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Main | | | | | | | | | | | |
| Brand Name | Aciphex. Known as Pariet in ROW. | | | | | | | | | |
| Generic Name | rabeprazole delayed release | | | | | | | | | |
| Indication | GERD, Heartburn, Peptic Ulcer | | | | | | | | | |
| Administration | Oral | | | | | | | | | |
| Mechanism | PPI | | | | | | | | | |
| Economics | Eisai co-promotion -- what are the details? | | | | | | | | | |
| Timeline | Filed 3/31/1998, approved 8/19/1999. | | | | | | | | | |
| IP | 5/8/2013 found to be enforceable, Teva loses case. 30-Month stay expires February 2007. 20mg delay release tablet being sued by TEVA, RDY and MYL | | | | | | | | | |
| Competition | Nexium (AZN), Prilosec (generic OTC), Protonix (WYE), Zantac (OTC), Axid (generic), Prevacid (Takeda/Abbott). | | | | | | | | | |
| Rx | | | | | | | | | | |
| | 2001 | 2002 | 2003 | 2004 | 2005 | 2006 | 2007 | 2008 | 2009 | 2010 |
| US | | | | | | | | | | |
| ROW | | | | | | | | | | |
| WW | | 697 | 966 | 1116 | 1169 | 1239 | 1357 | 1158 | 1096 | |
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| Clinical Trials | | | | | | | | | | |
| | Phase 3 GERD study vs placebo | | | | | | | | | |
| | At week 4, 63% of 10mg were healed vs 56% for 20mg, 54% for 40mg and 0% placebo. | | | | | | | | | |
| | Comparing across trials, Protonix label notes 46%, 58% and 75% healing rates for 10mg, 20mg and 40mg with 14% for placebo. | | | | | | | | | |
| | At week 8, 93% of 10mg were healed vs 84% for 20mg, 85% for 40mg and 12% for placebo. | | | | | | | | | |
| | Comparing across trials, Protonix label notes 66%, 84% and 93% cure rates for 10mg, 20mg and 40mg vs 40% placebo. | | | | | | | | | |
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| | Phase 3 GERD study vs ranitidine (Zantac) | | | | | | | | | |
| | At week 4, 59% were healed vs 36% for Zantac. | | | | | | | | | |
| | Comparing across trials, Protonix label notes 61% and 64% cure rates vs 22% for Axid. | | | | | | | | | |
| | At week 8, 87% were healed vs 66% for Zantac. | | | | | | | | | |
| | Comparing across trials, Protonix label notes 79% and 83% cure rates vs 41% for Axid. | | | | | | | | | |
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| Rx | | | | | | | | | | |
| 10/31/2008 | | | | | | | | | | |
| 10/24/2008 | | | | | | | | | | |
| 10/17/2008 | 133726 | | | | | | | | | |
| 10/10/2008 | 137437 | | | | | | | | | |
| 10/3/2008 | 142546 | | | | | | | | | |
| 9/26/2008 | 139554 | | | | | | | | | |
| 9/19/2008 | 136830 | | | | | | | | | |
| 9/12/2008 | 138729 | | | | | | | | | |
| 9/5/2008 | 132066 | | | | | | | | | |
| 8/29/2008 | 140859 | | | | | | | | | |
| 8/22/2008 | 135720 | | | | | | | | | |
| 8/15/2008 | 134693 | | | | | | | | | |