NALBUPHINE HYDROCHLORIDE - Generic Drug Details

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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 Abraxis Pharm, Abbott, Abbvie, Dr Reddys, Hospira, Igi Labs Inc, Rising, Somerset Theraps Llc, and Endo Operations, 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. Five suppliers are listed for this compound.

Sponsor

Phase

Yongtao Sun

Phase 4

Kasr El Aini Hospital

N/A

Chulalongkorn University

N/A

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Igi Labs Inc	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	072072-001	Apr 10, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Somerset Theraps Llc	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	216049-002	Sep 19, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Igi Labs Inc	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	072071-001	Apr 10, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Igi Labs Inc	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	072074-001	Apr 10, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Igi Labs Inc	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	INJECTABLE;INJECTION	072075-001	Apr 10, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	3
Applicants:	9
NDAs:	20
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	109
Patent Applications:	970
What excipients (inactive ingredients) are in NALBUPHINE HYDROCHLORIDE?	NALBUPHINE HYDROCHLORIDE excipients list
DailyMed Link:	NALBUPHINE HYDROCHLORIDE at DailyMed

Drug Class	Opioid Agonist/Antagonist
Mechanism of Action	Competitive Opioid Antagonists Partial Opioid Agonists