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Amoxicillin; Clavulanate Potassium Patent Expiration

Amoxicillin; Clavulanate Potassium is Used for treating community-acquired pneumonia and bacterial sinusitis caused by resistant bacterial pathogens such as beta-lactamase-producing pathogens and penicillin-resistant Streptococcus pneumoniae. It was first introduced by Us Antibiotics Llc in its drug Augmentin '250' on Aug 6, 1984. Other drugs containing Amoxicillin; Clavulanate Potassium are Augmentin '200', Augmentin Es-600, Augmentin Xr, Augmentin '875', Augmentin '125', Augmentin '400', Augmentin '500'. 15 different companies have introduced drugs containing Amoxicillin; Clavulanate Potassium.


Amoxicillin; Clavulanate Potassium Patents

Given below is the list of patents protecting Amoxicillin; Clavulanate Potassium, 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
Augmentin Xr US6746692 Modified release pharmaceutical formulation comprising amoxycillin Apr 04, 2020

(Expired)

 Us Antibiotics
Augmentin Xr US6783773 Composition comprising amoxicillin and potassium clavulanate Apr 04, 2020

(Expired)

 Us Antibiotics
Augmentin Xr US6878386 Method of treating a bacterial infection comprising amoxycillin and potassium clavulanate Apr 04, 2020

(Expired)

 Us Antibiotics
Augmentin Xr US7217430 Compositions and methods of treatment comprising amoxicillin and potassium clavulanate with xanthan Apr 04, 2020

(Expired)

 Us Antibiotics
Augmentin Xr US7250176 Method of treating a bacterial infection Apr 04, 2020

(Expired)

 Us Antibiotics



Amoxicillin; Clavulanate Potassium's Family Patents

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Amoxicillin; Clavulanate Potassium Generic API Manufacturers

Several generic applications have been filed for Amoxicillin; Clavulanate Potassium. The first generic version for Amoxicillin; Clavulanate Potassium was by Sandoz Inc and was approved on Mar 14, 2002. And the latest generic version is by Deva Holding As and was approved on Dec 11, 2023.

Given below is the list of companies who have filed for Amoxicillin; Clavulanate Potassium generic, along with the locations of their manufacturing plants worldwide.


1. APOTEX INC

Apotex Inc has filed for 3 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. Given below are the details of the strengths of this generic introduced by Apotex Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
875MG; EQ 125MG BASE

tablet Discontinued ORAL N/A Oct 20, 2008
500MG; EQ 125MG BASE

tablet Discontinued ORAL N/A Feb 24, 2009
250MG; EQ 125MG BASE

tablet Discontinued ORAL N/A Feb 24, 2009


Manufacturing Plant Locations
New

Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.

Country City Firm Name
Canada
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
North York Apotex Inc.





2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/5ML; EQ 62.5MG BASE/5ML

for suspension Prescription ORAL AB Apr 19, 2019
125MG/5ML; EQ 31.25MG BASE/5ML

for suspension Prescription ORAL AB Apr 19, 2019


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Sangareddy Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





3. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 6 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG/5ML; EQ 42.9MG BASE/5ML

for suspension Prescription ORAL AB Dec 20, 2011
200MG/5ML; EQ 28.5MG BASE/5ML

for suspension Prescription ORAL AB Dec 20, 2011
400MG/5ML; EQ 57MG BASE/5ML

for suspension Prescription ORAL AB Dec 20, 2011
500MG; EQ 125MG BASE

(reference standard)

tablet Prescription ORAL AB Jan 20, 2012
875MG; EQ 125MG BASE

tablet Prescription ORAL AB Jan 20, 2012
250MG; EQ 125MG BASE

tablet Prescription ORAL AB Jan 20, 2012


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





4. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 2 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG; EQ 28.5MG BASE

tablet, chewable Discontinued ORAL N/A Apr 18, 2002
400MG; EQ 57MG BASE

tablet, chewable Discontinued ORAL N/A Apr 18, 2002





5. CIPLA

Cipla Ltd has filed for 2 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/5ML; EQ 62.5MG BASE/5ML

for suspension Prescription ORAL AB Nov 25, 2008
600MG/5ML; EQ 42.9MG BASE/5ML

for suspension Prescription ORAL AB Dec 2, 2013


Manufacturing Plant Locations
New

Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.

Country City Firm Name
India
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Bangalore Cipla Ltd.
Raigad Cipla Limited
Mumbai Cipla Limited
Bengaluru Cipla Limited
Vasco Da Gama Cipla Limited
Pithampur, District Dhar Cipla Limited





6. DEVA HOLDING AS

Deva Holding As has filed for 5 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. Given below are the details of the strengths of this generic introduced by Deva Holding As.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG/5ML; EQ 42.9MG BASE/5ML

for suspension Prescription ORAL AB Sep 13, 2023
875MG; EQ 125MG BASE

tablet Prescription ORAL AB Sep 15, 2023
500MG; EQ 125MG BASE

tablet Prescription ORAL AB Sep 15, 2023
250MG/5ML; EQ 62.5MG BASE/5ML

for suspension Prescription ORAL AB Nov 29, 2023
400MG/5ML; EQ 57MG BASE/5ML

for suspension Prescription ORAL AB Dec 11, 2023





7. HIKMA PHARMS

Hikma Pharmaceuticals has filed for 4 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. 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
400MG/5ML; EQ 57MG BASE/5ML

for suspension Prescription ORAL AB Jan 25, 2005
200MG/5ML; EQ 28.5MG BASE/5ML

for suspension Prescription ORAL AB Jan 25, 2005
600MG/5ML; EQ 42.9MG BASE/5ML

for suspension Prescription ORAL AB Nov 9, 2007
875MG; EQ 125MG BASE

tablet Prescription ORAL AB Aug 23, 2016





8. MICRO LABS

Micro Labs Ltd has filed for 1 generic for Amoxicillin; Clavulanate Potassium. This 600mg/5ml;eq 42.9mg base/5ml version comes by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG/5ML; EQ 42.9MG BASE/5ML

for suspension Prescription ORAL AB Dec 8, 2023


Manufacturing Plant Locations
New

Micro Labs's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Micro Labs as present at those locations.

Country City Firm Name
India
Verna Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory
Bengaluru Micro Labs Limited
Bangalore Micro Labs Limited





9. MICRO LABS LTD INDIA

Micro Labs Ltd India has filed for 5 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. Given below are the details of the strengths of this generic introduced by Micro Labs Ltd India.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG; EQ 125MG BASE

tablet Prescription ORAL AB Dec 30, 2016
875MG; EQ 125MG BASE

tablet Prescription ORAL AB Dec 30, 2016
500MG; EQ 125MG BASE

tablet Prescription ORAL AB Dec 30, 2016
200MG/5ML; EQ 28.5MG BASE/5ML

for suspension Prescription ORAL AB May 21, 2021
400MG/5ML; EQ 57MG BASE/5ML

for suspension Prescription ORAL AB May 21, 2021





10. SANDOZ

Sandoz Inc has filed for 6 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
875MG; EQ 125MG BASE

(reference standard)

tablet Prescription ORAL AB Mar 14, 2002
500MG; EQ 125MG BASE

tablet Prescription ORAL AB Mar 15, 2002
200MG/5ML; EQ 28.5MG BASE/5ML

for suspension Prescription ORAL AB Jun 5, 2002
400MG/5ML; EQ 57MG BASE/5ML

for suspension Prescription ORAL AB Jun 5, 2002
250MG; EQ 125MG BASE

(reference standard)

tablet Prescription ORAL AB Aug 23, 2005
1GM; EQ 62.5MG BASE

(reference standard)

tablet, extended release Prescription ORAL N/A Apr 21, 2010


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





11. SANDOZ INC

Sandoz Inc has filed for 5 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. 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
875MG; EQ 125MG BASE

tablet Prescription ORAL AB Nov 21, 2002
500MG; EQ 125MG BASE

tablet Discontinued ORAL N/A Nov 27, 2002
200MG/5ML; EQ 28.5MG BASE/5ML

for suspension Prescription ORAL AB Dec 16, 2002
400MG/5ML; EQ 57MG BASE/5ML

for suspension Prescription ORAL AB Dec 16, 2002
600MG/5ML; EQ 42.9MG BASE/5ML

for suspension Prescription ORAL AB Aug 13, 2007


Manufacturing Plant Locations
New

Sandoz Inc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Sandoz Inc as present at those locations.

Country City Firm Name
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc





12. SUN PHARM INDS LTD

Sun Pharmaceutical Industries Ltd has filed for 7 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
875MG; EQ 125MG BASE

tablet Discontinued ORAL N/A Sep 17, 2002
500MG; EQ 125MG BASE

tablet Discontinued ORAL N/A Nov 4, 2002
400MG/5ML; EQ 57MG BASE/5ML

for suspension Discontinued ORAL N/A Mar 19, 2003
200MG/5ML; EQ 28.5MG BASE/5ML

for suspension Discontinued ORAL N/A Mar 19, 2003
200MG; EQ 28.5MG BASE

tablet, chewable Discontinued ORAL N/A Dec 3, 2003
400MG; EQ 57MG BASE

tablet, chewable Discontinued ORAL N/A Dec 3, 2003
600MG/5ML; EQ 42.9MG BASE/5ML

for suspension Discontinued ORAL N/A Jan 30, 2007





13. TEVA

Teva Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Amoxicillin; Clavulanate Potassium. All of these versions come by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG; EQ 125MG BASE

tablet Prescription ORAL AB Oct 30, 2002
600MG/5ML; EQ 42.9MG BASE/5ML

(reference standard)

for suspension Prescription ORAL AB Mar 12, 2004
200MG/5ML; EQ 28.5MG BASE/5ML

for suspension Prescription ORAL AB May 25, 2004
400MG/5ML; EQ 57MG BASE/5ML

(reference standard)

for suspension Prescription ORAL AB May 25, 2004
200MG; EQ 28.5MG BASE

tablet, chewable Prescription ORAL N/A Feb 9, 2005
400MG; EQ 57MG BASE

(reference standard)

tablet, chewable Prescription ORAL N/A Feb 9, 2005


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Fort Dodge TEVA Animal Health Inc
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Miami Teva Branded Pharmaceutical Products R & D, Inc.
Horsham Teva Branded Pharmaceutical Products R&D
India
Bhind Teva API India Ltd- Malanpur
Gajraula, Amroha Teva API India Private Ltd.
Canada
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Stouffville Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





14. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Amoxicillin; Clavulanate Potassium. This 875mg;eq 125mg base version comes by the name AMOXICILLIN AND CLAVULANATE POTASSIUM. 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
875MG; EQ 125MG BASE

tablet Prescription ORAL AB Oct 29, 2002