Page 1 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 SEE IMPORTANT INFORMATION ABOUT UPDATES DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER 021320 001 INGREDIENT NAME; TRADE NAME PATENT NUMBER 5968895 6180608 6423686 6455499 5843901 6699833 6273303 6702997 6702997 5932622 5273995 5273995*PED 6455574 5969156 5969156*PED 5686104 5686104*PED 6126971 6126971*PED 4681893 4681893*PED 4879303 4879303*PED 4572909 4572909*PED 4681893 4681893*PED 4879303 4879303*PED 4572909 4572909*PED 5273995 5273995*PED 6455574 5969156 5969156*PED 5686104 5686104*PED 6126971 6126971*PED 4681893 4681893*PED 4879303 4879303*PED 4572909 4572909*PED 5273995 5273995*PED 6455574 5969156 5969156*PED 5686104 5686104*PED PATENT/PED EXCL EXPIRES DEC DEC JUN JUN DEC DEC 11, 11, 07, 07, 01, 11, 2016 2016 2015 2015 2015 2016 PATENT CODE(S) DP DP U549 DS U549 DS DP DP ODE APR 20, 2021 DEC 28, 2021 DEC 28, 2021 AUG DEC JUN AUG JUL JAN NOV MAY JAN JUL SEP MAR MAR SEP JUL JAN SEP MAR MAR SEP JUL JAN DEC JUN AUG JUL JAN NOV MAY JAN JUL SEP MAR MAR SEP JUL JAN DEC JUN AUG JUL JAN NOV MAY 03, 28, 28, 11, 08, 08, 11, 11, 19, 19, 24, 24, 25, 25, 31, 31, 24, 24, 25, 25, 31, 31, 28, 28, 11, 08, 08, 11, 11, 19, 19, 24, 24, 25, 25, 31, 31, 28, 28, 11, 08, 08, 11, 11, 2016 2010 2011 2018 2016 2017 2014 2015 2013 2013 2009 2010 2007 2007 2006 2007 2009 2010 2007 2007 2006 2007 2010 2011 2018 2016 2017 2014 2015 2013 2013 2009 2010 2007 2007 2006 2007 2010 2011 2018 2016 2017 2014 2015 DP U558 U558 D-87 D-87 U562 DS DP U162 U552 DS DP U213 DP DS DP U161 DS DP DS DP U3 DS DP U161 DS DP DS DP U3 DS DP U162 U552 DS DP U213 DP DS DP U161 DS DP DS DP U3 DS DP U162 U552 DS DP U213 NC JAN 30, 2007 NC JAN 30, 2007 NC APR 16, 2007 APR 16, 2007 JAN 30, 2007 JAN 23, 2011 EXCLUS CODE EXCLUS EXPIRES
ABARELIX;PLENAXIS
021539 020899 020949 020949 020560 021575 020886 021540
001 001 001 002 005 001 001 001
ACETYLCYSTEINE;ACETADOTE ALBUMIN HUMAN;OPTISON ALBUTEROL SULFATE;ACCUNEB ALBUTEROL SULFATE;ACCUNEB ALENDRONATE SODIUM;FOSAMAX ALENDRONATE SODIUM;FOSAMAX ALITRETINOIN;PANRETIN AMLODIPINE BESYLATE;CADUET
021540 002
AMLODIPINE BESYLATE;CADUET
021540 003
AMLODIPINE BESYLATE;CADUET
Page 2 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER INGREDIENT NAME; TRADE NAME PATENT NUMBER 6126971 6126971*PED 4681893 4681893*PED 4879303 4879303*PED 4572909 4572909*PED 5273995 5273995*PED 6455574 5969156 5969156*PED 5686104 5686104*PED 6126971 6126971*PED 4681893 4681893*PED 4879303 4879303*PED 4572909 4572909*PED 5273995 5273995*PED 6455574 5969156 5969156*PED 5686104 5686104*PED 6126971 6126971*PED 4681893 4681893*PED 4879303 4879303*PED 4572909 4572909*PED 5273995 5273995*PED 6455574 5969156 5969156*PED 5686104 5686104*PED 6126971 6126971*PED 4681893 4681893*PED 4879303 4879303*PED 4572909 4572909*PED 5273995 5273995*PED 6455574 PATENT/PED EXCL EXPIRES JAN JUL SEP MAR MAR SEP JUL JAN DEC JUN AUG JUL JAN NOV MAY JAN JUL SEP MAR MAR SEP JUL JAN DEC JUN AUG JUL JAN NOV MAY JAN JUL SEP MAR MAR SEP JUL JAN DEC JUN AUG JUL JAN NOV MAY JAN JUL SEP MAR MAR SEP JUL JAN DEC JUN AUG 19, 19, 24, 24, 25, 25, 31, 31, 28, 28, 11, 08, 08, 11, 11, 19, 19, 24, 24, 25, 25, 31, 31, 28, 28, 11, 08, 08, 11, 11, 19, 19, 24, 24, 25, 25, 31, 31, 28, 28, 11, 08, 08, 11, 11, 19, 19, 24, 24, 25, 25, 31, 31, 28, 28, 11, 2013 2013 2009 2010 2007 2007 2006 2007 2010 2011 2018 2016 2017 2014 2015 2013 2013 2009 2010 2007 2007 2006 2007 2010 2011 2018 2016 2017 2014 2015 2013 2013 2009 2010 2007 2007 2006 2007 2010 2011 2018 2016 2017 2014 2015 2013 2013 2009 2010 2007 2007 2006 2007 2010 2011 2018 PATENT CODE(S) DP DS DP U161 DS DP DS DP U3 DS DP U162 U552 DS DP U213 DP DS DP U161 DS DP DS DP U3 DS DP U162 U552 DS DP U213 DP DS DP U161 DS DP DS DP U3 DS DP U162 U552 DS DP U213 DP DS DP U161 DS DP DS DP U3 DS DP U162 U552 NC JAN 30, 2007 NC JAN 30, 2007 NC JAN 30, 2007 NC JAN 30, 2007 EXCLUS CODE EXCLUS EXPIRES
021540 004
AMLODIPINE BESYLATE;CADUET
021540 005
AMLODIPINE BESYLATE;CADUET
021540 006
AMLODIPINE BESYLATE;CADUET
021540 007
AMLODIPINE BESYLATE;CADUET
Page 3 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER INGREDIENT NAME; TRADE NAME PATENT NUMBER 5969156 5969156*PED 5686104 5686104*PED 6126971 6126971*PED 4681893 4681893*PED 4879303 4879303*PED 4572909 4572909*PED 5273995 5273995*PED 6455574 5969156 5969156*PED 5686104 5686104*PED 6126971 6126971*PED 6730679 6730679 PATENT/PED EXCL EXPIRES JUL JAN NOV MAY JAN JUL SEP MAR MAR SEP JUL JAN DEC JUN AUG JUL JAN NOV MAY JAN JUL NOV NOV 08, 08, 11, 11, 19, 19, 24, 24, 25, 25, 31, 31, 28, 28, 11, 08, 08, 11, 11, 19, 19, 11, 11, 2016 2017 2014 2015 2013 2013 2009 2010 2007 2007 2006 2007 2010 2011 2018 2016 2017 2014 2015 2013 2013 2017 2017 PATENT CODE(S) DS DP U213 DP DS DP U161 DS DP DS DP U3 DS DP U162 U552 DS DP U213 DP DP DP ODE PED ODE PED NCE NCE 6723351 5164194 5164194*PED NOV 10, 2018 NOV 01, 2010 MAY 01, 2011 U573 U207 M-30 PED M-30 PED M-30 PED M-30 PED NP 6713446 6686346 6686346 4657927 4657927*PED 4657927 4657927*PED 4657927 4657927*PED 4657927 4657927*PED JAN APR APR APR OCT APR OCT APR OCT APR OCT 25, 29, 29, 14, 14, 14, 14, 14, 14, 14, 14, 2022 2017 2017 2004 2004 2004 2004 2004 2004 2004 2004 DP DP U557 DP U557 U175 U175 U175 DP U175 MAR SEP MAR SEP MAR SEP MAR SEP MAY 02, 02, 02, 02, 02, 02, 02, 02, 10, 2007 2007 2007 2007 2007 2007 2007 2007 2007 MAR SEP MAR SEP APR APR 14, 14, 14, 14, 20, 20, 2004 2004 2004 2004 2009 2009 NC JAN 30, 2007 EXCLUS CODE EXCLUS EXPIRES
021540 008
AMLODIPINE BESYLATE;CADUET
021007 001 021007 002 020333 001 020333 002 021264 021264 021248 020114 001 002 001 001
AMPRENAVIR;AGENERASE AMPRENAVIR;AGENERASE ANAGRELIDE HYDROCHLORIDE;AGRYLIN ANAGRELIDE HYDROCHLORIDE;AGRYLIN APOMORPHINE HYDROCHLORIDE;APOKYN APOMORPHINE HYDROCHLORIDE;APOKYN ARSENIC TRIOXIDE;TRISENOX AZELASTINE HYDROCHLORIDE;ASTELIN BENAZEPRIL HYDROCHLORIDE;LOTENSIN BENAZEPRIL HYDROCHLORIDE;LOTENSIN BENAZEPRIL HYDROCHLORIDE;LOTENSIN BENAZEPRIL HYDROCHLORIDE;LOTENSIN BISACODYL;HALFLYTELY BORTEZOMIB;VELCADE BUDESONIDE;RHINOCORT BUDESONIDE;RHINOCORT CARBOPLATIN;PARAPLATIN CARBOPLATIN;PARAPLATIN CARBOPLATIN;PARAPLATIN CARBOPLATIN;PARAPLATIN
019851 001 019851 002 019851 003 019851 004 021551 021602 020746 020746 019880 001 001 001 002 001
019880 002 019880 003 020452 001
Page 4 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER 020452 002 020452 003 020452 004 021621 001 021621 002 020989 021587 021149 021688 002 001 002 001 INGREDIENT NAME; TRADE NAME PATENT NUMBER 4657927 4657927*PED 4657927 4657927*PED 4657927 4657927*PED 4525358 4525358*PED 6455533 4525358 4525358*PED 6455533 5340821 6706681 6031003 6211244 6313146 6011068 6031003 6211244 6313146 6011068 6031003 6211244 6313146 6011068 PATENT/PED EXCL EXPIRES APR OCT APR OCT APR OCT JUN DEC JUL JUN DEC JUL JUL MAR DEC OCT DEC DEC DEC OCT DEC DEC DEC OCT DEC DEC 14, 14, 14, 14, 14, 14, 25, 25, 02, 25, 25, 02, 07, 16, 14, 23, 14, 14, 14, 23, 14, 14, 14, 23, 14, 14, 2004 2004 2004 2004 2004 2004 2007 2007 2018 2007 2007 2018 2013 2021 2016 2015 2016 2016 2016 2015 2016 2016 2016 2015 2016 2016 PATENT CODE(S) DP U175 DP U175 DP U175 DS DP U565 DP DS DP U565 DP U309 NP DP U559 DS DP U560 DS DP DS DP DS DP U560 DS DP DS DP U559 DS DP U560 DS DP DS DP ODE NCE ODE NCE ODE NCE I-421 PED I-421 PED I-421 PED I-421 PED 5965549 JUN 06, 2015 DP I-421 PED I-421 PED I-421 PED I-421 PED 4670444 4705789 4957922 4808583 4670444*PED 4705789*PED 4808583*PED 4957922*PED DEC NOV SEP FEB JUN MAY AUG MAR 09, 10, 18, 28, 09, 10, 28, 18, 2003 2004 2007 2006 2004 2005 2006 2008 MAR SEP MAR SEP MAR SEP MAR SEP 25, 25, 25, 25, 25, 25, 25, 25, 2007 2007 2007 2007 2007 2007 2007 2007 MAR 08, 2011 MAR 08, 2009 MAR 08, 2011 MAR 08, 2009 MAR 08, 2011 MAR 08, 2009 MAR SEP MAR SEP MAR SEP MAR SEP 25, 25, 25, 25, 25, 25, 25, 25, 2007 2007 2007 2007 2007 2007 2007 2007 FEB 24, 2007 EXCLUS CODE EXCLUS EXPIRES
CARBOPLATIN;PARAPLATIN CARBOPLATIN;PARAPLATIN CARBOPLATIN;PARAPLATIN CETIRIZINE HYDROCHLORIDE;ZYRTEC CETIRIZINE HYDROCHLORIDE;ZYRTEC CEVIMELINE HYDROCHLORIDE;EVOXAC CHLORPHENIRAMINE MALEATE;CHILDREN’S ADVIL ALL CHORIOGONADOTROPIN ALFA;OVIDREL CINACALCET HYDROCHLORIDE;SENSIPAR
021688 002
CINACALCET HYDROCHLORIDE;SENSIPAR
021688 003
CINACALCET HYDROCHLORIDE;SENSIPAR
019537 001 019537 002 019537 003 019537 004 >ADD> 020805 001 019847 001 020780 001 020780 002 019857 001 019858 001
CIPROFLOXACIN HYDROCHLORIDE;CIPRO CIPROFLOXACIN HYDROCHLORIDE;CIPRO CIPROFLOXACIN HYDROCHLORIDE;CIPRO CIPROFLOXACIN HYDROCHLORIDE;CIPRO CIPROFLOXACIN HYDROCHLORIDE;CIPRO HC CIPROFLOXACIN;CIPRO CIPROFLOXACIN;CIPRO CIPROFLOXACIN;CIPRO CIPROFLOXACIN;CIPRO IN DEXTROSE 5% CIPROFLOXACIN;CIPRO IN SODIUM CHLO
Page 5 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER 021473 002 021644 021038 021392 021392 021392 021392 021392 021392 021168 001 001 001 002 003 004 005 006 001 INGREDIENT NAME; TRADE NAME PATENT NUMBER 4670444 4670444*PED 6716867 LA LA LA LA LA LA 6528090 6713086 5212326 6528090 6528091 6713086 5212326 4959366 4959366 4959366 6316443 4797413 4619939 6703418 6703418 6703418 6703396 DEC DEC JAN DEC DEC DEC JAN SEP SEP SEP APR APR OCT FEB FEB FEB MAR 18, 18, 29, 18, 18, 18, 29, 25, 25, 25, 17, 28, 28, 26, 26, 26, 09, 2018 2018 2008 2018 2018 2018 2008 2007 2007 2007 2011 2008 2003 2011 2011 2011 2021 DP DP U579 DS DP DP DP U579 DS DP I-429 MAY 19, 2007 PATENT/PED EXCL EXPIRES DEC 09, 2003 JUN 09, 2004 MAR 31, 2019 PATENT CODE(S) DS DP U555 NDF U572 I-133 I-133 I-133 I-133 I-133 I-133 APR APR APR APR APR APR 09, 09, 09, 09, 09, 09, 2007 2007 2007 2007 2007 2007 FEB 05, 2007 EXCLUS CODE EXCLUS EXPIRES
CIPROFLOXACIN;CIPRO XR CLOBETASOL PROPIONATE;CLOBEX DEXMEDETOMIDINE;PRECEDEX DILTIAZEM HYDROCHLORIDE;CARDIZEM DILTIAZEM HYDROCHLORIDE;CARDIZEM DILTIAZEM HYDROCHLORIDE;CARDIZEM DILTIAZEM HYDROCHLORIDE;CARDIZEM DILTIAZEM HYDROCHLORIDE;CARDIZEM DILTIAZEM HYDROCHLORIDE;CARDIZEM DIVALPROEX SODIUM;DEPAKOTE ER DIVALPROEX SODIUM;DEPAKOTE ER
021168 002
020449 020931 020931 020931 020869 020408 020862 020862 018651 018651 018651 021500 021504 021371 021166 021040 020992 020992 020992 020992
001 001 002 003 001 001 001 002 001 002 003 001 001 001 001 001 002 003 004 006
DOCETAXEL;TAXOTERE DOFETILIDE;TIKOSYN DOFETILIDE;TIKOSYN DOFETILIDE;TIKOSYN DORZOLAMIDE HYDROCHLORIDE;COSOPT DORZOLAMIDE HYDROCHLORIDE;TRUSOPT DOXERCALCIFEROL;HECTOROL DOXERCALCIFEROL;HECTOROL DRONABINOL;MARINOL DRONABINOL;MARINOL DRONABINOL;MARINOL EMTRICITABINE;EMTRIVA EPINEPHRINE;LIDOSITE TOPICAL SYS ESTRADIOL HEMIHYDRATE;ESTRASORB ESTRADIOL;ESTROGEL ESTRADIOL;PREFEST ESTROGENS, CONJUGATED SYNTHETIC A;CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A;CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A;CENESTIN ESTROGENS, CONJUGATED SYNTHETIC A;CENESTIN ETHINYL ESTRADIOL;OVCON-35 FENOLDOPAM MESYLATE;CORLOPAM FINASTERIDE;PROSCAR FLUCONAZOLE;DIFLUCAN FLUCONAZOLE;DIFLUCAN FLUCONAZOLE;DIFLUCAN FLUCONAZOLE;DIFLUCAN
DP U561 DS DP U103 DP U104 I-424 I-424 U563 U563 U563 DS DP NP NDF NDF MAY 04, 2007 OCT 09, 2006 FEB 09, 2007 FEB FEB FEB FEB FEB 05, 05, 05, 05, 05, 2007 2007 2007 2007 2007 APR 23, 2007 APR 23, 2007
6747019
MAR 20, 2020
U311 D-85 D-85 D-85 NS D-85
021490 001 019922 001 020180 001 019949 001 019949 002 019949 003 019949 004
6667050 4760071 5886184 6046183 4404216 4404216*PED 4404216 4404216*PED 4404216 4404216*PED 4404216 4404216*PED
JUN 12, 2021 JUN NOV MAR JAN JUL JAN JUL JAN JUL JAN JUL 19, 19, 20, 29, 29, 29, 29, 29, 29, 29, 29, 2006 2012 2011 2004 2004 2004 2004 2004 2004 2004 2004
DP U1 I-422 DS DP U262 DS DP U577 APR 01, 2007
Page 6 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER 020090 001 020090 002 019950 003 019950 005 019950 001 019950 002 019950 004 020985 001 021235 001 >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> 021077 001 021433 001 INGREDIENT NAME; TRADE NAME PATENT NUMBER 4404216 4404216*PED 4404216 4404216*PED 4404216 4404216*PED 4404216 4404216*PED 4404216 4404216*PED 4404216 4404216*PED 4404216 4404216*PED 6670335 5910319 5985322 6170717 6315173 6510969 6743413 6253762 6546928 6170717 6315173 6510969 6743413 6253762 6546928 6170717 6315173 6510969 6743413 6253762 6546928 5929028 5767251 4589402 4589402 4589402 5929028 4589402 5767251 4589402 4589402 PATENT/PED EXCL EXPIRES JAN JUL JAN JUL JAN JUL JAN JUL JAN JUL JAN JUL JAN JUL JUN MAY MAY DEC DEC DEC JUN APR APR DEC DEC DEC JUN APR APR DEC DEC DEC JUN APR APR JAN JUN JUL JUL JUL JAN JUL JUN JUL JUL 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 29, 02, 29, 29, 23, 23, 23, 01, 14, 14, 23, 23, 23, 01, 14, 14, 23, 23, 23, 01, 14, 14, 14, 16, 26, 26, 26, 14, 26, 16, 26, 26, 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2004 2021 2017 2017 2017 2017 2017 2021 2015 2015 2017 2017 2017 2021 2015 2015 2017 2017 2017 2021 2015 2015 2018 2015 2004 2004 2004 2018 2004 2015 2004 2004 PATENT CODE(S) EXCLUS CODE EXCLUS EXPIRES
FLUCONAZOLE;DIFLUCAN FLUCONAZOLE;DIFLUCAN FLUCONAZOLE;DIFLUCAN IN DEXTROSE FLUCONAZOLE;DIFLUCAN IN DEXTROSE FLUCONAZOLE;DIFLUCAN IN SODIUM C FLUCONAZOLE;DIFLUCAN IN SODIUM C FLUCONAZOLE;DIFLUCAN IN SODIUM C FLUOROURACIL;CARAC FLUOXETINE HYDROCHLORIDE;PROZAC WEEKLY FLUTICASONE PROPIONATE;ADVAIR DISKUS 100/50 FLUTICASONE PROPIONATE;FLOVENT HFA
DP U68 U396 U397 DP DP DP DP DP DP DP DP DP DP DP DP DP DP DP DP DP DP DP DS U568 U569 U570 DP U567 U568 DS U569 U570 NP NP NP MAR 25, 2007 MAR 25, 2007 MAR 25, 2007 MAY 19, 2004 MAY 19, 2007 M-33 NP U581 U582 U583 NP U581 U582 U583 NP U581 U582 U583 U567 MAY 14, 2007 MAY 14, 2007 APR 21, 2007 MAY 14, 2007
021433 002
FLUTICASONE PROPIONATE;FLOVENT HFA
021433 003
FLUTICASONE PROPIONATE;FLOVENT HFA
021211 001
FOLLITROPIN ALFA/BETA;FOLLISTIM AQ
021211 002
FOLLITROPIN ALFA/BETA;FOLLISTIM AQ
021765 021765 021765 021493 020509 020509
001 002 003 001 001 002
FOLLITROPIN ALFA/BETA;GONAL-F FOLLITROPIN ALFA/BETA;GONAL-F FOLLITROPIN ALFA/BETA;GONAL-F GATIFLOXACIN;ZYMAR GEMCITABINE HYDROCHLORIDE;GEMZAR GEMCITABINE HYDROCHLORIDE;GEMZAR
6333045 4808614 4808614
AUG 20, 2019 MAY 15, 2010 MAY 15, 2010
DP DS DS I-428 I-428
Page 7 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER 021158 076345 076345 076345 076604 021604 076478 020723 020685 020685 020685 020685 021629 020563 020563 021425 020571 001 001 002 003 001 001 001 001 001 003 005 006 001 001 002 003 001 INGREDIENT NAME; TRADE NAME PATENT NUMBER 6723734 PATENT/PED EXCL EXPIRES MAR 20, 2018 PATENT CODE(S) DS DP PC PC PC PC NP PC I-420 6689761 6689761 6689761 6689761 6221633 4364921 4604463 6403569 4604463*PED 6403569*PED FEB FEB FEB FEB JUN MAR AUG APR FEB OCT 10, 10, 10, 10, 18, 06, 20, 28, 20, 28, 2021 2021 2021 2021 2018 2005 2007 2020 2008 2020 U554 U554 U554 U554 DS DP U471 DS DP U113 U449 M-12 M-12 M-12 M-12 NDF M-32 PED M-32 PED M-32 PED 6696493 6031007 6703403 6703403 JAN 18, 2021 APR 01, 2017 JUN 26, 2016 JUN 26, 2016 U433 NP DP U553 U257 U257 PC NPP PED NPP PED NPP PED 5747061 5747061 6676967 6676967 6676967 6683102 6683102 OCT OCT SEP SEP SEP DEC DEC 25, 25, 20, 20, 20, 03, 03, 2013 2013 2013 2013 2013 2021 2021 DP U576 DP U575 U548 U548 U548 U189 U189 NP NP APR 27, 2007 APR 27, 2007 AUG MAR SEP MAR SEP MAR SEP 20, 11, 11, 11, 11, 11, 11, 2004 2007 2007 2007 2007 2007 2007 MAR 01, 2007 AUG AUG AUG AUG MAY MAR SEP MAR SEP MAR SEP 30, 30, 30, 30, 27, 05, 05, 05, 05, 05, 05, 2005 2005 2005 2005 2007 2007 2007 2007 2007 2007 2007 OCT OCT OCT OCT JAN JUL MAR 31, 31, 31, 11, 07, 29, 02, 2004 2004 2004 2004 2007 2004 2007 EXCLUS CODE EXCLUS EXPIRES
