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Last Updated: November 22, 2024

Pyridoxine hydrochloride - Generic Drug Details


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What are the generic drug 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
US Patents:0
Tradenames:2
Applicants:10
NDAs:11
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 146
Clinical Trials: 80
Patent Applications: 6,661
What excipients (inactive ingredients) are in pyridoxine hydrochloride?pyridoxine hydrochloride excipients list
DailyMed Link:pyridoxine hydrochloride at DailyMed
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
Watson Labs PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 083760-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dell Labs PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 083772-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Luitpold PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 080669-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Elkins Sinn PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 080581-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bel Mar PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 080761-001 Approved Prior to Jan 1, 1982 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

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