Taclonex is a drug owned by Leo Pharma As. 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 Jan 25, 2023. Details of Taclonex'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). | |||
| US6787529 | Topical composition |
Jan, 2020
(4 years ago) |
Expired
|
| US6753013 | Pharmaceutical composition |
Jan, 2020
(4 years ago) |
Expired
|
| US5763426 | Crystalline form of a vitamin D analogue |
Jun, 2015
(9 years ago) |
Expired
|
| USRE39706 | Crystalline form of a vitamin D analogue |
Jun, 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 Taclonex's patents.
Latest Legal Activities on Taclonex's Patents
Given below is the list of recent legal activities going on the following patents of Taclonex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 08 Jun, 2007 | US6787529 |
| Recordation of Patent Grant Mailed Critical | 07 Sep, 2004 | US6787529 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Sep, 2004 | US6787529 |
| Issue Notification Mailed Critical | 19 Aug, 2004 | US6787529 |
| Receipt into Pubs | 11 Aug, 2004 | US6787529 |
| Dispatch to FDC | 09 Aug, 2004 | US6787529 |
| Workflow - Drawings Finished | 09 Aug, 2004 | US6787529 |
| Application Is Considered Ready for Issue Critical | 09 Aug, 2004 | US6787529 |
| Receipt into Pubs | 21 Jul, 2004 | US6787529 |
| Issue Fee Payment Received Critical | 20 Jul, 2004 | US6787529 |
FDA has granted several exclusivities to Taclonex. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Taclonex, 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 Taclonex.
Exclusivity Information
Taclonex holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Taclonex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-659) | Oct 17, 2015 |
| New Patient Population(NPP) | Jul 25, 2022 |
| Pediatric Exclusivity(PED) | Jan 25, 2023 |
US patents provide insights into the exclusivity only within the United States, but Taclonex 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 Taclonex's family patents as well as insights into ongoing legal events on those patents.
Taclonex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Taclonex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 25, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Taclonex Generic API suppliers:
Betamethasone Dipropionate; Calcipotriene is the generic name for the brand Taclonex. 5 different companies have already filed for the generic of Taclonex, with Padagis Israel having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Taclonex's generic
How can I launch a generic of Taclonex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Taclonex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Taclonex'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 Taclonex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.005%/0.064% | 31 Mar, 2010 | 1 | 14 Jan, 2013 | 27 Jan, 2020 | Eligible |
Alternative Brands for Taclonex
Taclonex which is used for treating plaque psoriasis., 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.
About Taclonex
Taclonex is a drug owned by Leo Pharma As. It is used for treating plaque psoriasis. Taclonex uses Betamethasone Dipropionate; Calcipotriene as an active ingredient. Taclonex was launched by Leo Pharma As in 2015.
Approval Date:
Taclonex was approved by FDA for market use on 29 October, 2015.
Active Ingredient:
Taclonex uses Betamethasone Dipropionate; Calcipotriene as the active ingredient. Check out other Drugs and Companies using Betamethasone Dipropionate; Calcipotriene ingredient
Treatment:
Taclonex is used for treating plaque psoriasis.
Dosage:
Taclonex is available in ointment form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.064%;0.005% | OINTMENT | Prescription | TOPICAL |
Taclonex is a drug owned by Leo Pharma As. It is protected by 2 US drug patents filed in 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 25, 2023. Details of Taclonex'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). | |||
| US6753013 | Pharmaceutical composition |
Jan, 2020
(4 years ago) |
Expired
|
| US6787529 | Topical composition |
Jan, 2020
(4 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 Taclonex's patents.
Latest Legal Activities on Taclonex's Patents
Given below is the list of recent legal activities going on the following patents of Taclonex.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Post Issue Communication - Certificate of Correction | 08 Jun, 2007 | US6787529 |
| Recordation of Patent Grant Mailed Critical | 07 Sep, 2004 | US6787529 |
| Patent Issue Date Used in PTA Calculation Critical | 07 Sep, 2004 | US6787529 |
| Issue Notification Mailed Critical | 19 Aug, 2004 | US6787529 |
| Receipt into Pubs | 11 Aug, 2004 | US6787529 |
| Dispatch to FDC | 09 Aug, 2004 | US6787529 |
| Workflow - Drawings Finished | 09 Aug, 2004 | US6787529 |
| Application Is Considered Ready for Issue Critical | 09 Aug, 2004 | US6787529 |
| Receipt into Pubs | 21 Jul, 2004 | US6787529 |
| Issue Fee Payment Received Critical | 20 Jul, 2004 | US6787529 |
FDA has granted several exclusivities to Taclonex. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Taclonex, 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 Taclonex.
Exclusivity Information
Taclonex holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Taclonex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-659) | Oct 17, 2015 |
| New Patient Population(NPP) | Jul 25, 2022 |
| Pediatric Exclusivity(PED) | Jan 25, 2023 |
US patents provide insights into the exclusivity only within the United States, but Taclonex 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 Taclonex's family patents as well as insights into ongoing legal events on those patents.
Taclonex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Taclonex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 25, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Taclonex Generic API suppliers:
Betamethasone Dipropionate; Calcipotriene Hydrate is the generic name for the brand Taclonex. 5 different companies have already filed for the generic of Taclonex, with Padagis Israel having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Taclonex's generic
Alternative Brands for Taclonex
Taclonex which is used for treating plaque psoriasis., 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.
About Taclonex
Taclonex is a drug owned by Leo Pharma As. It is used for treating plaque psoriasis. Taclonex uses Betamethasone Dipropionate; Calcipotriene Hydrate as an active ingredient. Taclonex was launched by Leo Pharma As in 2015.
Approval Date:
Taclonex was approved by FDA for market use on 29 October, 2015.
Active Ingredient:
Taclonex uses Betamethasone Dipropionate; Calcipotriene Hydrate as the active ingredient. Check out other Drugs and Companies using Betamethasone Dipropionate; Calcipotriene Hydrate ingredient
Treatment:
Taclonex is used for treating plaque psoriasis.
Dosage:
Taclonex is available in suspension form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.064%;0.005% | SUSPENSION | Prescription | TOPICAL |