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
(9 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
(8 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
(9 years ago) |
Expired
|
| USRE42461 | Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents |
Oct, 2016
(9 years ago) |
Expired
|
|
US5686104 (Pediatric) | Stable oral CI-981 formulation and process of preparing same |
May, 2015
(10 years ago) |
Expired
|
| US5686104 | Stable oral CI-981 formulation and process of preparing same |
Nov, 2014
(11 years ago) |
Expired
|
|
US5846966 (Pediatric) | Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors |
Mar, 2014
(11 years ago) |
Expired
|
| US5846966 | Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors |
Sep, 2013
(12 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 Liptruzet's patents.
Latest Legal Activities on Liptruzet's Patents
Given below is the list of recent legal activities going on the following patents of Liptruzet.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change | 08 Nov, 2017 | USRE42461 |
| Recordation of Patent Grant Mailed | 14 Jun, 2011 | USRE42461 |
| Email Notification | 26 May, 2011 | USRE42461 |
| Issue Notification Mailed | 25 May, 2011 | USRE42461 |
| Dispatch to FDC | 13 May, 2011 | USRE42461 |
| Application Is Considered Ready for Issue | 24 Jan, 2011 | USRE42461 |
| Email Notification | 20 Jan, 2011 | USRE42461 |
| Electronic Review | 20 Jan, 2011 | USRE42461 |
| Mail Notice of Allowance | 20 Jan, 2011 | USRE42461 |
| Issue Fee Payment Received | 20 Jan, 2011 | USRE42461 |
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 |