torisel Drug Patent Profile
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When do Torisel patents expire, 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for torisel?
- What are the global sales for torisel?
- What is Average Wholesale Price for torisel?
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 |
![torisel drug patent expirations Drug patent expirations by year for torisel](/p/graph/s/t/torisel-patent-expirations.png)
![Drug Prices for torisel](/p/graph/drug-price/torisel.png)
Recent Clinical Trials for torisel
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Barrow Neurological Institute | Early Phase 1 |
Nader Sanai | Early Phase 1 |
Ivy Brain Tumor Center | 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 |
---|---|---|---|
Spain | 2586739 | ⤷ Sign Up | |
Cyprus | 1117701 | ⤷ Sign Up | |
Denmark | 1553940 | ⤷ Sign Up | |
Australia | 2247495 | ⤷ 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 | 300348 | Netherlands | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY |
0763039 | 18/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0763039 | C00763039/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: WYETH, US |
0763039 | 08C0018 | France | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |