Drugs Off-Patent Reports
Drugs Off-Patent Reports 2 Over USD $100 million
PHARMACEUTICALDRUG DEVELOPMENT
D R U G SD R U G SoFF-Patents
REPORTSREPORTS
2000ISSN 0793 694X
L O C U M P U B L I S H I N G H O U S E
Drugs Off-Patent Reports
Drugs Off-Patent Reports 3 Over USD $100 million
SERIAL NUMBER - DO NO REMOVE! - REGISTERED WITH
LOCUM INTERNATIONAL PUBLISHERS REGISTRATION SERVICESWARNING: THIS ISSUE A IS MULTIPLE PAGE UV ENCODED EDITION.
Drugs Off-Patent Reports
First International Edition - 01.First published and distributed in UK, US, EU, RSA, Israel and Japan in November 1996: byLocum International Publishing House (Houston, Israel, South Africa). Second InternationalEdition - 02 (First to Fourth Print). Third International Edition - 04 (First to Fourth Print).Fourth printing published and distributed in UK, US, EU, Israel, Asia, and Japan in January2001 by Locum International Publishing House (Houston, Israel, South Africa) in HardCover; Soft and Spiral Cover; Electronic Diskette; and e-mail attachment versions. All printand electronic versions identical in content and format.
Copyright © 1995 - 2001, Handbook of Pharmaceutical Generic Development.Text Copyright © 1995 - 2000, Handbook of Pharmaceutical Generic Development.Illustration copyright © 1995 - 2000, Handbook of Pharmaceutical Generic Development.Locum International Publishing House PO Box 874, 50 Gilad Street Kochav Yair 44864Israel. - All right reserved.
ISSN 0793 8632ISSN 0793 8640 - Electronic Version (Diskette, CD ROM and e-mail attachment version)Handbook Development 24 volume seriesGeneral Generic Development ISSN Series number 0793 7407General Generic Development ISSN Series number 0793 7792 - Electronic Issue (Disketteand e-mail attachment version are identical in size and content to the printed hard or softcover version.)
Duplication: No part of this publication may be reproduced, stored in a retrievalsystem or transmitted in any form or by any means, electronic, mechanical,photocopying, microfilming, recording or otherwise, without the prior writtenpermission of the copyright owner or subject to the following conditions:Authorization to photocopy items for internal or personal use or internal or personaluse of specific company personnel, is granted by Locum International PublishingHouse, provided that the base fee of $1 per page is paid directly to the CopyrightClearance Center (CCC) 222 Rosewood Drive, Danvers, MA 01923 USA. Fororganizations that have been granted a photocopy license by CCC, a separatesystem of payment has been arranged.For additional information, contact the Publications Department Locum InternationalPublishing House; PO Box 874, 50 Gilad Street, Kochav Yair, 44864 Israel.
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Drugs Off-Patent Reports
Drugs Off-Patent Reports 4 Over USD $100 million
L o c u m I n t e r n a t i o n a lISSN 0793 694X
L o c u m I n t e r n a t i o n a l P u b l i s h e r s
A IAGIM DrugDevelopmentPublication
DRUGSDRUGSoverover
$100m
Copyright ©1995-2001 by LocumPublishing House Inc. All RightsReserved.
Neither this drug development letter norany part may be reproduced ortransmitted in any form or by any means,electronic or mechanical, includingphotocopying, microfilming andrecording, or by any information storageand retrieval system, without thepermission of the publishers.
A L o c u m H o u s e P u b l i c a t i o n
Drugs Off-Patent Reports
Drugs Off-Patent Reports 5 Over USD$ 100 million
P H A R M A C E U T I C A L
DRUG DEVELOPMENT
DRUGSOFF-Patents
ReportsReports
2000ISSN 0793 694X
[This report consists of 24 pages]
Drugs Off-Patent Reports
Drugs Off-Patent Reports 6 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
HOW THE CODES WORK
Generic Drug Products generally have two codes namely a PATENT USE Code andan EXCLUSIVITY code. These two patent protection codes usually expire at quitedifferent times.
Generally when the New Chemical Entity (NCE) expires the Generic equivalent ofthe Brand Leader may be manufactured after appropriate ANDA approval. Howeverseveral exclusivity's may be in force (i.e. the 'N' or 'D' codes) such as 'New Dosage','New Salt' or 'New Strength' etc. The 'D codes' apply to New Dosing Schedules andare much less common.
Naturally the package insert of an on-market generic drug will not show a newindication still protected by an I-code exclusivity. Thus I-code exclusivity's may run forseveral years while the generic is being marketed. The same applies for the 'N' and'D' codes as well.
