VANCOMYCIN HYDROCHLORIDE Drug Patent Profile

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, Hainan Poly, Hainan Poly Pharm, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sandoz Inc, 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.

Summary for VANCOMYCIN HYDROCHLORIDE

International Patents:	47
US Patents:	5
Applicants:	30
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

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

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

J01XA	Glycopeptide antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

FDA Regulatory Exclusivity protecting VANCOMYCIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sagent Pharms	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	200837-002	Sep 2, 2014	AP	RX	No	No
Zhejiang Novus Pharm	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	POWDER;INTRAVENOUS, ORAL	210274-004	Jan 20, 2023		RX	Yes	Yes
Hikma	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	204360-001	Oct 15, 2018	AP	RX	No	No

International Patents for VANCOMYCIN HYDROCHLORIDE

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	731955	Glycopeptide compositions
Slovenia	3215173
Eurasian Patent Organization	201790997	КОМПОЗИЦИИ ГЛИКОПЕПТИДОВ