Temodar is a drug owned by Merck Sharp And Dohme Corp. It is protected by 5 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 08, 2023. Details of Temodar'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). | |||
| US6987108 | Pharmaceutical formulations of antineoplastic agents and processes of making and using the same |
Sep, 2023
(1 year, 7 months ago) |
Expired
|
| US8623868 | Processes of making and using pharmaceutical formulations of antineoplastic agents |
Feb, 2023
(2 years ago) |
Expired
|
| US7786118 | Pharmaceutical formulations of antineoplastic agents |
Feb, 2023
(2 years ago) |
Expired
|
|
US5260291 (Pediatric) | Tetrazine derivatives |
Feb, 2014
(11 years ago) |
Expired
|
| US5260291 | Tetrazine derivatives |
Aug, 2013
(11 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 Temodar's patents.
Latest Legal Activities on Temodar's Patents
Given below is the list of recent legal activities going on the following patents of Temodar.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jan, 2022 | US7786118 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jan, 2018 | US7786118 |
| Correspondence Address Change Critical | 26 Aug, 2011 | US7786118 |
| Correspondence Address Change Critical | 26 Aug, 2011 | US6987108 |
| Post Issue Communication - Certificate of Correction | 09 Feb, 2011 | US7786118 |
| Recordation of Patent Grant Mailed Critical | 31 Aug, 2010 | US7786118 |
| Patent Issue Date Used in PTA Calculation Critical | 31 Aug, 2010 | US7786118 |
| Issue Notification Mailed Critical | 11 Aug, 2010 | US7786118 |
| Application Is Considered Ready for Issue Critical | 03 Aug, 2010 | US7786118 |
| Dispatch to FDC | 03 Aug, 2010 | US7786118 |
FDA has granted several exclusivities to Temodar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Temodar, 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 Temodar.
Exclusivity Information
Temodar holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Temodar's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE) | Mar 15, 2012 |
Several oppositions have been filed on Temodar's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Temodar's generic, the next section provides detailed information on ongoing and past EP oppositions related to Temodar patents.
Temodar's Oppositions Filed in EPO
Temodar has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Mar 04, 2009, by Chemagis Ltd.. This opposition was filed on patent number EP03709188A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP03709188A | Mar, 2009 | CHEMAGIS LTD. | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Temodar 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 Temodar's family patents as well as insights into ongoing legal events on those patents.
Temodar's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Temodar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 08, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Temodar Generic API suppliers:
Temozolomide is the generic name for the brand Temodar. 17 different companies have already filed for the generic of Temodar, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Temodar's generic
How can I launch a generic of Temodar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Temodar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Temodar'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 Temodar -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg, 20 mg, 100 mg and 250 mg | 20 Mar, 2007 | 1 | 01 Mar, 2010 | 11 Aug, 2013 | Eligible |
| 140 mg and 180 mg | 24 Mar, 2008 | 1 | 01 Mar, 2010 | 11 Aug, 2013 | Eligible |
About Temodar
Temodar is a drug owned by Merck Sharp And Dohme Corp. It is used for treating malignant neoplasms. Temodar uses Temozolomide as an active ingredient. Temodar was launched by Merck Sharp Dohme in 2009.
Approval Date:
Temodar was approved by FDA for market use on 27 February, 2009.
Active Ingredient:
Temodar uses Temozolomide as the active ingredient. Check out other Drugs and Companies using Temozolomide ingredient
Treatment:
Temodar is used for treating malignant neoplasms.
Dosage:
Temodar is available in the following dosage forms - capsule form for oral use, powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG/VIAL | POWDER | Prescription | INTRAVENOUS |
| 140MG | CAPSULE | Discontinued | ORAL |
| 180MG | CAPSULE | Discontinued | ORAL |
| 5MG | CAPSULE | Discontinued | ORAL |
| 20MG | CAPSULE | Discontinued | ORAL |
| 100MG | CAPSULE | Discontinued | ORAL |
| 250MG | CAPSULE | Discontinued | ORAL |