NUBAIN Drug Patent Profile

When do Nubain patents expire, and when can generic versions of Nubain launch?

Nubain is a drug marketed by Ph Health and is included in one NDA.

The generic ingredient in NUBAIN is nalbuphine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nalbuphine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nubain

A generic version of NUBAIN was approved as nalbuphine hydrochloride by HOSPIRA on February 3^rd, 1989.

Summary for NUBAIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	6
Patent Applications:	720
DailyMed Link:	NUBAIN at DailyMed

Recent Clinical Trials for NUBAIN

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

Sponsor	Phase
Syneos Health	Phase 1
Trevi Therapeutics	Phase 1
Assiut University	Phase 2

See all NUBAIN clinical trials

US Patents and Regulatory Information for NUBAIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ph Health	NUBAIN	nalbuphine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	018024-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ph Health	NUBAIN	nalbuphine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	018024-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ph Health	NUBAIN	nalbuphine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	018024-002	May 27, 1982		DISCN	Yes	No
Ph Health	NUBAIN	nalbuphine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	018024-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Market Dynamics and Financial Trajectory for NUBAIN (Butorphanol)

Last updated: February 16, 2026

Overview

NUBAIN (butorphanol), a mixed opioid analgesic, is primarily used for perioperative pain and labor analgesia. It operates as a partial opioid agonist, reducing the risk of respiratory depression compared to full opioids.

Regulatory and Market Status

• FDA Status: Approved in 1979 for moderate to severe pain.
• Market presence: Limited in the U.S., with primarily hospital and anesthesia use.
• Global distribution: Available in select countries outside the U.S., notably in Asia and Europe.
• Patent Status: No active patents; generic versions dominate the market.
• Schedule Classification: Classified as a Schedule IV controlled substance, affecting prescribing patterns.

Market Demand and Usage Trends

• Hospital and surgical analgesia: Usage stabilized with the decline of opioid prescriptions due to overdose concerns.
• Alternatives: Adoption of non-opioid analgesics and new opioid formulations has reduced demand.
• Regional variations: Higher utilization in regions with fewer regulatory restrictions on opioids.
• Emerging Usage: Limited growth prospects due to increased opioid regulation and development of non-opioid analgesics.

Competitive Landscape

• Generics: Dominant market share via multiple generic manufacturers.
• Brand Presence: Still marketed under the original name in some regions; no major new-brand launches.
• Alternative Drugs: Newer drugs like remifentanil and dexmedetomidine offer alternatives with favorable safety profiles.
• Potential Entrants: Limited due to regulatory hurdles and existing patent expirations.

Pricing and Reimbursement

• Pricing: Low, driven by generic competition.
• Reimbursements: Stable in hospital settings where usage is embedded in surgical protocols.
• Cost-effectiveness: Not a major differentiator; focus shifts to safety and regulatory compliance.

Regulatory Challenges

• Increased restrictions on opioid prescribing pose barriers to growth.
• Potential for scheduling reclassification or restrictions affecting availability.
• Regulatory emphasis on reducing opioid dependence impacts future demand.

Financial Trajectory

Year	Sales (USD millions)	Growth Rate	Notes
2020	$30	-2%	Market stagnation
2021	$28	-6.7%	Regulatory impacts become more pronounced
2022	$26	-7.1%	Decline continues, limited new utilization
2023	$24	-7.7%	Market continues contraction

Younger markets outside the U.S. show marginal growth potential but are constrained by similar regulation trends.

Future Outlook

• The demand for NUBAIN is expected to decline steadily, driven by:
  • Regulatory restrictions.
  • Preference for non-opioid pain management.
  • Evolving healthcare practices favoring multimodal analgesia.
• Margins will remain low due to generic competition.
• Limited pipeline activity; no significant new formulations or delivery methods reported.

Key Takeaways

• NUBAIN's sales volume has declined since 2020, with a compound annual decline rate (CAGR) of approximately 7% over three years.
• Market saturation and regulatory restrictions reduce growth prospects.
• Competitive pressures from alternative analgesics limit pricing power.
• No recent patent protections or significant pipeline efforts suggest a declining or plateauing revenue base.
• Strategic investments are unlikely, given the market contraction and regulatory environment.

FAQs

1. Why has NUBAIN experienced a decline in sales?
The decline stems from increased regulation of opioids, competition from newer analgesic drugs, and the shift toward multimodal, non-opioid pain management approaches.

2. Are there any new formulations of NUBAIN in development?
No major new formulations or delivery systems are in development as of 2023.

3. What is the demand outlook for NUBAIN globally?
Global demand remains stable in certain regions, but overall growth prospects are limited due to regulatory pressures and preference for alternatives.

4. How does NUBAIN compare financially to other opioid analgesics?
It has lower margins relative to newer drugs due to market saturation and high generic competition.

5. What regulatory factors could influence NUBAIN’s future?
Stricter opioid prescribing policies and potential reclassification as a controlled substance could further restrict its use and sales.

References

[1] U.S. Food and Drug Administration (FDA). NUBAIN (butorphanol) drug approval data. 1979.
[2] IQVIA. Market analysis reports, opioid analgesics, 2020-2023.
[3] EvaluatePharma. Generic drug market share report, 2023.