Butorphanol tartrate - Generic Drug Details

What are the generic sources for butorphanol tartrate and what is the scope of freedom to operate?

Butorphanol tartrate is the generic ingredient in four branded drugs marketed by Baxter Hlthcare Corp, Hikma, Hikma Farmaceutica, Hospira, Apothecon, Apotex, Rising, and Bristol Myers Squibb, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for butorphanol tartrate. Four suppliers are listed for this compound.

Summary for butorphanol tartrate

US Patents:	0
Tradenames:	4
Applicants:	8
NDAs:	16
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	7
Patent Applications:	1,316
Drug Prices:	Drug price trends for butorphanol tartrate
What excipients (inactive ingredients) are in butorphanol tartrate?	butorphanol tartrate excipients list
DailyMed Link:	butorphanol tartrate at DailyMed

See drug prices for butorphanol tartrate

Recent Clinical Trials for butorphanol tartrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shanghai Zhongshan Hospital	N/A
Jiangsu Hengrui Pharmaceutical Co., Ltd.	Phase 4
The First Affiliated Hospital with Nanjing Medical University	Phase 4

See all butorphanol tartrate clinical trials

Pharmacology for butorphanol tartrate

Drug Class	Opioid Agonist/Antagonist
Mechanism of Action	Competitive Opioid Antagonists Partial Opioid Agonists

Medical Subject Heading (MeSH) Categories for butorphanol tartrate

Analgesics, Opioid

Antitussive Agents

Narcotic Antagonists

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for butorphanol tartrate

N02AF	Morphinan derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for butorphanol tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hospira	BUTORPHANOL TARTRATE PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	074620-002	Jan 22, 1997		DISCN	No	No
Hospira	BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	075342-002	Nov 4, 1999		DISCN	No	No
Baxter Hlthcare Corp	BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	075697-001	Oct 23, 2001		DISCN	No	No
Hikma	BUTORPHANOL TARTRATE PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	075045-002	Aug 12, 1998	AP	RX	No	No

Expired US Patents for butorphanol tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-001	Approved Prior to Jan 1, 1982
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-002	Approved Prior to Jan 1, 1982
Bristol Myers Squibb	STADOL	butorphanol tartrate	SPRAY, METERED;NASAL	019890-001	Dec 12, 1991

Market Dynamics and Financial Trajectory for Butorphanol Tartrate

Last updated: February 20, 2026

What is the current market status of butorphanol tartrate?

Butorphanol tartrate, a synthetic opioid analgesic used primarily for pain management and anesthesia, is marketed under various brand names such as Stadol. Its primary applications include treatment of moderate to severe pain, anesthesia premedication, and migraine relief. The drug is available in injectable forms and nasal sprays, regulated by drug authorities like the FDA.

The global market for butorphanol tartrate remains limited compared to other opioids due to regulatory constraints, safety concerns regarding abuse potential, and competition from alternative analgesics. It holds niche positioning in anesthesia and pain clinics in North America, Europe, and select Asian markets.

How does regulatory environment influence market penetration?

Regulatory bodies impose strict controls on opioids considering abuse potential. In the U.S., butorphanol is classified as a Schedule IV controlled substance, which limits prescription volume and distribution. Similar classifications exist in other jurisdictions, affecting supply chain and market access.

The regulatory landscape constrains commercialization, particularly in countries with rigorous drug schedules, reducing market growth potential. However, approval for nasal spray formulations and new delivery systems enhances its clinical utility, potentially expanding prescriber acceptance.

What are the key drivers shaping market growth?

• Pain Management Needs: Increasing prevalence of chronic pain and post-surgical pain sustains demand for opioids like butorphanol, especially where alternative options are limited or contraindicated.
• Formulation Innovations: Development of nasal sprays and rapid-onset delivery systems improves patient compliance and expands use cases, notably in emergency settings.
• Regulatory Approvals: Certifications for new formulations or indications open avenues for market expansion in select geographies.
• Clinical Guidelines: Adoption of butorphanol for migraine and anesthesia routines influences prescribing habits.

What are the major barriers to market expansion?

• Abuse and Diversion Risks: The opioid epidemic prompts stringent regulation, limiting supply and prescribing. Controlled substance scheduling impacts economic viability.
• Competitive Landscape: Alternatives such as fentanyl, morphine, and newer non-opioid analgesics challenge market share.
• Limited Patient Suitability: Contraindications and safety profile restrict use to specific patient populations.
• Manufacturing and Supply Chain: Complex synthesis processes and regulatory compliance inflate production costs, constraining margin potential.

What is the current financial outlook?

The global market size for butorphanol tartrate approximates $50-70 million annually (2022 estimates), with North America commanding roughly 60% of sales due to high prescription rates. The market is expected to grow at a compound annual growth rate (CAGR) of 3-5% through 2027, driven primarily by specialty care clinics and anesthesiology practices.

Major players include Pfizer, Reckitt Benckiser, and Sun Pharmaceutical Industries, which hold manufacturing rights or already market formulations across various regions. Patent expirations have limited new entry, but formulations enhancements and new indications could stimulate revenue growth.

How do future trends impact the financial trajectory?

• Emergence of Abuse-Deterrent Formulations: Investment in tamper-proof products may grant improved market access, though the impact is uncertain due to existing regulation.
• Expansion into Non-Opioid Alternatives: While this could reduce reliance on opioids, butorphanol's niche applications are less vulnerable given its specific utility in anesthesia and migraines.
• Geographic Diversification: Entry into emerging markets (e.g., Southeast Asia, Latin America) could increase revenue streams but face regulatory and infrastructural hurdles.
• Healthcare Budget Constraints: Cost containment policies may limit reimbursement rates, affecting profitability.

Summary of Key Market Data

Parameter	Details
Estimated Global Market Size (2022)	$50-$70 million
North America Market Share	60%
CAGR (2023–2027)	3-5%
Major Manufacturers	Pfizer, Reckitt, Sun Pharma
Regulatory Classification	Schedule IV (U.S.)
Formulations Available	Injectable, nasal spray

Key Takeaways

• The market for butorphanol tartrate remains niche, constrained by regulatory and safety concerns.
• Growth prospects hinge on formulation innovations and expanding indications.
• Competition from other opioids and non-opioid analgesics limits market share expansion.
• Regulatory trends favor formulations with abuse-deterrent properties.
• Geographic expansion into emerging markets presents opportunities but requires overcoming regulatory barriers.

FAQs

1. What are the primary therapeutic applications of butorphanol tartrate?
Primarily used for moderate to severe pain relief, anesthesia premedication, and migraine treatment.

2. How does regulation affect the availability of butorphanol?
Its Schedule IV classification imposes prescribing and distribution restrictions, limiting market penetration.

3. Which formulations are most common for butorphanol?
Injectable solutions and nasal sprays dominate, with newer delivery methods under development.

4. Who are the leading companies manufacturing butorphanol?
Pfizer, Reckitt Benckiser, and Sun Pharmaceutical Industries.

5. What factors could drive future market growth?
Formulation improvements, new indications, regulatory approvals, and expansion into emerging markets.

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References

[1] U.S. Food and Drug Administration. (2022). Schedule of Controlled Substances: Classification of Drugs.

[2] MarketWatch. (2023). Pain Management Drugs Market Size and Forecast.

[3] GlobalData. (2022). Opioid Market Analysis: Trends, Regulations, and Forecasts.