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: N213378

Product 002
OLANZAPINE; SAMIDORPHAN L-MALATE (LYBALVI) TABLET 10MG;EQ 10MG BASE

Patent Data

Product No Patent No Patent Expiration Drug Substance Drug Product Patent Use Code Delist Requested Submission Date
002 7262298 11/23/2025 DS
06/25/2021
002 8778960 02/13/2032
U-3136 METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
U-3137 METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
06/25/2021
002 9119848 08/30/2031 DS
06/25/2021
002 9126977 08/23/2031 DP
U-3136 METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
U-3137 METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
06/25/2021
002 9517235 08/23/2031
U-3138 METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE
U-3139 METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCTION OF THE ADVERSE METABOLIC PROFILE
06/25/2021
002 10300054 08/23/2031 DP
U-3140 METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
U-3141 METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
06/25/2021
002 10716785 08/23/2031
U-3136 METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
U-3137 METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN, WITH REDUCED ANTIPSYCHOTIC INDUCED WEIGHT GAIN
06/25/2021
002 11185541 08/23/2031
U-3140 METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
12/22/2021

Exclusivity Data

Product No Exclusivity Code Exclusivity Expiration
002
NCENEW CHEMICAL ENTITY
COMPETITIVE GENERIC THERAPY
05/28/2026

 

 


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