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
(7 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
(8 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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 |
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| Abbvie |
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| Adhera |
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| Allergan |
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| Ani Pharms |
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| Azurity |
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| Boehringer Ingelheim |
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| Cosette |
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| Noden Pharma |
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| Novartis |
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| Upjohn |
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| Waylis Therap |
| |||||||||||||
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 |
| |
| Novartis |
| |
| Novartis Pharms Corp |
|
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 - tablet form for oral use, capsule 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 |