Exforge is a drug owned by Novartis Pharmaceuticals Corp. 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 Jul 08, 2019. Details of Exforge'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). | |||
| US6395728 | Method of treatment and pharmaceutical composition |
Jul, 2019
(5 years ago) |
Expired
|
|
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
|
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's patents.
Latest Legal Activities on Exforge's Patents
Given below is the list of recent legal activities going on the following patents of Exforge.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| File Marked Found | 20 Dec, 2016 | US6395728 |
| File Marked Found | 25 May, 2007 | US6395728 |
| Patent Issue Date Used in PTA Calculation Critical | 28 May, 2002 | US6395728 |
| Recordation of Patent Grant Mailed Critical | 28 May, 2002 | US6395728 |
| Issue Notification Mailed Critical | 10 May, 2002 | US6395728 |
| Receipt into Pubs | 02 May, 2002 | US6395728 |
| Application Is Considered Ready for Issue Critical | 24 Apr, 2002 | US6395728 |
| Issue Fee Payment Received Critical | 19 Apr, 2002 | US6395728 |
| Issue Fee Payment Verified Critical | 19 Apr, 2002 | US6395728 |
| Workflow -Received 85b - Unmatched | 19 Apr, 2002 | US6395728 |
US patents provide insights into the exclusivity only within the United States, but Exforge 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's family patents as well as insights into ongoing legal events on those patents.
Exforge's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Exforge's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 08, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Exforge Generic API suppliers:
Amlodipine Besylate; Valsartan is the generic name for the brand Exforge. 11 different companies have already filed for the generic of Exforge, with Torrent having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Exforge's generic
How can I launch a generic of Exforge before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Exforge's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Exforge'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/160 mg | 22 Oct, 2007 | 1 | 28 Mar, 2013 | 08 Jul, 2019 | Eligible |
| 5 mg/320 mg | 26 Nov, 2007 | 1 | 28 Mar, 2013 | 08 Jul, 2019 | Eligible |
| 10 mg/160 mg | 01 Oct, 2007 | 1 | 28 Mar, 2013 | 08 Jul, 2019 | Eligible |
| 10 mg/320 mg | 09 Nov, 2007 | 1 | 28 Mar, 2013 | 08 Jul, 2019 | Eligible |
Alternative Brands for Exforge
Exforge 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 |
| |||||||||||||
| Waylis Therap |
| |||||||||||||
About Exforge
Exforge is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating high blood pressure. Exforge uses Amlodipine Besylate; Valsartan as an active ingredient. Exforge was launched by Novartis in 2007.
Approval Date:
Exforge was approved by FDA for market use on 20 June, 2007.
Active Ingredient:
Exforge uses Amlodipine Besylate; Valsartan as the active ingredient. Check out other Drugs and Companies using Amlodipine Besylate; Valsartan ingredient
Treatment:
Exforge is used for treating high blood pressure.
Dosage:
Exforge is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE;160MG | TABLET | Prescription | ORAL |
| EQ 10MG BASE;320MG | TABLET | Prescription | ORAL |
| EQ 5MG BASE;320MG | TABLET | Prescription | ORAL |
| EQ 5MG BASE;160MG | TABLET | Prescription | ORAL |