DRUGS REPORTS

Drugs Off-Patent Reports 

PHARMACEUTICAL 

DRUG DEVELOPMENT 

DRUGS 

oFF-Patents 

REPORTS 

2002 

ISSN 0793 694X 

LOCUM PUBLISHING HOUSE 

Drugs Off-Patent Reports 2 Over USD $100 million



First International Edition - 01. 

First published and distributed in UK, US, EU, RSA, Israel and Japan in November 1996: by 

Locum International Publishing House (Houston, Israel, South Africa). Second International 

Edition - 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 January 

2001 by Locum International Publishing House (Houston, Israel, South Africa) in Hard 

Cover; Soft and Spiral Cover; Electronic Diskette; and e-mail attachment versions. All print 

and electronic versions identical in content and format. 

Copyright © 1995 - 2002, Handbook of Pharmaceutical Generic Development. 

Text Copyright © 1995 - 2002, Handbook of Pharmaceutical Generic Development. 

Illustration copyright © 1995 - 2002, Handbook of Pharmaceutical Generic Development. 

Locum International Publishing House PO Box 874, 50 Gilad Street Kochav Yair 44864 

Israel. - All right reserved. 

ISSN 0793 8632 

ISSN 0793 8640 - Electronic Version (Diskette, CD ROM and e-mail attachment version) 

Handbook Development 24 volume series 

General Generic Development ISSN Series number 0793 7407 

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and e-mail attachment version are identical in size and content to the printed hard or soft 

cover version.) 

Duplication: No part of this publication may be reproduced, stored in a retrieval 

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A IAGIM Drug 

Development 

Publication 

Locum International 

ISSN 0793 694X 


over 

$100m 

Copyright ©1995-2002 by Locum 

Publishing House Inc. All Rights 

Reserved. 

Neither this drug development letter nor 

any part may be reproduced or 

transmitted in any form or by any means, 

electronic or mechanical, including 

photocopying, microfilming and 

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Locum International 

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A L o c u m H o u s e P u b l i c a t i o n 



PHARMACEUTICAL 

DRUG DEVELOPMENT 


OFF-Patents 

Reports 

2002 

ISSN 0793 694X 

LAST UPDATE March 2002 

[This report consists of 24 pages] 

Drugs Off-Patent Reports 5 Over USD$ 100 million


Drugs Off-Patent 

Reports 

HOW THE CODES WORK 

Generic Drug Products generally have two codes namely a PATENT USE Code and 

an EXCLUSIVITY code. These two patent protection codes usually expire at quite 

different times. 

Generally when the New Chemical Entity (NCE) expires the Generic equivalent of 

the Brand Leader may be manufactured after appropriate ANDA approval. However 

several 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 and 

are much less common. 

Naturally the package insert of an on-market generic drug will not show a new 

indication still protected by an I-code exclusivity. Thus I-code exclusivity's may run for 

several years while the generic is being marketed. The same applies for the 'N' and 

'D' codes as well. 

Drug OFF 

Generic Patent 

or ON 

Name Holder 

Patent 

Marketer 

Patent 

Expiry 

+ 

Exclusivity 

Expiry 

Patent 

& 

Exclusivity 

Earliest 

Generic 

1999 

2000 1 

Trade Generic NAME Patent # DATE CODES DATE USD$ 

(Mil) 

More than 

one name 

may exist 

U-Codes 

apply here 

All other 

codes 

apply here 

DD/MM/YY 

In 

Millions 

of US 

Dollars 

U-Codes 

Apply to this 

Patent # and 

this Patent 

date. 

Several 

Patents may 

exist for each 

Generic 

The following codes 

apply to this 

exclusivity date:- 

All 

I-codes 

D-codes 

NCE 

NDF 

NE 

NC 

NS 

NP 

ODE 

This Date is the 

earliest generic 

marketing date and 

may apply to either 

the patent expiry or 

a Exclusivity Expiry. 

NOTE 

In many cases an 

OFF-Patent Generic 

may have an 

ON-Patent 

I Code; U Code or N 

code 

The Codes:- 

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 2001 1 USA + EU Sales 

D = New Dosing Schedule 

U = Code for 'Therapeutic Use' still 

under Patent Protection. 

I = Code for New Specific 

Indication under Exclusivity 

Protection. 




Reports 

ISSN 0793694X 

Electronic < Reports on Disk 

Reports on Web : 

e-- Reports 

Ï20v01Ò 

Drugs Over $100 million US Dollars 

Year of Expiration - 1997 

Drug OFF 

Generic Patent Patent Exclusivity Patent & Earliest 1999 

Patent 

Name Holder Expiry Expiry Exclusivity Generic 2001 1 

Marketer 

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 180 

204 

Lodine Etodolac AHP/Wye 

Ayerst 

Timoptic 

Trental 

Timolol 

maleate 

Merck & 

Co 

2/28/95 

6/1/91 

3/25/97 

9/26/95 

6/5/90 

8/30/85 

Zovirax Acyclovir BW 4/22/97 

8/27/95 

Glucotrol 

XL 

Glipizide 

Pfizer/ 

Pratt 

Zantac Ranitidine Glaxo 

Wellcome 

4/26/97 

2/28/97 

2/28/97 

- 

3/25/97 

4/3/97 

4/3/97 

- 

4/22/97 

N/A 4/26/97 

12/5/95 

7/25/97 

Taxol Paclitaxel B-M-S 12/29/97 

Toradol 

Ketorolac 

Pentoxifylline 

Hoechst- 

Roussel 

tromethamine 

Roche/ 

Syntex 

N/A 

5/16/95 

7/14/96 

- 

7/25/97 

- 

12/29/97 

5/16/97 

5/16/97 

NCE Expired 372 

411 

Expired 245 

270 

Expired 314 

346 

1.71 Expired 354 

394 

NDF Expired 153 

170 

D-21, 

I-116 

I - 77, 

NP,NCE 

Expired 2688 

2934 

Expired 513 

572 

NR Expired 295 

331. 




U = Code for 'Therapeutic Use' still I = Code for specific Indication D = New Dosing Schedule 

under Patent Protection 

under Exclusivity Protection 

1 

Includes Generics 




Reports 

ISSN 0793694X 


Drug OFF 


Patent 

Name Holder 

Marketer 

Patent 

Expiry 

Exclusivity 

Expiry 

Trade Generic NAME Patent # DATE 

mm/dd/YY 

Patent & 

Exclusivity 

Earliest 

Generic 

1999 

2001 1 

CODES DATE USD$ 

(Mil) 

RETIN A 

Tretinoin 

Gel 

Ortho/J&J 1/02/98 

4-247-547 

1/27/98 - Expired 101 

121 

Paraplatin Carboplatin B-M-S 2-20-96 

6/8/92 

8/28/98 

8/28/98 

- Expired 255 

285 

Lescol Fluvastatin Sandoz 

Novartis 

12/31/98 

NA 

- 

12/31/98 

D-31 

NCE 

Expired 349 

386 

Diltazem 

HCl 

Tiazac 

Forest 

/Biovail 

6/25/13 

5-529-791 

9/11/98 NS Expired 120 

166 

Oxycodone 

HCl 

Oxycontin 

Perdue 

Frederick 

2/05/08 12/12/985- 

266-331 

NDF Expired 300 

343 

Fluvastitin 

Sodium 

Lescol Norvaris 10/11/11 

5-354-772 

12/31/98 NCE Expired 247 

276. 

Drug OFF 


Patent 

Name Holder 

Marketer 

Patent 

Expiry 

Exclusivity 

Expiry 

Patent & 

Exclusivity 

Earliest 

Generic 

1999 

2001 1 




U = Code for Therapeutic Use still I = Code for specific Indication D = New Dosing Schedule 




Drug OFF 

Generic 

Patent 

Name 



Reports 

ISSN 0793694X 


Patent 

Holder 

Marketer 

Patent 

Expiry 

Exclusivity 

Expiry 

Patent & 

Exclusivity 

Earliest 

Generic 

1999 

2001 1 


(Mil) 

Primaxin Imipenen Merck & 2/18/99 M/D/YY - Expired 139 

cilastatin Na Co 4-194-047 

154 

Diclofenac Voltarin XR Novartis P 3/8/99 - Expired 132 

Na 

NDF 

158 

Etodolac Londine XL AHP 10/30/07 10\25\99 Expired 150 

CR 

Wyeth 4-966-768 

181 

NIZEROL Ketaconazole JNJ 

I - 88 Expired 155 

Janson 6/15/99 

186 

Zoladex Goserelin Zeneca 4/22/99 I - 88 Expired 138 

acetate 

162 

Daypro Oxaprozin Searle P 


Monsanto 

10/29/99 

360. 

Norcuron Vecuronium Organon 8/20/99 - 

- Expired 150 

bromide 

8/20/99 

152 

Vancenase 

AQ 

Vancenase 

Plain 

Vanceril 

Unasyn 

Beclo 

methasone 

dipropionate 

Beclo 

methasone 

dipropionate 

Beclo 

methasone 

dipropionate 

Ampicillin Sod/ 

sulbactam 

Sod. 

Schering- 

Plough 

Schering- 

Plough 

Schering- 

Plough 

Key 

P - 

6/26/99 NP 

12/21/99 

4-364-923 

12/21/99 

4-364-923 

Pfizer 11/18/97 

4-234-579 

M/D/YY 

M/D/YY 

- 

- 

Expired 285 

315 

Expired 65 

82 

Expired 190 

211 

M/D/YY - Expired 184 

199 

Versed Inj. Midazolam Roche/ 

Syntex 

11/18/99 12/20/99 

12/20/99 

- Expired 310 

353 

Nicoderm 

CQ 

Nicotine SKB - 

8/2/99 

NP Expired 160 

177 

Azmacort Triamcinalone 

acetonide 

RPR - 

18,117 

- 

10/30/99 

D-7 Expired 255 

273 

Luvox Fluvoxamine 

maleate 

U.S. 

Phillips 

P 

12/05/99 


201 

Omnipaque 

12/26/99 M/D/YY - Expired 265 

Iohexal 

Sanofi 4-250-133 

292 

Lamisil Terbinafine Novartis 12/30/06 

U-73 Expired 415 

cream HCl 

4-755-534 12/30/99 NCE 

452. 

Beconase Beclo 

+ 

Beclovent 

methasone 

dipropionate 

Glaxo- 

Wellcome 

12/21/99 

4-364-923 

12/21/99 

4-364-924 

M/D/YY - Expired 130 

45 

62 

89 




Reports 

ISSN 0793694X 


Drug OFF 


Patent 


Marketer 


(Mil) 

2/22/00 

Vasotec Enalaprilat Merck & 

Co. 

Hismanal Astemizole JNJ- 

Janssen 

Buspar Buspirone 

HCl 

Lotrisone 

Betamethaz 

one Diprop 

2/22/00 

4-374-829 

4/3/00 

4-219-559 

B-M-S 5/22/00 

4-182-763 

Schering 10/06/00 

4-298-604 

Gluco 

phage 

Ultram 

ZIAC 

CEFTIN 

Atrovent 

Cardura 

ZOLADEX 

Pepcid Famotidine Merck 

& Co. 

10/15/00 

4-283-408 

Pepcid Famotidine Merck 10/15/00 

AC 

& Co. 4-283-408 04/28/98 

Glucotril Glipizide Pfizer 

XL 

Pratt -- 

Intal Cormolyn Rhone- 9/20/00 

sodium Poulenc- 4-405-598 

Sevoflurane 

Metformin 

HCl 

Tramadol 

Hcl 

Bisoprolol 

fumerate 

Cefuroxime 

acetil 

Ipratropium 

Br 

Doxazosin 

mesylate 

Goserelin 

Acetate 

Rorer 

BM 

Squibb 

J/J - Mc 

Neil 

3/03/00 

- 

P 

AHP 3/24/00 

Lederle 4-258-062 7/31/97 

GW 5/12/00 M/D/YY 

4-267-320 

B 5/24/00 

Ingelheim 4-385-048 10/20/98 

Pfizer 10/18/00 

4-188-390 2/6/98 

Zeneca 4/22/99 

4-100-274 

ULTANE Abbott 12/26/04 

4-250-334 

Terazosin Hytrin Abbott 2/17/00 

4-251-532 

Neurontin Gabapentin WLA 

P Davis 

01/16/00 

5-084-479 

-- 

Expired 

02/22/00 

M/D/YY 

Expired 

-- 

04/03/00 

5/22/00 U-13 Expired 

05/22/00 

M/D/YY 

Expired 

-- 

10/06/00 

M/D/YY 

Expired 

-- 

10/15/00 

NS Expired 

10/15/00 

11/25/00 NDF Expired 

11/25/00 

M/D/YY 

Expired 

-- 

09/20/00 

M/D/YY NCE Expired 

3/03/00 

M/D/YY NCE Expired 

03/03/00 

U-63 

NCE 

-- 

NDF 

U-119 

NCE 

1-96 

6/27/00 -- 

I-191 

6/7/00 

NCE 

725 

860 

28 

33 

540 

611 

201 

233 

1350 

1487 

125 

138 

179 

199 

89 

98 

1110 

1302. 

453 

501. 

03/24/00 173 

198 

Expired 

05/12/00 

Expired 

05/24/00 

Expired 

10/18/00 

Expired 

06/27/00 

Expired 

06/07/00 

M/D/YY -- Expired 

02/17/00 

12/30/98 U-106 

(Epilepsy) 

Expired 

01/16/00 

425 

485. 

306 

346 

330 

401 

219 

244 

114 

134 

425 

598. 

500 

590 






Drug OFF 


Patent 

Name Holder 

Marketer 



Reports 

ISSN 0793694X 


Patent 

Expiry 

Exclusivit 

y 

Expiry 

Patent & 

Exclusivity 

Earliest 

Generic 

Trade Generic NAME Patent # DATE CODES DATE 

MM/DD/YY 

Calcitriol Calcijex Abbott 1/28/01 

inj 

4-308-264 

Prilosec 

Mertaza 

pine 

Ompera 

zole 

Astra 

Zeneca 

4/5/01 

4-255-431 

1999 

2001 1 

USD$ 

(Mil) 

1/28/01 - 01/28/01 190 

210 

3/22/99 U-108 10/01/01 3495 

I-23 

3540 

REMERON Organon P 6/14/01 NCE 06/14/01 132 

134 

Mevacor Lovastin Merck & Co 6/15/01 

4-231-938 

Accutane Isotretinoin Roche 8/7/01 

[Syntex] 4-464-394 

2/8/98 - 

I-117 

Brimonidine Alphagan Allergan P 9/06/01 - 

NCE 

PLENDIL Felodipine Merck 

& Co. 

Xalatan 

6/19/01 

4-264-611 

06/15/01 595 

300. 

M/D/YY -- 08/07/01 395 

462. 

09/06/01 98 

101 

M/D/YY U-3 06/19/01 150 

178 

Latano 

prost 

Pharmacia P 6/05/01 NCE 06/05/01 507 

417 

[207] 4q 

levaquin RWJ -- 12/17/01 I-246 12/17/01 288 

310 

Levofloxacin 

Lovenox 

Enoxaparin 

Na 

RPR 12/04/01 

4-692-435 

Milrinone Primacor Sanofi 2/2/01 

4-313-951 

Terconazole 

TERAZOL J+J 11/09/01 

4-358-449 

Lisinopril Zestril Astra- 

Zeneca 

Lisinopril Prinivil Merck 

& Co. 

Nicorette Nicotine 

(Mint) Polacrilex 

4q 

= Fourth Quarter 2000 

12/30/01 

4-374-829 

12/30/01 

4-374-829 

05/06/00 U-122 

NCE 

I-192 

12/04/01 299 

320 

M/D/YY - 02/02/01 101 

110 

M/D/YY - 11/09/01 103 

114 

11/24/98 - 12/30/01 600 

I-141 

646 

11/24/98 I-141 12/30/01 350 

365 

Pharmacia - - - 12/23/01 234 

266 










Reports 

ISSN 0793694X 


Drug OFF 


Patent 

Name Holder Expiry Expiry Exclusivit Generic 2001 1 

Marketer 

y 


Celebrex Celecoxib Pharmacia 

11/30/2015 

5-760-068 

Optiray 

320 

Optiray 

350 

Monopril / 

Vasopril 

(10.20mg) 

Ioversol Mallinc 12/30/02 

4-396-598 

Ioversol Mallinc 12/30/02 

4-396-598 

Fosinopril 

Na 

BMS 12/4/02 

4-337-201 

12/24/02 

{I-284} 

I-284 

U-19 

U-299 

12/24/02 1 507 

2 600 

[772] 4q 

4/12/02 -- 04/12/02 340 

255 

M/D/YY -- 10/11/02 105 

121 

12/28/98 - 12/13/02 205 

NCE 

08/03/02 - 

ODE 

08/03/02 250 

M/D/YY -- 12/30/02 168 

M/D/YY -- 12/30/02 69 

05/02/98 - 

I-92 

Axid Nizatidine Lilly 4/12/02 

4-375-547 

Suprax Cefixime AHP/ 10/11/02 

Lederle 4-409-214 

Effexor Venlafaxine 

AHP/ 12/13/02 

Wyeth 4-535-186 

Ayerst 

Cordarone Amio AHP/ 

darone Wyeth P 

Ayerst 

Relafen Nambutone Smith 

Kline 

Beecham 

12/13/02 

4-420-639 

Trovafloxacin 

TROVAN Pfizer -- 12/18/02 - 

mesylate 

NCE 

Carvedilol Coreg SKB 3/5/02 

4-503-067 

12/04/02 202 

M/D/YY -- 12/13/02 450 

380 

9/14/00 U-3 

NCE 

12/18/02 160 

155 

03/05/02 100 

101 

Midazolam VERSED 

inj 

4q 


Roche 6/20/00 

4-280-957 

4/15/02 PED 04/15/02 324 

380 










Reports 

ISSN 0793694X 


Drug OFF 


Patent 


Marketer 


Fluoxitine Prozac Lilly 12/2/03 

4-626-549 

M/D/YY - 12/02/03 2281 

3200 

Cipro 

Ciprofloxacin 

Beyer 

/Miles 

12/9/03 

4-670-444 

Ketoconaz 

ole 

NIZORAL JJ- 2/11/03 

4-942-162 

Floxin Ofloxacin JNJ- 09/02/03 

McNeil 4-382-892 

Flutica Glaxo 11/14/03 

Flovent sone Wellcome 4-335-121 

propionate 

Fluticasone 

Glaxo 11/14/03 

Flonase 

Wellcome 4-335-121 

propionate 

Serzone Nefaz BMS 03/16/03 

odone HCl 

4-338-317 

Biaxin Clarithro ABBOTT 5/25/03 

mycin 

4-331-803 

Lotensin Benazepril Novartis 08/11/03 

4-410-520 

6/03/00 - 

I-188 

5/30/00 - 

I-186 

12/16/00 - 

I-174 

10/07/00 - 

NDF 

10/19/97 - 

NDF 

12/22/99 - 

NCE 

12/09/03 908 

997 

02/11/03 158 

180 

09/02/03 190 

211 

11/14/03 294 

301 

11/14/03 440 

488 

03/16/03 239 

255 

M/D/YY 05/25/03 689 

749 

M/D/YY 08/11/03 295 

320 

Ortho 

NOV 777 

-28 

Ethinyl 

estradiol 

Ortho 

JJ 

9/26/03 

4-628-051 

12/31/99 - 

- 

12/26/03 205 

235 

Ortho- 

TRI 

Cyclin 

Ethinyl 

estradiol 

Ortho 

JJ 

9/26/03 

4-628-051 

12/31/99 U-66 

I-177 

12/26/03 254 

261 










Reports 

ISSN 0793694X 


Drug OFF 


Patent 

Trade Holder Expiry Expiry Exclusivity Generic 2001 1 

Name Marketer 


Claritin Loratadine Schering 4/21/04 

4/12/98 NCE 

06/21/04 1340 

4-659-716 

U-77 

1360 

Claritin-D 

Loratadine 

/D 


4-282-233 

- 

4/21/98 

U-77 

NC 

04/21/04 340 

345. 

Claritin-D 

24 

Loratadine 

/D 


4-282-233 

8/23/99 U-77 

NP 

04/21/04 320 

335 

Claritin 

ReadyTab 

Loratadine Schering 4/21/04 

4-659-716 

4/12/98 NCE 

U-142 

04/21/04 110 

115 

Duragesic Fentanyl JNJ- 

Janssen 

7/13/04 

4-588-580 

M/D/YY U-43 07/13/04 290 

289 

Diflucan 

Flucoazole 

PFizer 1/29/04 

4-404-216 

M/D/YY - - 01/29/04 495 

555 

Carbiplatin Paraplatin BMS 04/14/04 

4-657-927 

M/D/YY U-175 04/14/04 399 

435. 


