Benicar Patent Expiration

Benicar is a drug owned by Cosette Pharmaceuticals Inc. It is protected by 4 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 May 19, 2022. Details of Benicar'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).
US6878703

(Pediatric)

Pharmaceutical composition
May, 2022

(2 years ago)

Expired
US6878703 Pharmaceutical composition
Nov, 2021

(2 years ago)

Expired
US5616599

(Pediatric)

Angiotensin II antagosist 1-biphenylmethylimidazole compounds and their therapeutic use
Oct, 2016

(7 years ago)

Expired
US5616599 Angiotensin II antagosist 1-biphenylmethylimidazole compounds and their therapeutic use
Apr, 2016

(8 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 Benicar's patents.

Given below is the list of recent legal activities going on the following patents of Benicar.

Activity Date Patent Number
Patent litigations
Expire Patent 11 May, 2009 US6878703 (Litigated)
Correspondence Address Change 25 Apr, 2005 US6878703 (Litigated)
Patent Issue Date Used in PTA Calculation 12 Apr, 2005 US6878703 (Litigated)
Recordation of Patent Grant Mailed 12 Apr, 2005 US6878703 (Litigated)
Issue Notification Mailed 23 Mar, 2005 US6878703 (Litigated)
Receipt into Pubs 14 Mar, 2005 US6878703 (Litigated)
Dispatch to FDC 11 Mar, 2005 US6878703 (Litigated)
Application Is Considered Ready for Issue 11 Mar, 2005 US6878703 (Litigated)
Issue Fee Payment Received 01 Mar, 2005 US6878703 (Litigated)
Issue Fee Payment Verified 01 Mar, 2005 US6878703 (Litigated)


FDA has granted several exclusivities to Benicar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Benicar, 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 Benicar.

Exclusivity Information

Benicar holds 2 exclusivities. All of its exclusivities have expired in 2013. Details of Benicar's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Feb 04, 2013
Pediatric Exclusivity(PED) Aug 04, 2013

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US patents provide insights into the exclusivity only within the United States, but Benicar 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 Benicar's family patents as well as insights into ongoing legal events on those patents.

Benicar's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Benicar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 19, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Benicar Generics:

Olmesartan Medoxomil is the generic name for the brand Benicar. 23 different companies have already filed for the generic of Benicar, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Benicar's generic

How can I launch a generic of Benicar before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Benicar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Benicar'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 Benicar -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
5 mg, 20 mg and 40 mg 25 Apr, 2006 1 26 Oct, 2016 19 Nov, 2021 Eligible

Alternative Brands for Benicar

Benicar which is used for lowering high blood pressure., has several other brand drugs in the same treatment category and using the same active ingredient (Olmesartan Medoxomil). 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
Abbott
Hytrin Used for treating hypertension and symptomatic benign prostatic hyperplasia.
Abbvie
Teveten Used for managing high blood pressure.
Teveten Hct Used for managing high blood pressure.
Adhera
Prestalia Used for treating high blood pressure.
Allergan
Bystolic Used for treating high blood pressure.
Ani Pharms
Atacand Hct Used for treating high blood pressure.
Azurity
Edarbi Used for lowering blood pressure.
Epaned Used for managing heart failure and hypertension.
Edarbyclor Used for managing high blood pressure.
Boehringer Ingelheim
Twynsta Used for managing high blood pressure.
Micardis Used for the treatment of cardiovascular conditions such as myocardial infarction, hypertension, and stroke.
Micardis Hct Used for lowering high blood pressure.
Cosette
Azor

(uses Olmesartan Medoxomil)

Used for managing high blood pressure.
Tribenzor

(uses Olmesartan Medoxomil)

Used for lowering high blood pressure.
Benicar Hct

(uses Olmesartan Medoxomil)

Used for managing high blood pressure.
Noden Pharma
Tekturna Used for treating high blood pressure.
Tekturna Hct Used for lowering high blood pressure.
Novartis
Diovan Used for managing hypertension and reducing cardiovascular mortality in stable patients with left ventricular failure or dysfunction post-myocardial infarction.
Exforge Used for treating high blood pressure.
Tekamlo Used for treating high blood pressure.
Valturna Used for managing high blood pressure.
Amturnide Used for lowering high blood pressure (hypertension).
Diovan Hct Used for treating high blood pressure.
Exforge Hct Used for treating high blood pressure.
Upjohn
Inspra Used for treating hypertension, heart failure, and conditions related to hyperaldosteronism, often in combination with an ACE inhibitor.
Waylis Therap
Coreg Cr Used for managing congestive heart failure and hypertension to reduce mortality.

Apart from brand drugs containing the same ingredient, some generics have also been filed for Olmesartan Medoxomil, Benicar's active ingredient. Check the complete list of approved generic manufacturers for Benicar





About Benicar

Benicar is a drug owned by Cosette Pharmaceuticals Inc. It is used for lowering high blood pressure. Benicar uses Olmesartan Medoxomil as an active ingredient. Benicar was launched by Cosette in 2002.

Approval Date:

Benicar was approved by FDA for market use on 25 April, 2002.

Active Ingredient:

Benicar uses Olmesartan Medoxomil as the active ingredient. Check out other Drugs and Companies using Olmesartan Medoxomil ingredient

Treatment:

Benicar is used for lowering high blood pressure.

Dosage:

Benicar is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
20MG TABLET Prescription ORAL
40MG TABLET Prescription ORAL
5MG TABLET Prescription ORAL