Drug OFFDrug OFFor ONor ONPatentPatent
GenericName
PatentHolder
Marketer
PatentExpiry
+
ExclusivityExpiry
Patent&
Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)
More thanone namemay exist
U-Codesapply here
All othercodes
apply here
DD/MM/YY InMillionsof US
Dollars
The Codes:-NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for 'Therapeutic Use' stillunder Patent Protection.
I = Code for New SpecificIndication under ExclusivityProtection.
D = New Dosing Schedule
U-Codes
Apply to thisPatent # andthis Patent
date.Several
Patents mayexist for each
Generic
The following codesapply to this
exclusivity date:-All
I-codesD-codes
NCENDFNENCNSNP
ODE
This Date is theearliest generic
marketing date andmay apply to eitherthe patent expiry ora Exclusivity Expiry.
NOTEIn many cases an
OFF-Patent Genericmay have anON-Patent
I Code; U Code or Ncode
Drugs Off-Patent Reports
Drugs Off-Patent Reports 7 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Electronic < Reports on DiskReports on Web :
e-- ReportsÏ20v01Ò
Drugs Over $100 million US DollarsYear of Expiration - 1997
Drug OFFDrug OFFPatentPatent
GenericName
PatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Bactroban Mupirocin SKB 1/31/95
06/08/92
1/31/97
1/31/97
-
-
Expired 180204
Lodine Etodolac AHP/WyeAyerst
2/28/95
6/1/91
2/28/97
2/28/97
NCE Expired 372411
Timoptic Timololmaleate
Merck &Co
3/25/97
9/26/95
-
3/25/97
Expired 245
270
Trental Pentoxi-
fylline
Hoechst-
Roussel
6/5/90
8/30/85
4/3/97
4/3/97
Expired 314346
Zovirax Acyclovir BW 4/22/97
8/27/95
-
4/22/97
1.71 Expired 354394
Glucotrol
XL
Glipizide Pfizer/
Pratt
4/26/97
N/A 4/26/97
NDF Expired 153170
Zantac Ranitidine Glaxo
Wellcome
12/5/95
7/25/97
-
7/25/97
D-21,
I-116
Expired 26882934
Taxol Paclitaxel B-M-S 12/29/97
N/A
-
12/29/97
I - 77,
NP,NCE
Expired 513572
Toradol Ketorolac
trometh-
amine
Roche/
Syntex
5/16/95
7/14/96
5/16/97
5/16/97
NR Expired 295331.
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for 'Therapeutic Use' stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
1Includes Generics
Drugs Off-Patent Reports
Drugs Off-Patent Reports 8 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 1998
Drug OFFDrug OFFPatentPatent
GenericName
PatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATEmm/dd/YY
CODES DATE USD$(Mil)
RETIN A TretinoinGel
Ortho/J&J 1/02/984-247-547
1/27/98 - Expired 101121
Paraplatin Carboplatin B-M-S 2-20-96
6/8/92
8/28/98
8/28/98
- Expired 255285
Lescol Fluvastatin SandozNovartis
12/31/98
NA
-
12/31/98
D-31
NCE
Expired 349386
DiltazemHCl
Tiazac Forest/Biovail
6/25/135-529-791
9/11/98 NS Expired 120166
OxycodoneHCl
Oxycontin PerdueFrederick
2/05/08 12/12/985-266-331
NDF Expired 300343
FluvastitinSodium
Lescol Norvaris 10/11/115-354-772
12/31/98 NCE Expired 247276.
Drug OFFDrug OFFPatentPatent
GenericName
PatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
Drugs Off-Patent Reports
Drugs Off-Patent Reports 9 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 1999
Drug OFFDrug OFFPatentPatent
GenericName
PatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)
Primaxin Imipenencilastatin Na
Merck &Co
2/18/994-194-047
M/D/YY - Expired 139154
DiclofenacNa
Voltarin XR Novartis P 3/8/99 -NDF
Expired 132158
EtodolacCR
Londine XL AHPWyeth
10/30/074-966-768
10\25\99 Expired 150181
NIZEROL Ketaconazole JNJJanson 6/15/99
I - 88 Expired 155186
Zoladex Goserelinacetate
Zeneca 4/22/99 I - 88 Expired 138162
Daypro Oxaprozin SearleMonsanto
P10/29/99
NCE Expired 252360.
Norcuron Vecuroniumbromide
Organon 8/20/99 -8/20/99
- Expired 150152
VancenaseAQ
Beclomethasone
dipropionate
Schering-Plough
P -6/26/99 NP
Expired 285315
VancenasePlain
Beclomethasone
dipropionate
Schering-Plough
12/21/994-364-923
M/D/YY-
Expired 6582
Vanceril Beclomethasone
dipropionate
Schering-Plough
Key
12/21/994-364-923
M/D/YY-
Expired 190211
Unasyn Ampicillin Sod/sulbactam
Sod.
Pfizer 11/18/974-234-579
M/D/YY - Expired 184199
Versed Inj. Midazolam Roche/Syntex
11/18/99 12/20/9912/20/99
- Expired 310353
NicodermCQ
Nicotine SKB -8/2/99
NP Expired 160177
Azmacort Triamcinaloneacetonide
RPR -18,117
-10/30/99
D-7 Expired 255273
Luvox Fluvoxaminemaleate
U.S.Phillips
P12/05/99
NCE Expired 179201
OmnipaqueIohexal Sanofi
12/26/994-250-133
M/D/YY - Expired 265292
Lamisilcream
TerbinafineHCl
Novartis 12/30/064-755-534 12/30/99
U-73NCE
Expired 415452.
Beconase+
Beclovent
Beclomethasone
dipropionateGlaxo-
Wellcome
12/21/994-364-92312/21/99
4-364-924
M/D/YY - Expired 130456289
Drugs Off-Patent Reports
Drugs Off-Patent Reports 10 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2000Drug OFFDrug OFF
PatentPatentGeneric
NamePatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)
Vasotec Enalaprilat Merck &Co.
2/22/004-374-829
2/22/00-- Expired
02/22/00725860
Hismanal Astemizole JNJ-Janssen
4/3/004-219-559
M/D/YY -- Expired04/03/00
2833
Buspar BuspironeHCl
B-M-S 5/22/004-182-763
5/22/00 U-13 Expired05/22/00
540611
Lotrisone Betamethazone Diprop
Schering 10/06/004-298-604
M/D/YY -- Expired10/06/00
201233
Pepcid Famotidine Merck& Co.
10/15/004-283-408
M/D/YY -- Expired10/15/00
13501487
PepcidAC
Famotidine Merck& Co.
10/15/004-283-408 04/28/98
NS Expired10/15/00
125138
GlucotrilXL
Glipizide PfizerPratt --
11/25/00 NDF Expired11/25/00
179199
Intal Cormolynsodium
Rhone-Poulenc-
Rorer
9/20/004-405-598
M/D/YY -- Expired09/20/00
8998
Glucophage
MetforminHCl
BMSquibb
3/03/00-
M/D/YY NCE Expired3/03/00
11101302.
Ultram TramadolHcl
J/J - McNeil P M/D/YY NCE Expired
03/03/00
453501.
ZIAC Bisoprololfumerate
AHPLederle
3/24/004-258-062 7/31/97
U-63NCE
03/24/00 173198
CEFTIN Cefuroximeacetil
GW 5/12/004-267-320
M/D/YY -- Expired05/12/00
425485.
Atrovent IpratropiumBr
BIngelheim
5/24/004-385-048 10/20/98
NDFU-119
Expired05/24/00
306346
Cardura Doxazosinmesylate
Pfizer 10/18/004-188-390 2/6/98
NCE1-96
Expired10/18/00
330401
ZOLADEX GoserelinAcetate
Zeneca 4/22/994-100-274
6/27/00 --I-191
Expired06/27/00
219244
Sevo-flurane
ULTANE Abbott 12/26/044-250-334
6/7/00NCE Expired
06/07/00114134
Terazosin Hytrin Abbott 2/17/004-251-532
M/D/YY -- Expired02/17/00
425598.
Neurontin Gabapentin WLAP Davis
01/16/00
5-084-479
12/30/98 U-106(Epilepsy)
Expired01/16/00
500590
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use still I = Code for specific Indication D = New Dosing Schedule
Drugs Off-Patent Reports
Drugs Off-Patent Reports 12 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2001Drug OFFDrug OFF
PatentPatentGeneric
NamePatentHolder
Marketer
PatentExpiry
Exclusivity
Expiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATEMM/DD/YY
USD$(Mil)
Calcitriolinj
Calcijex Abbott 1/28/014-308-264
1/28/01 - 01/28/01 190210
Prilosec Omperazole
AstraZeneca
4/5/014-255-431
3/22/99 U-108I-23
10/01/01 34953540
Mertazapine
REMERON Organon P 6/14/01 NCE 06/14/01 132134
Mevacor Lovastin Merck & Co 6/15/014-231-938
2/8/98 -I-117
06/15/01 595300.
Accutane Isotretinoin Roche[Syntex]
8/7/014-464-394
M/D/YY -- 08/07/01 395462.
Brimonidine Alphagan Allergan P 9/06/01 -NCE
09/06/01 98101
PLENDIL Felodipine Merck& Co.
