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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Patent and Exclusivity Search Results from query on Appl No 021991 Product 001 in the OB_Rx list.


Patent Data

Appl No Prod No Patent No Patent
Expiration
Drug Substance
Claim
Drug Product
Claim
Patent Use
Code
Delist
Requested
N021991 001 7399787 Feb 9, 2025 U - 892
N021991 001 7456219 Mar 11, 2027 Y
N021991 001 7652069 Mar 4, 2023 Y
N021991 001 7732490 Mar 4, 2023 U - 892
N021991 001 7851509 Feb 21, 2024 Y U - 892
N021991 001 8067472 Mar 4, 2023 U - 892
N021991 001 8093295 May 16, 2026 Y
N021991 001 8101663 Mar 4, 2023 U - 892
N021991 001 8450372 Mar 18, 2028 U - 892
N021991 001 RE38506 Jul 7, 2015 Y Y

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021991 001 ODE Oct 6, 2013


Additional information:

  1. Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as described in 21 CFR 314.53(d)(5).
  2. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor. These patents may not be flagged with respect to other claims which may apply.


View a list of all patent use codes
View a list of all exclusivity codes

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through October 2014
Patent and Generic Drug Product Data Last Updated November 25, 2014

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