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Last Updated: March 19, 2024

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, Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings Pharm, Strides Pharma, Watson Labs, Azurity, Lederle, Alkem Labs Ltd, Amneal, Steriscience, Baxter Hlthcare, Hikma, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hainan Poly, Hainan Poly Pharm, Hikma Pharms, Hospira, Hospira Inc, Knack, Meitheal, Mylan Labs Ltd, Pharm Assoc, Sagent Pharms, Sandoz, Sandoz Inc, Teva Pharms Usa, Xellia Pharms Aps, Pharmacia And Upjohn, Samson Medcl, and Zhejiang Novus Pharm, and is included in sixty-three NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vancomycin hydrochloride has fifty-six patent family members in twenty-nine countries.

There are twenty drug master file entries for vancomycin hydrochloride. Thirty-one suppliers are listed for this compound.

Recent Clinical Trials for vancomycin hydrochloride

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

SponsorPhase
German Cancer Research CenterPhase 2
Michael DillPhase 2
National Center for Tumor Diseases, HeidelbergPhase 2

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 Strength NDA ANDAs Submitted Submissiondate
FIRVANQ KIT For Oral Solution vancomycin hydrochloride 25 mg/mL and 50 mg/mL 208910 1 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
Avet Lifesciences VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 202464-001 Oct 9, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062911-001 Aug 4, 1988 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sagent Pharms VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 200837-001 Aug 10, 2012 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira Inc VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 065455-001 Apr 29, 2009 AP RX 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.