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Last Updated: October 15, 2019

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LUTATHERA Drug Profile

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When do Lutathera patents expire, and what generic alternatives are available?

Lutathera is a drug marketed by Aaa Usa Inc and is included in one NDA.

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 LUTATHERA
Drug patent expirations by year for LUTATHERA
Drug Prices for LUTATHERA

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Generic Entry Opportunity Date for LUTATHERA
Generic Entry Date for LUTATHERA*:
Constraining patent/regulatory exclusivity:
TREATMENT OF SOMATOSTATIN RECEPTOR-POSITIVE GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS (GEP-NETS) INCLUDING FOREGUT, MIDGUT, AND HINDGUT NEUROENDOCRINE TUMORS IN ADULTS
NDA:
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.

Recent Clinical Trials for LUTATHERA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Advanced Accelerator ApplicationsPhase 2
King's College Hospital NHS TrustPhase 2
Advanced Accelerator ApplicationsPhase 3

See all LUTATHERA clinical trials

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   See Pricing   See Pricing   See Pricing
Aaa Usa Inc LUTATHERA lutetium dotatate lu-177 SOLUTION;INTRAVENOUS 208700-001 Jan 26, 2018 RX Yes Yes   See Pricing   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
Dow
Express Scripts
Boehringer Ingelheim
McKesson

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