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Technetium tc-99m tilmanocept - Generic Drug Details
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What are the generic drug sources for technetium tc-99m tilmanocept and what is the scope of freedom to operate?
Technetium tc-99m tilmanocept
is the generic ingredient in one branded drug marketed by Cardinal Health 414 and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Technetium tc-99m tilmanocept has twenty-six patent family members in twelve countries.
There are four drug master file entries for technetium tc-99m tilmanocept. One supplier is listed for this compound.
Summary for technetium tc-99m tilmanocept
| International Patents: | 26 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 4 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 6 |
| DailyMed Link: | technetium tc-99m tilmanocept at DailyMed |
Recent Clinical Trials for technetium tc-99m tilmanocept
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| Eben Rosenthal | Phase 2 |
| National Cancer Institute (NCI) | Phase 1 |
US Patents and Regulatory Information for technetium tc-99m tilmanocept
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cardinal Health 414 | LYMPHOSEEK KIT | technetium tc-99m tilmanocept | INJECTABLE;INJECTION | 202207-001 | Mar 13, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Cardinal Health 414 | LYMPHOSEEK KIT | technetium tc-99m tilmanocept | INJECTABLE;INJECTION | 202207-001 | Mar 13, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Cardinal Health 414 | LYMPHOSEEK KIT | technetium tc-99m tilmanocept | INJECTABLE;INJECTION | 202207-001 | Mar 13, 2013 | 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 |
International Patents for technetium tc-99m tilmanocept
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2012516328 | Start Trial |
| Australia | 5270500 | Start Trial |
| Japan | 6509796 | Start Trial |
| Japan | 2007332380 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for technetium tc-99m tilmanocept
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1178838 | 15C0033 | France | Start Trial | PRODUCT NAME: TILMANOCEPT; REGISTRATION NO/DATE: EU/1/14/955 20141121 |
| 1178838 | 300736 | Netherlands | Start Trial | PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119 |
| 1178838 | 1590025-1 | Sweden | Start Trial | PRODUCT NAME: TILMANOCEPT; REG. NO/DATE: EU/1/14/955 20141120 |
| 1178838 | 122015000033 | Germany | Start Trial | PRODUCT NAME: TILMANOCEPT; REGISTRATION NO/DATE: C(2014) 8901 FINAL 20141119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
