Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Additional Information about Patents

  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.

Patent and Exclusivity for: N022074

Product 001
LANREOTIDE ACETATE (SOMATULINE DEPOT) SOLUTION EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
001 5595760 03/08/2020 DP
U-831 METHOD OF ADMINISTERING LANREOTIDE ACETATE

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
001
I-754TO REDUCE THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY WHEN USED FOR THE TREATMENT OF ADULTS WITH CARCINOID SYNDROME
COMPETITIVE GENERIC THERAPY
09/15/2020
001
ODE-82TREATMENT OF PATIENTS WITH UNRESECTABLE,WELL- OR MODERATELY-DIFFERENTIATED LOCALLY ADVANCED OR METASTATIC GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS TO IMPROVE PROGRESSION-FREE SURVIVAL
COMPETITIVE GENERIC THERAPY
12/16/2021
001
ODE-156TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY
COMPETITIVE GENERIC THERAPY
09/15/2024

 

 


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