Clarinex-d 12 Hour is a drug owned by Organon Llc. It is protected by 10 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-d 12 Hour'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
(4 years ago) |
Expired
|
| US6709676 | Extended release oral dosage composition |
Feb, 2021
(4 years ago) |
Expired
|
| US8187630 | Extended release oral dosage composition |
Dec, 2020
(4 years ago) |
Expired
|
| US7618649 | Extended release oral dosage composition |
Dec, 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
(5 years ago) |
Expired
|
| US6100274 | 8-chloro-6,11-dihydro-11- ](4-piperidylidine)-5H-benzo[5,6]cyclohepta[1,2-bpyridine oral compositions |
Jul, 2019
(6 years ago) |
Expired
|
|
US7214684 (Pediatric) | Methods for the treatment of allergic rhinitis |
Jun, 2015
(10 years ago) |
Expired
|
|
US7214683 (Pediatric) | Compositions of descarboethoxyloratadine |
Jun, 2015
(10 years ago) |
Expired
|
| US7214683 | Compositions of descarboethoxyloratadine |
Dec, 2014
(10 years ago) |
Expired
|
| US7214684 | Methods for the treatment of allergic rhinitis |
Dec, 2014
(10 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-d 12 Hour's patents.
Latest Legal Activities on Clarinex-d 12 Hour's Patents
Given below is the list of recent legal activities going on the following patents of Clarinex-d 12 Hour.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 01 Jul, 2024 | US8187630 |
| Maintenance Fee Reminder Mailed
Critical | 15 Jan, 2024 | US8187630 |
| Expire Patent
Critical | 20 Dec, 2021 | US7618649 |
| Maintenance Fee Reminder Mailed
Critical | 05 Jul, 2021 | US7618649 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Oct, 2019 | US8187630 |
| Expire Patent
Critical | 10 Jun, 2019 | US7214684 |
| Maintenance Fee Reminder Mailed
Critical | 24 Dec, 2018 | US7214684 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED
Critical | 29 Jun, 2012 | US8187630 |
| Terminal Disclaimer Filed
Critical | 27 Jun, 2012 | US8187630 |
| Patent Issue Date Used in PTA Calculation
Critical | 29 May, 2012 | US8187630 |
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-d 12 Hour and ongoing
litigations to
help you estimate the early arrival of Clarinex-d 12 Hour generic.
Clarinex-d 12 Hour's Litigations
Clarinex-d 12 Hour 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-d 12 Hour'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-d 12 Hour 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-d 12 Hour's family patents as well as insights into
ongoing legal events
on those patents.
Clarinex-d 12 Hour's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Clarinex-d 12 Hour'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-d 12 Hour Generic API suppliers:
Desloratadine; Pseudoephedrine Sulfate is the generic name for the brand Clarinex-d 12 Hour. 1 company has already filed for the generic of Clarinex-d 12 Hour. Check out the entire list of companies who have already received approval for Clarinex-d 12 Hour's generic
How can I launch a generic of Clarinex-d 12 Hour before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Clarinex-d 12 Hour's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Clarinex-d 12 Hour'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-d 12 Hour -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg/120 mg | 01 Jun, 2007 | 1 | 18 Feb, 2021 | Extinguished | |
| 5 mg/240 mg | 21 Jun, 2006 | 1 | 26 Apr, 2011 | 28 Mar, 2022 | Extinguished |
Alternative Brands for Clarinex-d 12 Hour
Clarinex-d 12 Hour which is used for managing symptoms of allergic rhinitis., has several other brand drugs in the same treatment category and using the same active ingredient (Desloratadine; Pseudoephedrine Sulfate). 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 |
| |||||
| Merck Sharp Dohme |
| |||||
| Organon |
| |||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Desloratadine; Pseudoephedrine Sulfate, Clarinex-d 12 Hour's active ingredient. Check the complete list of approved generic manufacturers for Clarinex-d 12 Hour
About Clarinex-d 12 Hour
Clarinex-D 12 Hour is a drug owned by Organon Llc. It is used for managing symptoms of allergic rhinitis. Clarinex-D 12 Hour uses Desloratadine; Pseudoephedrine Sulfate as an active ingredient. Clarinex-D 12 Hour was launched by Organon Llc in 2006.
Approval Date:
Clarinex-d 12 Hour was approved by FDA for market use on 01 February, 2006.
Active Ingredient:
Clarinex-d 12 Hour uses Desloratadine; Pseudoephedrine Sulfate as the active ingredient. Check out other Drugs and Companies using Desloratadine; Pseudoephedrine Sulfate ingredient
Treatment:
Clarinex-d 12 Hour is used for managing symptoms of allergic rhinitis.
Dosage:
Clarinex-d 12 Hour is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.5MG;120MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |