VANCOMYCIN HYDROCHLORIDE Drug Patent Profile

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When do Vancomycin Hydrochloride patents expire, and what generic alternatives are available?

Vancomycin Hydrochloride is a drug marketed by Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings Pharm, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hikma, 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, Zhejiang Novus Pharm, Samson Medcl, and Baxter Hlthcare. and is included in fifty-three NDAs. There are five patents protecting this drug.

This drug has forty-seven patent family members in twenty-nine countries.

The generic ingredient in VANCOMYCIN HYDROCHLORIDE is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vancomycin Hydrochloride

A generic version of VANCOMYCIN HYDROCHLORIDE was approved as vancomycin hydrochloride by FRESENIUS KABI USA on March 17^th, 1987.

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Summary for VANCOMYCIN HYDROCHLORIDE

International Patents:	47
US Patents:	5
Applicants:	29
NDAs:	53
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	429
Patent Applications:	1,331
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

Drug patent expirations by year for VANCOMYCIN HYDROCHLORIDE

Recent Clinical Trials for VANCOMYCIN HYDROCHLORIDE

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

Sponsor	Phase
Chang Gung Memorial Hospital	N/A
Hospital Universitario Evangelico de Curitiba	Phase 3
University of Duhok	N/A

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

VANCOMYCIN HYDROCHLORIDE is protected by five US patents and two FDA Regulatory Exclusivities.

Patents protecting VANCOMYCIN HYDROCHLORIDE

Glycopeptide compositions
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Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS

Glycopeptide compositions
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Patent Expiration: ⤷ Sign Up

Glycopeptide compositions
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Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS

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FDA Regulatory Exclusivity protecting VANCOMYCIN HYDROCHLORIDE

PATENT CHALLENGE
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COMPETITIVE GENERIC THERAPY
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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
Sandoz	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	090250-001	Apr 27, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zhejiang Novus Pharm	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	POWDER;INTRAVENOUS, ORAL	210274-004	Jan 20, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	203300-001	Aug 11, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	205694-003	Jun 6, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	204125-002	Dec 28, 2015	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-003	Feb 15, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Baxter Hlthcare	VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	050671-005	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

See the table below for patents covering VANCOMYCIN HYDROCHLORIDE around the world.

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Country	Patent Number	Title	Estimated Expiration
Mexico	2017005749	COMPOSICIONES ANTIBIÓTICAS. (GLYCOPEPTIDE COMPOSITIONS.)	⤷ Sign Up
South Korea	20230096142	글리코펩티드 조성물 (GLYCOPEPTIDE COMPOSITIONS)	⤷ Sign Up
Israel	252120	תכשירים של גליקופפטיד (Glycopeptide compositions)	⤷ Sign Up
Slovenia	3542812		⤷ Sign Up
European Patent Office	3542812	COMPOSITIONS DE GLYCOPEPTIDE (GLYCOPEPTIDE COMPOSITIONS)	⤷ Sign Up
European Patent Office	3834837	COMPOSITIONS DE GLYCOPEPTIDE (GLYCOPEPTIDE COMPOSITIONS)	⤷ Sign Up
Serbia	59851	KOMPOZICIJE GLIKOPEPTIDA (GLYCOPEPTIDE COMPOSITIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration