Clarinex Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Clarinex.

Activity Date Patent Number
Patent litigations
Expire Patent 20 Dec, 2021 US7618649
Maintenance Fee Reminder Mailed 05 Jul, 2021 US7618649
Expire Patent 31 Aug, 2020 US7405223
Maintenance Fee Reminder Mailed 16 Mar, 2020 US7405223
Expire Patent 10 Jun, 2019 US7214684
Maintenance Fee Reminder Mailed 24 Dec, 2018 US7214684
Correspondence Address Change 26 Aug, 2011 US6514520
Patent Issue Date Used in PTA Calculation 17 Nov, 2009 US7618649
Recordation of Patent Grant Mailed 17 Nov, 2009 US7618649
Issue Notification Mailed 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.

Last updated on November 5, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7405223 June, 2007 Decision
(21 Feb, 2008)
Melton B. Affrime et al
US7214683 December, 2004 Decision
(24 Mar, 2005)
ABERG et al

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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


Family Patents

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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 Generic API suppliers:

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

Alternative Brands for Clarinex

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
Allegra used for treating allergic rhinitis and skin manifestations of chronic idiopathic urticaria in children.
Allegra-d 12 Hour Allergy And Congestion Used for treating allergic rhinitis, respiratory allergies, nasal swelling, sinus congestion, and pressure in adults and children aged 12 and older.
Organon
Clarinex D 24 Hour

(uses Desloratadine)

Used for relieving both nasal and non-nasal symptoms of seasonal allergic rhinitis.
Organon Llc
Clarinex-d 12 Hour

(uses Desloratadine)

Used for managing symptoms of allergic rhinitis.

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 Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Clarinex.

Activity Date Patent Number
Patent litigations
Expire Patent 20 Dec, 2021 US7618649
Maintenance Fee Reminder Mailed 05 Jul, 2021 US7618649
Expire Patent 31 Aug, 2020 US7405223
Maintenance Fee Reminder Mailed 16 Mar, 2020 US7405223
Expire Patent 10 Jun, 2019 US7214684
Maintenance Fee Reminder Mailed 24 Dec, 2018 US7214684
Correspondence Address Change 26 Aug, 2011 US6514520
Patent Issue Date Used in PTA Calculation 17 Nov, 2009 US7618649
Recordation of Patent Grant Mailed 17 Nov, 2009 US7618649
Issue Notification Mailed 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.

Last updated on November 5, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US7214683 December, 2004 Decision
(24 Mar, 2005)
ABERG et al

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


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 Generic API suppliers:

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

Alternative Brands for Clarinex

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
Allegra used for treating allergic rhinitis and skin manifestations of chronic idiopathic urticaria in children.
Allegra-d 12 Hour Allergy And Congestion Used for treating allergic rhinitis, respiratory allergies, nasal swelling, sinus congestion, and pressure in adults and children aged 12 and older.
Organon
Clarinex D 24 Hour

(uses Desloratadine)

Used for relieving both nasal and non-nasal symptoms of seasonal allergic rhinitis.
Organon Llc
Clarinex-d 12 Hour

(uses Desloratadine)

Used for managing symptoms of allergic rhinitis.

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