TORISEL Drug Patent Profile
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Which patents cover Torisel, and when can generic versions of Torisel launch?
Torisel is a drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-six patent family members in thirty-three countries.
The generic ingredient in TORISEL is temsirolimus. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the temsirolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Torisel
A generic version of TORISEL was approved as temsirolimus by ACCORD HLTHCARE on July 30th, 2018.
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Summary for TORISEL
| International Patents: | 76 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 140 |
| Patent Applications: | 3,938 |
| Drug Prices: | Drug price information for TORISEL |
| What excipients (inactive ingredients) are in TORISEL? | TORISEL excipients list |
| DailyMed Link: | TORISEL at DailyMed |
Recent Clinical Trials for TORISEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ivy Brain Tumor Center | Early Phase 1 |
| Barrow Neurological Institute | Early Phase 1 |
| Nader Sanai | Early Phase 1 |
Paragraph IV (Patent) Challenges for TORISEL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TORISEL | Injection | temsirolimus | 25 mg/mL, 1.8 mL vial | 022088 | 1 | 2011-05-25 |
US Patents and Regulatory Information for TORISEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for TORISEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for TORISEL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer Europe MA EEIG | Torisel | temsirolimus | EMEA/H/C/000799 Renal-cell carcinomaTorisel is indicated for the first-line treatment of adult patients with advanced renal-cell carcinoma (RCC) who have at least three of six prognostic risk factors.Mantle-cell lymphomaTorisel is indicated for the treatment of adult patients with relapsed and / or refractory mantle-cell lymphoma (MCL). |
Authorised | no | no | no | 2007-11-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for TORISEL
See the table below for patents covering TORISEL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 101131794 | ⤷ Sign Up | |
| Spain | 2586739 | ⤷ Sign Up | |
| Portugal | 2462934 | ⤷ Sign Up | |
| New Zealand | 537829 | Parenteral formulations containing a rapamycin hydroxyester | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TORISEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0763039 | 122008000023 | Germany | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| 0763039 | 300348 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY |
| 0763039 | C00763039/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: WYETH, US |
| 0763039 | SPC017/2008 | Ireland | ⤷ Sign Up | SPC017/2008: 20090911, EXPIRES: 20200413 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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