Torisel is a drug owned by Pf Prism Cv. It is protected by 14 US drug patents filed from 2013 to 2015. Out of these, 4 drug patents are active and 10 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 10, 2032. Details of Torisel's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| USRE44768 | Rapamycin hydroxyesters |
Feb, 2019
(6 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8791097 (Pediatric) | Anti-tumor activity of CCI-779 in papillary renal cell cancer |
Nov, 2032
(7 years from now) | Active |
| US8791097 | Anti-tumor activity of CCI-779 in papillary renal cell cancer |
May, 2032
(7 years from now) | Active |
|
US8026276 (Pediatric) | Parenteral CCI-779 formulations containing cosolvents, an antioxidant, and a surfactant |
Jul, 2026
(1 year, 2 months from now) | Active |
| US8026276 | Parenteral CCI-779 formulations containing cosolvents, an antioxidant, and a surfactant |
Jan, 2026
(8 months from now) | Active |
|
US8299116 (Pediatric) | CCI-779 concentrate formulations |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
|
US8455539 (Pediatric) | CCI-779 concentrate formulations |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
|
US8722700 (Pediatric) | CCI-779 formulations for parenteral administration |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US8455539 | CCI-779 concentrate formulations |
Jul, 2023
(1 year, 9 months ago) |
Expired
|
| US8722700 | CCI-779 formulations for parenteral administration |
Jul, 2023
(1 year, 9 months ago) |
Expired
|
| US8299116 | CCI-779 concentrate formulations |
Jul, 2023
(1 year, 9 months ago) |
Expired
|
|
USRE44768 (Pediatric) | Rapamycin hydroxyesters |
Aug, 2019
(5 years ago) |
Expired
|
|
US5362718 (Pediatric) | Rapamycin hydroxyesters |
Oct, 2014
(10 years ago) |
Expired
|
| US5362718 | Rapamycin hydroxyesters |
Apr, 2014
(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 Torisel's patents.
Latest Legal Activities on Torisel's Patents
Given below is the list of recent legal activities going on the following patents of Torisel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 17 Jun, 2024 | US8299116 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Feb, 2023 | US8026276 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Dec, 2021 | US8791097 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Oct, 2021 | US8722700 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8455539 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Mar, 2020 | US8299116 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Feb, 2019 | US8026276 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Dec, 2017 | US8791097 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Oct, 2017 | US8722700 |
| Email Notification Critical | 14 Nov, 2016 | US8455539 |
FDA has granted several exclusivities to Torisel. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Torisel, 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 Torisel.
Exclusivity Information
Torisel holds 5 exclusivities. All of its exclusivities have expired in 2015. Details of Torisel's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-91) | Apr 26, 2013 |
| M(M-92) | Jul 09, 2013 |
| Pediatric Exclusivity(PED) | Jan 09, 2014 |
| Orphan Drug Exclusivity(ODE) | May 30, 2014 |
| M(M-61) | May 30, 2015 |
Several oppositions have been filed on Torisel'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 Torisel's generic, the next section provides detailed information on ongoing and past EP oppositions related to Torisel patents.
Torisel's Oppositions Filed in EPO
Torisel has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 12, 2008, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP03771828A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP12153823A | Mar, 2017 | Accord Healthcare | Revoked |
| EP12153823A | Mar, 2017 | Generics (U.K.) Limited | Revoked |
| EP08742616A | Mar, 2016 | Generics (UK) Limited | Opposition rejected |
| EP03771828A | Nov, 2008 | Wichmann, Hendrik | Revoked |
| EP03771828A | Nov, 2008 | Teva Pharmaceutical Industries Ltd. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Torisel 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 Torisel's family patents as well as insights into ongoing legal events on those patents.
Torisel's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Torisel's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 10, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Torisel Generic API suppliers:
Temsirolimus is the generic name for the brand Torisel. 2 different companies have already filed for the generic of Torisel, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Torisel's generic
How can I launch a generic of Torisel before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Torisel's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Torisel'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 Torisel -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg/mL, 1.8 mL vial | 25 May, 2011 | 1 | 18 Apr, 2014 | Extinguished |
About Torisel
Torisel is a drug owned by Pf Prism Cv. It is used for treating metastatic papillary renal cell carcinoma. Torisel uses Temsirolimus as an active ingredient. Torisel was launched by Pf Prism Cv in 2007.
Approval Date:
Torisel was approved by FDA for market use on 30 May, 2007.
Active Ingredient:
Torisel uses Temsirolimus as the active ingredient. Check out other Drugs and Companies using Temsirolimus ingredient
Treatment:
Torisel is used for treating metastatic papillary renal cell carcinoma.
Dosage:
Torisel is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG/ML (25MG/ML) | SOLUTION | Prescription | INTRAVENOUS |