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LYMPHOSEEK KIT Drug Profile
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When do Lymphoseek Kit patents expire, and when can generic versions of Lymphoseek Kit launch?
Lymphoseek Kit is a drug marketed by Cardinal Health 414 and is included in one NDA. There are two patents protecting this drug.
This drug has twenty-seven patent family members in twelve countries.
The generic ingredient in LYMPHOSEEK KIT is technetium tc-99m tilmanocept. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m tilmanocept profile page.
US ANDA Litigation and Generic Entry Outlook for Lymphoseek Kit
Lymphoseek Kit was eligible for patent challenges on March 13, 2017.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 27, 2033. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for LYMPHOSEEK KIT
| International Patents: | 27 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 22 |
| DailyMed Link: | LYMPHOSEEK KIT at DailyMed |
Generic Entry Opportunity Date for LYMPHOSEEK KIT
Generic Entry Date for LYMPHOSEEK KIT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
INJECTABLE;INJECTION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for LYMPHOSEEK KIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| John O. Prior | Early Phase 1 |
| Stanford University | Phase 2 |
| Anna Cruceta | Phase 4 |
US Patents and Regulatory Information for LYMPHOSEEK KIT
| 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 | 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 | ||||
| >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 LYMPHOSEEK KIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Netherlands | 300736 | Start Trial |
| Japan | 2002544243 | Start Trial |
| Japan | 2015164933 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LYMPHOSEEK KIT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1178838 | 300736 | Netherlands | Start Trial | PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119 |
| 1178838 | 122015000033 | Germany | Start Trial | PRODUCT NAME: TILMANOCEPT; REGISTRATION NO/DATE: C(2014) 8901 FINAL 20141119 |
| 1178838 | 15C0033 | France | Start Trial | PRODUCT NAME: TILMANOCEPT; REGISTRATION NO/DATE: EU/1/14/955 20141121 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
