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Temsirolimus - Generic Drug Details
» See Plans and Pricing
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. Three 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 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 31 |
| Clinical Trials: | 219 |
| Patent Applications: | 3,385 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for temsirolimus |
| DailyMed Link: | temsirolimus at DailyMed |
Recent Clinical Trials for temsirolimus
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mercator MedSystems, Inc. | Phase 3 |
| Roche Pharma AG | Phase 2 |
| Ulrik Lassen | Phase 2 |
Paragraph IV (Patent) Challenges for TEMSIROLIMUS
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TORISEL | SOLUTION;INTRAVENOUS | temsirolimus | 022088 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gland Pharma Ltd | TEMSIROLIMUS | temsirolimus | SOLUTION;INTRAVENOUS | 207383-001 | Aug 16, 2019 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | AP | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| >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 | Start Trial | Start Trial |
| Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for temsirolimus
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2681451 | Start Trial |
| New Zealand | 537829 | Start Trial |
| Spain | 2300622 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for temsirolimus
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0763039 | PA2008009,C0763039 | Lithuania | Start Trial | PRODUCT NAME: TEMSIROLIMUSUM; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| 0763039 | C300348 | Netherlands | Start Trial | PRODUCT NAME: TEMSIROLIMUS, DESGEWENST IN DE VORM VAN EEN; REGISTRATION NO/DATE: EU/1/07/424/001 20071119 |
| 0763039 | 122008000023 | Germany | Start Trial | 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 |
