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TOTECT Drug Profile
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See Plans and PricingWhich patents cover Totect, and what generic alternatives are available?
Totect is a drug marketed by Clinigen Hlthcare 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. Nine 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: | 2 |
| Bulk Api Vendors: | 46 |
| Clinical Trials: | 3 |
| 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 |
|---|---|
| M.D. Anderson Cancer Center | Phase 2 |
| National Cancer Institute (NCI) | Phase 2 |
| Children's Oncology Group | Phase 3 |
Pharmacology for TOTECT
| Drug Class | Cytoprotective Agent |
Synonyms for TOTECT
| (+)-Razoxane hydrochloride |
| (S)-4,4'-(1-Methyl-1,2-ethanediyl)bis-2,6-piperazinedione hydrochloride |
| (S)-4,4'-(propane-1,2-diyl)bis(piperazine-2,6-dione) hydrochloride |
| 003D010 |
| 1263283-43-7 |
| 149003-01-0 |
| 2,6-Piperazinedione, 4,4'-((1S)-1-methyl-1,2-ethanediyl)bis-, hydrochloride (1:1) |
| 2,6-Piperazinedione, 4,4'-(1-methyl-1,2-ethanediyl)bis-, hydrochloride, (S)- |
| 4-[(2S)-2-(3,5-dioxopiperazin-1-yl)propyl]piperazine-2,6-dione hydrochloride |
| 5346058Q7S |
| AC-9014 |
| AC1OCF6D |
| ADR-529 |
| ADR-529 hydrochloride |
| AKOS015900046 |
| AN-7454 |
| AOB6763 |
| AOB6863 |
| API0005176 |
| AS-16976 |
| C11H16N4O4.HCl |
| Cardioxane |
| CHEBI:50224 |
| CHEMBL1200778 |
| D07807 |
| Dexrazoxane (Hydrochloride) |
| Dexrazoxane (TN) |
| Dexrazoxane HCl |
| Dexrazoxane HCl (ICRF-187, ADR-529) |
| Dexrazoxane hydrochloride |
| Dexrazoxane hydrochloride (ICRF-187, ADR-529) |
| Dexrazoxane hydrochloride [ORANGE BOOK] |
| Dexrazoxane hydrochloride [VANDF] |
| Dexrazoxane hydrochloride [WHO-DD] |
| DTXSID60164152 |
| FT-0700082 |
| I14-10061 |
| ICRF 187 hydrochloride |
| ICRF-187 |
| ICRF-187 hydrochloride |
| KDX-0811 |
| MolPort-023-276-958 |
| Razoxane (+)-form hydrochloride [MI] |
| Razoxane hydrochloride, (S)- |
| s1222 |
| Savene |
| Savene (TN) |
| SCHEMBL18188 |
| SW220147-1 |
| TopoTect |
| Totect (TN) |
| UNII-5346058Q7S |
| UNII-BR9T89F617 component BIFMNMPSIYHKDN-FJXQXJEOSA-N |
| W-5214 |
| X5010 |
| Zinecard |
| Zinecard (TN) |
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 Hlthcare | 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 |
International Patents for TOTECT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Spain | 2220424 | Start Trial |
| Norway | 20014433 | Start Trial |
| Austria | 265215 | Start Trial |
| Norway | 327354 | Start Trial |
| China | 1346275 | Start Trial |
| Russian Federation | 2252761 | Start Trial |
| China | 1199644 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
