Temsirolimus - Generic Drug Details
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What are the generic drug 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: | 35 |
Clinical Trials: | 221 |
Patent Applications: | 7,597 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Rapa Therapeutics LLC | Phase 2 |
Mercator MedSystems, Inc. | Phase 3 |
Roche Pharma AG | Phase 2 |
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Accord Hlthcare | TEMSIROLIMUS | temsirolimus | SOLUTION;INTRAVENOUS | 203153-001 | Jul 30, 2018 | AP | RX | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
>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 | See Plans and Pricing | See Plans and Pricing |
Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | See Plans and Pricing | See Plans and Pricing |
>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 |
---|---|---|---|
European Patent Office | 1553940 | FORMULATIONS PARENTERALES CONTENANT UN HYDROXYESTER DE RAPAMYCINE (PARENTERAL FORMULATIONS CONTAINING A RAPAMYCIN HYDROXYESTER) | See Plans and Pricing |
Japan | 5345105 | See Plans and Pricing | |
Costa Rica | 7647 | FORMULACIONES PARENTALES QOE CONTIENEN UN HIDROXIESTER DE RAPAMICINA | See Plans and Pricing |
Portugal | 1553940 | See Plans and Pricing | |
Australia | 2008236621 | Anti-tumor activity of temsirolimus in papillary renal cell cancer | See Plans and Pricing |
Brazil | PI0809322 | USO DE UM COMPOSTO | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for temsirolimus
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0763039 | 08C0018 | France | See Plans and Pricing | PRODUCT NAME: TEMSIROLIMUS; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0763039 | PA2008009 | Lithuania | See Plans and Pricing | PRODUCT NAME: TEMSIROLIMUSUM; REG. NO/DATE: EU/1/07/424/001 20071119 |
0763039 | 18/2008 | Austria | See Plans and Pricing | PRODUCT NAME: TEMSIROLIMUS ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0763039 | SPC/GB08/025 | United Kingdom | See Plans and Pricing | PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/07/424/001 20071119 |
0763039 | C300348 | Netherlands | See Plans and Pricing | PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
0763039 | 122008000023 | Germany | See Plans and Pricing | 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 |