Temodar Patent Expiration

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, 3 months ago)

Expired
US8623868 Processes of making and using pharmaceutical formulations of antineoplastic agents
Feb, 2023

(1 year, 10 months ago)

Expired
US7786118 Pharmaceutical formulations of antineoplastic agents
Feb, 2023

(1 year, 10 months ago)

Expired
US5260291

(Pediatric)

Tetrazine derivatives
Feb, 2014

(10 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.

Given below is the list of recent legal activities going on the following patents of Temodar.

Activity Date Patent Number
Patent litigations
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 26 Aug, 2011 US7786118
Correspondence Address Change 26 Aug, 2011 US6987108
Post Issue Communication - Certificate of Correction 09 Feb, 2011 US7786118
Recordation of Patent Grant Mailed 31 Aug, 2010 US7786118
Patent Issue Date Used in PTA Calculation 31 Aug, 2010 US7786118
Issue Notification Mailed 11 Aug, 2010 US7786118
Application Is Considered Ready for Issue 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

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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
Patent litigations
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

Temodar has patent protection in a total of 23 countries. It's US patent count contributes only to 28.2% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Temodar.

Family Patents

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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. 16 different companies have already filed for the generic of Temodar, with Rising 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