NCE = New Chemical Entity NE = New Active Salt or Ester NP = New Drug Product 


U = Code for Therapeutic Use still 


I = Code for specific Indication 






Reports 

ISSN 0793694X 


Drug OFF 


Patent 


Marketer 


Quinapril Accupril WLambert 4/10/05 

5-747-504 

Pamidronate 

DiNa 

Aredia Novartis 07/29/05 

4-711-880 

Retrovir Zidovudine Glaxo 

Wellcome 

Zithromax 

Pravachol 

Pfizer 

(Pliva) 

Zocor Simvastatin Merck 

& Co. 

9/17/05 

4-837-208 

10/14/05 

4-517-359 

BMS 10/20/05 

4-346-227 

12/23/05 

4-444-784 

Lorabid Loracarbef E. Lilly 11/24/05 

4-708-956 

Zofran 

Lupron 

Depot-3 

Lupron 

Depot-4 

Lupron 

Depot 

Luprolide 

Acetate 

Luprolide 

Acetate 

Luprolide 

Acetate 

Azithromycin 

Pravastin 

sodium 

Ondansetron 

Glaxo- 

Wellcome 

TAP 

Pharm 

TAP 

Pharm 

TAP 

Pharm 

06/25/05 

4-695-578 

07/03/05 

4-677-191 

M/D/YY 

U210 

- 

07/16/99 - 

I-158 

04/10/05 357 

386. 

07/29/05 242 

251 

M/D/YY - - 09/17/05 127 

157 

M/D/YY - - 10/14/05 1080 

1255. 

M/D/YY 10/20/05 1130 

1210 

M/D/YY U-59 

I-128 

12/23/05 1920 

2090 

M/D/YY - - 12/24/05 129 

165 

04/19/98 U-183 

D-20 

I-9 + I-151 

- 

03/07/00 

07/03/05 

4-677-191 05/30/00 

07/03/05 

4-677-191 

CEFZIL Cefprozil BMS 11/28/05 

4-520-022 

Sporonox Itraconazole J & J 12/23/05 

4-791-111 

- 

NP 

- 

NS 

06/25/05 510 

550. 

07/03/05 270 

298 

07/03/05 122 

125 

M/D/YY - - 07/03/05 255 

264 

M/D/YY U-4 11/28/05 358 

390 

11/28/05 195 

238 




U = Code for Therapeutic Use still 


I = Code for specific Indication 






Reports 

ISSN 0793694X 


Drug OFF 


Patent 

Name Holder 

Marketer 

Patent 

Expiry 

Exclusivit 

y 

Expiry 

Patent & 

Exclusivit 

y 

Earliest 

Generic 

1999 

2001 1 


Proscar Finasteride Merck 

& Co. 

6/19/06 

4-760-071 

6/19/97 

NCE 

06/19/06 255 

000 

GEMZAR Gemcitabine E Lilly 2/28/06 

4-808-614 

5/15/01 NCE 02/28/06 215 

229 

TIMOPTIC 

XE 

Timolol 

maleate 

Merck 

& Co. 

08/29/06 

4-861-769 

M/D/YY 

08/29/06 100 

111 

Ambien 

Zolpiderm 

Tartrate 

Searle 

Monsanto 

10/21/06 

4-382-938 

12/16/97 U-74 

NCE 

10/21/06 

535 

705 

[207] 4q 

K-DUR KCl S Plough 09/05/06 

4-863-743 

M/D/YY 

U-99 09/05/06 240 

264 

PAXIL 

Paroxitine 

HCl 

SKB 12/29/06 

4-721-723 

12/29/97 NCE 

U-12 

12/29/06 1205 

1374 

Prempro- 

14/14 

Estrogen 

conjugated 

AHP 

Wyeth Ar 

02/05/06 

4-826-831 

M/D/YY 02/05/06 

460 

498 

4q 











Reports 

ISSN 0793694X 


Drug OFF 


Patent 


Marketer 


(Mil) 

QUET- 

IAPINE 

Sibutramin 

e HCl 

Propulsid 

Kytril 

Seroquel Astra - 

Zen 

03/20/07 

4-879-288 

MERIDIA KNOLL 5/29/07 

Cisapride 

Risperdal Risperi - 

Zytrec 

Tabs/Syrup 

Fosamax 

done 

Cetirazine 

HCl 

JNJ- 

Allendronate 

Na 

Janssen 

4-929-629 

10/9/07 

4-962-115 

S-K-B 12/29/07 

4-886-808 

Monohydrate 

JNJ- 

Granisetron 

Janssen 

12/29/07 

4-804-663 

5-158-952 

Pfizer 06/25/07 

4-525-358 

Merck 

Co. 

