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Linezolid Patent Expiration

Linezolid is used for treating microbial infections. It was first introduced by Pfizer Inc in its drug Zyvox on Apr 18, 2000. Another drug containing Linezolid is Linezolid In Sodium Chloride 0.9% In Plastic Container. 23 different companies have introduced drugs containing Linezolid.


Linezolid Patents

Given below is the list of patents protecting Linezolid, 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
Zyvox US6514529

(Pediatric)

 Oxazolidinone tablet formulation Sep 15, 2021

(Expired)

 Pfizer
Zyvox US6559305

(Pediatric)

 Linezolid—crystal form II Jul 29, 2021

(Expired)

 Pfizer
Zyvox US6514529 Oxazolidinone tablet formulation Mar 15, 2021

(Expired)

 Pfizer
Zyvox US6559305 Linezolid—crystal form II Jan 29, 2021

(Expired)

 Pfizer
Zyvox US6559305 Linezolid—crystal form II Jan 29, 2021

(Expired)

 Pfizer
Zyvox US5688792

(Pediatric)

 Substituted oxazine and thiazine oxazolidinone antimicrobials May 18, 2015

(Expired)

 Pfizer
Zyvox US5688792 Substituted oxazine and thiazine oxazolidinone antimicrobials Nov 18, 2014

(Expired)

 Pfizer



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 Linezolid's patents.

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

Activity Date Patent Number
Patent litigations
Correspondence Address Change
Critical
 29 Aug, 2014 US6559305(Litigated)
Correspondence Address Change
Critical
 28 Aug, 2014 US6514529
Patent Issue Date Used in PTA Calculation
Critical
 06 May, 2003 US6559305(Litigated)
Recordation of Patent Grant Mailed
Critical
 06 May, 2003 US6559305(Litigated)
Issue Notification Mailed
Critical
 17 Apr, 2003 US6559305(Litigated)
Receipt into Pubs 07 Apr, 2003 US6559305(Litigated)
Application Is Considered Ready for Issue
Critical
 03 Apr, 2003 US6559305(Litigated)
Receipt into Pubs 02 Apr, 2003 US6559305(Litigated)
Receipt into Pubs 03 Mar, 2003 US6559305(Litigated)
Workflow - File Sent to Contractor 03 Mar, 2003 US6559305(Litigated)


Linezolid's Family Patents

Family Patents

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Linezolid Generic API Manufacturers

Several generic applications have been filed for Linezolid. The first generic version for Linezolid was by Teva Pharmaceuticals Usa and was approved on Jun 27, 2012. And the latest generic version is by Hetero Labs Ltd and was approved on Oct 31, 2022.

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


1. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 1 generic for Linezolid. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet Prescription ORAL AB Dec 21, 2015


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Vadodara Alembic Pharmaceuticals, Ltd
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited





2. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 1 generic for Linezolid. 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
600MG

tablet Prescription ORAL AB Dec 21, 2015





3. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 1 generic for Linezolid. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet Discontinued ORAL N/A Dec 21, 2015





4. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Linezolid. 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
600MG

tablet Prescription ORAL AB Apr 25, 2019





5. EUGIA PHARMA

Eugia Pharma Specialities Ltd has filed for 1 generic for Linezolid. 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
600MG/300ML (2MG/ML)

solution Prescription INTRAVENOUS AP Aug 4, 2016


Manufacturing Plant Locations
New

Eugia Pharma'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 Eugia Pharma as present at those locations.

Country City Firm Name
India
Pashamylaram Eugia Pharma Specialities Limited
Riico Industrial Area EUGIA Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited





6. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 1 generic for Linezolid. 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
600MG/300ML (2MG/ML)

solution Prescription INTRAVENOUS AP Mar 15, 2016


Manufacturing Plant Locations
New

Fresenius Kabi Usa'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 Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Grand Island Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Skokie Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA LLC
Lake Zurich Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
North Andover Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA, LLC





7. GATE PHARMS

Gate Pharmaceuticals has filed for 1 generic for Linezolid. Given below are the details of the strengths of this generic introduced by Gate Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet Discontinued ORAL N/A Feb 5, 2016





8. GLENMARK SPECLT

Glenmark Specialty Sa has filed for 1 generic for Linezolid. Given below are the details of the strengths of this generic introduced by Glenmark Speclt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet Prescription ORAL AB Dec 21, 2015





9. HETERO LABS

Hetero Labs Ltd has filed for 1 generic for Linezolid. Given below are the details of the strengths of this generic introduced by Hetero Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML

for suspension Prescription ORAL AB Oct 31, 2022


Manufacturing Plant Locations
New

Hetero 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 Hetero Labs as present at those locations.

