TEMSIROLIMUS - Generic Drug Details
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What are the generic sources for temsirolimus and what is the scope of freedom to operate?
Temsirolimus
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Gland Pharma Ltd, and Pf Prism Cv, and is included in three NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Temsirolimus has seventy-six patent family members in thirty-three countries.
There are five drug master file entries for temsirolimus. Five suppliers are listed for this compound.
Summary for TEMSIROLIMUS
International Patents: | 76 |
US Patents: | 5 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 36 |
Clinical Trials: | 222 |
Patent Applications: | 6,821 |
What excipients (inactive ingredients) are in TEMSIROLIMUS? | TEMSIROLIMUS excipients list |
DailyMed Link: | TEMSIROLIMUS at DailyMed |
Recent Clinical Trials for TEMSIROLIMUS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Nader Sanai | Early Phase 1 |
Ivy Brain Tumor Center | Early Phase 1 |
Barrow Neurological Institute | Early Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for TEMSIROLIMUS
Paragraph IV (Patent) Challenges for TEMSIROLIMUS
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 TEMSIROLIMUS
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 | ⤷ Sign Up | |||
Gland Pharma Ltd | TEMSIROLIMUS | temsirolimus | SOLUTION;INTRAVENOUS | 207383-001 | Aug 16, 2019 | AP | RX | No | No | ⤷ 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 | 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 | ||
Accord Hlthcare | TEMSIROLIMUS | temsirolimus | SOLUTION;INTRAVENOUS | 203153-001 | Jul 30, 2018 | AP | RX | No | No | ⤷ 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 TEMSIROLIMUS
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 |
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 TEMSIROLIMUS
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 TEMSIROLIMUS
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 1553940 | ⤷ Sign Up | |
Mexico | PA05001013 | FORMULACIONES PARENTALES QUE CONTIENEN UN HIDROXIESTER DE RAPAMICINA. (PARENTERAL FORMULATIONS CONTAINING A RAPAMYCIN HYDROXYESTER.) | ⤷ Sign Up |
Portugal | 2462934 | ⤷ Sign Up | |
Slovenia | 2462934 | ⤷ Sign Up | |
Hungary | E026022 | ⤷ Sign Up | |
Cyprus | 1117701 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TEMSIROLIMUS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0763039 | C300348 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0763039 | PA2008009,C0763039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0763039 | 122008000023 | Germany | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0763039 | 08C0018 | France | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0763039 | PA2008009 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119 |
0763039 | 18/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |