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TOTECT Drug Profile
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» See Plans and PricingWhich patents cover Totect, and when can generic versions of Totect launch?
Totect is a drug marketed by Clinigen and is included in one NDA. There is one patent protecting this drug.
This drug has twenty-two patent family members in sixteen countries.
The generic ingredient in TOTECT is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Totect
A generic version of TOTECT was approved as dexrazoxane hydrochloride by WEST-WARD PHARMS INT on September 28th, 2004.
Summary for TOTECT
| International Patents: | 22 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 4 |
| Patent Applications: | 230 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TOTECT |
| DailyMed Link: | TOTECT at DailyMed |
Recent Clinical Trials for TOTECT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| M.D. Anderson Cancer Center | Phase 2 |
| National Cancer Institute (NCI) | Phase 3 |
Pharmacology for TOTECT
| Drug Class | Cytoprotective Agent |
US Patents and Regulatory Information for TOTECT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinigen | TOTECT | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 022025-001 | Sep 6, 2007 | RX | Yes | Yes | Start Trial | Start Trial | 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 TOTECT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Clinigen | TOTECT | dexrazoxane hydrochloride | INJECTABLE;INJECTION | 022025-001 | Sep 6, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TOTECT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 0009473 | Start Trial |
| China | 1199644 | Start Trial |
| European Patent Office | 1459752 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
