LUTATHERA Drug Patent Profile
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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 twenty-five patent family members in fourteen countries.
The generic ingredient in LUTATHERA is lutetium lu 177 dotatate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lutetium lu 177 dotatate profile page.
DrugPatentWatch® Generic Entry Outlook for Lutathera
Lutathera was eligible for patent challenges on January 26, 2022.
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: | 25 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 39 |
| Patent Applications: | 11 |
| Drug Prices: | Drug price information for LUTATHERA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LUTATHERA |
| What excipients (inactive ingredients) are in LUTATHERA? | LUTATHERA excipients list |
| DailyMed Link: | LUTATHERA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
|---|---|
| GI Research Foundation | Phase 2 |
| Novartis | Phase 2 |
| University of Chicago | Phase 1/Phase 2 |
US Patents and Regulatory Information for LUTATHERA
LUTATHERA is protected by two US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LUTATHERA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting LUTATHERA
Stable, concentrated radionuclide complex solutions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Stable, concentrated radionuclide complex solutions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting LUTATHERA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS
Exclusivity Expiration: ⤷ Try a Trial
| 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 lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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
When does loss-of-exclusivity occur for LUTATHERA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 9655
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 18433575
Estimated Expiration: ⤷ Try a Trial
Patent: 22203683
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2021001148
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 53630
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2584875
Estimated Expiration: ⤷ Try a Trial
Patent: 2867512
Estimated Expiration: ⤷ Try a Trial
Patent: 2955188
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 21000506
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 26686
Estimated Expiration: ⤷ Try a Trial
Patent: 26687
Estimated Expiration: ⤷ Try a Trial
Patent: 56262
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2018006567
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 0314
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 21531306
Estimated Expiration: ⤷ Try a Trial
Patent: 22500355
Estimated Expiration: ⤷ Try a Trial
Patent: 22501313
Estimated Expiration: ⤷ Try a Trial
Patent: 22502505
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 202100645X
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 210035855
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 2019489
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering LUTATHERA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2022502505 | 併用療法 | ⤷ Try a Trial |
| China | 112867512 | 联合疗法 (Combination therapy) | ⤷ Try a Trial |
| Australia | 2022203683 | Stable, concentrated radionuclide complex solutions | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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