Clarinex is a drug owned by Organon Llc A Sub Of Organon And Co. It is protected by 14 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 19, 2021. Details of Clarinex'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). | |||
|
US7618649 (Pediatric) | Extended release oral dosage composition |
Jun, 2021
(3 years ago) |
Expired
|
| US7618649 | Extended release oral dosage composition |
Dec, 2020
(3 years ago) |
Expired
|
|
US7405223 (Pediatric) | Treating allergic and inflammatory conditions |
Jan, 2020
(4 years ago) |
Expired
|
|
US6100274 (Pediatric) | 8-chloro-6,11-dihydro-11- ](4-piperidylidine)-5H-benzo[5,6]cyclohepta[1,2-bpyridine oral compositions |
Jan, 2020
(4 years ago) |
Expired
|
| US6100274 | 8-chloro-6,11-dihydro-11- ](4-piperidylidine)-5H-benzo[5,6]cyclohepta[1,2-bpyridine oral compositions |
Jul, 2019
(5 years ago) |
Expired
|
| US7405223 | Treating allergic and inflammatory conditions |
Jul, 2019
(5 years ago) |
Expired
|
|
US5607697 (Pediatric) | Taste masking microparticles for oral dosage forms |
Dec, 2015
(8 years ago) |
Expired
|
|
US7214684 (Pediatric) | Methods for the treatment of allergic rhinitis |
Jun, 2015
(9 years ago) |
Expired
|
|
US7214683 (Pediatric) | Compositions of descarboethoxyloratadine |
Jun, 2015
(9 years ago) |
Expired
|
|
US7211582 (Pediatric) | Methods for treating urticaria using descarboethoxyloratadine |
Jun, 2015
(9 years ago) |
Expired
|
| US5607697 | Taste masking microparticles for oral dosage forms |
Jun, 2015
(9 years ago) |
Expired
|
| US7214684 | Methods for the treatment of allergic rhinitis |
Dec, 2014
(9 years ago) |
Expired
|
| US7211582 | Methods for treating urticaria using descarboethoxyloratadine |
Dec, 2014
(9 years ago) |
Expired
|
| US7214683 | Compositions of descarboethoxyloratadine |
Dec, 2014
(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 Clarinex's patents.
Latest Legal Activities on Clarinex's Patents
Given below is the list of recent legal activities going on the following patents of Clarinex.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 20 Dec, 2021 | US7618649 |
| Maintenance Fee Reminder Mailed Critical | 05 Jul, 2021 | US7618649 |
| Expire Patent Critical | 31 Aug, 2020 | US7405223 |
| Maintenance Fee Reminder Mailed Critical | 16 Mar, 2020 | US7405223 |
| Expire Patent Critical | 10 Jun, 2019 | US7214684 |
| Maintenance Fee Reminder Mailed Critical | 24 Dec, 2018 | US7214684 |
| Correspondence Address Change Critical | 26 Aug, 2011 | US6514520 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Nov, 2009 | US7618649 |
| Recordation of Patent Grant Mailed Critical | 17 Nov, 2009 | US7618649 |
| Issue Notification Mailed Critical | 28 Oct, 2009 | US7618649 |
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 Clarinex and ongoing litigations to help you estimate the early arrival of Clarinex generic.
Clarinex's Litigations
Clarinex been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 09, 2004, against patent number US7214683. The petitioner , challenged the validity of this patent, with ABERG et al as the respondent. Click below to track the latest information on how companies are challenging Clarinex's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7405223 | June, 2007 |
Decision
(21 Feb, 2008) | Melton B. Affrime et al | |
| US7214683 | December, 2004 |
Decision
(24 Mar, 2005) | ABERG et al | |
US patents provide insights into the exclusivity only within the United States, but Clarinex 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 Clarinex's family patents as well as insights into ongoing legal events on those patents.
Clarinex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Clarinex's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 19, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Clarinex Generics:
Desloratadine is the generic name for the brand Clarinex. 10 different companies have already filed for the generic of Clarinex, with Reddys having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Clarinex's generic
How can I launch a generic of Clarinex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Clarinex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Clarinex'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 Clarinex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg | 21 Jun, 2006 | 11 | 25 Oct, 2010 | 07 Jul, 2019 | Extinguished |
| 2.5 mg and 5 mg | 21 Jun, 2006 | 3 | 12 Jul, 2010 | 07 Jul, 2019 | Extinguished |
| 0.5 mg/mL | 08 May, 2008 | 1 | 01 Jun, 2018 | Extinguished |
Clarinex Competitors
Understanding your competition is essential for market success. Clarinex which is used for treating symptoms of allergic rhinitis and chronic idiopathic urticaria., has several other brand drugs in the same treatment category and using the same active ingredient (Desloratadine). 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.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Chattem Sanofi |
| |||||
| Organon |
| |||||
| Organon Llc |
| |||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Desloratadine, Clarinex's active ingredient. Check the complete list of approved generic manufacturers for Clarinex
About Clarinex
Clarinex is a drug owned by Organon Llc A Sub Of Organon And Co. It is used for treating symptoms of allergic rhinitis and chronic idiopathic urticaria. Clarinex uses Desloratadine as an active ingredient. Clarinex was launched by Organon in 2005.
