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Last Updated: August 10, 2020

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VANCOMYCIN HYDROCHLORIDE - Generic Drug Details

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

Vancomycin hydrochloride is the generic ingredient in seven branded drugs marketed by Ani Pharms Inc, Akorn, Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Strides Pharma, Watson Labs, Rxmtm Theraps Llc, Lederle, Baxter Hlthcare, West-ward Pharms Int, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Gland Pharma Ltd, Hainan Poly Pharm, Hikma, Hikma Pharms, Hospira, Hospira Inc, Mylan Labs Ltd, Pharm Assoc, Sagent Pharms, Sandoz, Sandoz Inc, Teva Pharms Usa, Xellia Pharms Aps, Pharmacia And Upjohn, and Samson Medcl, and is included in fifty-one NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vancomycin hydrochloride has thirty patent family members in twenty-two countries.

There are twenty-two drug master file entries for vancomycin hydrochloride. Twenty-four suppliers are listed for this compound.

Summary for VANCOMYCIN HYDROCHLORIDE
Recent Clinical Trials for VANCOMYCIN HYDROCHLORIDE

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

SponsorPhase
University of Texas Southwestern Medical CenterPhase 4
Saskatchewan Health Authority - Regina AreaN/A
Bezmialem Vakif UniversityPhase 3

See all VANCOMYCIN HYDROCHLORIDE clinical trials

Pharmacology for VANCOMYCIN HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for VANCOMYCIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for VANCOMYCIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
FIRVANQ KIT FOR SOLUTION;ORAL vancomycin hydrochloride 208910 2020-05-18

US Patents and Regulatory Information for VANCOMYCIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride CAPSULE;ORAL 065453-001 Jun 18, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062931-001 Oct 29, 1992 AP RX No Yes   Start Trial   Start Trial   Start Trial
Gland Pharma Ltd VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 205694-001 Jan 21, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc VANCOCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062716-001 Mar 13, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Hainan Poly Pharm VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 212332-001 Jun 12, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Sagent Pharms VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 200837-002 Sep 2, 2014 AP RX No No   Start Trial   Start Trial   Start Trial
Xellia Pharms Aps VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 204125-002 Dec 28, 2015 AP RX No No   Start Trial   Start Trial   Start 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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