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Last Updated: March 14, 2025

STILPHOSTROL Drug Patent Profile


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Which patents cover Stilphostrol, and when can generic versions of Stilphostrol launch?

Stilphostrol is a drug marketed by Bayer Pharms and is included in one NDA.

The generic ingredient in STILPHOSTROL is diethylstilbestrol diphosphate. There are twenty-six drug master file entries for this compound. Additional details are available on the diethylstilbestrol diphosphate profile page.

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Summary for STILPHOSTROL
Drug patent expirations by year for STILPHOSTROL

US Patents and Regulatory Information for STILPHOSTROL

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
Showing 1 to 2 of 2 entries

Diethylstilbestrol (DES): Market Dynamics and Financial Trajectory

Overview of Diethylstilbestrol (DES)

Diethylstilbestrol, also known as stilbestrol or stilboestrol, is a synthetic nonsteroidal estrogen medication that has been used for various medical indications. Despite its historical significance, its use has been significantly curtailed due to adverse health outcomes and the availability of safer alternatives[1][5].

Historical Use and Indications

DES was once widely used for several medical conditions, including:

  • Pregnancy support for women with a history of recurrent miscarriage
  • Hormone therapy for menopausal symptoms and estrogen deficiency
  • Treatment of prostate cancer and breast cancer
  • Other uses such as growth promotion in animals[1][5].

However, by 2007, its use was largely limited to the treatment of prostate cancer and breast cancer due to the discovery of its harmful effects.

Adverse Health Outcomes

The use of DES has been linked to several adverse health outcomes, including:

  • Infertility
  • Miscarriage
  • Ectopic pregnancy
  • Preeclampsia
  • Preterm birth
  • Stillbirth
  • Infant death
  • Menopause prior to age 45
  • Breast cancer
  • Cervical cancer
  • Vaginal cancer[1].

These adverse effects have significantly impacted its market dynamics and financial trajectory.

Current Market Status

Limited Use in Cancer Treatment

Despite the risks, DES is still considered for the treatment of prostate cancer and, to a lesser extent, breast cancer. However, its use is often advocated against in favor of bioidentical estrogens like polyestradiol phosphate and estradiol, which have lower risks of cardiovascular toxicity[1].

Decline in Prescriptions

The discovery of DES's harmful effects has led to a substantial decline in its prescriptions. The FDA's advisory in 1971 to stop prescribing DES to pregnant women due to its link to a rare vaginal cancer in female offspring marked a significant turning point in its usage[5].

Financial Trajectory

Reduced Revenue

The decline in prescriptions and the limited scope of its current use have resulted in reduced revenue for manufacturers. The market for DES is no longer a significant contributor to the pharmaceutical industry's overall revenue.

Pharmaceutical Company Involvement

Historically, several major pharmaceutical companies, including Bristol Myers Squibb, Eli Lilly and Co., and Bayer Pharmaceuticals Corp, were involved in the production and distribution of DES. However, with the decline in its use, these companies have shifted their focus to other, safer medications[5].

Pricing and Availability

The pricing of DES is relatively low due to its limited use and the availability of generic versions. For instance, the cost of diethylstilbestrol powder is around $13.77 per gram, which is relatively inexpensive compared to other medications[5].

Market Dynamics

Regulatory Environment

The regulatory environment has played a crucial role in the market dynamics of DES. The FDA's withdrawal of approval for high-dose oral and parenteral drug products containing DES has significantly impacted its market presence[5].

Competitive Landscape

The competitive landscape for estrogen therapies has shifted towards bioidentical estrogens and other safer alternatives. This shift has further reduced the market share of DES.

Patient and Physician Preferences

Both patients and physicians have become more cautious about using DES due to its associated risks. This has led to a preference for other treatments that offer similar therapeutic benefits with fewer side effects.

Future Outlook

Continued Decline

Given the adverse health outcomes and the availability of safer alternatives, the market for DES is expected to continue its decline. The focus will likely remain on bioidentical estrogens and other treatments that offer better safety profiles.

Niche Use

While DES may still be used in certain niche cases, such as in the treatment of prostate cancer where other options are not viable, its overall market impact will remain minimal.

Key Takeaways

  • DES is a synthetic nonsteroidal estrogen with a history of widespread use that has been significantly curtailed due to adverse health outcomes.
  • Its current use is largely limited to the treatment of prostate cancer and, to a lesser extent, breast cancer.
  • The market for DES has declined substantially due to regulatory actions, patient and physician preferences, and the availability of safer alternatives.
  • The financial trajectory of DES is characterized by reduced revenue and a shift in focus by pharmaceutical companies towards other medications.

FAQs

What is Diethylstilbestrol (DES) used for today?

DES is primarily used today in the treatment of prostate cancer and, in some cases, breast cancer, although its use is often advocated against in favor of safer alternatives.

Why has the use of DES declined?

The use of DES has declined due to its association with various adverse health outcomes, including infertility, miscarriage, and several types of cancer.

What are the safer alternatives to DES?

Safer alternatives to DES include bioidentical estrogens such as polyestradiol phosphate and estradiol, which have lower risks of cardiovascular toxicity.

How has the FDA impacted the use of DES?

The FDA has significantly impacted the use of DES by issuing advisories and withdrawing approval for high-dose oral and parenteral drug products containing DES.

What is the current market status of DES?

The current market status of DES is characterized by limited use and reduced revenue, with a continued decline expected in the future.

Sources

  1. Wikipedia: Diethylstilbestrol
  2. DrugBank: Diethylstilbestrol: Uses, Interactions, Mechanism of Action
  3. UNODC: World Drug Report 2022 (for context on drug market trends, though not directly related to DES)
  4. Delaware Health and Social Services: Recent market dynamics affecting the GHIP (for context on health care market dynamics, though not directly related to DES)

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