Claritin-d 24 Hour is a drug owned by Bayer Healthcare Llc. It is protected by 2 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 Apr 23, 2013. Details of Claritin-d 24 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). | |||
|
US5314697 (Pediatric) | Stable extended release oral dosage composition comprising loratadine and pseudoephedrine |
Apr, 2013
(11 years ago) |
Expired
|
| US5314697 | Stable extended release oral dosage composition comprising loratadine and pseudoephedrine |
Oct, 2012
(12 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Claritin-d 24 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 Claritin-d 24 Hour's family patents as well as insights into ongoing legal events on those patents.
Claritin-d 24 Hour's Family Patents
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Generic Launch
Generic Release Date:
Claritin-d 24 Hour's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 23, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Claritin-d 24 Hour Generic API suppliers:
Loratadine; Pseudoephedrine Sulfate is the generic name for the brand Claritin-d 24 Hour. 5 different companies have already filed for the generic of Claritin-d 24 Hour, with Perrigo Pharma Intl having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Claritin-d 24 Hour's generic
How can I launch a generic of Claritin-d 24 Hour before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Claritin-d 24 Hour's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Claritin-d 24 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 Claritin-d 24 Hour -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/240 mg |
Alternative Brands for Claritin-d 24 Hour
There are several other brand drugs using the same active ingredient (Loratadine; Pseudoephedrine Sulfate) as Claritin-d 24 Hour. 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 | |
|---|---|---|
| Organon |
| |
| Organon Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Loratadine; Pseudoephedrine Sulfate, Claritin-d 24 Hour's active ingredient. Check the complete list of approved generic manufacturers for Claritin-d 24 Hour
About Claritin-d 24 Hour
Claritin-D 24 Hour is a drug owned by Bayer Healthcare Llc. Claritin-D 24 Hour uses Loratadine; Pseudoephedrine Sulfate as an active ingredient. Claritin-D 24 Hour was launched by Bayer Healthcare Llc in 2002.
Approval Date:
Claritin-d 24 Hour was approved by FDA for market use on 27 November, 2002.
Active Ingredient:
Claritin-d 24 Hour uses Loratadine; Pseudoephedrine Sulfate as the active ingredient. Check out other Drugs and Companies using Loratadine; Pseudoephedrine Sulfate ingredient
Dosage:
Claritin-d 24 Hour is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG;240MG | TABLET, EXTENDED RELEASE | Over the counter | ORAL |