Hepsera is a drug owned by Gilead Sciences Inc. It is protected by 2 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 23, 2018. Details of Hepsera'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). | |||
| US6451340 | Nucleotide analog compositions |
Jul, 2018
(6 years ago) |
Expired
|
| US5663159 | Prodrugs of phosphonates |
Sep, 2014
(10 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 Hepsera's patents.
Latest Legal Activities on Hepsera's Patents
Given below is the list of recent legal activities going on the following patents of Hepsera.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 17 Sep, 2002 | US6451340 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 17 Sep, 2002 | US6451340 (Litigated) |
| Issue Notification Mailed Critical | 29 Aug, 2002 | US6451340 (Litigated) |
| Receipt into Pubs | 13 Aug, 2002 | US6451340 (Litigated) |
| Application Is Considered Ready for Issue Critical | 09 Aug, 2002 | US6451340 (Litigated) |
| Issue Fee Payment Verified Critical | 30 Jul, 2002 | US6451340 (Litigated) |
| Receipt into Pubs | 02 Jul, 2002 | US6451340 (Litigated) |
| Workflow - File Sent to Contractor | 08 May, 2002 | US6451340 (Litigated) |
| Receipt into Pubs | 07 May, 2002 | US6451340 (Litigated) |
| Dispatch to Publications | 06 May, 2002 | US6451340 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Hepsera 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 Hepsera's family patents as well as insights into ongoing legal events on those patents.
Hepsera's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Hepsera's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 23, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Hepsera Generic API suppliers:
Adefovir Dipivoxil is the generic name for the brand Hepsera. 2 different companies have already filed for the generic of Hepsera, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Hepsera's generic
How can I launch a generic of Hepsera before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Hepsera's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Hepsera'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 Hepsera -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg | 08 Jun, 2010 | 1 | 29 Aug, 2013 | 23 Jul, 2018 | Eligible |
About Hepsera
Hepsera is a drug owned by Gilead Sciences Inc. It is used for treating chronic hepatitis B virus infection. Hepsera uses Adefovir Dipivoxil as an active ingredient. Hepsera was launched by Gilead in 2002.
Approval Date:
Hepsera was approved by FDA for market use on 20 September, 2002.
Active Ingredient:
Hepsera uses Adefovir Dipivoxil as the active ingredient. Check out other Drugs and Companies using Adefovir Dipivoxil ingredient
Treatment:
Hepsera is used for treating chronic hepatitis B virus infection.
Dosage:
Hepsera is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |