Exforge Hct is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 6 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 Nov 16, 2023. Details of Exforge 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). | |||
|
US8475839 (Pediatric) | Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same |
Nov, 2023
(1 year, 5 months ago) |
Expired
|
| US8101599 | Pharmaceutical composition containing anti-hypertensive agents |
May, 2023
(1 year, 11 months ago) |
Expired
|
| US8475839 | Solid dosage forms of valsartan, amlodipine and hydrochlorothiazide and method of making the same |
May, 2023
(1 year, 11 months ago) |
Expired
|
|
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
|
|
US5399578 (Pediatric) | Acyl compounds |
Sep, 2012
(12 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 Exforge Hct's patents.
Latest Legal Activities on Exforge Hct's Patents
Given below is the list of recent legal activities going on the following patents of Exforge Hct.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 26 Feb, 2024 | US8101599 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 11 Sep, 2023 | US8101599 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Dec, 2020 | US8475839 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 11 Jul, 2019 | US8101599 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 02 Jul, 2013 | US8475839 |
| Recordation of Patent Grant Mailed Critical | 02 Jul, 2013 | US8475839 |
| Email Notification Critical | 13 Jun, 2013 | US8475839 |
| Issue Notification Mailed Critical | 12 Jun, 2013 | US8475839 |
| Dispatch to FDC | 06 Jun, 2013 | US8475839 |
| Issue Fee Payment Received Critical | 05 Jun, 2013 | US8475839 |
FDA has granted several exclusivities to Exforge Hct. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Exforge 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 Exforge Hct.
Exclusivity Information
Exforge Hct holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Exforge Hct's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Apr 30, 2012 |
Several oppositions have been filed on Exforge Hct's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Exforge Hct's generic, the next section provides detailed information on ongoing and past EP oppositions related to Exforge Hct patents.
Exforge Hct's Oppositions Filed in EPO
Exforge Hct has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 20, 2010, by Lupin Limited. This opposition was filed on patent number EP03732397A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP03732397A | Jan, 2010 | Teva Pharmaceutical Industries Ltd. | Revoked |
| EP03732397A | Jan, 2010 | Sanovel Ilac Sanayii ve Ticaret A.S. | Revoked |
| EP03732397A | Jan, 2010 | KRKA, d.d., Novo mesto | Revoked |
| EP03732397A | Jan, 2010 | Lupin Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but Exforge 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 Exforge Hct's family patents as well as insights into ongoing legal events on those patents.
Exforge Hct's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Exforge Hct's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 16, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Exforge Hct Generic API suppliers:
Amlodipine Besylate; Hydrochlorothiazide; Valsartan is the generic name for the brand Exforge Hct. 6 different companies have already filed for the generic of Exforge Hct, with Aurobindo Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Exforge Hct's generic
How can I launch a generic of Exforge Hct before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Exforge Hct's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Exforge 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 Exforge Hct -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/12.5 mg/160 mg, 5 mg/25 mg/160 mg, 10 mg/25 mg/160 mg and 10 mg/25 mg/320 mg | 14 Sep, 2009 | 1 | 25 Sep, 2012 | 18 Jul, 2017 | Eligible |
| 10 mg/12.5 mg/ 160 mg | 22 Oct, 2009 | 1 | 25 Sep, 2012 | 18 Jul, 2017 | Eligible |
Alternative Brands for Exforge Hct
Exforge Hct which is used for treating high blood pressure., 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.
| 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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About Exforge Hct
Exforge Hct is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating high blood pressure. Exforge Hct uses Amlodipine Besylate; Hydrochlorothiazide; Valsartan as an active ingredient. Exforge Hct was launched by Novartis in 2009.
Approval Date:
Exforge Hct was approved by FDA for market use on 30 April, 2009.
Active Ingredient:
Exforge Hct uses Amlodipine Besylate; Hydrochlorothiazide; Valsartan as the active ingredient. Check out other Drugs and Companies using Amlodipine Besylate; Hydrochlorothiazide; Valsartan ingredient
Treatment:
Exforge Hct is used for treating high blood pressure.
Dosage:
Exforge Hct is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE;12.5MG;160MG | TABLET | Prescription | ORAL |
| EQ 5MG BASE;12.5MG;160MG | TABLET | Prescription | ORAL |
| EQ 5MG BASE;25MG;160MG | TABLET | Prescription | ORAL |
| EQ 10MG BASE;25MG;320MG | TABLET | Prescription | ORAL |
| EQ 10MG BASE;25MG;160MG | TABLET | Prescription | ORAL |