Diovan Hct is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 3 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 Dec 18, 2017. Details of Diovan Hct'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
|
|
US5399578 (Pediatric) | Acyl compounds |
Sep, 2012
(12 years ago) |
Expired
|
FDA has granted several exclusivities to Diovan Hct. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Diovan Hct, 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 Hct.
Exclusivity Information
Diovan Hct holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Diovan Hct's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-567) | Jul 31, 2011 |
US patents provide insights into the exclusivity only within the United States, but Diovan Hct 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 Hct's family patents as well as insights into ongoing legal events on those patents.
Diovan Hct's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Diovan Hct's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 18, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Diovan Hct Generic API suppliers:
Hydrochlorothiazide; Valsartan is the generic name for the brand Diovan Hct. 10 different companies have already filed for the generic of Diovan Hct, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Diovan Hct's generic
How can I launch a generic of Diovan Hct before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Diovan Hct's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Diovan Hct'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 Hct -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 80 mg/12.5 mg 160 mg/12.5 mg 160 mg/25 mg | 02 Dec, 2005 | 1 | 21 Sep, 2012 | 18 Jun, 2017 | Eligible |
| 320 mg/12.5 mg and 320 mg/25 mg | 07 Feb, 2007 | 1 | 21 Sep, 2012 | 18 Jun, 2017 | Eligible |
Alternative Brands for Diovan Hct
Diovan Hct which is used for treating high blood pressure., has several other brand drugs in the same treatment category and using the same active ingredient (Hydrochlorothiazide; 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 |
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Apart from brand drugs containing the same ingredient, some generics have also been filed for Hydrochlorothiazide; Valsartan, Diovan Hct's active ingredient. Check the complete list of approved generic manufacturers for Diovan Hct
About Diovan Hct
Diovan Hct is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating high blood pressure. Diovan Hct uses Hydrochlorothiazide; Valsartan as an active ingredient. Diovan Hct was launched by Novartis in 1998.
Approval Date:
Diovan Hct was approved by FDA for market use on 06 March, 1998.
Active Ingredient:
Diovan Hct uses Hydrochlorothiazide; Valsartan as the active ingredient. Check out other Drugs and Companies using Hydrochlorothiazide; Valsartan ingredient
Treatment:
Diovan Hct is used for treating high blood pressure.
Dosage:
Diovan Hct is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12.5MG;320MG | TABLET | Prescription | ORAL |
| 25MG;320MG | TABLET | Prescription | ORAL |
| 25MG;160MG | TABLET | Prescription | ORAL |
| 12.5MG;80MG | TABLET | Prescription | ORAL |
| 12.5MG;160MG | TABLET | Prescription | ORAL |