Viewing data from:

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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Teligent Pharma, Inc. FDA-2017-P-3675 · 5 docket documents Teligent Pharma, Inc. filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Nalbuphine Hydrochloride Injection ANDAs 070914, 070915, 070916, and 070918 held by Hospira, Inc. as a second reference-listed drug product, citing the	505(q)	2017-06-13	Denied	Teligent Pharma, Inc.
Sterling Winthrop, Inc. - Citizen Petition FDA-1992-P-0380 · 4 docket documents Sterling Winthrop Inc. submitted this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval of ANDA 72-960 for Nalbuphine Hydrochloride Injection USP 20 mg in a 2 mL Carpuject sterile cartridge needle-unit, which differs in packaging configura	Other	2010-09-17	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

51 trials from ClinicalTrials.gov, 36 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Effect of Caudal Nalbuphine on Postoperative Analgesia in Children NCT02618876	N/A	Completed	Assiut University	60	2015-11 → 2019-12
Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain NCT02445599	Phase 4	Completed	University of Debrecen	3	2014-04 → 2016-04
Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus NCT02143973	Phase 2/3	Completed	Trevi Therapeutics	167	2014-09 → 2016-01
PRISM Study-Pruritus Relief Through Itch Scratch Modulation NCT03497975	Phase 2/3	Completed	Trevi Therapeutics	353	2018-08-07 → 2023-02-24
Intrathecal Nalbuphine Versus Midazolam in Cesarean Section NCT03918187	Phase 1	Completed	Zagazig University	90	2019-04-10 → 2019-12-01
Nalbuphine Plus Caudal Bupivacaine in Hypospadius Repair NCT03476772	N/A	Completed	Assiut University	60	2018-03-01 → 2020-10-01
A Bioavailability Study of Sebacoyl Dinalbuphine Ester IM Injection in Healthy Volunteers NCT02446301	Phase 1	Completed	Lumosa Therapeutics Co., Ltd.	12	2015-01 → 2015-04
Effect of Intravenous Nalbuphine on Emergence Agitation NCT03470077	Phase 2	Completed	Assiut University	80	2019-07-31 → 2020-12-01
Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy NCT02820051	N/A	Completed	Hospital Universitario Dr. Jose E. Gonzalez	102	2014-02 → 2014-07
Nalbuphine as an Adjuvant to Local Anaesthetic Mixture in Peribulbar Cataract Surgery NCT03436836	N/A	Completed	Cairo University	40	2018-01-14 → 2018-02-28

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