GEMIFLOXACIN MESYLATE;FACTIVE GLYBURIDE;GLYBURIDE AND METFOR GLYBURIDE;GLYBURIDE AND METFOR GLYBURIDE;GLYBURIDE AND METFOR HYDROCODONE BITARTRATE;HYDROCODONE BITARTRA IBUPROFEN;CHILDREN’S ELIXSURE IBUPROFEN;IBUPROFEN AND PSEUDO IMIQUIMOD;ALDARA INDINAVIR SULFATE;CRIXIVAN INDINAVIR SULFATE;CRIXIVAN INDINAVIR SULFATE;CRIXIVAN INDINAVIR SULFATE;CRIXIVAN INSULIN GLULISINE RECOMBINANT;APIDRA INSULIN LISPRO RECOMBINANT;HUMALOG INSULIN LISPRO RECOMBINANT;HUMALOG PEN IOPROMIDE;ULTRAVIST (PHARMACY IRINOTECAN HYDROCHLORIDE;CAMPTOSAR
NCE D-86 D-86
APR 16, 2009 JUN 02, 2007 JUN 02, 2007
021281 021281 021428 021428 021566 020905
001 002 001 002 001 001
LANSOPRAZOLE;PREVACID LANSOPRAZOLE;PREVACID LANSOPRAZOLE;PREVACID LANSOPRAZOLE;PREVACID LANSOPRAZOLE;PREVACID IV LEFLUNOMIDE;ARAVA LEFLUNOMIDE;ARAVA LEFLUNOMIDE;ARAVA LEVOCARNITINE;CARNITOR LEVOFLOXACIN;IQUIX LIDOCAINE;ORAQIX LOPINAVIR;KALETRA LOPINAVIR;KALETRA LORATADINE;LORATADINE LOSARTAN POTASSIUM;COZAAR LOSARTAN POTASSIUM;COZAAR LOSARTAN POTASSIUM;COZAAR LOTEPREDNOL ETABONATE;ALREX LOTEPREDNOL ETABONATE;LOTEMAX LOVASTATIN;ADVICOR LOVASTATIN;ADVICOR LOVASTATIN;ADVICOR METAXALONE;SKELAXIN METAXALONE;SKELAXIN METFORMIN HYDROCHLORIDE;FORTAMET METFORMIN HYDROCHLORIDE;FORTAMET
020905 002 020905 003 020182 021571 021451 021226 021251 075505 020386 001 001 001 001 001 001 001
020386 002 020386 003 020803 020583 021249 021249 021249 013217 013217 021574 021574 001 001 001 002 003 001 002 001 002
Page 8 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER 076545 021308 076307 076307 020762 >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> 001 001 001 002 001 INGREDIENT NAME; TRADE NAME PATENT NUMBER PATENT/PED EXCL EXPIRES PATENT CODE(S) EXCLUS CODE PC RTO PC PC 6723713 6723713*PED 5723147 5807572 5891467 5931089 5997899 5962016 6071534 6171613 6193998 6241999 5723147 5807572 5891467 5931089 5997899 5962016 6071534 6171613 6193998 6241999 5723147 5807572 5891467 5931089 5997899 5962016 6071534 6171613 6193998 6241999 6716830 6716830*PED 6676967 6676967 6676967 5229382 5229382 5229382 5229382 5229382 5229382 5229382 5229382 5229382 5229382 JAN JUL MAR SEP JAN JUL SEP JAN FEB OCT SEP SEP MAR SEP JAN JUL SEP JAN FEB OCT SEP SEP MAR SEP JAN JUL SEP JAN FEB OCT SEP SEP SEP MAR SEP SEP SEP APR APR APR APR APR APR APR APR APR APR 27, 27, 03, 15, 31, 14, 01, 31, 18, 01, 01, 01, 03, 15, 31, 14, 01, 31, 18, 01, 01, 01, 03, 15, 31, 14, 01, 31, 18, 01, 01, 01, 20, 29, 20, 20, 20, 23, 23, 23, 23, 23, 23, 23, 23, 23, 23, 2014 2014 2015 2015 2017 2015 2016 2017 2008 2016 2016 2016 2015 2015 2017 2015 2016 2017 2008 2016 2016 2016 2015 2015 2017 2015 2016 2017 2008 2016 2016 2016 2019 2020 2013 2013 2013 2011 2001 2011 2011 2011 2011 2011 2011 2011 2011 U574 DP U584 DP DP U584 DP DP U584 DP DP DP DP U584 DP DP U584 DP DP U584 DP DP DP DP U584 DP DP U584 DP DP U584 DP DP DP DP U548 U548 U548 DS DP U149 U547 DS DP U149 U547 DS DP U149 U547 DS DP U149 U547 DS DP U149 U547 PC NDF I-417 I-417 I-417 I-417 I-417 SEP 19, 2004 MAY 25, 2007 JAN 14, 2007 JAN 14, 2007 JAN 14, 2007 JAN 14, 2007 JAN 14, 2007 EXCLUS EXPIRES MAY JUN JUN JUN 29, 29, 14, 14, 2004 2004 2004 2004
METFORMIN HYDROCHLORIDE;METFORMIN HCL MICONAZOLE NITRATE;MONISTAT 1 COMBINATI MIRTAZAPINE;MIRTAZAPINE MIRTAZAPINE;MIRTAZAPINE MOMETASONE FUROATE MONOHYDRATE;NASONEX MORPHINE SULFATE;DEPODUR
021671 001
021671 002
MORPHINE SULFATE;DEPODUR
021671 003
MORPHINE SULFATE;DEPODUR
021598 001 020381 020381 020381 076648 021494 020592 002 003 004 001 001 001
MOXIFLOXACIN HYDROCHLORIDE;VIGAMOX NIACIN;NIASPAN NIACIN;NIASPAN NIACIN;NIASPAN NITROFURANTOIN;NITROFURANTOIN (MONO NIZATIDINE;AXID OLANZAPINE;ZYPREXA OLANZAPINE;ZYPREXA OLANZAPINE;ZYPREXA OLANZAPINE;ZYPREXA OLANZAPINE;ZYPREXA
NCE PED
DEC 10, 2004 JUN 10, 2005
020592 002 020592 003 020592 004 020592 005
Page 9 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER 020592 006 021253 001 021086 001 021086 002 021086 003 021086 004 021087 001 INGREDIENT NAME; TRADE NAME PATENT NUMBER 5229382 5229382 5229382 PATENT/PED EXCL EXPIRES APR 23, 2011 APR 23, 2011 APR 23, 2011 PATENT CODE(S) DS DP U149 DS DP U547 DS DP U571 EXCLUS CODE I-417 NDF NP I-417 I-400 I-417 I-400 I-417 I-400 I-417 I-400 NCE PED EXCLUS EXPIRES JAN 14, 2007 MAR MAR JAN JUL JAN JUL JAN JUL JAN JUL OCT APR 29, 29, 14, 10, 14, 10, 14, 10, 14, 10, 27, 27, 2007 2007 2007 2006 2007 2006 2007 2006 2007 2006 2004 2005
OLANZAPINE;ZYPREXA OLANZAPINE;ZYPREXA OLANZAPINE;ZYPREXA ZYDIS OLANZAPINE;ZYPREXA ZYDIS OLANZAPINE;ZYPREXA ZYDIS OLANZAPINE;ZYPREXA ZYDIS OSELTAMIVIR PHOSPHATE;TAMIFLU
021246 001
OSELTAMIVIR PHOSPHATE;TAMIFLU
5763483 5866601 5952375 5763483*PED 5866601*PED 5952375*PED 5866601 5952375 5763483 5763483*PED 5866601*PED 5952375*PED 5872147 6670351 6576659 6090799 5872147 6670351 6576659 6090799 6743441
DEC FEB FEB JUN AUG AUG FEB FEB DEC JUN AUG AUG DEC OCT DEC JUL DEC OCT DEC JUL APR
27, 02, 02, 27, 02, 02, 02, 02, 27, 27, 02, 02, 05, 20, 05, 18, 05, 20, 05, 18, 26,
2016 2016 2016 2017 2016 2016 2016 2016 2016 2017 2016 2016 2017 2012 2017 2017 2017 2012 2017 2017 2020
NCE PED U376
OCT 27, 2004 APR 27, 2005
>ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD> >ADD>
021492 001 021492 002 013718 001
OXALIPLATIN;ELOXATIN OXALIPLATIN;ELOXATIN OXANDROLONE;OXANDRIN
I-425 I-425 U585 U585 U585 U585 U585 U585 U585 U585 DP U318 PC M-31 PED M-31 PED
JAN 09, 2007 JAN 09, 2007
013718 002
OXANDROLONE;OXANDRIN
021351 002 076168 001 020819 001 020819 002
OXYBUTYNIN;OXYTROL OXYCODONE HYDROCHLORIDE;OXYCODONE HCL PARICALCITOL;ZEMPLAR PARICALCITOL;ZEMPLAR
021462 001 020639 001 020639 002
PEMETREXED DISODIUM;ALIMTA QUETIAPINE FUMARATE;SEROQUEL QUETIAPINE FUMARATE;SEROQUEL
5246925 5246925*PED 5587497 5587497*PED 6136799 6136799*PED 6361758 6361758*PED 5217974 5344932 4879288 4879288
APR OCT DEC JUN APR OCT APR OCT MAR SEP SEP
17, 17, 24, 24, 08, 08, 08, 08, 29, 06, 26,
2012 2012 2013 2014 2018 2019 2018 2018 2011 2011 2011
U314
SEP MAR OCT MAR OCT
26, 31, 01, 31, 01,
2004 2007 2007 2007 2007
DP U551 DS DP DS DP U550 DS DP U550 NCE ODE I-419 I-418 I-419 I-418 FEB FEB JAN JAN JAN JAN 04, 04, 12, 12, 12, 12, 2009 2011 2007 2007 2007 2007
SEP 26, 2011
Page 10 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER 020639 003 020639 004 020639 005 020741 020741 020741 020903 001 002 003 002 INGREDIENT NAME; TRADE NAME PATENT NUMBER 4879288 4879288 4879288 6677358 6677358 6677358 6177074 6177074*PED 6461605 6461605*PED 6472373 6472373*PED 6524570 6524570*PED PATENT/PED EXCL EXPIRES SEP 26, 2011 SEP 26, 2011 SEP 26, 2011 JUN JUN JUN NOV MAY NOV MAY SEP MAR NOV MAY 12, 12, 12, 01, 01, 01, 01, 21, 21, 01, 01, 2018 2018 2018 2016 2017 2016 2017 2017 2018 2016 2017 PATENT CODE(S) DS DP U550 DS DP U550 DS DP U550 DS DP U546 DS DP U546 DS DP U546 U454 U454 U478 U478 U479 U479 U499 U499 PC PC NCE 6703403 6703403 5474995 5691374 6063811 6239173 5474995*PED 5691374*PED 6063811*PED 6239173*PED 5474995 5691374 6063811 6239173 5474995*PED 5691374*PED 6063811*PED 6239173*PED 6239173 5474995 5691374 6063811 5474995*PED 5691374*PED 6063811*PED 6239173*PED 5474995 5691374 6063811 6239173 5474995*PED 5691374*PED 6063811*PED 6239173*PED JUN JUN JUN MAY MAY JUN DEC NOV NOV DEC JUN MAY MAY JUN DEC NOV NOV DEC JUN JUN MAY MAY DEC NOV NOV DEC JUN MAY MAY JUN DEC NOV NOV DEC 26, 26, 24, 18, 06, 24, 24, 18, 06, 24, 24, 18, 06, 24, 24, 18, 06, 24, 24, 24, 18, 06, 24, 18, 06, 24, 24, 18, 06, 24, 24, 18, 06, 24, 2016 2016 2013 2015 2017 2013 2013 2015 2017 2013 2013 2015 2017 2013 2013 2015 2017 2013 2013 2013 2015 2017 2013 2015 2017 2013 2013 2015 2017 2013 2013 2015 2017 2013 U564 U564 DS DP U266 U266 DS DP U266 NCE I-353 M-27 PED PED PED I-423 NCE I-353 M-27 PED PED PED I-423 NCE I-353 M-27 PED PED PED I-423 NCE I-353 M-27 PED PED PED OCT 03, 2004 OCT 03, 2004 MAY 25, 2009 MAY APR AUG NOV OCT FEB MAR MAY APR AUG NOV OCT FEB MAR MAY APR AUG NOV OCT FEB MAR MAY APR AUG NOV FEB OCT 20, 11, 06, 20, 11, 06, 26, 20, 11, 06, 20, 11, 06, 26, 20, 11, 06, 20, 11, 06, 26, 20, 11, 06, 20, 06, 11, 2004 2005 2006 2004 2005 2007 2007 2004 2005 2006 2004 2005 2007 2007 2004 2005 2006 2004 2005 2007 2007 2004 2005 2006 2004 2007 2005 EXCLUS CODE I-419 I-418 I-419 I-418 I-419 I-418 EXCLUS EXPIRES JAN JAN JAN JAN JAN JAN 12, 12, 12, 12, 12, 12, 2007 2007 2007 2007 2007 2007
