Livalo is a drug owned by Kowa Co Ltd. It is protected by 9 US drug patents filed from 2013 to 2019 out of which all have expired. Livalo's patents have been open to challenges since 16 November, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 19, 2024. Details of Livalo'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). | |||
|
US7022713 (Pediatric) | Hyperlipemia therapeutic agent |
Aug, 2024
(4 months ago) |
Expired
|
|
US8557993 (Pediatric) | Crystalline forms of pitavastatin calcium |
Aug, 2024
(4 months ago) |
Expired
|
| US7022713 | Hyperlipemia therapeutic agent |
Feb, 2024
(10 months ago) |
Expired
|
| US8557993 | Crystalline forms of pitavastatin calcium |
Feb, 2024
(10 months ago) |
Expired
|
|
US5856336 (Pediatric) | Quinoline type mevalonolactones |
Jun, 2021
(3 years ago) |
Expired
|
| US5856336 | Quinoline type mevalonolactones |
Jan, 2021
(3 years ago) |
Expired
|
| US6465477 | Stable pharmaceutical composition |
Dec, 2016
(8 years ago) |
Expired
|
| US5854259 | Quinoline type mevalonolactones |
Dec, 2015
(8 years ago) |
Expired
|
| US5753675 | Quinoline analogs of mevalonolactone and derivatives thereof |
May, 2015
(9 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 Livalo's patents.
Latest Legal Activities on Livalo's Patents
Given below is the list of recent legal activities going on the following patents of Livalo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 31 Mar, 2021 | US8557993 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Sep, 2017 | US7022713 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Oct, 2013 | US8557993 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 15 Oct, 2013 | US8557993 (Litigated) |
| Email Notification Critical | 26 Sep, 2013 | US8557993 (Litigated) |
| Issue Notification Mailed Critical | 25 Sep, 2013 | US8557993 (Litigated) |
| Dispatch to FDC | 20 Sep, 2013 | US8557993 (Litigated) |
| Application Is Considered Ready for Issue Critical | 30 Aug, 2013 | US8557993 (Litigated) |
| Issue Fee Payment Verified Critical | 28 Aug, 2013 | US8557993 (Litigated) |
| Issue Fee Payment Received Critical | 28 Aug, 2013 | US8557993 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Livalo and ongoing litigations to help you estimate the early arrival of Livalo generic.
Livalo's Litigations
Livalo been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 18, 2015, against patent number US5856336. The petitioner Mylan Pharmaceuticals Inc., challenged the validity of this patent, with Nissan Chemical Industries, Ltd. as the respondent. Click below to track the latest information on how companies are challenging Livalo's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US5856336 | July, 2015 |
Terminated-Denied
(04 Feb, 2016) | Nissan Chemical Industries Ltd. | Sawai USA, Inc. |
| US5856336 | April, 2015 |
Terminated-Denied
(20 Oct, 2015) | Nissan Chemical Industries, Ltd. | Mylan Pharmaceuticals Inc. |
FDA has granted some exclusivities to Livalo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Livalo, 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 Livalo.
Exclusivity Information
Livalo holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Livalo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Aug 03, 2014 |
| New Patient Population(NPP) | May 16, 2022 |
| Pediatric Exclusivity(PED) | Nov 16, 2022 |
US patents provide insights into the exclusivity only within the United States, but Livalo 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 Livalo's family patents as well as insights into ongoing legal events on those patents.
Livalo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Livalo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 19, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Livalo Generic API suppliers:
Pitavastatin Calcium is the generic name for the brand Livalo. 8 different companies have already filed for the generic of Livalo, with Amneal Pharms Ny having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Livalo's generic
How can I launch a generic of Livalo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Livalo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Livalo'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 Livalo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg, 2 mg, and 4 mg | 05 Aug, 2013 | 7 | 20 Dec, 2016 | 19 Feb, 2024 | Eligible |
About Livalo
Livalo is a drug owned by Kowa Co Ltd. It is used for improving lipid profiles in patients with hyperlipidemia or mixed dyslipidemia. Livalo uses Pitavastatin Calcium as an active ingredient. Livalo was launched by Kowa Co in 2009.
Approval Date:
Livalo was approved by FDA for market use on 03 August, 2009.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Livalo is 03 August, 2009, its NCE-1 date is estimated to be 16 November, 2021.
Active Ingredient:
Livalo uses Pitavastatin Calcium as the active ingredient. Check out other Drugs and Companies using Pitavastatin Calcium ingredient
Treatment:
Livalo is used for improving lipid profiles in patients with hyperlipidemia or mixed dyslipidemia.
Dosage:
Livalo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 4MG BASE | TABLET | Prescription | ORAL |
| EQ 2MG BASE | TABLET | Prescription | ORAL |
| EQ 1MG BASE | TABLET | Prescription | ORAL |