Page 186 - Orange Book Cumulative Supplement 10 October 2012
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PATENT & EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 10 - October 2012
See List footnote for information regarding List content
PATENT PATENT EXCLUSIVITY
EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
APPL/PROD DATE REQUESTED DATE
NO PATENT NO CODES CODE(S)
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N022577 001 5922695 Jul 25, 2017 DS U-248 M-95 Oct 01, 2013
5922695 Jul 25, 2017 DS U-250 NPP Aug 16, 2015
NPP Mar 24, 2013
5922695 Jul 25, 2017 DS U-256 NDF Jan 18, 2015
5922695 Jul 25, 2017 DS U-999 ODE Mar 24, 2017
5922695 Jul 25, 2017 DS U-1275 PED Sep 24, 2017
PED Jul 18, 2015
5922695*PED Jan 25, 2018
PED Apr 01, 2014
5935946 Jul 25, 2017 DS DP U-999 PED Sep 24, 2013
5935946 Jul 25, 2017 DS DP U-1275
5935946 Jul 25, 2017 DS DP U-248
5935946 Jul 25, 2017 DS DP U-250
5935946 Jul 25, 2017 DS DP U-256
5935946*PED Jan 25, 2018
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-250
5977089 Jul 25, 2017 DS DP U-256
5977089 Jul 25, 2017 DS DP U-999
5977089 Jul 25, 2017 DS DP U-1275
5977089*PED Jan 25, 2018
6043230 Jul 25, 2017 U-1275
6043230 Jul 25, 2017 U-248
6043230 Jul 25, 2017 U-250
6043230 Jul 25, 2017 U-256
6043230 Jul 25, 2017 U-999
6043230*PED Jan 25, 2018
TERIFLUNOMIDE - AUBAGIO
N202992 001 5459163 Oct 17, 2012 DP NCE Sep 12, 2017
5679709 Oct 21, 2014 DP U-1285
TERIFLUNOMIDE - AUBAGIO
N202992 002 5459163 Oct 17, 2012 DP NCE Sep 12, 2017
5679709 Oct 21, 2014 DP U-1285
TESAMORELIN ACETATE - EGRIFTA
N022505 002 5861379 May 26, 2015 DS DP U-1100 NCE Nov 10, 2015
6020311 May 26, 2015 DS DP U-1100
7144577 Jul 14, 2020 U-1100
7316997 Aug 14, 2023 U-1100
TESTOSTERONE - ANDROGEL
N022309 002 NP Apr 29, 2014
TESTOSTERONE - ANDROGEL
N022309 003 NP Apr 29, 2014
TESTOSTERONE - TESTIM
N021454 001 8178518 Apr 21, 2023 DP
TESTOSTERONE - TESTOSTERONE
N202763 001 NP Feb 14, 2015
THALIDOMIDE - THALOMID
N020785 001 8143283 Mar 01, 2013 U-1236
8204763 Aug 28, 2018 U-1249