6/19/014-264-611
M/D/YY U-3 06/19/01 150178
Xalatan Latanoprost
Pharmacia P 6/05/01 NCE 06/05/01 507510
Levo-floxacin
levaquin RWJ -- 12/17/01 I-246 12/17/01 288310
Lovenox Enox-aparin Na
RPR 12/04/014-692-435
05/06/00 U-122NCEI-192
12/04/01 299320
Milrinone Primacor Sanofi 2/2/014-313-951
M/D/YY - 02/02/01 101110
Tercon-azole
TERAZOL J+J 11/09/014-358-449
M/D/YY - 11/09/01 103114
Lisinopril Zestril Astra-Zeneca
12/30/014-374-829
11/24/98 -I-141
12/30/01 600646
Lisinopril Prinivil Merck& Co.
12/30/014-374-829
11/24/98 I-141 12/30/01 350365
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
Drugs Off-Patent Reports
Drugs Off-Patent Reports 13 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2002
Drug OFFDrug OFFPatentPatent
GenericName
PatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivit
y
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Axid Nizatidine Lilly 4/12/02
4-375-547
4/12/02 -- 04/12/02 340255
Suprax Cefixime AHP/
Lederle
10/11/02
4-409-214
M/D/YY -- 10/11/02 105
121
Effexor Venlafa-xine
AHP/
Wyeth
Ayerst
12/13/02
4-535-186
12/28/98 -
NCE
12/13/02 205
Cordarone Amio
darone
AHP/Wyeth
AyerstP
08/03/02 -
ODE
08/03/02 250
Optiray320
Ioversol Mallinc 12/30/024-396-598
M/D/YY -- 12/30/02 168
Optiray350
Ioversol Mallinc 12/30/024-396-598
M/D/YY -- 12/30/02 69
Monopril /Vasopril
(10.20mg)
FosinoprilNa
BMS 12/4/02
4-337-201
05/02/98 -
I-92
12/04/02 202
Relafen Nambutone Smith
Kline
Beecham
12/13/02
4-420-639
M/D/YY -- 12/13/02 450380
Trovaflox-acin
mesylate
TROVAN Pfizer -- 12/18/02 -
NCE
12/18/02 160155
Carvedilol Coreg SKB 3/5/024-503-067
9/14/00 U-3NCE
03/05/02 100101
Midazolam VERSEDinj
Roche 6/20/004-280-957
4/15/02 PED 04/15/02 324380
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
Drugs Off-Patent Reports
Drugs Off-Patent Reports 14 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2003Drug OFFDrug OFF
PatentPatentGeneric
NamePatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Fluoxitine Prozac Lilly 12/2/034-626-549
M/D/YY - 12/02/03 22813200
Cipro Cipro-floxacin
Beyer/Miles
12/9/034-670-444
6/03/00 -
I-18812/09/03 908
997
Ketoconazole
NIZORAL JJ- 2/11/03
4-942-162
5/30/00 -
I-18602/11/03 158
180
Floxin Ofloxacin JNJ-
McNeil
09/02/034-382-892
12/16/00 -
I-17409/02/03 190
211
Flovent
Fluticasone
propionate
Glaxo
Wellcome
11/14/034-335-121
10/07/00 -
NDF11/14/03 294
301
Flonase
Flutica-
sone
propionate
Glaxo
Wellcome
11/14/034-335-121
10/19/97 -
NDF11/14/03 440
488
Serzone Nefaz
odone HCl
BMS 03/16/034-338-317
12/22/99 -
NCE03/16/03 239
255
Biaxin Clarithromycin
ABBOTT 5/25/034-331-803
M/D/YY 05/25/03 689749
Lotensin Benazepril Novartis 08/11/034-410-520
M/D/YY 08/11/03 295320
OrthoNOV 777
-28
Ethinyl
estradiol
OrthoJJ
9/26/034-628-051
12/31/99 -
-12/26/03 205
235
Ortho-TRI
Cyclin
Ethinyl
estradiol
OrthoJJ
9/26/034-628-051
12/31/99 U-66
I-17712/26/03 254
261
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP= New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
Drugs Off-Patent Reports
Drugs Off-Patent Reports 15 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2004Drug OFFDrug OFF
PatentPatentGeneric
TradeName
PatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Claritin Loratadine Schering 4/21/04
4-659-716
4/12/98 NCE
U-77
06/21/04 1340
1360
Claritin-D Loratadine/D
Schering 4/21/04
4-282-233
-
4/21/98
U-77NC
04/21/04 340345.
