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: | 6,775 |
| 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 |
|---|---|
| Barrow Neurological Institute | Early Phase 1 |
| Nader Sanai | Early Phase 1 |
| Ivy Brain Tumor Center | 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 | |||
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | ||
| >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 |
| >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 | 2144611 | ⤷ Sign Up | |
| China | 1671385 | Parenteral formulations containing a rapamycin hydroxyester | ⤷ Sign Up |
| Cyprus | 1116492 | ⤷ Sign Up | |
| Ukraine | 82328 | ПАРЕНТЕРАЛЬНАЯ КОМПОЗИЦИЯ НА ОСНОВЕ ГИДРОКСИЭСТЕРА РАПАМИЦИНА (ВАРИАНТЫ) И СПОСОБ ЕЕ ПРИГОТОВЛЕНИЯ;ПАРЕНТЕРАЛЬНА КОМПОЗИЦІЯ НА ОСНОВІ ГІДРОКСІЕСТЕРУ РАПАМІЦИНУ (ВАРІАНТИ) ТА СПОСІБ ЇЇ ПРИГОТУВАННЯ (PARENTERAL FORMULATIONS OF RAPAMYCIN HYDROXYESTER (VARIANTS) AND A METHOD FOR ITS PREPARATION) | ⤷ 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 | SPC/GB08/025 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUS AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK 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 | PA2008009,C0763039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TEMSIROLIMUSUM; 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
