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Last Updated: March 28, 2024

Pyridoxine hydrochloride - Generic Drug Details


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What are the generic sources for pyridoxine hydrochloride and what is the scope of patent protection?

Pyridoxine hydrochloride is the generic ingredient in two branded drugs marketed by Lilly, Bel Mar, Dell Labs, Dr Reddys, Elkins Sinn, Epic Pharma Llc, Fresenius Kabi Usa, Luitpold, Mylan Institutional, and Watson Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for pyridoxine hydrochloride. Two suppliers are listed for this compound.

Summary for pyridoxine hydrochloride
Recent Clinical Trials for pyridoxine hydrochloride

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

SponsorPhase
Anahuac UniversityN/A
Valenta Pharm JSCN/A
All India Institute of Medical Sciences, New DelhiPhase 2/Phase 3

See all pyridoxine hydrochloride clinical trials

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

US Patents and Regulatory Information for pyridoxine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Elkins Sinn PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 080581-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dell Labs PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 083771-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bel Mar PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 080761-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 080572-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 080618-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Epic Pharma Llc PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 087967-001 Oct 1, 1982 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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