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, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, 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 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:	30
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	429
Patent Applications:	1,997
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
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

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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
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-005	May 13, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-001	Feb 15, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	204125-001	Dec 28, 2015	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hainan Poly Pharm	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	212332-001	Jun 12, 2019	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zhejiang Novus Pharm	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	POWDER;INTRAVENOUS, ORAL	210274-003	Jan 20, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	204107-001	Dec 28, 2015	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	CAPSULE;ORAL	065510-002	Apr 9, 2012		DISCN	No	No	⤷ 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
Denmark	3542812		⤷ Sign Up
Eurasian Patent Organization	201790997	КОМПОЗИЦИИ ГЛИКОПЕПТИДОВ	⤷ Sign Up
Japan	2020183424	グリコペプチド組成物 (GLYCOPEPTIDE COMPOSITIONS)	⤷ Sign Up
South Korea	20170078830	글리코펩티드 조성물 (GLYCOPEPTIDE COMPOSITIONS)	⤷ Sign Up
European Patent Office	4147710	COMPOSITIONS GLYCOPEPTIDIQUES EN SOLUTION (GLYCOPEPTIDE COMPOSITIONS IN SOLUTION)	⤷ Sign Up
New Zealand	731955	Glycopeptide compositions	⤷ Sign Up
Singapore	11201703568W	GLYCOPEPTIDE COMPOSITIONS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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