Claritin-D
24
Loratadine/D
Schering 4/21/04
4-282-233
8/23/99 U-77NP
04/21/04 320335
Claritin
ReadyTab
Loratadine Schering 4/21/04
4-659-716
4/12/98 NCEU-142
04/21/04 110115
Duragesic Fentanyl JNJ-
Janssen
7/13/044-588-580
M/D/YY U-43 07/13/04 290289
Diflucan Fluco-azole
PFizer 1/29/044-404-216
M/D/YY - -- - 01/29/04 495555
Carbplatin Paraplatin BMS 04/14/044-657-927
M/D/YY U-175 04/14/04 399435.
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength
NCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug Product
NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales
U = Code for Therapeutic Use stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
Drugs Off-Patent Reports
Drugs Off-Patent Reports 16 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2005Drug OFFDrug OFF
PatentPatentGeneric
NamePatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Quinapril Accupril WLambert 4/10/055-747-504
M/D/YY U210-
04/10/05 357386.
Pamidro-nate DiNa
Aredia Novartis 07/29/054-711-880
07/16/99 --I-158
07/29/05 242251
Retrovir Zidovudine GlaxoWellcome
9/17/054-837-208
M/D/YY - -- - 09/17/05 127157
Zithromax Azithro-mycin
Pfizer(Pliva)
10/14/054-517-359
M/D/YY - -- - 10/14/05 10801255.
Pravachol Pravastinsodium
BMS 10/20/054-346-227
M/D/YY 10/20/05 11301210
Zocor Simvastatin Merck& Co.
12/23/054-444-784
M/D/YY U-59I-128
12/23/05 19202090
Lorabid Loracarbef E. Lilly 11/24/054-708-956
M/D/YY - -- - 12/24/05 129165
Zofran Ondan-setron
Glaxo-Wellcome
06/25/054-695-578
04/19/98 U-183D-20
I-9 + I-151
06/25/05 510550.
LupronDepot-3
LuprolideAcetate
TAPPharm
07/03/054-677-191
-03/07/00
-NP
07/03/05 270298
LupronDepot-4
LuprolideAcetate
TAPPharm
07/03/054-677-191 05/30/00
-NS
07/03/05 122125
LupronDepot
LuprolideAcetate
TAPPharm
07/03/054-677-191
M/D/YY - -- - 07/03/05 255264
CEFZIL Cefprozil BMS 11/28/054-520-022
M/D/YY U-4 11/28/05 358390
Sporonox Itraconazole J & J 12/23/054-791-111
11/28/05 195238
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New Strength
NCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug Product
NDF = New Dosage Form NC = New Combination 20001 USA + EU Sales
U = Code for Therapeutic Use stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
Drugs Off-Patent Reports
Drugs Off-Patent Reports 17 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2006
Drug OFFDrug OFFPatentPatent
GenericName
PatentHolder
Marketer
PatentExpiry
Exclusivity
Expiry
Patent &Exclusivit
y
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
Proscar Finasteride Merck
& Co.
6/19/06
4-760-071
6/19/97NCE
06/19/06 255000
GEMZAR Gemcitabine E Lilly 2/28/06
4-808-614
5/15/01 NCE 02/28/06 215229
TIMOPTICXE
Timololmaleate
Merck
& Co.
08/29/06
4-861-769
M/D/YY 08/29/06 100111
Ambien Zolpiderm
Tartrate
SearleMonsanto
10/21/06
4-382-938
12/16/97 U-74NCE
10/21/06 575
638
K-DUR KCl S Plough 09/05/064-863-743
M/D/YYU-99 09/05/06 240
264
PAXIL ParoxitineHCl
SKB 12/29/064-721-723
12/29/97 NCEU-12
12/29/06 12051374
Prempro-14/14
Estrogenconjugated
AHPWyeth Ar
02/05/064-826-831
M/D/YY 02/05/06 460498
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
Drugs Off-Patent Reports
Drugs Off-Patent Reports 18 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2007
Drug OFFDrug OFFPatentPatent
GenericName
PatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)
QUET-IAPINE
Seroquel Astra -Zen
03/20/07
4-879-288
9/26/02 -NCE
03/20/07 105112
Sibutramine HCl
MERIDIA KNOLL 5/29/07
4-929-629
11/22/02 -NCE
05/29/07 155165
Propulsid Cisapride
Mono-
hydrate
JNJ-
Janssen
10/9/07
4-962-115
07/29/98 U-79
NCE
10/09/07 500560
Kytril Grani-setron
S-K-B 12/29/074-886-808
12/29/98 NCE
U-89
12/29/07 269299
Risperdal Risperi -
done
JNJ-
Janssen
12/29/074-804-6635-158-952
10/17/00U-90D-37NCE
12/29/07[10/29/09]
690
733
ZytrecTabs/Syrup
CetirazineHCl
Pfizer 06/25/074-525-358
12/08/0O NCE 06/25/07 525601
Fosamax Allendro-nate Na
MerckCo.
