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Last Updated: December 5, 2022

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, Akorn, Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Strides Pharma, Watson Labs, Azurity, Lederle, Steriscience, Baxter Hlthcare, Hikma, Aspiro, Emcure Pharms Ltd, 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, and Samson Medcl, and is included in fifty-eight NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Recent Clinical Trials for vancomycin hydrochloride

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

SponsorPhase
Assistance Publique Hopitaux De MarseillePhase 4
Panhandle Eye Group, LLPPhase 3
Rutgers, The State University of New JerseyPhase 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 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
Aspiro VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 216591-001 Jul 6, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lederle VANCOLED vancomycin hydrochloride FOR SOLUTION;ORAL 063321-002 Oct 15, 1993 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Labs Ltd VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 091469-001 Jul 1, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Steriscience VANCOCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 060180-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062912-003 Jul 10, 2020 RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Xellia Pharms Aps VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride SOLUTION;INTRAVENOUS 211962-004 Feb 15, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Xellia Pharms Aps VANCOMYCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 206243-002 Dec 23, 2015 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Philippines 12017500720 GLYCOPEPTIDE COMPOSITIONS See Plans and Pricing
Saudi Arabia 517381446 تركيبات مضاد حيوي (ANTIBIOTIC COMPOSITIONS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2016071495 See Plans and Pricing
Denmark 3215173 See Plans and Pricing
Croatia P20210342 See Plans and Pricing
Spain 2903419 See Plans and Pricing
Denmark 3542812 See Plans and Pricing
>Country >Patent Number >Title >Estimated 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.