Nalbuphine hydrochloride - Generic Drug Details

What are the generic sources for nalbuphine hydrochloride and what is the scope of patent protection?

Nalbuphine hydrochloride is the generic ingredient in three branded drugs marketed by Abraxis Pharm, Abbott, Abbvie, Dr Reddys, Hospira, Igi Labs Inc, Rising, Somerset Theraps Llc, and Endo Operations, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for nalbuphine hydrochloride. Five suppliers are listed for this compound.

Summary for nalbuphine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	9
NDAs:	20
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	109
Patent Applications:	1,003
What excipients (inactive ingredients) are in nalbuphine hydrochloride?	nalbuphine hydrochloride excipients list
DailyMed Link:	nalbuphine hydrochloride at DailyMed

Recent Clinical Trials for nalbuphine hydrochloride

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

Sponsor	Phase
Yongtao Sun	Phase 4
Kasr El Aini Hospital	N/A
Chulalongkorn University	N/A

See all nalbuphine hydrochloride clinical trials

Pharmacology for nalbuphine hydrochloride

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

Medical Subject Heading (MeSH) Categories for nalbuphine hydrochloride

Analgesics, Opioid

Narcotic Antagonists

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for nalbuphine hydrochloride

N02AF	Morphinan derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for nalbuphine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Igi Labs Inc	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	072074-001	Apr 10, 1989		DISCN	No	No
Igi Labs Inc	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	072073-001	Apr 10, 1989		DISCN	No	No
Abbvie	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	020200-001	Mar 12, 1993		DISCN	No	No
Somerset Theraps Llc	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	216049-001	Sep 19, 2024	AP	RX	No	No

Nalbuphine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Nalbuphine Hydrochloride

Introduction to Nalbuphine Hydrochloride

Nalbuphine hydrochloride is a semi-synthetic opioid that has garnered significant attention in the pharmaceutical industry due to its potent analgesic effects and unique mechanism of action. It is primarily used to relieve moderate to severe pain, making it a valuable option for patients undergoing surgery, experiencing chronic pain, or suffering from conditions like cancer.

Primary Uses of Nalbuphine Hydrochloride

Nalbuphine hydrochloride is used in various medical settings to manage pain. Its primary applications include:

• Surgical Pain Management: It is often administered to patients undergoing surgery to alleviate post-operative pain.
• Chronic Pain Conditions: Nalbuphine is effective in managing chronic pain associated with conditions such as cancer and other long-term pain disorders[1].

Mechanism of Action

Unlike traditional opioids, nalbuphine hydrochloride has both agonist and antagonist properties. It acts as a κ (kappa) opioid receptor agonist and a μ (mu) opioid receptor antagonist. This dual mechanism reduces the risk of addiction and respiratory depression, making it a safer alternative to traditional opioids[2].

Market Growth Drivers

The market for nalbuphine hydrochloride is driven by several key factors:

• Increasing Prevalence of Pain-Related Conditions: The rising incidence of chronic pain conditions globally is a significant driver of the market.
• Advancements in Drug Formulations: New formulations such as extended-release tablets and injectable forms are improving bioavailability and patient compliance, contributing to market growth[1].
• Regulatory Support: Regulatory approvals and support for new product launches are also fueling the expansion of the nalbuphine hydrochloride market[4].

Market Size and Forecast

The nalbuphine hydrochloride market is projected to experience substantial growth in the coming years. Here are some key forecasts:

• Valuation: The market is expected to reach a valuation of several billion dollars within the next five years, driven by a compound annual growth rate (CAGR) of over 10% annually[1].
• Geographical Segmentation: The market is segmented into regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Hospital segment is expected to expand significantly, retaining its position throughout the forecast period[3][4].

Competitive Landscape

The competitive landscape of the nalbuphine hydrochloride market is characterized by:

• Strategic Collaborations: Pharmaceutical companies are engaging in strategic partnerships to accelerate research and development, and to launch new products[1].
• Mergers and Acquisitions: There has been a surge in mergers and acquisitions, with companies aiming to consolidate their positions and enhance their product portfolios[1].
• Key Players: Companies such as Acme, Glenmark, Dr. Reddy's, and others are focusing on expanding their business and strengthening their product portfolios in the global market[4].

New Product Launches and Innovations

Recent trends in the nalbuphine hydrochloride market include the launch of new formulations:

• Extended-Release Forms: Extended-release tablets and injectable forms are gaining traction due to their improved bioavailability and patient compliance[1].
• Intranasal Forms: Intranasal nalbuphine formulations are also being developed, offering an alternative route of administration[2].

Financial Trajectory

The financial trajectory of the nalbuphine hydrochloride market is promising:

• Investment Opportunities: With a strong projected growth rate, the market presents significant investment opportunities. Stakeholders can capitalize on the upward trajectory, especially in emerging markets where access to pain management options is expanding[1].
• Revenue Growth: The market is expected to grow at a CAGR of 3 to 5 percent from its current valuation, indicating substantial revenue growth in the forecast period[3].

Regulatory Environment

The regulatory environment is supportive of the nalbuphine hydrochloride market:

• Fast Track Approval: Nalbuphine hydrochloride has received fast track approval in the US, which accelerates its development and review process[2].
• Global Approvals: The drug has been approved in various countries, facilitating its global distribution and use[2].

Patient-Centric Care

The growing emphasis on patient-centric care is driving the demand for nalbuphine hydrochloride:

• Favorable Safety Profile: Nalbuphine’s favorable safety profile and efficacy align well with the trend towards patient-centric care, making it an attractive option for both physicians and patients[1].

Future Prospects

Looking ahead, the nalbuphine hydrochloride market is set to evolve further:

• Continued Research: Ongoing research into its applications will likely enhance its adoption in various medical fields, including oncology and post-operative care[1].
• Increasing Adoption: Regulatory support and the growing need for effective pain management solutions will drive further innovation and adoption of nalbuphine hydrochloride[1].

Key Takeaways

• Market Growth: The nalbuphine hydrochloride market is poised for significant expansion driven by increasing awareness of pain management options and rising incidences of chronic pain conditions.
• Competitive Landscape: Strategic collaborations, new product launches, and mergers and acquisitions are key trends in the market.
• Financial Trajectory: The market offers promising investment opportunities with a strong projected growth rate.
• Regulatory Support: Fast track approvals and global regulatory support are facilitating the market's growth.
• Patient-Centric Care: The drug's favorable safety profile and efficacy make it a preferred choice in patient-centric care.

FAQs

What are the primary uses of nalbuphine hydrochloride?

Nalbuphine hydrochloride is primarily used for managing moderate to severe pain, often in surgical settings or for chronic pain conditions[1].

How does nalbuphine hydrochloride differ from other opioids?

Unlike traditional opioids, nalbuphine hydrochloride has both agonist and antagonist properties, reducing the risk of addiction and respiratory depression[1][2].

What is driving the growth of the nalbuphine hydrochloride market?

Key factors include the increasing prevalence of pain-related conditions, advancements in drug formulations, and regulatory support for new product launches[1][3].

Are there any recent trends in the nalbuphine hydrochloride market?

Recent trends include new product launches, strategic partnerships, and a rise in mergers and acquisitions aimed at enhancing market position and innovation[1].

Why should investors consider the nalbuphine hydrochloride market?

With a strong projected growth rate and a focus on effective pain management solutions, the nalbuphine hydrochloride market presents promising investment opportunities[1].

Sources

1. Market Research Intellect: Nalbuphine Hydrochloride: Rising Demand and Market Dynamics in Pharma and Healthcare.
2. Synapse: Nalbuphine Hydrochloride - Drug Targets, Indications, Patents.
3. Market Research Intellect: Global nalbuphine hcl market size and forecast.
4. Cognitive Market Research: Nalbuphine HCL Market Report 2024 (Global Edition).