08/06/074-621-0775-849-726
09/29/07 U-114NCE
08/06/07[06/06/15]
505
756
Aerobid Flunisolide Forrest 06/12/074-933-168 M/D/YY
- 06/12/07 220
245
LOTREL Amlodipine
Besylate
Novartis 3/25/07
4-879-303
07/31/97 NC 03/25/07 166187
NORVASC Amlodipine
Besylate
Pfizer 3/25/07
4-879-303
07/31/97 NCE 03/25/07 12051270
Camptosar irinotecanHCL
(oncology)
Pharm-acia
08/20/07
4-604-463
06/14/01 NCE 08/20/07 293299
Effexor XR Venlafaxine AHP-Wyeth
12/13/07
4-535-186
10/20/00 NDF 12/13/07 210
233
Suprane Desflurane BOCOhmeda
2/2/074-762-856
9/18/97 U-67NCE
02/02/07 8089
Drugs Off-Patent Reports
Drugs Off-Patent Reports 19 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2008Drug OFFDrug OFF
PatentPatentGeneric
NamePatentHolder
Marketer
PatentExpiry
Exclusivity
Expiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)
Depakote Divalproexsodium
DR Tablets
Abbott 1/29/085-212-326 6/20/99
-I-181
01/20/08 694765
Casodex Bicalut-amide
Zenaca 10/01/084-636-505
10/4/00 -NCE
10/01/08 135144
Serevent SalmeterolXinafoate
AllenHanburys
2/12/084-922-4745-380-922
01/10/12 NCE 02/12/08[01/10/12]
280310
Neurontin Gabapentin WLAP Davis
05/02/084-894-476
12/30/98 NCE 05/02/08 500504
Neurontin Gabapentin WLAParkeDavis
01/16/004-087-544
12/30/98 U-106 [01/16/00] 500480
ZERIT Stavudine BMS 06/25/084-978-655
06/24/99 NCEU-94
06/25/08 241265
DDAVP DesmopressinAcetate
RhonePoulenc
Rorer
9/10/085-407-3985-763-407
M/D/YY 09/10/08[12/23/13]
170198
Lamictal Lamot-rigine
Cerenex 07/22/084-602-017
08/24/05 U106NCE+ODE
I-247
07/22/08[12/14/01]
135155
LamictalCD
Lamot-rigine
Cerenex 07/22/084-602-017
08/24/05I-247
[12/14/01] n/a
TRUSOPT Dorzol-amide HCl
Merck Co. 04/28/084-479-413 12/09/99
-NCE
04/28/08 115133
PROGRAF
Tacrolimus Fujisawa 04/08/084-894-366
M/D/YY 04/08/08 135139
Zemuron RocuroniumBr
Akzo-Organ 04/13/084-894-369
03/17/99 -NCE
04/13/08 115126
Altace Ramipril HoeschtRoussel
10/29/085-061-722
08/22/98 -I-134
10/29/08 121144
VALTREX Valacyclovir Glaxo-W 08/05/084-957-924
06/23/98 -NE
08/05/08 165178
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
Drugs Off-Patent Reports
Drugs Off-Patent Reports 20 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2009Drug OFFDrug OFF
PatentPatentGeneric
NamePatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$ (Mil)
EPIVIR Lami-vudine
Glaxo 02/08/095-047-407
11/17/00 -NCE
02/08/09 260298
Tylenol Acetaminophen
JNJ-McNeil
8/11/094-000-000 M/D/YY
NDF 0/00/09 699780
Prevacid Lanso-prazol
TAPPPharm
05/10/094-628 098 05/10/00
-NCE
05/10/09 20382290
COZAAR LosartanPot.
MerckCo
10/06/095-153-197 4/14/00
-NCE
10/06/09 350398
Rispedal Risperi-done
J & JJansen
10/27/095-158-952 12/29/98
U-90NCE
10/27/09 9901106
HYZAARHydochlor-
thiazide Merck 08/11/095-153-197 4/14/99
U-3NCE
08/11/09 140178
Year of Expiration - 2010Drug OFFDrug OFF
PatentPatentGeneric
NamePatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusiv
ity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)
Neurontin Gabapentin WLAParkeDavis
01/02/105-084-479 12/30/98
-NCE
1/02/010 755902
Famvir Famciclovir SKB 09/21/105-246-937
6/29/99 U-96NCE
09/21/10 155185
Inverase Saquinavirmesalate
Roche 11/19/104-000-000
M/D/YY NCE 0/00/10 160178
Aricept Donepezil Pfizer 11/25/104-895-841
11/25/01 -NCE
11/25/10 300334
Sigular MontelukastNa
Merck 11/30/105-565-473
2/20/03 -NCE
11/30/10 198240
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
Drugs Off-Patent Reports
Drugs Off-Patent Reports 21 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2011Drug OFFDrug OFF
PatentPatentGeneric
NamePatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)
Magnevist Gadopen-tetate
Dimeg-lumine
BERLEX 11/08/114-000-000
M/D/YY 0/00/11 99108
VIAGRA Sildenafil Pfizer 06/18/115-250-534
03/27/03 -NCE
06/18/11 9901289
Year of Expiration - 2012Drug OFFDrug OFF
PatentPatentGeneric
NamePatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivit
y
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)
Eldepryl Selegiline MYL &WATS-
Somerset
04/23/125-242-950
06/05/96 04/23/12 180220
Zoloft Setraline PfizerRoerig
08/13/125-248-699
07/08/00 U-12 08/13/12 19001995
Serevent SalmeterolXinafoate
AllenHanburys
01/10/124-922-4745-380-922
02/04/9901/10/12
-NCE
[02/12/08]01/10/12
345388
DETROL TolterodineTartrate
PharmaciaUpJohn
01/17/125-382-600 03/25/03
-NCE
01/17/12 329360
DIOVAN Valsartan Novartis03/21/12
5-399-57812/23/01 U-12
NCE03/21/12 155
180
PLATINOL Cisplatin BMS05/08/12
5-562-925- -
-05/08/12 115
140
COMBIVIR
Lamivudine GW05/15/12
5-859-02111/17/00- U-248
NCE05/15/12 305
355
TAXOTERE Docetaxel
for Inj. RPR07/03/12
5-403-85805/14/01 -
NCE07/03/12 125
240ZOMEC Zolmitripta
n Astra
Zeneca11/14/12
5-466-69911/25/02- -
NCE11/14/12 98
115SUSTIVA Efavirenz 07/08/12
5-811-423 U-25607/08/12 N/A
Drugs Off-Patent Reports
Drugs Off-Patent Reports 22 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2013
Drug OFFDrug OFFPatentPatent
GenericName
PatentHolder
Marketer
PatentExpiry
+
ExclusivityExpiry
Patent &Exclusivit
y
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)
Wellbutrin BupropionHCl
Cerenex 08/12/134-507-323
M/D/YY - 08/12/13 155310
ZYBAN BupropionHCl
Cerenex 08/12/135-731-000
05/14/00NP
08/12/13 200289
ALLEGRA Fexo-fenadine
HCl
HoechstMarionRoussel
11/26/135-578-610
07/25/01 U-138NCE
11/26/13 360420
ALLEGRAD
Fexo-fenadine
HCl
HoechstMarionRoussel
11/26/135-578-610
12/24/00 U-138NC
11/26/13 105140
Zoloft Sertraline PfizerRoerig
8/13/125-249-699 08/07/00
NCE 08/13/12 16291780
Imitrex SumatriptanSuccinate
CerenexGlaxo
09/10/135-554-639
8/26/00 NDFU-72
09/10/13 898990
DDAVP DesmopressinAcetate
RhonePoulencRorer
9/10/085-407-3985-763-407
M/D/YY [09/10/08]12/23/13
170210
Accolate Zafirlukast AstraZeneca
01/06/135-482-963
- - 01/09/13 146159
CRIXIVAN IndinavirSulfate
MerckCo
05/07/135-413-999
3/13/01 U-132NCE
05/07/13 335356
ASACOL Mesalamine P&G 07/30/135-541-171
8/18/00 U-141I-203
07/30/13 163183
REZULIN Troglitazone Warner-L 09/13/135-478-852
01/29/02 U-163NCE
09/13/13 855930
Magnevist GadapentetateDi-meglumine
Berlex 10/01/135-560-903
- --
10/1/13 128155
Viracept NelfinavirMesalate
Agguron 10/07/135-484-926
03/14/02 -NCE
10/07/13 399410
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
