Vancomycin Hydrochloride Patent Expiration

Vancomycin Hydrochloride is Used for treating bacterial infections in the gastrointestinal tract. It was first introduced by Ani Pharmaceuticals Inc in its drug Vancocin Hydrochloride on Apr 15, 1986. Other drugs containing Vancomycin Hydrochloride are Vancomycin Hydrochloride, Firvanq Kit, Vancomycin Hydrochloride In Plastic Container. 35 different companies have introduced drugs containing Vancomycin Hydrochloride.


Vancomycin Hydrochloride Patents

Given below is the list of patents protecting Vancomycin Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Firvanq Kit US10493028 Composition and method for vancomycin oral liquid Mar 13, 2035 Azurity
Firvanq Kit US10688046 Composition and method for vancomycin oral liquid Mar 13, 2035 Azurity
Firvanq Kit US10959946 Composition and method for vancomycin oral liquid Mar 13, 2035 Azurity
Firvanq Kit US10959947 Composition and method for vancomycin oral liquid Mar 13, 2035 Azurity
Firvanq Kit US10959948 Composition and method for vancomycin oral liquid Mar 13, 2035 Azurity
Firvanq Kit US10959949 Composition and method for vancomycin oral liquid Mar 13, 2035 Azurity
Firvanq Kit US11638692 Composition and method for vancomycin oral liquid Mar 13, 2035 Azurity
Vancomycin Hydrochloride US10039804 Glycopeptide compositions Nov 06, 2035 Xellia Pharms Aps
Vancomycin Hydrochloride US10188697 Glycopeptide compositions Nov 06, 2035 Xellia Pharms Aps
Vancomycin Hydrochloride US10849956 Glycopeptide compositions Nov 06, 2035 Xellia Pharms Aps
Vancomycin Hydrochloride US11517609 Glycopeptide compositions Nov 06, 2035 Xellia Pharms Aps
Vancomycin Hydrochloride US11628200 Glycopeptide compositions Nov 06, 2035 Xellia Pharms Aps


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Vancomycin Hydrochloride's patents.

Given below is the list recent legal activities going on the following patents of Vancomycin Hydrochloride.

Event Date Patent/Publication
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 15 May, 2024 US10849956
Electronic Review 19 May, 2023 US11628200
Email Notification 19 May, 2023 US11628200
Miscellaneous Communication to Applicant - No Action Count 18 May, 2023 US11628200
Mail Miscellaneous Communication to Applicant 18 May, 2023 US11628200
Electronic Review 21 Apr, 2023 US11628200
Email Notification 21 Apr, 2023 US11628200
Mail Miscellaneous Communication to Applicant 21 Apr, 2023 US11628200
Miscellaneous Communication to Applicant - No Action Count 18 Apr, 2023 US11628200
Patent Issue Date Used in PTA Calculation 18 Apr, 2023 US11628200



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Vancomycin Hydrochloride Generics

Several generic applications have been filed for Vancomycin Hydrochloride. The first generic version for Vancomycin Hydrochloride was by Ani Pharmaceuticals Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Eugia Pharma Specialities Ltd and was approved on Aug 4, 2023.

Given below is the list of companies who have filed for Vancomycin Hydrochloride generic.


1. XELLIA PHARMS APS

Xellia Pharmaceuticals Aps has filed for 4 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Xellia Pharms Aps.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/VIAL injectable Prescription INJECTION AP Dec 28, 2015
EQ 1GM BASE/VIAL injectable Prescription INJECTION AP Dec 28, 2015
EQ 10GM BASE/VIAL injectable Prescription INJECTION AP Dec 28, 2015
EQ 5GM BASE/VIAL injectable Prescription INJECTION AP Dec 28, 2015


2. MYLAN LABS LTD

Mylan Laboratories Ltd has filed for 4 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/VIAL injectable Prescription INJECTION AP Dec 30, 2008
EQ 5GM BASE/VIAL injectable Prescription INJECTION AP Dec 30, 2008
EQ 1GM BASE/VIAL injectable Prescription INJECTION AP Dec 30, 2008
EQ 10GM BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP Sep 19, 2011


3. AMNEAL

Amneal Pharmaceuticals Llc has filed for 1 generic for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/5ML for solution Prescription ORAL AA Jun 23, 2023


4. PHARM ASSOC

Pharmaceutical Associates Inc has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Pharm Assoc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/VIAL injectable Discontinued INJECTION N/A Jun 30, 2008
EQ 1GM BASE/VIAL injectable Discontinued INJECTION N/A Jun 30, 2008


5. ASPIRO

Aspiro Pharma Ltd has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Aspiro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/VIAL injectable Prescription INJECTION AP Jul 6, 2022
EQ 1GM BASE/VIAL injectable Prescription INJECTION AP Jul 6, 2022


6. STERISCIENCE

Steriscience Pte Ltd has filed for 5 different strengths of generic version for Vancomycin Hydrochloride. All of these versions come by the name VANCOCIN HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Steriscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** injectable Discontinued INJECTION N/A Nov 17, 1987
EQ 500MG BASE/VIAL injectable Discontinued INJECTION N/A Mar 13, 1987
EQ 1GM BASE/VIAL injectable Discontinued INJECTION N/A Mar 13, 1987
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** injectable Discontinued INJECTION N/A Nov 17, 1987
EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** injectable Discontinued INJECTION N/A Nov 17, 1987


7. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE capsule Prescription ORAL AB Apr 9, 2012
EQ 125MG BASE capsule Prescription ORAL AB Apr 9, 2012


8. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 6 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Eugia Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 10GM BASE/VIAL injectable Prescription INJECTION AP Mar 29, 2016
EQ 5GM BASE/VIAL injectable Prescription INJECTION AP Mar 29, 2016
EQ 1GM BASE/VIAL injectable Prescription INJECTION AP Mar 31, 2016
EQ 500MG BASE/VIAL injectable Prescription INJECTION AP Mar 31, 2016
EQ 1.25GM BASE/VIAL powder Prescription INTRAVENOUS AP Aug 4, 2023
EQ 1.5GM BASE/VIAL powder Prescription INTRAVENOUS AP Aug 4, 2023


9. SAMSON MEDCL

Samson Medical Technologies Llc has filed for 1 generic for Vancomycin Hydrochloride. This eq 100gm base version comes by the name VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER. Given below are the details of the strengths of this generic introduced by Samson Medcl.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 100GM BASE powder Prescription INTRAVENOUS N/A Jan 6, 2016


10. PAI HOLDINGS PHARM

Pai Holdings Llc Dba Pharmaceutical Associates Inc has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Pai Holdings Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 125MG BASE capsule Discontinued ORAL N/A Apr 9, 2012
EQ 250MG BASE capsule Discontinued ORAL N/A Apr 9, 2012


11. HIKMA PHARMS

Hikma Pharmaceuticals has filed for 1 generic for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Hikma Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 750MG BASE/VIAL injectable Prescription INJECTION AP Oct 3, 2018


12. HAINAN POLY PHARM

Hainan Poly Pharmaceutical Co Ltd has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Hainan Poly Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1GM BASE/VIAL injectable Prescription INJECTION AP Jun 12, 2019
EQ 500MG BASE/VIAL injectable Prescription INJECTION AP Jun 12, 2019


13. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 4 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1GM BASE/VIAL injectable Discontinued INJECTION N/A Dec 23, 2015
EQ 5GM BASE/VIAL injectable Discontinued INJECTION N/A Dec 23, 2015
EQ 10GM BASE/VIAL injectable Discontinued INJECTION N/A Dec 23, 2015
EQ 500MG BASE/VIAL injectable Discontinued INJECTION N/A Dec 23, 2015


14. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 11 different strengths of generic version for Vancomycin Hydrochloride. Out of these eq 500mg base/vial **federal register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** version comes by the name VANCOLED, eq 1gm base/vial **federal register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** version comes by the name VANCOLED, eq 10gm base/vial **federal register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** version comes by the name VANCOLED, eq 5gm base/vial **federal register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** version comes by the name VANCOLED, eq 2gm base/vial **federal register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** version comes by the name VANCOLED. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** injectable Discontinued INJECTION N/A Jul 22, 1986
EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** injectable Discontinued INJECTION N/A Mar 30, 1988
EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** injectable Discontinued INJECTION N/A May 11, 1988
EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** injectable Discontinued INJECTION N/A May 11, 1988
EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** injectable Discontinued INJECTION N/A May 11, 1988
EQ 500MG BASE/VIAL injectable Discontinued INJECTION N/A Aug 11, 2020
EQ 1GM BASE/VIAL injectable Prescription INJECTION AP Aug 11, 2020
EQ 5GM BASE/VIAL injectable Prescription INJECTION AP Oct 15, 2018
EQ 10GM BASE/VIAL injectable Prescription INJECTION AP Oct 15, 2018
EQ 1.5GM BASE/VIAL powder Prescription INTRAVENOUS AP Jun 29, 2023
EQ 1.25GM BASE/VIAL powder Prescription INTRAVENOUS AP Jun 29, 2023


15. WATSON LABS

Watson Laboratories Inc has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 125MG BASE capsule Discontinued ORAL N/A Apr 9, 2012
EQ 250MG BASE capsule Discontinued ORAL N/A Apr 9, 2012


16. LUPIN LTD

Lupin Ltd has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 125MG BASE capsule Prescription ORAL AB Jan 28, 2015
EQ 250MG BASE capsule Prescription ORAL AB Jan 28, 2015


17. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 4 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1GM BASE/VIAL injectable Prescription INJECTION AP Jan 21, 2016
EQ 500MG BASE/VIAL injectable Prescription INJECTION AP Jan 21, 2016
EQ 10GM BASE/VIAL injectable Prescription INJECTION AP Jun 6, 2023
EQ 5GM BASE/VIAL injectable Prescription INJECTION AP Jun 6, 2023


