VANCOMYCIN Drug Patent Profile

Which patents cover Vancomycin, and when can generic versions of Vancomycin launch?

Vancomycin is a drug marketed by Xellia Pharms Aps, 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, Meitheal, Mylan Labs Ltd, Pharm Assoc, Sagent Pharms, Sandoz, Sandoz Inc, Teva Pharms Usa, Zhejiang Novus Pharm, Samson Medcl, and Baxter Hlthcare. and is included in fifty-four NDAs. There are six patents protecting this drug.

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vancomycin

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

Summary for VANCOMYCIN

International Patents:	47
US Patents:	5
Applicants:	30
NDAs:	54
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	423
Patent Applications:	745
Drug Prices:	Drug price information for VANCOMYCIN
What excipients (inactive ingredients) are in VANCOMYCIN?	VANCOMYCIN excipients list
DailyMed Link:	VANCOMYCIN at DailyMed

See drug prices for VANCOMYCIN

See drug sales revenues for VANCOMYCIN

Recent Clinical Trials for VANCOMYCIN

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

Sponsor	Phase
German Cancer Research Center	Phase 2
Michael Dill	Phase 2
National Center for Tumor Diseases, Heidelberg	Phase 2

See all VANCOMYCIN clinical trials

Pharmacology for VANCOMYCIN

Drug Class

Glycopeptide Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for VANCOMYCIN

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

US Patents and Regulatory Information for VANCOMYCIN

VANCOMYCIN is protected by five US patents.

Patents protecting VANCOMYCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Labs Ltd	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	091554-001	Sep 19, 2011	AP	RX	No	Yes
Mylan Labs Ltd	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	POWDER;INTRAVENOUS	209481-002	Jul 10, 2018		RX	Yes	Yes
Hainan Poly	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	215821-002	Nov 18, 2021	AP	RX	No	No
Fresenius Kabi Usa	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	062663-003	Jun 3, 1988	AP	RX	No	Yes
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	091377-002	Sep 9, 2015		DISCN	No	No

International Patents for VANCOMYCIN

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

Country	Patent Number	Title	Estimated Expiration
Slovenia	3215173
Hungary	E049857
Slovenia	3542812
Philippines	12017500720	GLYCOPEPTIDE COMPOSITIONS
Serbia	59851	KOMPOZICIJE GLIKOPEPTIDA (GLYCOPEPTIDE COMPOSITIONS)