Drugs Off-Patent Reports
Drugs Off-Patent Reports 23 Over USD$ 100 million
DR U G S Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2014
NASONEXMometasone
Fumaratemonohydrate
HoechstMarionRoussel
01/27/145-837-699 10/01/00
-NDF
01/27/14 120
PLAVIX Clopidogrelbisulfate
BMS 01/31/145-576-328
11/17/02 -NCE
01/31/14 141188
ZYPREXA Olanzapine E Lilly 2/25/145-605-897
09/30/01 U-176U-149
2/25/14 13441455
LIPITOR AtorvastatinCa
WLPfizer
5/4/145-385-929
12/17/01 -NCE
5/4/14 20102112
EVISTA Raloxifene E Lilly 06/24/145-641-790
12/09/02 -NCE
06/24/14 121141
NORVIR Ritonavir Abbot 07/15/145-648-497
03/01/01 U-190NCE
07/15/14 138159
SUSTIVA Efavirenz 09/02/145-648-4975-663-169
U-25721/05/1309/02/14
N/A
Year of Expiration - 215rug OFFrug OFFPatentPatent
GenericName
PatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)
Sporanox Itraconazole JNJ-Janssen
01/13/155-707-975
2/21/00 NCE/ NDFI-04, I-155
01/13/15 12191334
Diprivan Propofol AstraZenacca
030/22/155-714-520
6/11/199 -NP
03/22/15 349388
Prempro-14/14
estrogenconjugated
AHPWyeth Ar
1/17/155-547-948
M/D/YY - 01/17/15 460498
Miacalcin CalcitoninSalmon
Novartis 03/31/155-733-569
08/17/98 U-227NDF
13/31/15 185220
COREG Carvedilol SKB 06/07/155-760-069
- -U-233
06/07/15 158199
FOSAMAX AlendronateNa
MerckCo
06/06/155-849-726
09/29/00 -NCE
06/06/15 600689
ALLEGRA Fexo-fenadine
HCl
HoechstMarionRoussel
02/28/155-855-9125-738-872
12/24/00 U-138NC
02/28/15 [105+]185
PEPCIDAC
Famotodine Merck& Co.
06/06/155-854-267
09/29/00 U-267 06/06/15 600680
NA = Not Applicable ODE = Orphan Drug Exclusivity NS = New StrengthNCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug ProductNDF = New Dosage Form NC = New Combination 20001 USA + EU SalesU = Code for Therapeutic Use stillunder Patent Protection
I = Code for specific Indicationunder Exclusivity Protection
D = New Dosing Schedule
U-Codes apply topatent expiry only
I-Codes apply to exclusivity, ODE and all NEWpresentations and forms
Drugs Off-Patent Reports
Drugs Off-Patent Reports 24 Over USD$ 100 million
D r u g s Off-PatentR e p o r t s
I S S N 0 7 9 3 6 9 4 X
Year of Expiration - 2016Drug OFFDrug OFF
PatentPatentGeneric
NamePatentHolder
Marketer
PatentExpiry
ExclusivityExpiry
Patent &Exclusivity
EarliestGeneric
199920001
Trade Generic NAME Patent # DATE CODES DATE USD$(Mil)
REBETOL Ribavirin ICN 01/23/165-767-097
12/09/01 -I-249
01/23/16 10000
AGGRASTAT
TibofibanHCl
Merck 10/23/165-733-919
05/14/03 -NCE
10/23/16 1632
Year of Expiration - 2017
PRELAY Trolitazone Sankyo 11/13/175-859-037
01/29/02 U-251NCE
11/13/17 N/AN/A
US GENERIC DRUG SALES FORCAST
8.249.34
10.93
13
14.5
16.9 17.1
21.8
0
5
10
15
20
25
1998 1999 2000 2001 2002 2003 2004 2005
Sales Year
US
D$
(Bill
ion
s)
Drugs Off-Patent Reports
Drugs Off-Patent Reports 25 Over USD$ 100 million
Total $ Sales of Expiring Drugs - Next 10 Years
1.1
3.6
7.1 7.3
3.1
6.6
3.8
7
2.8
4
2
3.2
1.6
0
1
2
3
4
5
6
7
8
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
Expiration Year
Mar
ket
Val
ue
($B
illio
ns)
Generic Market Share of Total Rx Business
3540 42 43 43 44 47 47.2 48.4 49.1 50.5
0
10
20
30
40
50
60
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
Sales Year
% M
arke
t S
har
e
World Retail Rx Sales - $216.3 ($ Billions)
94
5.3
98.9
51.7
52.7
14.9
13.8
9.3
9.2
13.1
5.1
4.6
3.4
5.5
0 10 20 30 40 50 60 70 80 90 100
US
Canada
North Am.
Japan
Europe
Germany
France
Italy
UK
Spain
S America
Brazil
Mexico
Argentinia
RE
GIO
N
Rx Market Value - Key Markets
Retail Rx sales in Europeand Japan almost equal
Cardiovascular productsamount to $42 billion of total
Fastest growing segmentmusculoskeletal - $12 billion