Claritin is a drug owned by Bayer Healthcare Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 01, 2018. Details of Claritin'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). | |||
| US6132758 | Stabilized antihistamine syrup |
Jun, 2018
(6 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Claritin 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's family patents as well as insights into ongoing legal events on those patents.
Claritin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Claritin's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 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)
Claritin Generic API suppliers:
Loratadine is the generic name for the brand Claritin. 28 different companies have already filed for the generic of Claritin, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Claritin's generic
How can I launch a generic of Claritin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Claritin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Claritin'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/mL | |||||
| 10 mg |
Alternative Brands for Claritin
There are several other brand drugs using the same active ingredient (Loratadine) as Claritin. 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 | ||
|---|---|---|---|
| Bayer Healthcare Llc |
| ||
| Merck Sharp Dohme |
| ||
| Organon |
| ||
| Organon Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Loratadine, Claritin's active ingredient. Check the complete list of approved generic manufacturers for Claritin
About Claritin
Claritin is a drug owned by Bayer Healthcare Llc. Claritin uses Loratadine as an active ingredient. Claritin was launched by Bayer Healthcare Llc in 2002.
Approval Date:
Claritin was approved by FDA for market use on 27 November, 2002.
Active Ingredient:
Claritin uses Loratadine as the active ingredient. Check out other Drugs and Companies using Loratadine ingredient
Dosage:
Claritin is available in syrup form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG/ML | SYRUP | Over the counter | ORAL |