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, 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, 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-one suppliers are listed for this compound.

Summary for VANCOMYCIN HYDROCHLORIDE

International Patents:	56
US Patents:	12
Tradenames:	6
Applicants:	35
NDAs:	63
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	423
Patent Applications:	1,997
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VANCOMYCIN HYDROCHLORIDE
What excipients (inactive ingredients) are in VANCOMYCIN HYDROCHLORIDE?	VANCOMYCIN HYDROCHLORIDE excipients list
DailyMed Link:	VANCOMYCIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for VANCOMYCIN HYDROCHLORIDE

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

Sponsor	Phase
University of Cologne	Phase 2
Heidelberg University	Phase 2
Universitätsmedizin Mannheim	Phase 2

See all VANCOMYCIN HYDROCHLORIDE clinical trials

Pharmacology for VANCOMYCIN HYDROCHLORIDE

Drug Class	Glycopeptide Antibacterial

Medical Subject Heading (MeSH) Categories for VANCOMYCIN HYDROCHLORIDE

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes 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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	201251-001	Dec 23, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	VANCOLED	vancomycin hydrochloride	INJECTABLE;INJECTION	062682-003	May 11, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	VANCOCIN HYDROCHLORIDE	vancomycin hydrochloride	CAPSULE;ORAL	050606-002	Apr 15, 1986	AB	RX	Yes	Yes	⤷ 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
Baxter Hlthcare	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	050671-004	Jan 25, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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

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Country	Patent Number	Title	Estimated Expiration
Tunisia	2017000182	GLYCOPEPTIDE COMPOSITIONS	⤷ Sign Up
Japan	2020183424	グリコペプチド組成物 (GLYCOPEPTIDE COMPOSITIONS)	⤷ Sign Up
Japan	2017533218	グリコペプチド組成物	⤷ Sign Up
China	106573037		⤷ Sign Up
Singapore	11201703568W	GLYCOPEPTIDE COMPOSITIONS	⤷ Sign Up
>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.