Zetia is a drug owned by Organon Llc A Sub Of Organon And Co. It is protected by 10 US drug patents filed in 2013. Out of these, 2 drug patents are active and 8 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 30, 2026. Details of Zetia's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US7612058 (Pediatric) | Methods for inhibiting sterol absorption |
Apr, 2026
(1 year, 5 months from now) | Active |
| US7612058 | Methods for inhibiting sterol absorption |
Oct, 2025
(11 months from now) | Active |
|
US7030106 (Pediatric) | Sterol absorption inhibitor compositions |
Jul, 2022
(2 years ago) |
Expired
|
| US7030106 | Sterol absorption inhibitor compositions |
Jan, 2022
(2 years ago) |
Expired
|
|
USRE37721 (Pediatric) | Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents |
Apr, 2017
(7 years ago) |
Expired
|
|
USRE42461 (Pediatric) | Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents |
Apr, 2017
(7 years ago) |
Expired
|
| USRE37721 | Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents |
Oct, 2016
(8 years ago) |
Expired
|
| USRE42461 | Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents |
Oct, 2016
(8 years ago) |
Expired
|
|
US5846966 (Pediatric) | Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors |
Mar, 2014
(10 years ago) |
Expired
|
| US5846966 | Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors |
Sep, 2013
(11 years ago) |
Expired
|
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 Zetia's patents.
Latest Legal Activities on Zetia's Patents
Given below is the list of recent legal activities going on the following patents of Zetia.
| 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 |
FDA has granted several exclusivities to Zetia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zetia, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zetia.
Exclusivity Information
Zetia holds 2 exclusivities. All of its exclusivities have expired in 2015. Details of Zetia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Pediatric Exclusivity(PED) | Dec 05, 2011 |
| M(M-109) | Jan 24, 2015 |
Several oppositions have been filed on Zetia's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Zetia's generic, the next section provides detailed information on ongoing and past EP oppositions related to Zetia patents.
Zetia's Oppositions Filed in EPO
Zetia has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 22, 2008, by Egis Gyógyszergyár Nyrt. This opposition was filed on patent number EP02707500A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP02770534A | Jul, 2009 | TEVA PHARMACEUTICAL INDUSTRIES LTD. | Opposition procedure closed |
| EP02707500A | Feb, 2008 | EGIS Gyógyszergyár Nyrt | Revoked |
US patents provide insights into the exclusivity only within the United States, but Zetia is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Zetia's family patents as well as insights into ongoing legal events on those patents.
Zetia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zetia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 30, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zetia Generic API suppliers:
Ezetimibe is the generic name for the brand Zetia. 16 different companies have already filed for the generic of Zetia, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zetia's generic
How can I launch a generic of Zetia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zetia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zetia's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Zetia -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg | 25 Oct, 2006 | 1 | 26 Jun, 2015 | 25 Jan, 2022 | Eligible |
Alternative Brands for Zetia
Zetia which is used for lowering cholesterol levels in patients with primary hyperlipidemia., has several other brand drugs in the same treatment category and using the same active ingredient (Ezetimibe). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Organon |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Ezetimibe. Given below is the list of those drugs and companies owning them.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Ezetimibe, Zetia's active ingredient. Check the complete list of approved generic manufacturers for Zetia
About Zetia
Zetia is a drug owned by Organon Llc A Sub Of Organon And Co. It is used for lowering cholesterol levels in patients with primary hyperlipidemia. Zetia uses Ezetimibe as an active ingredient. Zetia was launched by Organon in 2002.
Approval Date:
Zetia was approved by FDA for market use on 25 October, 2002.
Active Ingredient:
Zetia uses Ezetimibe as the active ingredient. Check out other Drugs and Companies using Ezetimibe ingredient
Treatment:
Zetia is used for lowering cholesterol levels in patients with primary hyperlipidemia.
Dosage:
Zetia is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET | Prescription | ORAL |