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 three patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-eight patent family members in fifteen 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 January 25, 2039. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Summary for LUTATHERA
| International Patents: | 38 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 41 |
| 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
*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 |
|---|---|
| University of Wisconsin, Madison | Phase 1 |
| University College, London | Phase 2 |
| Pashtoon M. Kasi | Phase 2 |
Paragraph IV (Patent) Challenges for LUTATHERA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| LUTATHERA | Injection | lutetium lu 177 dotatate | 10 mCi/mL | 208700 | 1 | 2023-11-13 |
US Patents and Regulatory Information for LUTATHERA
LUTATHERA is protected by three US patents and six FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of LUTATHERA is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable, concentrated radionuclide complex solutions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting LUTATHERA
TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS), INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Aaa Usa Inc | LUTATHERA | lutetium lu 177 dotatate | SOLUTION;INTRAVENOUS | 208700-001 | Jan 26, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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
Patent: SOLUCIONES DE COMPLEJOS DE RADIONÚCLIDOS ESTABLES Y CONCENTRADAS
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 18433575
Patent: Stable, concentrated radionuclide complex solutions
Estimated Expiration: ⤷ Sign Up
Patent: 22203683
Patent: Stable, concentrated radionuclide complex solutions
Estimated Expiration: ⤷ Sign Up
Patent: 24201217
Patent: Stable, concentrated radionuclide complex solutions
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2021001148
Patent: soluções estáveis de complexo de radionuclídeo concentrado
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 53630
Patent: SOLUTIONS COMPLEXES CONCENTREES STABLES DE RADIONUCLEIDES (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2584875
Patent: 稳定的、浓缩的放射性核素络合物溶液 (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 2867512
Patent: 联合疗法 (Combination therapy)
Estimated Expiration: ⤷ Sign Up
Patent: 2955188
Patent: 治疗神经内分泌肿瘤的方法 (METHOD OF TREATMENT OF NEUROENDOCRINE TUMORS)
Estimated Expiration: ⤷ Sign Up
Patent: 7122707
Patent: 联合疗法 (Combination therapy)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 21000506
Patent: Soluciones de complejos de radionúclidos estables y concentradas
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 26686
Patent: SOLUTIONS COMPLEXES CONCENTRÉES STABLES DE RADIONUCLÉIDES (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 26687
Patent: PROCÉDÉ DE TRAITEMENT DE TUMEURS NEUROENDOCRINES (METHOD OF TREATMENT OF NEUROENDOCRINE TUMORS)
Estimated Expiration: ⤷ Sign Up
Patent: 56262
Patent: POLYTHÉRAPIE (COMBINATION THERAPY)
Estimated Expiration: ⤷ Sign Up
Germany
Patent: 2018006567
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 0314
Patent: תמיסות קומפלקס של רדיונוקליד יציבות ומורוכזות (Stable, concentrated radionuclide complex solutions)
Estimated Expiration: ⤷ Sign Up
Patent: 3560
Patent: תמיסות קומפלקס של רדיונוקליד יציבות ומורוכזות (Stable, concentrated radionuclide complex solutions)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 58451
Estimated Expiration: ⤷ Sign Up
Patent: 58484
Estimated Expiration: ⤷ Sign Up
Patent: 02218
Estimated Expiration: ⤷ Sign Up
Patent: 21531306
Patent: 神経内分泌腫瘍の処置の方法
Estimated Expiration: ⤷ Sign Up
Patent: 22500355
Patent: 安定な濃厚放射性核種錯体溶液
Estimated Expiration: ⤷ Sign Up
Patent: 22501313
Patent: 安定な濃厚放射性核種錯体溶液
Estimated Expiration: ⤷ Sign Up
Patent: 22502505
Patent: 併用療法
Estimated Expiration: ⤷ Sign Up
Patent: 23107801
Patent: 併用療法 (COMBINATION THERAPY)
Estimated Expiration: ⤷ Sign Up
Patent: 23117417
Patent: 安定な濃厚放射性核種錯体溶液 (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS)
Estimated Expiration: ⤷ Sign Up
Patent: 23126209
Patent: 安定な濃厚放射性核種錯体溶液 (STABLE CONCENTRATED RADIONUCLIDE COMPLEX SOLUTION)
Estimated Expiration: ⤷ Sign Up
Patent: 24038132
Patent: 神経内分泌腫瘍の処置の方法 (METHOD OF TREATMENT OF NEUROENDOCRINE TUMORS)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 21000805
Patent: SOLUCIONES DE COMPLEJOS DE RADIONUCLIDOS ESTABLES Y CONCENTRADAS. (STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS.)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202100645X
Patent: STABLE, CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2643582
Estimated Expiration: ⤷ Sign Up
Patent: 210035855
Patent: 안정한 농축 방사성 핵종 복합체 용액
Estimated Expiration: ⤷ Sign Up
Patent: 240033296
Patent: 안정한 농축 방사성 핵종 복합체 용액 (STABLE CONCENTRATED RADIONUCLIDE COMPLEX SOLUTIONS)
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 2019489
Patent: Stable, concentrated radionuclide complex solutions
Estimated Expiration: ⤷ Sign Up
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 | 2022500355 | 安定な濃厚放射性核種錯体溶液 | ⤷ Sign Up |
| China | 117122707 | 联合疗法 (Combination therapy) | ⤷ Sign Up |
| Australia | 2022203683 | Stable, concentrated radionuclide complex solutions | ⤷ Sign Up |
| Israel | 280314 | תמיסות קומפלקס של רדיונוקליד יציבות ומורוכזות (Stable, concentrated radionuclide complex solutions) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LUTATHERA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 4095130 | 2024C/528 | Belgium | ⤷ Sign Up | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212 |
| 4095130 | LUC00352 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDE TETRAXETAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1703 20221212 |
| 4095130 | 301281 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LUTETIUM (177-LU)-VIPIVOTIDE TETRAXETAN; REGISTRATION NO/DATE: EU/1/22/1703, 20221212 |
| 4095130 | CA 2024 00027 | Denmark | ⤷ Sign Up | PRODUCT NAME: LUTETIUM (177LU) VIPIVOTIDETETRAXETAN; REG. NO/DATE: EU/1/22/1703 20221212 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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