NALBUPHINE HYDROCHLORIDE Drug Patent Profile

Which patents cover Nalbuphine Hydrochloride, and when can generic versions of Nalbuphine Hydrochloride launch?

Nalbuphine Hydrochloride is a drug marketed by Abbott, Abbvie, Dr Reddys, Hospira, Igi Labs Inc, and Rising. and is included in fifteen NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nalbuphine Hydrochloride

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

Summary for NALBUPHINE HYDROCHLORIDE

US Patents:	0
Applicants:	6
NDAs:	15
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	103
Patent Applications:	660
Formulation / Manufacturing:	see details
DailyMed Link:	NALBUPHINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NALBUPHINE HYDROCHLORIDE

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

Sponsor	Phase
Assiut University	Early Phase 1
Sinew Pharma Inc.	Phase 2
Li-Jen Hsin	Phase 4

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
Abbott	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	070917-001	Feb 3, 1989		DISCN	No	No
Rising	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	207595-002	Jan 11, 2019		DISCN	No	No
Hospira	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	070916-001	Feb 3, 1989	AP	RX	No	Yes
Dr Reddys	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	074471-002	Mar 19, 1998		DISCN	No	No
Igi Labs Inc	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	072073-001	Apr 10, 1989		DISCN	No	No
Hospira	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	070918-001	Feb 3, 1989	AP	RX	No	Yes
Rising	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	207595-001	Jan 11, 2019		DISCN	No	No