, further reducing its market viability[5].

Litigation and Compensation

The financial trajectory of DESdP has been impacted by litigation and compensation claims related to its adverse health effects. This has led to significant financial burdens on companies involved in its production and distribution, contributing to the decline in its market presence[2].

Conclusion

The market dynamics and financial trajectory of diethylstilbestrol diphosphate are characterized by a significant decline in usage and revenue due to regulatory changes, the discovery of adverse health effects, and the introduction of alternative treatments. While it remains available for certain medical applications, its market presence is vastly diminished compared to its peak in the mid-20th century.

Key Takeaways

  • Regulatory Changes: Strict regulations and bans on certain uses have significantly impacted the market for DESdP.
  • Adverse Health Effects: The discovery of harmful health effects has led to a decline in its medical use.
  • Alternative Treatments: The introduction of bioidentical estrogens has reduced the market share of DESdP.
  • Financial Decline: The revenue from DESdP has decreased substantially due to reduced demand and increased litigation costs.
  • Current Market Status: DESdP is still available but from limited suppliers, and its use is largely restricted to specific medical applications.

FAQs

Q: What was the primary medical use of diethylstilbestrol diphosphate (DESdP)? A: DESdP was primarily used for the treatment of prostate cancer and breast cancer.

Q: Why has the use of DESdP declined over the years? A: The use of DESdP has declined due to regulatory changes, the discovery of adverse health effects, and the introduction of alternative treatments.

Q: What are the current regulatory status and restrictions on DESdP? A: DESdP is listed as a hazardous waste by the EPA, and its use is strictly regulated. It is no longer manufactured by U.S. pharmaceutical companies but is available from some suppliers.

Q: How has the introduction of alternative treatments affected the market for DESdP? A: The introduction of bioidentical estrogens has reduced the market share of DESdP due to their lower risk of cardiovascular toxicity and other adverse effects.

Q: What are some of the economic factors influencing the financial trajectory of DESdP? A: Economic factors include healthcare costs, reimbursement policies, and litigation costs related to adverse health effects.

Sources

  1. National Toxicology Program. RoC Profile: Diethylstilbestrol.
  2. Australian Parliament House. DIETHYLSTILBESTROL.
  3. ScienceDirect. Diethylstilbestrol - an overview.
  4. PubMed. Induction of apoptosis by diethylstilbestrol in hormone-insensitive prostate cancer cells.
  5. Wikipedia. Diethylstilbestrol.

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