08/06/07 

4-621-077 

5-849-726 

9/26/02 - 

NCE 

11/22/02 - 

NCE 

07/29/98 U-79 

NCE 

12/29/98 NCE 

10/17/00 

Aerobid Flunisolide Forrest 06/12/07 

4-933-168 M/D/YY 

LOTREL 

NORVASC 

Camptosar 

Amlodipine 

Besylate 

Amlodipine 

Besylate 

irinotecan 

HCL 

(oncology) 

Novartis 3/25/07 

4-879-303 

Pfizer 3/25/07 

Pharmacia 

Effexor XR Venlafaxine AHP- 

Wyeth 

Suprane Desflurane BOC 

Ohmeda 

* US 2000 SALES 

4-879-303 

08/20/07 

4-604-463 

12/13/07 

4-535-186 

2/2/07 

4-762-856 

U-89 

U-90 

D-37 

NCE 

03/20/07 105 

112 

05/29/07 155 

165 

10/09/07 500 

560 

12/29/07 269 

299 

12/29/07 

[10/29/09] 

690 

733 

12/08/0O NCE 06/25/07 525 

601 

09/29/07 U-114 

NCE 

08/06/07 

[06/06/15] 

505 

756 

- 06/12/07 220 

245 

07/31/97 NC 03/25/07 166 

187 

07/31/97 NCE 03/25/07 1205 

1270 

06/14/01 NCE 08/20/07 293 

299 

[116]* 

10/20/00 NDF 12/13/07 210 

233 

9/18/97 U-67 

NCE 

02/02/07 

80 

89 


Drug OFF 


Patent 

Name Holder 

Marketer 



Reports 

ISSN 0793694X 


Patent 

Expiry 

Exclusivit 

y 

Expiry 

Patent & 

Exclusivity 

Earliest 

Generic 

1999 

2001 1 


(Mil) 

Depakote 

Casodex 

Serevent 

Divalproex 

sodium 

DR Tablets 



Parke 

Davis 

Abbott 1/29/08 

5-212-326 6/20/99 

Zenaca 10/01/08 

4-636-505 

Allen 2/12/08 

Hanburys 4-922-474 

5-380-922 

05/02/08 

P Davis 4-894-476 

01/16/00 

4-087-544 

ZERIT Stavudine BMS 06/25/08 

4-978-655 

DDAVP Desmopressin Rhone 9/10/08 

Acetate 

Poulenc 5-407-398 

Rorer 5-763-407 

Lamictal 

Lamictal 

CD 

TRUSOPT 

PROGRA 

F 

Zemuron 

Bicalutamide 

Salmeterol 

Xinafoate 

Lamotrigine 

Lamotrigine 

Dorzolamide 

HCl 

Cerenex 07/22/08 

4-602-017 

Cerenex 07/22/08 

4-602-017 

Merck Co. 04/28/08 

4-479-413 12/09/99 

Tacrolimus Fujisawa 04/08/08 

4-894-366 

Rocuronium Akzo-Organ 04/13/08 

Br 

4-894-369 

Altace Ramipril Hoescht 

Roussel 

10/29/08 

5-061-722 

VALTREX Valacyclovir Glaxo-W 08/05/08 

4-957-924 

- 

I-181 

10/4/00 - 

NCE 

01/10/12 NCE 

12/30/98 NCE 

12/30/98 U-106 

01/20/08 

10/01/08 

02/12/08 

[01/10/12] 

05/02/08 

[01/16/00] 

06/24/99 NCE 

U-94 

06/25/08 

M/D/YY 09/10/08 

[12/23/13] 

08/24/05 U106 

NCE+ODE 

I-247 

08/24/05 

I-247 

- 

NCE 

07/22/08 

[12/14/01] 

[12/14/01] 

694 

765 

135 

144 

280 

310 

500 

504 

500 

480 

241 

265 

170 

198 

135 

155 

n/a 

04/28/08 115 

133 

M/D/YY 04/08/08 135 

139 

03/17/99 - 

NCE 

08/22/98 - 

I-134 

06/23/98 - 

NE 

04/13/08 115 

126 

10/29/08 121 

144 

08/05/08 165 

178 










Reports 

ISSN 0793694X 


Drug OFF 


Patent 


Marketer 


EPIVIR Lamivudine 

5-047-407 

NCE 

298 

Glaxo 02/08/09 11/17/00 - 

02/08/09 

260 

Tylenol Acetamino JNJ- 8/11/09 

NDF 

0/00/09 

699 

phen McNeil 4-000-000 M/D/YY 

780 

Prevacid 

Lansoprazol 

TAPP 

Pharm 

05/10/09 

4-628 098 05/10/00 

- 

NCE 

05/10/09 

2038 

2290 

COZAAR 

Losartan 

Pot. 

Merck 

Co 

10/06/09 

5-153-197 4/14/00 

- 

NCE 

10/06/09 

350 

398 

Rispedal 

Risperidone 

J & J 

Jansen 

10/27/09 

5-158-952 12/29/98 

U-90 

NCE 

10/27/09 

990 

1106 

HYZAAR 

Hydochlorthiazide 

Merck 

08/11/09 

5-153-197 4/14/99 

U-3 

NCE 

08/11/09 

140 

178 


Drug OFF 


Patent 

Name Holder Expiry Expiry Exclusiv Generic 2001 1 

Marketer 

ity 


(Mil) 


