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TOTECT Drug Profile
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Which patents cover Totect, and when can generic versions of Totect launch?
Totect is a drug marketed by Clinigen and is included in one NDA.
The generic ingredient in TOTECT is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.
DrugPatentWatch® 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
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 54 |
| Clinical Trials: | 4 |
| Patent Applications: | 284 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for TOTECT |
| What excipients (inactive ingredients) are in TOTECT? | TOTECT excipients list |
| 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 |
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 | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| >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 | Try Before You Buy | Try Before You Buy |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TOTECT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1199644 | Try Before You Buy |
| Japan | 2002539168 | Try Before You Buy |
| European Patent Office | 1162981 | Try Before You Buy |
| Norway | 20014433 | Try Before You Buy |
| European Patent Office | 1459752 | Try Before You Buy |
| Germany | 60010241 | Try Before You Buy |
| Brazil | 0009473 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
