Ezetimibe Patent Expiration

Ezetimibe is Used for lowering cholesterol levels in patients with primary hyperlipidemia. It was first introduced by Organon Llc A Sub Of Organon And Co in its drug Zetia on Oct 25, 2002. 17 different companies have introduced drugs containing Ezetimibe.


Ezetimibe Patents

Given below is the list of patents protecting Ezetimibe, 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
Zetia US5846966 Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors Sep 21, 2013

(Expired)

Organon
Zetia US5846966

(Pediatric)

Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors Mar 21, 2014

(Expired)

Organon
Zetia US7030106 Sterol absorption inhibitor compositions Jan 25, 2022

(Expired)

Organon
Zetia US7030106

(Pediatric)

Sterol absorption inhibitor compositions Jul 25, 2022

(Expired)

Organon
Zetia US7612058 Methods for inhibiting sterol absorption Oct 30, 2025 Organon
Zetia US7612058

(Pediatric)

Methods for inhibiting sterol absorption Apr 30, 2026 Organon
Zetia USRE37721 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents Oct 25, 2016

(Expired)

Organon
Zetia USRE37721

(Pediatric)

Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents Apr 25, 2017

(Expired)

Organon
Zetia USRE42461 Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents Oct 25, 2016

(Expired)

Organon
Zetia USRE42461

(Pediatric)

Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents Apr 25, 2017

(Expired)

Organon


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 Ezetimibe's patents.

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

Event Date Patent/Publication
Patent litigations
Correspondence Address Change 10 Aug, 2021 US7030106
Payment of Maintenance Fee, 12th Year, Large Entity 15 Apr, 2021 US7612058
Payment of Maintenance Fee, 12th Year, Large Entity 14 Sep, 2017 US7030106
Post Issue Communication - Certificate of Correction 08 Jan, 2014 US7612058
Mail-Petition Decision - Granted 21 Oct, 2013 US7612058
Adjustment of PTA Calculation by PTO 21 Oct, 2013 US7612058
Petition Decision - Granted 21 Oct, 2013 US7612058
Correspondence Address Change 26 Aug, 2011 US7030106
Appellant's Complaint 30 Apr, 2010 US7612058
Petition Entered 22 Dec, 2009 US7612058



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Ezetimibe Generics

Several generic applications have been filed for Ezetimibe. The first generic version for Ezetimibe was by Glenmark Pharmaceuticals Ltd and was approved on Jun 26, 2015. And the latest generic version is by Macleods Pharmaceuticals Ltd and was approved on Apr 29, 2024.

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


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 1 generic for Ezetimibe. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Oct 26, 2018


2. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 1 generic for Ezetimibe. 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
10MG tablet Discontinued ORAL N/A Jun 12, 2017


3. RISING

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Discontinued ORAL N/A Apr 26, 2019


4. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 1 generic for Ezetimibe. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Apr 29, 2024


5. SANDOZ

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Jun 12, 2017


6. HETERO LABS LTD III

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Jul 26, 2022


7. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 1 generic for Ezetimibe. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Oct 23, 2020


8. ORIENT PHARMA

Orient Pharma Co Ltd has filed for 1 generic for Ezetimibe. Given below are the details of the strengths of this generic introduced by Orient Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Sep 13, 2022


9. OHM LABS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Jun 12, 2017


10. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Ezetimibe. 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
10MG tablet Prescription ORAL AB Aug 25, 2017


11. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 1 generic for Ezetimibe. 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
10MG tablet Prescription ORAL AB Dec 21, 2017


12. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Ezetimibe. 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
10MG tablet Prescription ORAL AB Jun 12, 2017


13. APOTEX

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Discontinued ORAL N/A Jun 12, 2017


14. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 1 generic for Ezetimibe. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Jun 26, 2015


15. AMNEAL PHARMS CO

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Jun 12, 2017


16. WATSON LABS INC

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG tablet Prescription ORAL AB Jun 12, 2017