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Temsirolimus - Generic Drug Details
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What are the generic sources for temsirolimus and what is the scope of temsirolimus patent protection?
Temsirolimus
is the generic ingredient in two branded drugs marketed by Accord Hlthcare and Pf Prism Cv, and is included in two NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Temsirolimus has one hundred and twenty-four patent family members in thirty-eight countries.
There are five drug master file entries for temsirolimus. Two suppliers are listed for this compound.
Summary for temsirolimus
| International Patents: | 124 |
| US Patents: | 7 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 5 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 69 |
| Clinical Trials: | 216 |
| Patent Applications: | 3,762 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for temsirolimus |
| DailyMed Link: | temsirolimus at DailyMed |
Synonyms for temsirolimus
| 1034922-90-1 |
| 162635-04-3 |
| 343261-52-9 |
| 42-(3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate)rapamycin |
| 42-[3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate]-rapamycin |
| 42-[3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate]rapamycin |
| 42-[3-Hydroxy-2-methylpropanoate |
| 624KN6GM2T |
| 635T043 |
| AB01274736_02 |
| AB01274736-01 |
| AC-8758 |
| AC1L3WME |
| AKOS025142069 |
| AKOS025402386 |
| AKOS032960291 |
| AM84554 |
| AN-5331 |
| AOB87306 |
| AS-11427 |
| BC677694 |
| BCP25281 |
| BDBM50343413 |
| BRD-K08177763-001-02-6 |
| C15182 |
| C56H87NO16 |
| CAS-162635-04-3 |
| CBPNZQVSJQDFBE-FUXHJELOSA-N |
| Cci 779 |
| CCI-779 |
| CCI779 |
| CHEBI:79699 |
| CHEMBL1201182 |
| CS-0129 |
| CTK8E8547 |
| D06068 |
| DB06287 |
| DSSTox_CID_20945 |
| DSSTox_GSID_40945 |
| DSSTox_RID_79605 |
| DTXSID2040945 |
| EBD30128 |
| EX-A957 |
| GTPL5892 |
| HSDB 7931 |
| HY-50910 |
| J-009958 |
| J-524319 |
| LS-186555 |
| LS-187004 |
| LS-187783 |
| MFCD00934421 |
| MolPort-003-850-408 |
| MolPort-042-665-740 |
| MolPort-044-561-110 |
| NCGC00167518-01 |
| NCGC00167518-02 |
| NCGC00167518-05 |
| NSC 683864 |
| NSC-683864 |
| NSC683864 |
| Rapamycin 42-(2,2-bis(hydroxymethyl)propionate) |
| Rapamycin 42-[2,2-bis(hydroxymethyl)propionate] |
| Rapamycin 42-[3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate |
| Rapamycin 42-[3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate] |
| Rapamycin 42-[3-hydroxy-2(hydroxymethyl)-2-methylpropanoate] |
| Rapamycin, 42-(3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate) |
| RL02091 |
| RT-015903 |
| s1044 |
| SCHEMBL16234472 |
| SCHEMBL16848395 |
| SCHEMBL18792 |
| SR-01000898799 |
| SR-01000898799-3 |
| T3574 |
| Temserolimus |
| Temsirolimus - Torisel |
| Temsirolimus (CCI-779, NSC 683864) |
| Temsirolimus (JAN/USAN/INN) |
| Temsirolimus [USAN:INN:BAN:JAN] |
| Temsirolimus [USAN] |
| Temsirolimus, >=98% (HPLC) |
| Temsirolimus(CCI-779) |
| Torisel |
| Torisel (TM) |
| Torisel (TN) |
| Tox21_112515 |
| UNII-624KN6GM2T |
| WAY-130,779 |
| WAY-CCI 779 |
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 | 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 | 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 | |||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
International Patents for temsirolimus
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Slovenia | 763039 | ➤ Sign Up |
| Austria | 350384 | ➤ Sign Up |
| Hungary | 225915 | ➤ Sign Up |
| South Korea | 20090130040 | ➤ Sign Up |
| European Patent Office | 1553940 | ➤ Sign Up |
| Country | Patent Number | Estimated Expiration |
Supplementary Protection Certificates for temsirolimus
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0763039 | 91438 | Luxembourg | ➤ Sign Up | 91438, EXPIRES: 20200414 |
| 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,C0763039 | Lithuania | ➤ Sign Up | PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| 0763039 | SPC017/2008 | Ireland | ➤ Sign Up | SPC017/2008: 20090911, EXPIRES: 20200413 |
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
