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Last Updated: March 29, 2024

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, 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
Igi Labs Inc NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 072073-001 Apr 10, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 206506-002 Feb 6, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Igi Labs Inc NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 072070-001 Apr 10, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 070916-001 Feb 3, 1989 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abraxis Pharm NALBUPHINE nalbuphine hydrochloride INJECTABLE;INJECTION 070751-001 Jul 2, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Igi Labs Inc NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 072074-001 Apr 10, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira NALBUPHINE HYDROCHLORIDE nalbuphine hydrochloride INJECTABLE;INJECTION 070915-001 Feb 3, 1989 AP RX No Yes ⤷  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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