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. Five 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	4,464,378

International Patents for STADOL

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

Country	Patent Number	Title	Estimated Expiration
Ireland	36687	N-SUBSTITUTED-14-HYDROXY-3-SUBSTITUTED MORPHINAN DERIVATIVES
Ireland	36688	3-SUBSTITUTED-MORPHINAN DERIVATIVES
Canada	1183778	METHODE D'ADMINISTRATION D'ANTAGONISTES ET D'ANALGESIQUES NARCOTIQUES ET NOUVELLE FORME POSOLOGIQUE LES CONTENANT (METHOD OF ADMINISTERING NARCOTIC ANTAGONISTS AND ANALGESICS AND NOVEL DOSAGE FORMS CONTAINING SAME)
Germany	2243961
Australia	4622872

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: STADOL

Last updated: July 31, 2025

Introduction

Stadol (generic: butorphanol tartrate) is a potent opioid analgesic marketed primarily for moderate to severe pain management. Originally introduced in the 1970s, it has carved a niche within opioid therapy due to its unique receptor activity profile, acting as a mixed agonist-antagonist at opioid receptors. Although its market presence has fluctuated over decades, understanding the dynamics shaping its current and future financial trajectory is vital for pharmaceutical manufacturers, healthcare providers, and investors navigating the evolving opioid landscape.

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Market Overview

The global analgesic market is among the fastest-growing sectors in pharma, driven by increasing incidences of acute and chronic pain, aging populations, and rising awareness of pain management. Within this sector, opioids traditionally comprise a substantial segment. However, regulatory reforms and opioid crisis concerns have introduced constraints and opportunities concerning drugs like Stadol.

Stadol’s pivotal role has historically been in hospital settings, especially in anesthesia and obstetrics, due to its efficacy and safety profile. Its current U.S. market share remains modest compared to other opioids such as morphine or fentanyl but persists in niche applications, such as obstetric analgesia, owing to its limited respiratory depression effects relative to other opioids.

Market Dynamics

1. Regulatory Environment and Abuse Concerns

The opioid epidemic has profoundly impacted the market dynamics of opioid analgesics. Regulatory agencies, notably the U.S. Food and Drug Administration (FDA), have implemented strict prescribing guidelines, tamper-resistant formulations, and comprehensive monitoring programs to curb misuse. These measures have led to decreased prescriptions of traditional opioids, indirectly affecting Stadol’s competitive position.

Despite its lower abuse potential compared to full mu-opioid receptor agonists, Stadol’s status remains under scrutiny. Its partial agonist activity at kappa receptors and mixed receptor profile may influence regulatory classification and prescriber perceptions, impacting its market access and volume.

2. Competition and Market Positioning

Stadol faces formidable competition from other opioids with broader indications and analgesic potency, such as morphine, oxycodone, and fentanyl derivatives. Non-opioid alternatives like NSAIDs, anticonvulsants, and nerve blocks further challenge its utilization, especially for chronic pain management.

However, Stadol’s unique pharmacological profile—offering less respiratory depression and lower dependency risk—positions it as a specialized agent in settings requiring targeted analgesia with reduced misuse potential. Its niche positioning in obstetrics—specifically for labor pain—remains a resilient segment, though off-label use and emerging alternatives influence its overall market share.

3. Patient Demographics and Prescriber Trends

The aging population globally escalates demand for effective pain relief, but prescribers are increasingly cautious regarding opioids. The adoption of multimodal pain strategies and opioid-sparing approaches diminishes reliance on drugs like Stadol. Nevertheless, specialized uses in anesthesia and obstetrics sustain some demand, particularly where alternative methods are contraindicated or less effective.

4. Approval and Formulation Changes

The patent lifecycle and regulatory approvals heavily influence Stadol’s market prospects. Although Stadol’s patents have long expired, the development of new formulations (e.g., nasal sprays, prefilled injections) or combination therapies could rejuvenate interest, provided regulatory pathways are navigated successfully.

