Xeloda is a drug owned by Cheplapharm Arzneimittel Gmbh. 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 Jun 10, 2017. Details of Xeloda'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). | |||
|
US5472949 (Pediatric) | N4 -(substituted-oxycarbonyl)-5'-deoxy-5-fluorocytidine compounds, compositions and methods of using same |
Jun, 2014
(10 years ago) |
Expired
|
| US5472949 | N4 -(substituted-oxycarbonyl)-5'-deoxy-5-fluorocytidine compounds, compositions and methods of using same |
Dec, 2013
(10 years ago) |
Expired
|
FDA has granted several exclusivities to Xeloda. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xeloda, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Xeloda.
Exclusivity Information
Xeloda holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Xeloda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-131) | Dec 10, 2016 |
| Pediatric Exclusivity(PED) | Jun 10, 2017 |
US patents provide insights into the exclusivity only within the United States, but Xeloda 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 Xeloda's family patents as well as insights into ongoing legal events on those patents.
Xeloda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xeloda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 10, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xeloda Generic API suppliers:
Capecitabine is the generic name for the brand Xeloda. 14 different companies have already filed for the generic of Xeloda, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xeloda's generic
How can I launch a generic of Xeloda before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xeloda's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xeloda'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 Xeloda -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg and 500 mg | 10 Nov, 2008 | 1 | 08 Aug, 2014 | 14 Dec, 2013 | Extinguished |
About Xeloda
Xeloda is a drug owned by Cheplapharm Arzneimittel Gmbh. It is used for treating tumors. Xeloda uses Capecitabine as an active ingredient. Xeloda was launched by Cheplapharm in 1998.
Approval Date:
Xeloda was approved by FDA for market use on 30 April, 1998.
Active Ingredient:
Xeloda uses Capecitabine as the active ingredient. Check out other Drugs and Companies using Capecitabine ingredient
Treatment:
Xeloda is used for treating tumors.
Dosage:
Xeloda is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG | TABLET | Prescription | ORAL |
| 150MG | TABLET | Prescription | ORAL |