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.

Sponsor	Phase
Anahuac University	N/A
Valenta Pharm JSC	N/A
All India Institute of Medical Sciences, New Delhi	Phase 2/Phase 3

Sponsor

Phase

Anahuac University

N/A

Valenta Pharm JSC

N/A

All India Institute of Medical Sciences, New Delhi

Phase 2/Phase 3

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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
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
>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:	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

Ingredient-type	Analogs/Derivatives Vitamin B 6
Drug Class	Vitamin B6 Analog