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
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 |
US7612058 (Pediatric) | Methods for inhibiting sterol absorption | Apr 30, 2026 | Organon |
| Zetia | US7612058 | Methods for inhibiting sterol absorption | Oct 30, 2025 | Organon |
| Zetia |
US7030106 (Pediatric) | Sterol absorption inhibitor compositions |
Jul 25, 2022
(Expired) | Organon |
| Zetia | US7030106 | Sterol absorption inhibitor compositions |
Jan 25, 2022
(Expired) | Organon |
| Zetia |
USRE37721 (Pediatric) | Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents |
Apr 25, 2017
(Expired) | Organon |
| Zetia |
USRE42461 (Pediatric) | Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents |
Apr 25, 2017
(Expired) | Organon |
| Zetia | USRE37721 | Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents |
Oct 25, 2016
(Expired) | Organon |
| Zetia | USRE42461 | Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents |
Oct 25, 2016
(Expired) | Organon |
| Zetia |
US5846966 (Pediatric) | Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors |
Mar 21, 2014
(Expired) | Organon |
| Zetia | US5846966 | Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors |
Sep 21, 2013
(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.
Latest Legal Activities on Ezetimibe's Patents
Given below is the list recent legal activities going on the following patents of Ezetimibe.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change Critical | 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 Critical | 21 Oct, 2013 | US7612058 |
| Correspondence Address Change Critical | 26 Aug, 2011 | US7030106 |
| Appellant's Complaint | 30 Apr, 2010 | US7612058 |
| Petition Entered | 22 Dec, 2009 | US7612058 |
Ezetimibe's Family Patents
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Ezetimibe Generic API Manufacturers
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, along with the locations of their manufacturing plants worldwide.
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. 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 |
3. 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 |
4. 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 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
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| United States |
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| Canada |
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| India |
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5. 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 |
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 |
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| United States |
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6. 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 |
7. 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 |
8. 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 |
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. 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 |
Manufacturing Plant Locations New
Orient Pharma's manufacturing plants are situated in 1 country - Taiwan. Given below are the details of these plant locations as well as the firm names of Orient Pharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| Taiwan |
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11. 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 |
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 |
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| Mexico |
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| India |
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12. 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 |
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 |
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| United States |
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| Spain |
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| India |
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13. 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 |
14. 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 |
15. 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 |
16. 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 |