QUETIAPINE FUMARATE;SEROQUEL QUETIAPINE FUMARATE;SEROQUEL QUETIAPINE FUMARATE;SEROQUEL REPAGLINIDE;PRANDIN REPAGLINIDE;PRANDIN REPAGLINIDE;PRANDIN RIBAVIRIN;REBETOL
076203 076192 021361 020659 020945 021042
001 001 001 001 001 001
RIBAVIRIN;RIBASPHERE RIBAVIRIN;RIBAVIRIN RIFAXIMIN;XIFAXAN RITONAVIR;NORVIR RITONAVIR;NORVIR ROFECOXIB;VIOXX
021042 002
ROFECOXIB;VIOXX
DS DP U266 U266 DS DP U266
021042 003
ROFECOXIB;VIOXX
DS DP U266 DS DP U266
021052 001
ROFECOXIB;VIOXX
U266 U266
Page 11 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER 021052 002 INGREDIENT NAME; TRADE NAME PATENT NUMBER 5474995 5691374 6063811 6239173 5474995*PED 5691374*PED 6063811*PED 6239173*PED 6727283 6509013 6509013 4968299 5096885 5096885 5763394 5763394 4816470 5037845 4816470*PED 5037845*PED 4816470 5037845 6368627 5863559 6020001 6020001*PED 6368627*PED 4816470*PED 5037845*PED 5863559*PED 4816470 5037845 6368627 5863559 6020001 6020001*PED 6368627*PED 4816470*PED 5037845*PED 5863559*PED 5037845 4816470 6368627 5863559 6020001 6020001*PED 6368627*PED 4816470*PED 5037845*PED 5863559*PED PATENT/PED EXCL EXPIRES JUN MAY MAY JUN DEC NOV NOV DEC 24, 18, 06, 24, 24, 18, 06, 24, 2013 2015 2017 2013 2013 2015 2017 2013 PATENT CODE(S) U266 U266 EXCLUS CODE NCE I-353 M-27 PED PED PED ODE NCE OCT 11, 2019 AUG 11, 2013 AUG 11, 2013 JUN MAR MAR JUN JUN DEC AUG JUN FEB DEC AUG MAR JAN MAR SEP SEP JUN FEB JUL DEC AUG MAR JAN MAR SEP SEP JUN FEB JUL AUG DEC MAR JAN MAR SEP SEP JUN FEB JUL 28, 17, 17, 09, 09, 28, 06, 28, 06, 28, 06, 02, 26, 02, 02, 02, 28, 06, 26, 28, 06, 02, 26, 02, 02, 02, 28, 06, 26, 06, 28, 02, 26, 02, 02, 02, 28, 06, 26, 2008 2009 2009 2015 2015 2006 2008 2007 2009 2006 2008 2012 2016 2012 2012 2012 2007 2009 2016 2006 2008 2012 2016 2012 2012 2012 2007 2009 2016 2008 2006 2012 2016 2012 2012 2012 2007 2009 2016 DP U580 NCE I-386 DP DP DP DP DP U72 U72 U72 U72 U444 U72 U444 SEP 15, 2004 APR 11, 2006 EXCLUS EXPIRES MAY APR AUG NOV FEB OCT 20, 11, 06, 20, 06, 11, 2004 2005 2006 2004 2007 2005
ROFECOXIB;VIOXX
021256 001 020990 020926 021179 021110 020280 020168 020168 020522 020522 020080 001 001 001 003 004 001 002 001 002 001
SECRETIN SYNTHETIC HUMAN;HUMAN SECRETIN SERTRALINE HYDROCHLORIDE;ZOLOFT SEVELAMER HYDROCHLORIDE;RENAGEL SEVELAMER HYDROCHLORIDE;RENAGEL SIROLIMUS;RAPAMUNE SOMATROPIN RECOMBINANT;GENOTROPIN PRESERVAT SOMATROPIN RECOMBINANT;NUTROPIN SOMATROPIN RECOMBINANT;NUTROPIN SOMATROPIN RECOMBINANT;NUTROPIN AQ SOMATROPIN RECOMBINANT;NUTROPIN AQ PEN SUMATRIPTAN SUCCINATE;IMITREX
APR 04, 2009 APR 09, 2009
020132 001
SUMATRIPTAN SUCCINATE;IMITREX
020132 002
SUMATRIPTAN SUCCINATE;IMITREX
U72 U72 U444 U72 U444
020132 003
SUMATRIPTAN SUCCINATE;IMITREX
U72 U72 U444 U72 U444
Page 12 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER 020626 001 INGREDIENT NAME; TRADE NAME PATENT NUMBER 4816470 5037845 5307953 5554639 5705520 5554639*PED 5705520*PED 4816470*PED 5037845*PED 5307953*PED 4816470 5037845 5307953 5554639 5705520 5554639*PED 5705520*PED 4816470*PED 5037845*PED 5307953*PED 4816470 5037845 5307953 5554639 5705520 5554639*PED 5705520*PED 4816470*PED 5037845*PED 5307953*PED 5859006 6140329 5859006 6140329 5859006 6140329 D459798 5635485 5681849 4755534 4680291 6121314 5681849 6121314 6121314 6121314 6005001 6005001 6005001 5856355 5856355 5856355 PATENT/PED EXCL EXPIRES DEC AUG DEC SEP DEC MAR