Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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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 021660 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
N021660 001 5439686 Feb 22, 2013 Y U - 1092
N021660 001 5439686 Feb 22, 2013 Y U - 1290
N021660 001 5498421 Mar 12, 2013 Y U - 1092
N021660 001 5498421 Mar 12, 2013 Y U - 1290
N021660 001 5498421 Mar 12, 2013 Y U - 634
N021660 001 6096331 Feb 22, 2013 Y U - 1092
N021660 001 6096331 Feb 22, 2013 Y U - 1290
N021660 001 6096331 Feb 22, 2013 Y U - 633
N021660 001 6506405 Feb 22, 2013 Y U - 1092
N021660 001 6506405 Feb 22, 2013 Y U - 1290
N021660 001 6506405 Feb 22, 2013 Y U - 633
N021660 001 6537579 Feb 22, 2013 U - 1092
N021660 001 6537579 Feb 22, 2013 U - 1290
N021660 001 6537579 Feb 22, 2013 U - 632
N021660 001 6749868 Feb 22, 2013 Y
N021660 001 6753006 Feb 22, 2013 Y
N021660 001 7820788 Mar 3, 2024 Y U - 1092
N021660 001 7820788 Mar 3, 2024 Y U - 1290
N021660 001 7923536 Dec 9, 2023 U - 1117
N021660 001 7923536 Dec 9, 2023 U - 1290
N021660 001 8034375 Aug 13, 2026 U - 1290
N021660 001 8138229 Dec 9, 2023 Y U - 1092
N021660 001 8138229 Dec 9, 2023 Y U - 1290
N021660 001 8268348 Feb 21, 2026 U - 1290
N021660 001 8314156 Dec 9, 2023 U - 1290
N021660 001 RE41884 Aug 14, 2016 U - 1117
N021660 001 RE41884 Aug 14, 2016 U - 1290

Exclusivity Data

Appl No Prod No Exclusivity Code Exclusivity Expiration
N021660 001 I - 658 Oct 11, 2015

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

Return to Electronic Orange Book Home Page

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 April, 2013
    Patent and Generic Drug Product Data Last Updated: May 20, 2013
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