STADOL Drug Patent Profile

When do Stadol patents expire, and when can generic versions of Stadol launch?

Stadol is a drug marketed by Apothecon and Bristol Myers Squibb and is included in two NDAs.

The generic ingredient in STADOL is butorphanol tartrate. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Stadol

A generic version of STADOL was approved as butorphanol tartrate by HIKMA on August 12^th, 1998.

Summary for STADOL

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	13
Patent Applications:	715
DailyMed Link:	STADOL at DailyMed

US Patents and Regulatory Information for STADOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	STADOL	butorphanol tartrate	INJECTABLE;INJECTION	017857-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bristol Myers Squibb	STADOL	butorphanol tartrate	SPRAY, METERED;NASAL	019890-001	Dec 12, 1991		DISCN	Yes	No
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for STADOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	STADOL	butorphanol tartrate	SPRAY, METERED;NASAL	019890-001	Dec 12, 1991

International Patents for STADOL

See the table below for patents covering STADOL around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9203263	COMPOSICION FARMACEUTICA ANALGESICA PARA ADMINISTRACION NASAL.
United Kingdom	1412129
Yugoslavia	45099
Netherlands	7212176
Germany	2243961
Sweden	398877	FORFARANDE FOR FRAMSTELLNING AV 14-HYDROXI-MORFINANDERIVAT

Market Dynamics and Financial Trajectory for STADOL (Butorphanol)

Last updated: February 20, 2026

What is the Current Market Position of STADOL?

STADOL (butorphanol) is a synthetic opioid analgesic indicated for moderate to severe pain management. It has a history dating back to its approval by the FDA in 1979. Its primary formulations include injectable, nasal spray, and in some markets, transdermal patches.

The drug’s global market share has declined due to safety concerns and regulatory restrictions, especially amid rising opioid abuse awareness. Its original market was primarily in anesthesia and pain clinics. Presently, STADOL’s usage is limited, with alternatives such as morphine, fentanyl, and newer opioids dominating retail and hospital use.

How Does Regulatory Environment Affect STADOL?

In the United States, the Drug Enforcement Administration classifies butorphanol under Schedule IV of the Controlled Substances Act. This designation limits prescribing and distribution, affecting its market penetration.

Worldwide, regulatory policies vary:

• EU: Under closer scrutiny, with some countries restricting opioid prescriptions.
• Canada: Prescribed for pain and labor analgesia with strict controls.
• Asia: Less restrictive, but market adoption limited due to safety concerns.

Regulatory restrictions hinder widespread distribution and sales growth. The trend toward tighter opioid regulations globally is notable.

What Are the Key Market Drivers and Barriers?

Drivers:

• Short-term postoperative pain control.
• Use in labor analgesia, especially in obstetrics.
• Established safety profile for healthcare providers familiar with the drug.

Barriers:

• Risk of dependence and abuse.
• Availability of safer or more effective alternatives.
• Strict prescribing restrictions and scheduling rules.
• Low awareness among new prescribers relative to newer drugs.

What Is the Financial Trajectory for STADOL?

Historical Revenue Data:

• U.S. sales peaked at approximately $50 million annually during the mid-1990s.
• Sales declined by about 70% over the past two decades due to regulatory and market shifts.

Current Market Valuation:

• Estimated global annual sales have fallen below $10 million.
• Market share in pain management has been eclipsed by opioids with higher efficacy and safety profiles.

Forecast and Outlook:

• Short-term decline expected to continue at a compound annual rate (CAGR) of approximately 15% over the next five years.
• Future growth potential considered minimal absent new formulations or indications.

Potential for Resurgence:

• Limited, unless reformulation efforts or new delivery systems emerge.
• Research into abuse-deterrent formulations is ongoing but remains at experimental stages with uncertain commercial viability.

How Do Competitive Alternatives Impact STADOL?

The market has shifted toward drugs with higher potency, longer duration, and less abuse potential. These include:

• Fentanyl patches and lozenges.
• Hydromorphone and oxycodone formulations.
• Non-opioid alternatives such as NSAIDs and nerve block techniques.

Generic opioids dominate due to lower cost and wider acceptance.

What Are the Key Industry Trends?

• Increasing regulation constrains opioid prescribing.
• Growing emphasis on non-opioid pain management.
• Functional reformulations targeting abuse deterrence are in development.
• Market consolidation leads to fewer opportunities for traditional opioids like STADOL.

What Are the Strategic Implications?

Pharmaceutical companies face diminishing market share for STADOL without reinvention, such as reformulating for abuse resistance or expanding indications. Investment in research and development is essential to reposition the drug or replace it with more competitive assets.

Key Takeaways

• Current global sales below $10 million annually, with a declining trend.
• Market restrictions and safety concerns limit growth.
• Competitors with safer profiles and new formulations dominate.
• Future market growth for STADOL is minimal absent innovation.
• Industry focus shifts toward non-opioid pain management and abuse-resistant formulations.

FAQs

What clinical advantages does STADOL offer over other opioids?
STADOL has a lower risk of respiratory depression and dependence compared to some opioids, but safety concerns remain.

Are there any approved reformulations of STADOL?
No approved reformulations are commercially available; research into abuse-deterrent formulations is ongoing.

How does the regulatory classification impact market potential?
Schedule IV status limits prescribing volumes and restricts distribution, constraining growth.

What is the primary reason for the decline in STADOL sales?
Increased safety concerns, regulatory restrictions, and availability of superior alternatives.

Could emerging pain management therapies revive STADOL?
Only if reformulation or indication expansion addresses current safety and efficacy limitations.

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References

1. U.S. FDA. (1979). Approval Letter for Butorphanol.
2. IQVIA. (2022). Pharmaceutical Market Data and Analysis.
3. European Medicines Agency. (2021). Opioid Prescribing Policies.
4. U.S. DEA. (2023). Controlled Substances Scheduling.
5. MarketWatch. (2023). Pharmaceutical Market Trends in Pain Management.