Liptruzet is a drug owned by Organon Llc A Sub Of Organon And Co. It is protected by 8 US drug patents filed from 2013 to 2014 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 Liptruzet's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US5969156 | Crystalline [R- (R*,R*)]-2-(4-Dfluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin) |
Jul, 2016
(8 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
USRE42461 (Pediatric) | Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents |
Apr, 2017
(7 years ago) |
Expired
|
|
US5969156 (Pediatric) | Crystalline [R- (R*,R*)]-2-(4-Dfluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)- 3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin) |
Jan, 2017
(7 years ago) |
Expired
|
| USRE42461 | Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents |
Oct, 2016
(8 years ago) |
Expired
|
|
US5686104 (Pediatric) | Stable oral CI-981 formulation and process of preparing same |
May, 2015
(9 years ago) |
Expired
|
| US5686104 | Stable oral CI-981 formulation and process of preparing same |
Nov, 2014
(10 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 Liptruzet. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Liptruzet, 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 Liptruzet.
Exclusivity Information
Liptruzet holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Liptruzet's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | May 03, 2016 |
US patents provide insights into the exclusivity only within the United States, but Liptruzet 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 Liptruzet's family patents as well as insights into ongoing legal events on those patents.
Liptruzet's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Liptruzet'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)
Liptruzet Generic API suppliers:
Atorvastatin Calcium; Ezetimibe is the generic name for the brand Liptruzet. 1 company has already filed for the generic of Liptruzet. Check out the entire list of companies who have already received approval for Liptruzet's generic
About Liptruzet
Liptruzet is a drug owned by Organon Llc A Sub Of Organon And Co. It is used for lowering cholesterol levels in individuals with primary hyperlipidemia, mixed hyperlipidemia, or homozygous familial hypercholesterolemia. Liptruzet uses Atorvastatin Calcium; Ezetimibe as an active ingredient. Liptruzet was launched by Organon in 2013.
Approval Date:
Liptruzet was approved by FDA for market use on 03 May, 2013.
Active Ingredient:
Liptruzet uses Atorvastatin Calcium; Ezetimibe as the active ingredient. Check out other Drugs and Companies using Atorvastatin Calcium; Ezetimibe ingredient
Treatment:
Liptruzet is used for lowering cholesterol levels in individuals with primary hyperlipidemia, mixed hyperlipidemia, or homozygous familial hypercholesterolemia.
Dosage:
Liptruzet is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |