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Last Updated: August 7, 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 freedom to operate?

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

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
Hikma VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 204360-002 Oct 15, 2018 AP RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 205780-002 Mar 31, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Rxmtm Theraps Llc FIRVANQ KIT vancomycin hydrochloride FOR SOLUTION;ORAL 208910-002 Jan 26, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Teva Pharms Usa VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 201251-002 Dec 23, 2015 DISCN 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

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