Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Deloitte
Boehringer Ingelheim
Harvard Business School
Argus Health
McKinsey
Farmers Insurance
AstraZeneca
McKesson

Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208700

« Back to Dashboard

NDA 208700 describes LUTATHERA, which is a drug marketed by Aaa Usa Inc and is included in one NDA. It is available from one supplier. Additional details are available on the LUTATHERA profile page.

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.
Summary for 208700
Tradename:LUTATHERA
Applicant:Aaa Usa Inc
Ingredient:lutetium dotatate lu-177
Patents:0
Generic Entry Opportunity Date for 208700
Generic Entry Date for 208700*:
Constraining patent/regulatory exclusivity:
TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS
Dosage:
SOLUTION;IV (INFUSION)

*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.

Suppliers and Packaging for NDA: 208700
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUTATHERA lutetium dotatate lu-177 SOLUTION;INTRAVENOUS 208700 NDA Advanced Accelerator Applications USA, Inc 69488-003 69488-003-01 1 VIAL in 1 PACKAGE (69488-003-01) > 20.5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength10mCi/ML
Approval Date:Jan 26, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 26, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jan 26, 2025
Regulatory Exclusivity Use:TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Argus Health
Daiichi Sankyo
Queensland Health
Baxter
Julphar
Boehringer Ingelheim
US Army
Cipla

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 verifification 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.