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Last Updated: March 26, 2026

STILBESTROL Drug Patent Profile


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

Stilbestrol is a drug marketed by Bristol Myers Squibb and Tablicaps and is included in seven NDAs.

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

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Summary for STILBESTROL
US Patents:0
Applicants:2
NDAs:7
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 18
DailyMed Link:STILBESTROL at DailyMed
Drug patent expirations by year for STILBESTROL

US Patents and Regulatory Information for STILBESTROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb STILBESTROL diethylstilbestrol INJECTABLE;INJECTION 004056-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Tablicaps STILBESTROL diethylstilbestrol TABLET, DELAYED RELEASE;ORAL 083003-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers Squibb STILBESTROL diethylstilbestrol INJECTABLE;INJECTION 004056-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Tablicaps STILBESTROL diethylstilbestrol TABLET;ORAL 083006-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Tablicaps STILBESTROL diethylstilbestrol TABLET, DELAYED RELEASE;ORAL 083005-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory of Stilbestrol (Diethylstilbestrol, DES)

Last updated: February 13, 2026

Overview
Diethylstilbestrol (DES), commonly known as Stilbestrol, was widely used as a hormone therapy from the 1940s to the 1970s. Its primary indications included hormone replacement therapy, treatment of certain cancers, and prevention of pregnancy complications. The drug was phased out due to safety concerns, notably its carcinogenic risk. Despite its discontinuation in many applications, the compound remains relevant in ongoing research and rare drug markets.


Market Dynamics

Historical Market Reach
DES's peak market occurred in the mid-20th century, with annual sales exceeding $100 million globally during the 1950s and 1960s. Major pharmaceutical firms such as Eli Lilly and Upjohn produced the drug. The decline in sales began post-1971 after the U.S. Food and Drug Administration (FDA) issued warnings about its carcinogenic potential, notably in uterine and vaginal cancers among women exposed in utero.

Regulatory Impact
The decline in DES use correlated with regulatory actions globally. The U.S. FDA revoked approval for most indications by the late 1970s. Similar bans or restrictions emerged in Europe, Australia, and other regions. These regulatory actions led to a sharp decline in market volume and forced companies to exit or reallocate DES-related resources.

Current Market Residues
Today, DES's market exists mainly within niche segments:

  • Research and Development: Used as a chemical standard in estrogen receptor studies, with limited commercial applications.
  • Legal Settlements and Compensation: Ongoing liabilities related to lawsuits in U.S. and other jurisdictions, with an estimated $500M allocated for settlements and legal fees since 1980.[1]
  • Historical Medical Archives: Small-scale use in specialized diagnostic or histological laboratories.

Emerging Developments
Minimal growth prospects exist for direct DES applications. However, derivative compounds and analogs are under investigation for potential therapeutic or diagnostic use, though none have gained regulatory approval.


Financial Trajectory

Period Market Size Key Drivers Regulatory Status Financials
1950s-1960s $100M+ Hormone therapy, cancer treatment Approved and widely prescribed High revenue, dominant market share
1970s Decline begins, approx. $70M Safety concerns surface, lawsuits emerge FDA and other agencies restrict use Revenue decline, lawsuits increase
1980s-1990s Below $10M Limited research use, residual legal liabilities Banned or heavily restricted for medical use Reduced revenue, legal costs escalate
2000s-2020s <$1M Narrow research applications, legal settlements No regulatory approval; mostly legal liabilities Marginal revenues, legal expenses

Key Revenue Factors
No major pharmaceutical companies generate significant revenue from DES sales. The financial activity is primarily legal settlements and research-related expenditures.

Legal and Litigation Costs
Litigation remains active; legal liabilities have totaled approximately $500 million in settlements and legal costs across several jurisdictions. These obligations influence companies' financial outlooks and dissuade new investment.

Potential Market Rebound?
No significant rebound is projected. Regulatory barriers, safety concerns, and obsolete applications restrict growth. Small niche research funding persists but does not alter overall trajectory.


Conclusion

DES’s market was historically significant but has largely disappeared except in legal and research settings. The compounded effect of safety concerns and regulatory bans restricts any revival. Firms involved primarily face legal liabilities rather than revenue opportunities.


Key Takeaways

  • DES's peak sales exceeded $100 million in the mid-20th century, with a sharp post-1971 decline due to safety concerns.
  • Modern use is confined to research, legal settlements, and rare diagnostic cases.
  • No new drugs or applications have emerged; derivative development is minimal and unlikely to rekindle significant market activity.
  • Legal liabilities continue to influence financial positions of firms historically involved in DES.
  • Future prospects for DES as a commercial product are negligible absent breakthroughs in safety or new therapeutic indications.

FAQs

1. Why did DES fall out of favor?
Revelations of its carcinogenic risks and increased legal liabilities led to regulatory bans, reducing its use in medical practice.

2. Are there ongoing legal cases related to DES?
Yes. Multiple class-action suits and individual lawsuits continue, especially concerning women exposed in utero and their offspring.

3. Is DES still used for any medical indications today?
No. Regulatory agencies prohibit its use for original indications; some research applications persist but on a minimal scale.

4. Are there any derivatives of DES under development?
Limited research exists; however, none have received regulatory approval or entered significant commercial phases.

5. Could future regulatory changes revive DES markets?
Highly unlikely. Safety data and legal frameworks favor its continued restriction.


References
[1] Legal and financial proceedings related to DES: Multiple court records and settlement disclosures (1980–2023).

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