Approval Date:
Clarinex was approved by FDA for market use on 14 July, 2005.
Active Ingredient:
Clarinex uses Desloratadine as the active ingredient. Check out other Drugs and Companies using Desloratadine ingredient
Treatment:
Clarinex is used for treating symptoms of allergic rhinitis and chronic idiopathic urticaria.
Dosage:
Clarinex is available in the following dosage forms - tablet form for oral use, tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 5MG | TABLET | Prescription | ORAL |
Clarinex is a drug owned by Merck Sharp And Dohme Corp. It is protected by 8 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 01, 2018. Details of Clarinex'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). | |||
|
US6514520 (Pediatric) | Stabilized antihistamine syrup |
Dec, 2018
(5 years ago) |
Expired
|
| US6514520 | Stabilized antihistamine syrup |
Jun, 2018
(6 years ago) |
Expired
|
|
US7211582 (Pediatric) | Methods for treating urticaria using descarboethoxyloratadine |
Jun, 2015
(9 years ago) |
Expired
|
|
US7214684 (Pediatric) | Methods for the treatment of allergic rhinitis |
Jun, 2015
(9 years ago) |
Expired
|
|
US7214683 (Pediatric) | Compositions of descarboethoxyloratadine |
Jun, 2015
(9 years ago) |
Expired
|
| US7214684 | Methods for the treatment of allergic rhinitis |
Dec, 2014
(9 years ago) |
Expired
|
| US7214683 | Compositions of descarboethoxyloratadine |
Dec, 2014
(9 years ago) |
Expired
|
| US7211582 | Methods for treating urticaria using descarboethoxyloratadine |
Dec, 2014
(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 Clarinex's patents.
Latest Legal Activities on Clarinex's Patents
Given below is the list of recent legal activities going on the following patents of Clarinex.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Expire Patent Critical | 20 Dec, 2021 | US7618649 |
| Maintenance Fee Reminder Mailed Critical | 05 Jul, 2021 | US7618649 |
| Expire Patent Critical | 31 Aug, 2020 | US7405223 |
| Maintenance Fee Reminder Mailed Critical | 16 Mar, 2020 | US7405223 |
| Expire Patent Critical | 10 Jun, 2019 | US7214684 |
| Maintenance Fee Reminder Mailed Critical | 24 Dec, 2018 | US7214684 |
| Correspondence Address Change Critical | 26 Aug, 2011 | US6514520 |
| Patent Issue Date Used in PTA Calculation Critical | 17 Nov, 2009 | US7618649 |
| Recordation of Patent Grant Mailed Critical | 17 Nov, 2009 | US7618649 |
| Issue Notification Mailed Critical | 28 Oct, 2009 | US7618649 |
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 Clarinex and ongoing litigations to help you estimate the early arrival of Clarinex generic.
Clarinex's Litigations
Clarinex been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 09, 2004, against patent number US7214683. The petitioner , challenged the validity of this patent, with ABERG et al as the respondent. Click below to track the latest information on how companies are challenging Clarinex's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
| | ||||
| US7214683 | December, 2004 |
Decision
(24 Mar, 2005) | ABERG et al | |
US patents provide insights into the exclusivity only within the United States, but Clarinex 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 Clarinex's family patents as well as insights into ongoing legal events on those patents.
Clarinex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Clarinex's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 01, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Clarinex Generics:
Desloratadine is the generic name for the brand Clarinex. 10 different companies have already filed for the generic of Clarinex, with Reddys having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Clarinex's generic
How can I launch a generic of Clarinex before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Clarinex's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Clarinex'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 Clarinex -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg | 21 Jun, 2006 | 11 | 25 Oct, 2010 | 07 Jul, 2019 | Extinguished |
| 2.5 mg and 5 mg | 21 Jun, 2006 | 3 | 12 Jul, 2010 | 07 Jul, 2019 | Extinguished |
| 0.5 mg/mL | 08 May, 2008 | 1 | 01 Jun, 2018 | Extinguished |
Clarinex Competitors
Understanding your competition is essential for market success. Clarinex which is used for treating symptoms of allergic rhinitis and chronic idiopathic urticaria., has several other brand drugs in the same treatment category and using the same active ingredient (Desloratadine). 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.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Chattem Sanofi |
| |||||
| Organon |
| |||||
| Organon Llc |
| |||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Desloratadine, Clarinex's active ingredient. Check the complete list of approved generic manufacturers for Clarinex
About Clarinex
Clarinex is a drug owned by Merck Sharp And Dohme Corp. It is used for treating symptoms of allergic rhinitis and chronic idiopathic urticaria. Clarinex uses Desloratadine as an active ingredient. Clarinex was launched by Merck Sharp Dohme in 2004.
Approval Date:
Clarinex was approved by FDA for market use on 01 September, 2004.
Active Ingredient:
Clarinex uses Desloratadine as the active ingredient. Check out other Drugs and Companies using Desloratadine ingredient
Treatment:
Clarinex is used for treating symptoms of allergic rhinitis and chronic idiopathic urticaria.
Dosage:
Clarinex is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | ORAL |