18. AVET LIFESCIENCES

Avet Lifesciences Ltd has filed for 4 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Avet Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 10GM BASE/VIAL injectable Discontinued INJECTION N/A Oct 9, 2013
EQ 1GM BASE/VIAL injectable Discontinued INJECTION N/A Oct 31, 2013
EQ 5GM BASE/VIAL injectable Discontinued INJECTION N/A Oct 31, 2013
EQ 500MG BASE/VIAL injectable Discontinued INJECTION N/A Oct 31, 2013


19. HOSPIRA INC

Hospira Inc has filed for 1 generic for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Hospira Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 10GM BASE/VIAL injectable Prescription INJECTION AP Apr 29, 2009


20. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 5 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5GM BASE/VIAL injectable Prescription INJECTION AP Jul 27, 2022
EQ 10GM BASE/VIAL injectable Prescription INJECTION AP Jul 27, 2022
EQ 500MG BASE/VIAL injectable Prescription INJECTION AP Jul 28, 2022
EQ 1GM BASE/VIAL injectable Prescription INJECTION AP Jul 28, 2022
EQ 750MG BASE/VIAL injectable Prescription INJECTION AP Sep 15, 2022


21. HAINAN POLY

Hainan Poly Pharm Co Ltd has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Hainan Poly.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5GM BASE/VIAL injectable Prescription INJECTION AP Nov 18, 2021
EQ 10GM BASE/VIAL injectable Prescription INJECTION AP Nov 18, 2021


22. SAGENT PHARMS

Sagent Pharmaceuticals Inc has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Sagent Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5GM BASE/VIAL injectable Prescription INJECTION AP Aug 10, 2012
EQ 10GM BASE/VIAL injectable Prescription INJECTION AP Sep 2, 2014


23. PHARMACIA AND UPJOHN

Pharmacia And Upjohn Co has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. All of these versions come by the name VANCOR. Given below are the details of the strengths of this generic introduced by Pharmacia And Upjohn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1GM BASE/VIAL injectable Discontinued INJECTION N/A Aug 1, 1988
EQ 500MG BASE/VIAL injectable Discontinued INJECTION N/A Aug 1, 1988


24. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/VIAL injectable Discontinued INJECTION N/A Apr 27, 2010
EQ 1GM BASE/VIAL injectable Discontinued INJECTION N/A Apr 27, 2010


25. LEDERLE

Lederle Parenterals Inc has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. All of these versions come by the name VANCOLED. Given below are the details of the strengths of this generic introduced by Lederle.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/6ML for solution Discontinued ORAL N/A Oct 15, 1993
EQ 250MG BASE/5ML for solution Discontinued ORAL N/A Oct 15, 1993


26. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 7 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP Mar 17, 1987
EQ 1GM BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP Jul 31, 1987
EQ 5GM BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP Jun 3, 1988
EQ 10GM BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP Nov 28, 1997
EQ 250MG BASE capsule Discontinued ORAL N/A Jun 18, 2012
EQ 125MG BASE capsule Discontinued ORAL N/A Jun 18, 2012
EQ 750MG BASE/VIAL injectable Prescription INJECTION AP Aug 17, 2016


27. ORIENT PHARMA CO LTD

Orient Pharma Co Ltd has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Orient Pharma Co Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 125MG BASE capsule Prescription ORAL AB Apr 29, 2019
EQ 250MG BASE capsule Prescription ORAL AB Apr 29, 2019


28. SANDOZ INC

Sandoz Inc has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Sandoz Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5GM BASE/VIAL injectable Discontinued INJECTION N/A Aug 10, 2012
EQ 10GM BASE/VIAL injectable Discontinued INJECTION N/A Aug 10, 2012


29. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. All of these versions come by the name VANCOCIN HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Ani Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 500MG BASE/6ML for solution Discontinued ORAL N/A Approved Prior to Jan 1, 1982
EQ 250MG BASE/5ML

(reference standard)

for solution Prescription ORAL AA Jul 13, 1983


30. HOSPIRA

Hospira Inc has filed for 6 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 1GM BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP Oct 29, 1992
EQ 500MG BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP Oct 29, 1992
EQ 5GM BASE/VIAL

(reference standard)

injectable Prescription INJECTION AP Dec 21, 1990
EQ 750MG BASE/VIAL injectable Prescription INJECTION AP May 27, 2009
EQ 1.5GM BASE/VIAL

(reference standard)

injectable Prescription INJECTION N/A Jul 10, 2020
EQ 10GM BASE/VIAL injectable Prescription INJECTION AP Sep 14, 2020


31. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/ML for solution Prescription ORAL AB Nov 14, 2022
EQ 25MG BASE/ML for solution Prescription ORAL AB Nov 14, 2022


32. KNACK

Knack Pharmaceuticals Inc has filed for 3 different strengths of generic version for Vancomycin Hydrochloride. Given below are the details of the strengths of this generic introduced by Knack.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 750MG BASE/VIAL injectable Discontinued INJECTION N/A Feb 15, 2022
EQ 500MG BASE/VIAL injectable Discontinued INJECTION N/A Feb 15, 2022
EQ 1GM BASE/VIAL injectable Discontinued INJECTION N/A Feb 15, 2022