Parke 

Davis 

Famvir Famciclovir SKB 09/21/10 

5-246-937 

Inverase Saquinavir Roche 11/19/10 

mesalate 

4-000-000 

Aricept Donepezil Pfizer 11/25/10 

4-895-841 

Sigular Montelukast Merck 11/30/10 

Na 

5-565-473 

01/02/10 

5-084-479 12/30/98 

- 

NCE 

1/02/010 

6/29/99 U-96 09/21/10 

NCE 

M/D/YY NCE 0/00/10 

11/25/01 - 

NCE 

2/20/03 - 

NCE 

11/25/10 

11/30/10 

755 

902 

155 

185 

160 

178 

300 

334 

198 

240 










Reports 

ISSN 0793694X 


Drug OFF 


Patent 


Marketer 


(Mil) 

Magnevist Gadopentetate 

4-000-000 

BERLEX 11/08/11 

Dimeglumine 

VIAGRA Sildenafil Pfizer 06/18/11 

5-250-534 

- - 0/00/11 

03/27/03 - 

NCE 

06/18/11 

99 

108 

990 

1289 

Xalatan Latanoprost Pharmacia 03/22/11 - - - - - - 507 

417 

[207] 4q 

4q 



Drug OFF 


Patent 

Name Holder Expiry Expiry Exclusivit Generic 2001 1 

Marketer 

y 


(Mil) 

Eldepryl Selegiline MYL & 

WATS- 

Somerset 

Zoloft Setraline Pfizer 

Roerig 

Serevent 

DETROL 

Salmeterol 

Xinafoate 

Tolterodine 

Tartrate 

Allen 

Hanburys 

Pharmacia 

UpJohn 

DIOVAN Valsartan Novartis 

PLATINOL Cisplatin BMS 

COMBIVI 

R 

Lamivudine 

GW 

04/23/12 

5-242-950 

08/13/12 

5-248-699 

01/10/12 

4-922-474 

5-380-922 

06/05/96 04/23/12 

07/08/00 U-12 

02/04/99 

01/10/12 

01/17/12 

5-382-600 03/25/03 

03/21/12 

5-399-578 

05/08/12 

5-562-925 

05/15/12 

5-859-021 

- 

NCE 

- 

NCE 

12/23/01 U-12 

NCE 

- - 

- 

11/17/00- U-248 

NCE 

TAXOTERE 

Docetaxel 

07/03/12 05/14/01 - 

for Inj. RPR 5-403-858 

NCE 

ZOMEC Zolmitripta Astra 11/14/12 11/25/02- - 

n Zeneca 5-466-699 

NCE 

SUSTIVA Efavirenz 07/08/12 

5-811-423 U-256 

08/13/12 

[02/12/08] 

01/10/12 

01/17/12 

03/21/12 

05/08/12 

05/15/12 

07/03/12 

11/14/12 

07/08/12 

180 

220 

1900 

1995 

345 

388 

329 

360 

[113]* 

155 

180 

115 

140 

305 

355 

125 

240 

98 

115 

N/A 


Drug OFF 


Patent 

Name Holder 

Marketer 



Reports 

ISSN 0793694X 


Patent 

Expiry 

+ 

Exclusivity 

Expiry 

Patent & 

Exclusivit 

y 

Earliest 

Generic 

1999 

2001 1 


(Mil) 

Wellbutrin Bupropion Cerenex 08/12/13 M/D/YY - 

08/12/13 

155 

HCl 

4-507-323 

310 

ZYBAN Bupropion Cerenex 08/12/13 05/14/00 

08/12/13 

200 

HCl 

5-731-000 

NP 

289 

ALLEGRA 

ALLEGRA 

D 

Fexofenadine 

HCl 

Fexofenadine 

HCl 

Hoechst 

Marion 

Roussel 

Hoechst 

Marion 

Roussel 

Zoloft Sertraline Pfizer 

Roerig 

Imitrex 

DDAVP 

Sumatriptan 

Succinate 

Desmopressin 

Acetate 

Cerenex 

Glaxo 

Rhone 

Poulenc 

Rorer 

Accolate Zafirlukast Astra 

Zeneca 

CRIXIVAN 

Indinavir 

Sulfate 

Merck 

Co 

11/26/13 

5-578-610 

11/26/13 

5-578-610 

8/13/12 

5-249-699 08/07/00 

09/10/13 

5-554-639 

9/10/08 

5-407-398 

5-763-407 

01/06/13 

5-482-963 

05/07/13 

5-413-999 

ASACOL Mesalamine P&G 07/30/13 

5-541-171 

REZULIN Troglitazone Warner-L 09/13/13 

5-478-852 

Magnevist 

Viracept 

Gadapentetate 

Di-meglumine 

Nelfinavir 

Mesalate 

Berlex 10/01/13 

5-560-903 

Agguron 10/07/13 

5-484-926 

07/25/01 U-138 

NCE 

12/24/00 U-138 

NC 

8/26/00 

11/26/13 

11/26/13 

360 

420 

105 

140 

NCE 08/13/12 1629 

1780 

NDF 

U-72 

09/10/13 898 

990 

M/D/YY [09/10/08] 

