Diovan Patent Expiration

Diovan is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 5 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 Apr 19, 2024. Details of Diovan'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).
US6294197

(Pediatric)

Solid oral dosage forms of valsartan
Dec, 2017

(6 years ago)

Expired
US6294197 Solid oral dosage forms of valsartan
Jun, 2017

(7 years ago)

Expired
US5972990

(Pediatric)

Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims
Apr, 2017

(7 years ago)

Expired
US5972990 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims
Oct, 2016

(7 years ago)

Expired
US5399578

(Pediatric)

Acyl compounds
Sep, 2012

(12 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 Diovan and ongoing litigations to help you estimate the early arrival of Diovan generic.

Diovan's Litigations

Diovan been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 01, 1, against patent number US5972990. The petitioner , challenged the validity of this patent, with PFEFFER et al as the respondent. Click below to track the latest information on how companies are challenging Diovan's patents.

Last updated on October 1, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US5972990 January, 1 Decision
(12 Feb, 1999)
PFEFFER et al


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

Exclusivity Information

Diovan holds 1 exclusivities. All of its exclusivities have expired in 2024. Details of Diovan's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Apr 19, 2024

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

Diovan's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Diovan's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 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)

Diovan Generics:

Valsartan is the generic name for the brand Diovan. 21 different companies have already filed for the generic of Diovan, with Zydus Lifesciences having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Diovan's generic

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

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

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
40 mg, 80 mg, 160 mg and 320 mg 28 Dec, 2004 1 26 Jun, 2014 18 Jun, 2017 Non-Forfeiture

Alternative Brands for Diovan

Diovan which is used for managing hypertension and reducing cardiovascular mortality in stable patients with left ventricular failure or dysfunction post-myocardial infarction., has several other brand drugs in the same treatment category and using the same active ingredient (Valsartan). 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 Used for managing high blood pressure.
Benicar Used for lowering high blood pressure.
Tribenzor Used for lowering high blood pressure.
Benicar Hct Used for managing high blood pressure.
Noden Pharma
Tekturna Used for treating high blood pressure.
Tekturna Hct Used for lowering high blood pressure.
Novartis
Exforge

(uses Valsartan)

Used for treating high blood pressure.
Tekamlo Used for treating high blood pressure.
Valturna

(uses Valsartan)

Used for managing high blood pressure.
Amturnide Used for lowering high blood pressure (hypertension).
Diovan Hct

(uses Valsartan)

Used for treating high blood pressure.
Exforge Hct

(uses Valsartan)

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 drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Valsartan. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Abbvie
Byvalson
Novartis
Entresto Sprinkle
Novartis Pharms Corp
Entresto


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





About Diovan

Diovan is a drug owned by Novartis Pharmaceuticals Corp. It is used for managing hypertension and reducing cardiovascular mortality in stable patients with left ventricular failure or dysfunction post-myocardial infarction. Diovan uses Valsartan as an active ingredient. Diovan was launched by Novartis in 2002.

Approval Date:

Diovan was approved by FDA for market use on 14 August, 2002.

Active Ingredient:

Diovan uses Valsartan as the active ingredient. Check out other Drugs and Companies using Valsartan ingredient

Treatment:

Diovan is used for managing hypertension and reducing cardiovascular mortality in stable patients with left ventricular failure or dysfunction post-myocardial infarction.

Dosage:

Diovan is available in the following dosage forms - capsule form for oral use, tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
40MG TABLET Prescription ORAL
160MG CAPSULE Discontinued ORAL
320MG TABLET Prescription ORAL
80MG TABLET Prescription ORAL