Financial Trajectory Analysis

1. Historical Revenue Performance

Historically, Stadol experienced peak revenues in the late 1970s and early 1980s, correlating with high opioid prescribing volumes. Its revenue peaked due to widespread inpatient and outpatient analgesic utilization. The subsequent decline aligns with escalating regulatory constraints, the opioid crisis, and increased competition.

2. Impact of Regulatory and Market Trends

Recent years display a downward revenue trend primarily due to tighter prescribing restrictions and a shift towards non-opioid pain management modalities. Yet, in niche markets—such as obstetrics—Stadol maintains consistent sales, supported by clinical tradition and limited alternatives.

3. Future Growth Drivers

• Reformulation and Innovation: Developing new delivery mechanisms or combining Stadol with other agents may unlock revitalized growth.
• Regulatory Relaxation or Differentiation: If regulatory agencies recognize the drug’s favorable safety profile, prescriber confidence could improve.
• Expanding Indications: Investigating off-label or new-approved analgesic uses could broaden market access.

4. Revenue Forecasts

Given industry trends, Stadol's revenues are expected to remain relatively stable in niche applications but unlikely to experience significant growth absent innovation. The ongoing opioid saturation and regulatory hurdles will continue to temper its market trajectory, projecting flat or marginally declining revenues over the next five years.

Risks and Opportunities

Risks:

• Stricter opioid regulations and crackdowns on prescriptions.
• Competition from non-opioid analgesics and emerging therapies.
• Negative public perception linked to opioids, regardless of Stadol’s safety profile.
• Patent and exclusivity expiration leading to generic competition.

Opportunities:

• Development of formulations with improved delivery or reduced side effects.
• Positioning as a safer analgesic alternative in hospital protocols.
• Expansion of indications through clinical trials demonstrating additional benefits.
• Targeted marketing in specialized medical settings.

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Conclusion

Stadol’s market dynamics are shaped by shifting regulatory landscapes, evolving prescriber habits, and nuanced clinical utility. While its revenues face pressures from societal and industry-wide changes to opioid prescribing practices, its niche positioning—particularly in obstetrics—can sustain its financial trajectory. Innovation and strategic positioning are essential for reversing decline trends and unlocking future growth potential.

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Key Takeaways

• Regulatory and societal repercussions have diminished Stadol’s broader market appeal, emphasizing niche applications.
• Its unique receptor activity profile offers potential for specialized clinical use, particularly where safety considerations are paramount.
• Market competition from both opioid and non-opioid therapies limits growth prospects, demanding innovation for future expansion.
• Patent expirations and generic entry have reduced profitability, necessitating formulation improvements for commercial revival.
• Strategic focus on targeted indications and formulation development remains key to maintaining viability amid a constrained opioid landscape.

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FAQs

1. How does Stadol compare safety-wise to other opioids?
Stadol’s partial agonist profile at kappa receptors results in less respiratory depression and dependency potential than full mu-opioid agonists, making it a safer option in specific clinical scenarios.

2. What is the primary market for Stadol today?
Its principal utilization remains in hospital and obstetric settings, especially for labor pain management, where its safety profile and administration routes are advantageous.

3. Are there ongoing efforts to reformulate Stadol?
While there is limited public information on recent reformulation efforts, developing alternative delivery methods or combination therapies could provide growth avenues.

4. How have regulations impacted Stadol’s sales?
Stricter opioid prescribing guidelines and increased scrutiny have led to decreased utilization except in niche applications, constraining sales volume.

5. What is the outlook for Stadol in the next five years?
Stadol’s revenue is expected to plateau or decline slightly without significant innovation or regulatory changes, emphasizing the importance of strategic adaptation.

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References

1. [1] U.S. Food and Drug Administration. (2022). Opioid Analgesics: Safety and Regulation.
2. [2] MarketWatch. (2023). Global Analgesic Market Trends.
3. [3] IMS Health. (2022). Pain Management Drug Usage & Prescribing Patterns.
4. [4] FDA. (2018). Guidance on Opioid Prescribing Practices.
5. [5] Professional Medical Journals. (2021). Efficacy and Safety of Butorphanol in Obstetric Pain.

[Note: All references are illustrative.]