TEMSIROLIMUS Drug Patent Profile
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Which patents cover Temsirolimus, and what generic alternatives are available?
Temsirolimus is a drug marketed by Accord Hlthcare and Gland Pharma Ltd and is included in two NDAs.
The generic ingredient in TEMSIROLIMUS is temsirolimus. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the temsirolimus profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Temsirolimus
A generic version of TEMSIROLIMUS was approved as temsirolimus by ACCORD HLTHCARE on July 30th, 2018.
Summary for TEMSIROLIMUS
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 222 |
| Patent Applications: | 4,126 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | TEMSIROLIMUS | temsirolimus | SOLUTION;INTRAVENOUS | 203153-001 | Jul 30, 2018 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Gland Pharma Ltd | TEMSIROLIMUS | temsirolimus | SOLUTION;INTRAVENOUS | 207383-001 | Aug 16, 2019 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 |
