Elidel is a drug owned by Bausch Health Us Llc. 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 Dec 26, 2018. Details of Elidel'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). | |||
|
US6423722 (Pediatric) | Crystalline macrolides and process for their preparation |
Dec, 2018
(5 years ago) |
Expired
|
| US6423722 | Crystalline macrolides and process for their preparation |
Jun, 2018
(6 years ago) |
Expired
|
|
US5912238 (Pediatric) | Heteroatoms-containing tricyclic compounds |
Dec, 2016
(7 years ago) |
Expired
|
| US5912238 | Heteroatoms-containing tricyclic compounds |
Jun, 2016
(8 years ago) |
Expired
|
|
US6352998 (Pediatric) | Pharmaceutical compositions |
Apr, 2016
(8 years ago) |
Expired
|
| US6352998 | Pharmaceutical compositions |
Oct, 2015
(9 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 Elidel's patents.
Latest Legal Activities on Elidel's Patents
Given below is the list of recent legal activities going on the following patents of Elidel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 27 Mar, 2015 | US6352998 |
| Correspondence Address Change Critical | 26 Mar, 2015 | US6352998 |
| Post Issue Communication - Certificate of Correction | 12 Aug, 2002 | US6352998 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Mar, 2002 | US6352998 |
| Recordation of Patent Grant Mailed Critical | 05 Mar, 2002 | US6352998 |
| Issue Notification Mailed Critical | 14 Feb, 2002 | US6352998 |
| Receipt into Pubs | 06 Feb, 2002 | US6352998 |
| Application Is Considered Ready for Issue Critical | 05 Feb, 2002 | US6352998 |
| Receipt into Pubs | 05 Feb, 2002 | US6352998 |
| Mail Response to 312 Amendment (PTO-271) Critical | 30 Jan, 2002 | US6352998 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Elidel and ongoing litigations to help you estimate the early arrival of Elidel generic.
Elidel's Litigations
Elidel been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 19, 1997, against patent number US5912238. The petitioner , challenged the validity of this patent, with DONALD as the respondent. Click below to track the latest information on how companies are challenging Elidel's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US5912238 | November, 1997 |
Decision
(19 Nov, 1997) | DONALD | |
US patents provide insights into the exclusivity only within the United States, but Elidel 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 Elidel's family patents as well as insights into ongoing legal events on those patents.
Elidel's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Elidel's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 26, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Elidel Generic API suppliers:
Pimecrolimus is the generic name for the brand Elidel. 2 different companies have already filed for the generic of Elidel, with Actavis Labs Ut Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Elidel's generic
About Elidel
Elidel is a drug owned by Bausch Health Us Llc. Elidel uses Pimecrolimus as an active ingredient. Elidel was launched by Bausch in 2001.
Approval Date:
Elidel was approved by FDA for market use on 13 December, 2001.
Active Ingredient:
Elidel uses Pimecrolimus as the active ingredient. Check out other Drugs and Companies using Pimecrolimus ingredient
Dosage:
Elidel is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1% | CREAM | Prescription | TOPICAL |