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 Abbvie, Abraxis Pharm, Abbott, Dr Reddys, Hospira, Igi Labs Inc, Rising, Somerset Theraps Llc, and Ph Health, 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. Six 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:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	154
Patent Applications:	1,053
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
Liaquat National Hospital & Medical College	PHASE1
Aga Khan University	NA
Ain Shams University	PHASE3

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
Dr Reddys	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	074471-002	Mar 19, 1998		DISCN	No	No
Hospira	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	070914-001	Feb 3, 1989	AP	RX	No	Yes
Dr Reddys	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	074471-001	Mar 19, 1998		DISCN	No	No
Abraxis Pharm	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	070751-002	Jul 2, 1986		DISCN	No	No

Market Dynamics and Financial Trajectory for Nalbuphine Hydrochloride

Last updated: July 27, 2025

Introduction
Nalbuphine hydrochloride, a synthetic opioid analgesic, has garnered attention within the pharmaceutical landscape for its dual efficacy in pain management and its unique pharmacological profile. Its market trajectory, shaped by evolving clinical use, regulatory pathways, and competitive dynamics, reflects broader trends in opioid therapeutics and pain management modalities.

Pharmacological Profile and Clinical Use
Nalbuphine hydrochloride acts as a kappa-opioid receptor agonist and a partial mu-opioid receptor antagonist, offering analgesic effects with a potentially reduced risk of respiratory depression and dependency compared to traditional opioids [1]. It is primarily prescribed for moderate to severe pain, often in hospital settings, owing to its safety profile. Approved formulations include injectable and pre-filled syringe forms, with off-label applications expanding into anesthesia adjuncts and obstetrics.

Market Landscape and Key Players
Global demand for analgesics sustains a steady growth trajectory, with nalbuphine occupying a niche driven by its contraindications for certain patient populations and alternative to more addictive opioids. Major pharmaceutical players, such as Pfizer, Johnson & Johnson, and Teva Pharmaceuticals, have historically manufactured and marketed nalbuphine formulations, benefiting from established supply chains and regulatory approvals.

The introduction of generic formulations in regions like North America and Europe has intensified market competition, reducing pricing and expanding access. Additionally, emerging markets in Asia-Pacific exhibit increasing demand due to expanding healthcare infrastructure and rising pain management needs [2].

Regulatory and Patent Landscapes
Nalbuphine hydrochloride's patent landscape is mature, with most proprietary protections expiring over the past decade. Regulatory bodies such as the FDA and EMA have approved multiple formulations, with some jurisdictions classifying the drug as Schedule IV opioids, influencing prescribing behaviors and market accessibility. New formulations—such as extended-release or combination products—are under clinical investigation, offering future growth avenues.

Market Trends and Growth Drivers
Several key factors influence the physician prescribing patterns and market growth:

• Shift towards Safer Opioids: As the opioid crisis continues, clinicians prefer agents with lower addiction potentials. Nalbuphine’s partial mu antagonism aligns with this trend, boosting its utilization.

• Pain Management Innovation: The paradigm shift to multimodal pain control and the integration of non-opioid analgesics incentivizes the development of combination therapies involving nalbuphine.

• Expanding Indications: Investigational uses, including in perioperative pain and labor analgesia, broaden the potential patient base.

• Regulatory Acceptance: Stringent opioid regulations have spurred demand for alternatives like nalbuphine, especially in institutional settings.

Challenges and Market Limitations
Despite growth drivers, notable challenges persist:

• Regulatory Scrutiny: As opioids face increasing oversight, market expansion may be constrained by prescribing restrictions.

• Stigma and Prescriber Hesitation: Societal attitudes toward opioids complicate clinician willingness to adopt new uses or formulations.

• Competitive Pressure: The proliferation of non-opioid analgesics and novel agents diminishes nalbuphine’s relative market share.

Financial Trajectory and Investment Insights
The financial outlook for nalbuphine hydrochloride hinges on regional regulatory developments, patent status, and clinical research outcomes. While revenue is currently moderate, growth potential exists within niche pain management segments and emerging markets.

• Market Valuation: The global analgesic market is projected to reach approximately $19 billion by 2027, with opioids accounting for a significant share, including agents like nalbuphine [3].

• Revenue Streams: Pharmaceutical companies derive income from branded formulations, generics, and potential combination products. Margins are affected by manufacturing costs, pricing strategies, and competitive dynamics.

• Investment Potential: Companies investing in reformulations, new indications, or regional expansion could capitalize on unmet needs and regulatory shifts. Conversely, high research and development costs and regulatory risks necessitate cautious positioning.

Future Outlook
Looking ahead, the trajectory of nalbuphine hydrochloride is likely to be shaped by:

• Regulatory Environment: Enhanced oversight may influence prescribing and market access.
• Research and Development: Innovations, such as abuse-deterrent formulations and fixed-dose combinations, could create new revenue streams.
• Market Penetration: Emerging economies and institutional settings offer untapped growth opportunities.
• Competition from Alternatives: Developments in non-opioid modalities or novel opioid receptor agents will influence market share.

Key Takeaways

• Nalbuphine hydrochloride occupies a niche in pain management, appealing due to its safety profile amidst an opioid-skeptical climate.
• The market benefits from genericization, regional expansion, and incremental clinical indications.
• Regulatory landscapes and societal attitudes towards opioids are critical determinants of growth.
• Investment prospects hinge on innovation, geographic diversification, and navigating regulatory hurdles.
• The evolving landscape necessitates vigilant monitoring of competitive, clinical, and legislative developments for strategic positioning.

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FAQs

1. What are the primary clinical advantages of nalbuphine hydrochloride over other opioids?
Nalbuphine’s partial mu-opioid antagonism reduces the risk of respiratory depression and dependency, offering a safer profile for moderate to severe pain management.

2. How does the patent status affect market growth for nalbuphine hydrochloride?
Most patents have expired, leading to widespread generic availability that decreases prices but also reduces exclusivity-driven revenues for brand manufacturers.

3. Which regions present the most significant growth opportunities for nalbuphine?
Emerging markets in Asia-Pacific and Latin America show increasing demand due to expanding healthcare infrastructure and evolving pain treatment protocols.

4. What are the regulatory challenges impacting nalbuphine’s market?
Stringent opioid scheduling, prescribing restrictions, and scrutiny over abuse potential can limit market access and prescribing volumes.

5. Are there ongoing developments to improve nalbuphine formulations?
Yes, research into extended-release formulations, abuse-deterrent systems, and combination therapies is ongoing, promising to enhance market appeal and treatment efficacy.

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Sources
[1] “Nalbuphine: Pharmacology and Clinical Use,” Journal of Pain & Symptom Management, 2021.
[2] “Analgesic Market Trends 2022-2027,” GlobalData Reports, 2022.
[3] “Opioid Market Outlook,” IQVIA Institute, 2022.