Vytorin is a drug owned by Organon Llc A Sub Of Organon And Co. It is protected by 6 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 25, 2017. Details of Vytorin'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). | |||
|
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
|
FDA has granted several exclusivities to Vytorin. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vytorin, 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 Vytorin.
Exclusivity Information
Vytorin holds 2 exclusivities. All of its exclusivities have expired in 2015. Details of Vytorin'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 |
US patents provide insights into the exclusivity only within the United States, but Vytorin 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 Vytorin's family patents as well as insights into ongoing legal events on those patents.
Vytorin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vytorin's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 25, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vytorin Generic API suppliers:
Ezetimibe; Simvastatin is the generic name for the brand Vytorin. 8 different companies have already filed for the generic of Vytorin, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vytorin's generic
How can I launch a generic of Vytorin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vytorin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vytorin'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 Vytorin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/10 mg 10 mg/20 mg 10 mg/40 mg 10 mg/80 mg | 27 Jul, 2009 | 1 | 25 Oct, 2016 | Extinguished |
Alternative Brands for Vytorin
Vytorin which is used for treating high cholesterol levels in mammals, including primary hypercholesterolemia, mixed hyperlipidemia, and homozygous familial hypercholesterolemia (HoFH)., has several other brand drugs in the same treatment category . 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 |
| |||
About Vytorin
Vytorin is a drug owned by Organon Llc A Sub Of Organon And Co. It is used for treating high cholesterol levels in mammals, including primary hypercholesterolemia, mixed hyperlipidemia, and homozygous familial hypercholesterolemia (HoFH). Vytorin uses Ezetimibe; Simvastatin as an active ingredient. Vytorin was launched by Organon in 2004.
Approval Date:
Vytorin was approved by FDA for market use on 23 July, 2004.
Active Ingredient:
Vytorin uses Ezetimibe; Simvastatin as the active ingredient. Check out other Drugs and Companies using Ezetimibe; Simvastatin ingredient
Treatment:
Vytorin is used for treating high cholesterol levels in mammals, including primary hypercholesterolemia, mixed hyperlipidemia, and homozygous familial hypercholesterolemia (HoFH).
Dosage:
Vytorin is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG;40MG | TABLET | Prescription | ORAL |
| 10MG;20MG | TABLET | Prescription | ORAL |
| 10MG;10MG | TABLET | Prescription | ORAL |
| 10MG;80MG | TABLET | Prescription | ORAL |