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NUBAIN

NDA

NALBUPHINE HYDROCHLORIDE | N018024 | PH HEALTH LTD

5 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

4 trials from ClinicalTrials.gov — 2 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)NCT07671924	Phase 2	Not Yet Recruiting	Trevi Therapeutics	100	2026-06 → 2027-09
Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets NCT07671911	Phase 3	Not Yet Recruiting	Trevi Therapeutics	306	2026-06 → 2028-07
Evaluation of Safety and Efficacy of Nalbuphine Versus Morphine for Postoperative Analgesia NCT06949852	Phase 3	Completed	Yangtze River Pharmaceutical Group Jiangsu Zilong Pharmaceutical Co. Ltd	289	2024-08-07 → 2025-08-04
Cough Reduction in IPF With Nalbuphine ER NCT05964335	Phase 2	Completed	Trevi Therapeutics	165	2024-02-06 → 2025-04-24

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain3 active DMFs2 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SPECGX LLCNALBUPHINE HYDROCHLORIDE (LOW BETA EPIMER) CODE 3310

DMF 114211995

FRANCOPIA A EUROAPI CONALBUPHINE HYDROCHLORIDE

DMF 211442007

SPECGX LLCNALBUPHINE HYDROCHLORIDE (1P)

DMF 236042010

MALLINCKRODT CHEMICAL INCInactiveNALBUPHINE HYDROCHLORIDE CODE 3300

DMF 28831977

SANOFI SYNTHELABO INCInactiveNALBUPHINE HYDROCHLORIDE

DMF 62791986

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Dec 29, 2025	SUPPL -44	View Letter (PDF)
Dec 19, 2023	SUPPL -43	View Letter (PDF)
Oct 8, 2019	SUPPL -42	View Letter (PDF)
Dec 19, 2016	SUPPL -41	View Letter (PDF)
Aug 31, 2005	SUPPL -40	View Letter (PDF)
May 30, 2003	SUPPL -36	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: May 27, 1982

#003 — 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Approved Prior to Jan 1, 1982

#004 — 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Approved Prior to Jan 1, 1982

#005 — 200MG/10ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Mar 2, 1984