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
(Expired) | Organon |
| Zetia | US7612058 | Methods for inhibiting sterol absorption |
Oct 30, 2025
(Expired) | 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 |
|---|---|---|
 | ||
| Court Processing Terminated | 13 Sep, 2024 | US7612058 |
| 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 |
| Adjustment of PTA Calculation by PTO | 21 Oct, 2013 | US7612058 |
| Petition Decision - Granted Critical
| 21 Oct, 2013 | US7612058 |
| Mail-Petition Decision - Granted | 21 Oct, 2013 | US7612058 |
| Correspondence Address Change Critical
| 26 Aug, 2011 | US7030106 |
| Decision in Civil Action - Remanded | 09 Sep, 2010 | US7612058 |
Ezetimibe's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Ezetimibe:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome | NewAmsterdam Pharma | NA |
ACTIVE NOT RECRUITING
(Sep 1, 2026)
| PHASE3 |
| A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults | AstraZeneca | NA |
ACTIVE NOT RECRUITING
(Jul 1, 2026)
| PHASE1 |
| Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol | Celltrion Pharm, Inc. | NA |
COMPLETED
(May 1, 2026)
| PHASE3 |
| A CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque | NewAmsterdam Pharma | NA |
ACTIVE NOT RECRUITING
(Apr 1, 2026)
| PHASE3 |