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Last Updated: November 22, 2024

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 six 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 Speclts, Hikma, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hikma Pharms, Hospira, Hospira Inc, Knack, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sandoz Inc, Slate Run Pharma, Teva Pharms Usa, Xellia Pharms Aps, Pharmacia And Upjohn, Samson Medcl, Zhejiang Novus Pharm, and Baxter Hlthcare, 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 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
Chang Gung Memorial HospitalN/A
Hospital Universitario Evangelico de CuritibaPhase 3
University of DuhokN/A

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
Hospira VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062912-001 Aug 4, 1988 AP RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 063076-002 Sep 14, 2020 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 204107-002 Dec 28, 2015 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Labs Ltd VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 065432-001 Dec 30, 2008 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Xellia Pharms Aps VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride SOLUTION;INTRAVENOUS 211962-006 May 13, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for VANCOMYCIN HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Cyprus 1122960 ⤷  Sign Up
Australia 2015229069 ⤷  Sign Up
Serbia 59851 KOMPOZICIJE GLIKOPEPTIDA (GLYCOPEPTIDE COMPOSITIONS) ⤷  Sign Up
South Korea 20230096142 글리코펩티드 조성물 (GLYCOPEPTIDE COMPOSITIONS) ⤷  Sign Up
Canada 2941867 COMPOSITION DE VANCOMYCINE ORALE LIQUIDE ET PROCEDE ASSOCIE (COMPOSITION AND METHOD FOR VANCOMYCIN ORAL LIQUID) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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