12/23/13 

170 

210 

- - 01/09/13 146 

159 

3/13/01 U-132 

NCE 

8/18/00 U-141 

I-203 

01/29/02 U-163 

NCE 

- - 

- 

03/14/02 - 

NCE 

05/07/13 335 

356 

07/30/13 163 

183 

09/13/13 855 

930 

10/1/13 128 

155 

10/07/13 399 

410 









NASONEX 

Mometasone 

Fumarate 

monohydrate 

Clopidogrel 

bisulfate 

DRUGS Off-Patent 

Reports 

ISSN 0793694X 


Hoechst 

Marion 

Roussel 

PLAVIX 

BMS 01/31/14 

5-576-328 

ZYPREXA Olanzapine E Lilly 2/25/14 

5-605-897 

LIPITOR Atorvastatin WL 5/4/14 

Ca Pfizer 5-385-929 

EVISTA Raloxifene E Lilly 06/24/14 

5-641-790 

01/27/14 

5-837-699 10/01/00 

- 

NDF 

11/17/02 - 

NCE 

09/30/01 U-176 

U-149 

12/17/01 - 

NCE 

12/09/02 - 

NCE 

01/27/14 

01/31/14 

2/25/14 

5/4/14 

06/24/14 

120 

141 

188 

1344 

1455 

2010 

2112 

121 

141 

NORVIR Ritonavir Abbot 07/15/14 

5-648-497 

SUSTIVA Efavirenz 09/02/14 

5-648-497 

5-663-169 

rug OFF 

Generic 

Patent 

Name 

03/01/01 U-190 

NCE 


Patent 

Holder 

Marketer 

Patent 

Expiry 

Exclusivity 

Expiry 

U-257 

Patent & 

Exclusivity 

07/15/14 

21/05/13 

09/02/14 

Earliest 

Generic 

138 

159 

N/A 

1999 

2001 1 


(Mil) 

Sporanox Itraconazole JNJ- 01/13/15 2/21/00 NCE/ NDF 

01/13/15 

1219 

Janssen 5-707-975 

I-04, I-155 

1334 

Diprivan Propofol Astra 030/22/15 6/11/199 - 

03/22/15 

349 

Zenacca 5-714-520 

NP 

388 

Prempro- estrogen AHP 1/17/15 M/D/YY - 

01/17/15 

460 

14/14 conjugated Wyeth Ar 5-547-948 

498 

Miacalcin Calcitonin 

Salmon 

Novartis 03/31/15 

5-733-569 

COREG Carvedilol SKB 06/07/15 

5-760-069 

FOSAMAX Alendronate Merck 06/06/15 

Na 

Co 5-849-726 

ALLEGRA Fexofenadine 

Hoechst 02/28/15 

Marion 5-855-912 

HCl Roussel 5-738-872 

PEPCID 

AC 

Famotodine 

Merck 

& Co. 

06/06/15 

5-854-267 

08/17/98 U-227 

NDF 

- - 

U-233 

09/29/00 - 

NCE 

12/24/00 U-138 

NC 

13/31/15 185 

220 

06/07/15 158 

199 

06/06/15 600 

689 

02/28/15 [105+] 

185 

09/29/00 U-267 06/06/15 600 

680 







U-Codes apply to 

patent expiry only 

I-Codes apply to exclusivity, ODE and all NEW 

presentations and forms 




Reports 

ISSN 0793694X 


Drug OFF 


Patent 


Marketer 


(Mil) 

REBETOL Ribavirin ICN 01/23/16 12/09/01 - 

01/23/16 

100 

5-767-097 

I-249 

00 

AGGRAS 

TAT 

Tibofiban 

HCl 

Merck 10/23/16 

5-733-919 

05/14/03 - 

NCE 

10/23/16 

16 

32 


PRELAY Trolitazone Sankyo 11/13/17 

5-859-037 

01/29/02 U-251 

NCE 

11/13/17 

N/A 

N/A 

US GENERIC DRUG SALES FORCAST 

25 

21.8 

20 

16.9 17.1 

USD$ (Billions) 

15 

10 

8.24 

9.34 

10.93 

13 

14.5 

5 

0 

1998 1999 2000 2001 2002 2003 2004 2005 

Sales Year 



% Market Share 

60 

50 

40 

30 

20 

10 

0 

35 

1992 

Generic Market Share of Total Rx Business 

40 42 43 43 44 

47 47.2 48.4 49.1 50.5 

1993 

1994 

1995 

1996 

1997 

1998 

1999 

2000 

2001 

2002 

Sales Year 

8 

7 

Total $ Sales of Expiring Drugs - Next 10 Years 

7.1 

7.3 

7 

6.6 

Market Value ($Billions) 

6 

5 

4 

3 

2 

1 

1.1 

3.6 

3.1 

3.8 

2.8 

4 

2 

3.2 

1.6 

0 

1998 

1999 

2000 

2001 

2002 

2003 

2004 

2005 

2006 

2007 

2008 

2009 

2010 

Expiration Year 

Argentinia 

3.4 

World Retail Rx Sales - $216.3 ($ Billions) 

Cardiovascular products 

amount to $42 billion of total 

Mexico 

Brazil 

S America 

4.6 

5.1 

13.1 

Fastest growing segment 

musculoskeletal - $12 billion 

Spain 

5.5 

REGION 

UK 

Italy 

France 

9.2 

9.3 

13.8 

Germany 

Europe 

14.9 

52.7 

Retail Rx sales in Europe 

and Japan almost equal 

Japan 

51.7 

North Am. 

98.9 

Canada 

5.3 

US 

94 

0 10 20 30 40 50 60 70 80 90 100 

Rx Market Value - Key Markets

DRUGS REPORTS

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