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 Jun 11, 2028. 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
(2 years ago) |
Expired
|
| US6903083 | Stabilized hydroxyvitamin D |
Jul, 2021
(4 years ago) |
Expired
|
| US5602116 | Method for treating and preventing secondary hyperparathyroidism |
Feb, 2014
(11 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) |
FDA has granted several exclusivities to Hectorol. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Hectorol, 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
Hectorol.
Exclusivity Information
Hectorol holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Hectorol's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-14) | Jun 11, 2028 |
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 last expiry date of its patents and exclusivities combined is estimated to be Jun 11, 2028 (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 | Discontinued | ORAL |
| 0.5MCG | CAPSULE | Discontinued | ORAL |
| 1MCG | CAPSULE | Discontinued | ORAL |