Country City Firm Name
India
Mahaboob Nagar Hetero Labs Ltd. Unit VI
Mahabubnagar Hetero Labs Limited (Unit V)
Sanath Nagar Hetero Labs Ltd
Sangareddy Hetero Labs Limited
Hyderabad Hetero Labs Limited - Unit III
Bodugallam Hetero Labs Limited (Unit III)
Visakhapatnam Hetero Labs Ltd. - Unit IX





10. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 1 generic for Linezolid. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet Prescription ORAL AB Dec 21, 2015





11. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Linezolid. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG/5ML

for suspension Prescription ORAL AB Jun 3, 2015
600MG/300ML (2MG/ML)

solution Prescription INTRAVENOUS AP Aug 22, 2022


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





12. HOSPIRA

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG/300ML (2MG/ML)

solution Discontinued INTRAVENOUS N/A Jul 7, 2015


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Clayton Hospira, Inc.
Lake Forest Hospira Inc
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Mcpherson Hospira, Inc., A Pfizer Company
Morgan Hill Hospira Inc
Rocky Mount Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





13. HQ SPCLT PHARMA

Hq Specialty Pharma Corp has filed for 2 different strengths of generic version for Linezolid. Given below are the details of the strengths of this generic introduced by Hq Spclt Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG/100ML (2MG/ML)

solution Prescription INTRAVENOUS AP Jul 7, 2017
600MG/300ML (2MG/ML)

solution Prescription INTRAVENOUS AP Jul 7, 2017





14. MYLAN LABS LTD

Mylan Laboratories Ltd has filed for 2 different strengths of generic version for Linezolid. 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
600MG/300ML (2MG/ML)

solution Prescription INTRAVENOUS AP Dec 6, 2017
200MG/100ML (2MG/ML)

solution Prescription INTRAVENOUS AP Dec 6, 2017





15. NANG KUANG PHARM CO

Nang Kuang Pharmaceutical Co Ltd has filed for 2 different strengths of generic version for Linezolid. Given below are the details of the strengths of this generic introduced by Nang Kuang Pharm Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG/300ML (2MG/ML)

solution Prescription INTRAVENOUS AP Dec 20, 2016
200MG/100ML (2MG/ML)

solution Prescription INTRAVENOUS AP Dec 20, 2016





16. NOVEL LABS INC

Novel Laboratories Inc has filed for 1 generic for Linezolid. Given below are the details of the strengths of this generic introduced by Novel Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet Prescription ORAL AB Aug 22, 2016





17. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Linezolid. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet Prescription ORAL AB Dec 21, 2015


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Saddle Brook Rising Pharmaceuticals, Inc.
Mount Morris Rising Creek Bakery LLC
Livingston Risingsun Iodine Products Corp.
Decatur Rising Pharma Holdings, Inc
Fort Bragg Rising Tide Sea Vegetables
East Brunswick Rising Pharma Holding, Inc.
Rising Sun Rising Sun Veterinary Clinic
Phoenix Rising Sun Farms Inc
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





18. SAGENT PHARMS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG/300ML (2MG/ML)

solution Prescription INTRAVENOUS AP Mar 2, 2017
200MG/100ML (2MG/ML)

solution Prescription INTRAVENOUS AP Mar 2, 2017





19. SANDOZ

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG/300ML (2MG/ML)

solution Prescription INTRAVENOUS AP Jul 16, 2015
200MG/100ML (2MG/ML)

solution Prescription INTRAVENOUS AP Jul 16, 2015


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





20. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 1 generic for Linezolid. Given below are the details of the strengths of this generic introduced by Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG/300ML (2MG/ML)

solution Discontinued INTRAVENOUS N/A Jun 27, 2012





21. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 1 generic for Linezolid. 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
600MG

tablet Discontinued ORAL N/A May 18, 2015





22. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Linezolid. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
600MG

tablet Prescription ORAL AB Feb 22, 2017