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LUTATHERA Drug Profile
» See Plans and Pricing
Which patents cover Lutathera, and when can generic versions of Lutathera launch?
Lutathera is a drug marketed by Aaa Usa Inc and is included in one NDA. There are two patents protecting this drug.
This drug has four patent family members in one country.
The generic ingredient in LUTATHERA is lutetium dotatate lu-177. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lutetium dotatate lu-177 profile page.
US ANDA Litigation and Generic Entry Outlook for Lutathera
Lutathera will be eligible for patent challenges on January 26, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 25, 2038. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for LUTATHERA
| International Patents: | 4 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 13 |
| Drug Prices: | Drug price information for LUTATHERA |
| DailyMed Link: | LUTATHERA at DailyMed |
Generic Entry Opportunity Date for LUTATHERA
Generic Entry Date for LUTATHERA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*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 LUTATHERA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1 |
| Melanoma and Skin Cancer Trials Limited | Phase 1/Phase 2 |
| M.D. Anderson Cancer Center | Phase 2 |
US Patents and Regulatory Information for LUTATHERA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aaa Usa Inc | LUTATHERA | lutetium dotatate lu-177 | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Aaa Usa Inc | LUTATHERA | lutetium dotatate lu-177 | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Aaa Usa Inc | LUTATHERA | lutetium dotatate lu-177 | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Aaa Usa Inc | LUTATHERA | lutetium dotatate lu-177 | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | 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 LUTATHERA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2020021310 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2020064693 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2020021465 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2020021322 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