JUN JUN FEB JUN DEC AUG DEC SEP DEC MAR JUN JUN FEB JUN DEC AUG DEC SEP DEC MAR JUN JUN FEB JUN JAN JUL JAN JUL JAN JUL SEP APR OCT DEC JUL MAY OCT MAY MAY MAY MAY MAY MAY MAY MAY MAY 28, 06, 02, 10, 10, 10, 10, 28, 06, 02, 28, 06, 02, 10, 10, 10, 10, 28, 06, 02, 28, 06, 02, 10, 10, 10, 10, 28, 06, 02, 12, 11, 12, 11, 12, 11, 24, 21, 28, 30, 14, 18, 28, 18, 18, 18, 18, 18, 18, 18, 18, 18, 2006 2008 2012 2013 2011 2014 2012 2007 2009 2013 2006 2008 2012 2013 2011 2014 2012 2007 2009 2013 2006 2008 2012 2013 2011 2014 2012 2007 2009 2013 2016 2016 2016 2016 2016 2016 2015 2015 2014 2006 2004 2012 2014 2012 2012 2012 2012 2012 2012 2012 2012 2012 PATENT CODE(S) U72 U232 U232 EXCLUS CODE EXCLUS EXPIRES
SUMATRIPTAN;IMITREX
020626 002
SUMATRIPTAN;IMITREX
U72 U232 U232
020626 003
SUMATRIPTAN;IMITREX
U72 U232 U232
021368 001 021368 002 021368 003 021388 001 021144 001 021124 002
TADALAFIL;CIALIS TADALAFIL;CIALIS TADALAFIL;CIALIS TALC;TALC TELITHROMYCIN;KETEK TERBINAFINE HYDROCHLORIDE;LAMISIL AT
DS DP DP U155 DS DP DP U155 DS DP DP U155 DP DS DP U578 U73 U73 U504 DP DP DP DP DP U504 U540 U502 U540 U502 U504 DP U502 U504 U540 ODE NCE DEC 24, 2004 APR 01, 2009
020846 001
TERBINAFINE;LAMISIL
Page 13 of 13 PATENT TERM EXTENSION AND NEW PATENTS - JUNE 30, 2004 DOCKET NUMBER *95S-0117 See report footnotes for information regarding report content APPL/PROD NUMBER 020898 021618 021618 021395 020771 020505 020505 020505 020505 020505 020505 020844 020844 020844 021257 001 001 002 001 002 001 002 003 004 005 006 001 002 003 001 INGREDIENT NAME; TRADE NAME PATENT NUMBER 6365127 5610163 5559269 5559269*PED PATENT/PED EXCL EXPIRES NOV 24, 2015 MAR 11, 2014 NOV 05, 2013 MAY 05, 2014 PATENT CODE(S) DS DP U556 DS DP U566 U318 NCE NCE NCE D-88 D-88 D-88 D-88 D-88 D-88 D-88 D-88 D-88 6011062 5849792 5889052 5510383 4859660 5116844 5364938 5567817 5773443 DEC DEC DEC AUG NOV AUG NOV OCT JAN 22, 22, 02, 03, 19, 11, 15, 22, 25, 2014 2014 2014 2013 2007 2009 2011 2013 2011 DP DP U383 DP U383 DP U383 NCE DP U540 DS DS DP U540 DS DP U540 NCE I-409 MAY 28, 2009 MAY 24, 2007 NOV 14, 2006 MAY 17, 2009 MAY 17, 2009 JAN 30, 2009 DEC DEC DEC DEC DEC DEC DEC DEC DEC 16, 16, 16, 16, 16, 16, 16, 16, 16, 2006 2006 2006 2006 2006 2006 2006 2006 2006 EXCLUS CODE EXCLUS EXPIRES
THYROTROPIN ALFA;THYROGEN TINIDAZOLE;TINDAMAX TINIDAZOLE;TINDAMAX TIOTROPIUM BROMIDE MONOHYDRATE;SPIRIVA TOLTERODINE TARTRATE;DETROL TOPIRAMATE;TOPAMAX TOPIRAMATE;TOPAMAX TOPIRAMATE;TOPAMAX TOPIRAMATE;TOPAMAX TOPIRAMATE;TOPAMAX TOPIRAMATE;TOPAMAX TOPIRAMATE;TOPAMAX SPRINKLE TOPIRAMATE;TOPAMAX SPRINKLE TOPIRAMATE;TOPAMAX SPRINKLE TRAVOPROST;TRAVATAN
>ADD>
021595 001 020675 001 021630 001
TROSPIUM CHLORIDE;SANCTURA URSODIOL;URSO VORICONAZOLE;VFEND
Footnotes: 1. Patents are published upon receipt by the Orange Book Staff and may not reflect the official receipt date as describled in 21 CFR 314.53(c)(3)(5). 2. Patents submitted on FDA Form 3542 and listed after August 18, 2003 will have one to three patent codes indicating specific patent claims as submitted by the sponsor: DS = Drug Substance claim DP = Drug Product claim U and number = Method of Use claim (may be multiple). Specific Method of use claims are listed at http://www.fda.gov/cder/orange/patex.htm 3. Patents listed prior to August 18, 2003 are flagged with method of use claims only as applicable and submitted by the sponsor. They may not be flagged with respect to other claims which may apply. 4. *PED and PED represent pediatric exclusivity. Patents with pediatric exclusivity granted after August 18, 2003 will be indicated with *PED as was done prior to August 18, 2003. Patents with *PED added after August 18, 2003 will not contain any information relative to the patent itself other than the *PED extension. Information related specifically to the patent will be conveyed on the original patent only.