Hectorol is a drug owned by Sanofi Genzyme. 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 Sep 14, 2023. Details of Hectorol'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). | |||
| US7148211 | Formulation for lipophilic agents |
Sep, 2023
(1 year, 3 months ago) |
Expired
|
| US6903083 | Stabilized hydroxyvitamin D |
Jul, 2021
(3 years ago) |
Expired
|
| US5602116 | Method for treating and preventing secondary hyperparathyroidism |
Feb, 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 Hectorol's patents.
Latest Legal Activities on Hectorol's Patents
Given below is the list of recent legal activities going on the following patents of Hectorol.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 31 May, 2018 | US7148211 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 12 Dec, 2006 | US7148211 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 12 Dec, 2006 | US7148211 (Litigated) |
| Issue Notification Mailed Critical | 22 Nov, 2006 | US7148211 (Litigated) |
| Dispatch to FDC | 15 Nov, 2006 | US7148211 (Litigated) |
| Application Is Considered Ready for Issue Critical | 14 Nov, 2006 | US7148211 (Litigated) |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 27 Feb, 2006 | US6903083 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 21 Feb, 2006 | US7148211 (Litigated) |
| Issue Fee Payment Received Critical | 21 Feb, 2006 | US7148211 (Litigated) |
| Issue Fee Payment Verified Critical | 21 Feb, 2006 | US7148211 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Hectorol 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 Hectorol's family patents as well as insights into ongoing legal events on those patents.
Hectorol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Hectorol's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 14, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Hectorol Generic API suppliers:
Doxercalciferol is the generic name for the brand Hectorol. 12 different companies have already filed for the generic of Hectorol, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Hectorol's generic
How can I launch a generic of Hectorol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Hectorol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Hectorol'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 Hectorol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mcg | 12 Feb, 2010 | 1 | 09 Sep, 2016 | 11 Feb, 2014 | Extinguished |
| 0.5 mcg and 2.5 mcg | 25 Mar, 2009 | 1 | 18 Jul, 2021 | Eligible | |
| 2 mcg/mL, 2 mL ampules | 15 Oct, 2007 | 1 | Extinguished | ||
| 2 mcg/mL, 1 mL in 2 mL vial | 28 Dec, 2011 | 1 | Extinguished |
About Hectorol
Hectorol is a drug owned by Sanofi Genzyme. It is used for managing secondary hyperparathyroidism in chronic kidney disease patients undergoing dialysis. Hectorol uses Doxercalciferol as an active ingredient. Hectorol was launched by Sanofi in 2000.
Approval Date:
Hectorol was approved by FDA for market use on 06 April, 2000.
Active Ingredient:
Hectorol uses Doxercalciferol as the active ingredient. Check out other Drugs and Companies using Doxercalciferol ingredient
Treatment:
Hectorol is used for managing secondary hyperparathyroidism in chronic kidney disease patients undergoing dialysis.
Dosage:
Hectorol is available in the following dosage forms - injectable form for injection use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MCG/2ML (2MCG/ML) | INJECTABLE | Prescription | INJECTION |
| 2MCG/ML (2MCG/ML) | INJECTABLE | Prescription | INJECTION |
| 2.5MCG | CAPSULE | Prescription | ORAL |
| 0.5MCG | CAPSULE | Prescription | ORAL |
| 1MCG | CAPSULE | Prescription | ORAL |