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Last Updated: March 28, 2024

Nalbuphine hydrochloride - Generic Drug Details


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What are the generic sources for nalbuphine hydrochloride and what is the scope of freedom to operate?

Nalbuphine hydrochloride is the generic ingredient in three branded drugs marketed by Abraxis Pharm, Abbott, Abbvie, Dr Reddys, Hospira, Igi Labs Inc, Rising, and Par Pharm Inc, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for nalbuphine hydrochloride. Four suppliers are listed for this compound.

Summary for nalbuphine hydrochloride
Recent Clinical Trials for nalbuphine hydrochloride

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

SponsorPhase
Assiut UniversityEarly Phase 1
Sinew Pharma Inc.Phase 2
Li-Jen HsinPhase 4

See all nalbuphine hydrochloride clinical trials

Pharmacology for nalbuphine hydrochloride
Medical Subject Heading (MeSH) Categories for nalbuphine hydrochloride

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
Rising NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 207595-002 Jan 11, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 074471-002 Mar 19, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm Inc NUBAIN nalbuphine hydrochloride INJECTABLE;INJECTION 018024-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbott NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 070917-001 Feb 3, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abraxis Pharm NALBUPHINE nalbuphine hydrochloride INJECTABLE;INJECTION 070752-001 Sep 24, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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