BUTORPHANOL TARTRATE - Generic Drug Details

What are the generic drug 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:	48
Clinical Trials:	7
Patent Applications:	6,502
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
Hospira	BUTORPHANOL TARTRATE PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	074626-001	Jan 23, 1997	AP	RX	No	Yes
Hospira	BUTORPHANOL TARTRATE PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	074620-001	Jan 22, 1997		DISCN	No	No
Hikma Farmaceutica	BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	078247-001	Apr 29, 2009		DISCN	No	No
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Hikma	BUTORPHANOL TARTRATE PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	075045-002	Aug 12, 1998	AP	RX	No	No
Bristol Myers Squibb	STADOL	butorphanol tartrate	SPRAY, METERED;NASAL	019890-001	Dec 12, 1991		DISCN	No	No
Hospira	BUTORPHANOL TARTRATE PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	074626-002	Jan 23, 1997	AP	RX	No	Yes

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	3,819,635
Bristol Myers Squibb	STADOL	butorphanol tartrate	SPRAY, METERED;NASAL	019890-001	Dec 12, 1991	4,464,378
Apothecon	STADOL PRESERVATIVE FREE	butorphanol tartrate	INJECTABLE;INJECTION	017857-002	Approved Prior to Jan 1, 1982	3,819,635

BUTORPHANOL TARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Butorphanol Tartrate

Introduction

Butorphanol tartrate, a synthetically derived opioid agonist-antagonist analgesic, has been a significant player in the pain management market for several decades. This article delves into the market dynamics and financial trajectory of butorphanol tartrate, highlighting its current status, future prospects, and the challenges it faces.

Market Size and Growth

The butorphanol market has shown steady growth in recent years. As of 2023, the market size was estimated at USD 271.47 million, and it is expected to reach USD 283.74 million in 2024, with a projected growth to USD 364.75 million by 2030 at a Compound Annual Growth Rate (CAGR) of 4.30%[3].

Market Segmentation

Product Type

Butorphanol tartrate is available in various forms, including injections and nasal sprays. The nasal spray formulation has gained popularity due to its longer duration of action, typically lasting 4 to 5 hours compared to injectable forms[2].

Application

The drug is used for managing various types of pain, including cancer pain, labor pain, migraine pain, and postoperative pain. Each application segment has its own market dynamics and growth potential[3].

Distribution Channel

Butorphanol tartrate is distributed through both offline and online channels. The offline channel, which includes pharmacies and hospitals, remains the dominant distribution method, although online channels are gaining traction[3].

Market Drivers

Regulatory Environment

Stringent regulatory policies, particularly in regions like the United States and Europe, influence the butorphanol market. Compliance with these regulations is crucial for market expansion[3].

Expanding Applications

The drug's use in veterinary medicine and animal healthcare is a growing segment, offering new opportunities for market growth[3].

Collaborative Efforts

Collaborations between pharmaceutical companies and research institutions are driving advanced drug development and innovative delivery systems, such as transdermal patches and inhalable forms[3].

Increasing Healthcare Expenditure

Growing investment in pain management research and development is a significant driver for the butorphanol market[3].

Market Restraints

Competition from Alternatives

The rise of non-opioid pain management therapies poses a significant threat to butorphanol's market share. These alternatives are gaining popularity due to concerns over opioid dependency and side effects[3].

High Production Costs

The high cost of synthesizing and producing butorphanol tartrate increases the overall market pricing, making it less competitive in some markets[3].

Market Opportunities

Emerging Markets

There is significant potential for growth in emerging countries with increasing healthcare access. Expanding into these markets can help offset the challenges faced in developed regions[3].

Innovative Formulations

Developing innovative long-acting formulations and alternate delivery systems can enhance the drug's market position. Personalized medicine through genetic research is another area ripe for innovation[3].

Market Challenges

Regulatory Approvals

Stringent regulatory approvals and the high cost associated with these processes are major challenges for market expansion. Regulatory oversight by bodies like the FDA and EMA is particularly stringent[3].

Public Perception and Opioid Crisis

Negative public perception and the ongoing opioid crisis affect the market's growth. Addressing these issues through R&D, educational programs, and strategic partnerships is essential[3].

Geographical Market Dynamics

Americas

The United States is a key market for butorphanol tartrate, driven by high rates of chronic pain and surgical procedures. Canada follows similar trends but is influenced by Health Canada's regulations[3].

Asia-Pacific

Countries like China, India, and Japan present growing opportunities due to their expanding healthcare infrastructure. However, regulatory stringency varies across these regions[3].

Europe, Middle East & Africa

European countries under the EMA focus on balancing effective pain management with opioid misuse mitigation. The Middle East and Africa have diverse markets with varying regulatory environments[3].

Financial Trajectory

Price Trends

Recent reports indicate significant price increases for butorphanol tartrate, with a 40% increase over the last three calendar years. For example, Pfizer Inc.'s generic butorphanol tartrate saw a price increase from $23.57 to $43.87[4].

Revenue Projections

The projected growth from USD 271.47 million in 2023 to USD 364.75 million by 2030 indicates a stable financial trajectory despite the challenges. This growth is driven by increasing healthcare expenditure and the expansion into new therapeutic areas[3].

Key Takeaways

• The butorphanol tartrate market is expected to grow at a CAGR of 4.30% from 2023 to 2030.
• The market is driven by stringent regulatory environments, expanding applications, and collaborative efforts in drug development.
• Challenges include competition from non-opioid alternatives, high production costs, and stringent regulatory approvals.
• Emerging markets and innovative formulations offer significant growth opportunities.
• Geographical dynamics vary, with the Americas and Asia-Pacific being key regions.

FAQs

What are the primary applications of butorphanol tartrate?

Butorphanol tartrate is primarily used for managing cancer pain, labor pain, migraine pain, and postoperative pain.

What are the different forms in which butorphanol tartrate is available?

Butorphanol tartrate is available in injection and nasal spray forms, with the nasal spray having a longer duration of action.

What are the major challenges facing the butorphanol tartrate market?

The major challenges include competition from non-opioid pain management therapies, high production costs, and stringent regulatory approvals.

How is the butorphanol tartrate market expected to grow in the future?

The market is expected to grow at a CAGR of 4.30% from 2023 to 2030, reaching USD 364.75 million by 2030.

What are some potential opportunities for growth in the butorphanol tartrate market?

Opportunities lie in creating innovative long-acting formulations, expanding into emerging markets, and obtaining regulatory approval for new indications.

Cited Sources:

1. FDA Approval Document: Butorphanol Tartrate Approval - accessdata.fda.gov
2. Boehringer-Ingelheim Prescribing Information: BUTORPHANOL TARTRATE Nasal Spray USP, 10 mg/mL CIV Rx
3. 360iResearch Report: Butorphanol Market Size & Share 2025-2030
4. Texas Department of State Health Services Report: 2024 Price Increase Report