Lotrel is a drug owned by Sandoz Inc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 19, 2017. Details of Lotrel'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). | |||
| US6162802 | Synergistic combination therapy using benazepril and amlodipine for the treatment of cardiovascular disorders and compositions therefor |
Dec, 2017
(6 years ago) |
Expired
|
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 Lotrel and ongoing litigations to help you estimate the early arrival of Lotrel generic.
Lotrel's Litigations
Lotrel been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 14, 1994, against patent number US6162802. The petitioner , challenged the validity of this patent, with PAPA et al as the respondent. Click below to track the latest information on how companies are challenging Lotrel's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6162802 | April, 1994 |
Decision
(04 Jul, 1776) | PAPA et al | |
US patents provide insights into the exclusivity only within the United States, but Lotrel 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 Lotrel's family patents as well as insights into ongoing legal events on those patents.
Lotrel's Family Patents
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Generic Launch
Generic Release Date:
Lotrel's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 19, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Lotrel Generic API suppliers:
Amlodipine Besylate; Benazepril Hydrochloride is the generic name for the brand Lotrel. 10 different companies have already filed for the generic of Lotrel, with Teva Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Lotrel's generic
How can I launch a generic of Lotrel before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Lotrel's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Lotrel'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 Lotrel -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg/10 mg 5 mg/10 mg 5 mg/20 mg 10 mg/20 mg | 09 Jun, 2004 | 1 | 18 Mar, 2007 | 19 Dec, 2017 | Eligible |
| 5 mg/40 mg and 10 mg/40 mg | 17 Nov, 2006 | 1 | 29 Jul, 2010 | 19 Dec, 2017 | Eligible |
Alternative Brands for Lotrel
Lotrel which is used for managing high blood pressure and cardiovascular conditions., 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.
About Lotrel
Lotrel is a drug owned by Sandoz Inc. It is used for managing high blood pressure and cardiovascular conditions. Lotrel uses Amlodipine Besylate; Benazepril Hydrochloride as an active ingredient. Lotrel was launched by Sandoz in 1995.
Approval Date:
Lotrel was approved by FDA for market use on 03 March, 1995.
Active Ingredient:
Lotrel uses Amlodipine Besylate; Benazepril Hydrochloride as the active ingredient. Check out other Drugs and Companies using Amlodipine Besylate; Benazepril Hydrochloride ingredient
Treatment:
Lotrel is used for managing high blood pressure and cardiovascular conditions.
Dosage:
Lotrel is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2.5MG BASE;10MG | CAPSULE | Prescription | ORAL |
| EQ 5MG BASE;10MG | CAPSULE | Prescription | ORAL |
| EQ 5MG BASE;20MG | CAPSULE | Prescription | ORAL |
| EQ 10MG BASE;20MG | CAPSULE | Prescription | ORAL |
| EQ 10MG BASE;40MG | CAPSULE | Prescription | ORAL |
| EQ 5MG BASE;40MG | CAPSULE | Prescription | ORAL |