Generic drug name | Company | Date of NOC/c(d/mo/yr) | Date NOC/c fulfilled(d/mo/yr) | Time from NOC/c to fulfillment, d | No. of unique confirmatory studies listed in Qualifying Notice | No. of confirmatory studies with publications | ||
---|---|---|---|---|---|---|---|---|
Based on company response | Based on database search* | No publication identified for study | ||||||
Company responded | ||||||||
Abacavir | GlaxoSmithKline | 04/06/1999 | 10/09/2001 | 829 | 3 | 3 | NA | |
Alteplase | Hoffmann-La Roche | 16/02/1999 | 26/01/2005 | 2171 | 2 | 2 | NA | |
Anastrozole† | AstraZeneca | 30/06/2004 | 02/12/2008 | 1616 | 3 | 1 | 1 | 1 |
Bortezomib | Janssen-Ortho | 27/01/2005 | 11/09/2007 | 957 | 1‡ | 1‡ | NA | |
24/04/2006 | 11/09/2007 | 505 | 1‡ | 1‡ | NA | |||
Capecitabine | Hoffmann-La Roche | 07/12/2005 | 23/10/2008 | 1051 | 1 | 1 | NA | |
Darunavir | Janssen-Ortho | 28/07/2006 | 11/02/2009 | 929 | 2 | 2 | NA | |
Dasatinib | Bristol-Myers Squibb | 26/03/2007 | 19/11/2009 | 969 | 2 | 2 | NA | |
Exemestane | Pfizer | 12/05/2006 | 06/06/2008 | 756 | 3 | 3 | NA | |
Gefitinib | AstraZeneca | 17/12/2003 | 18/12/2009 | 2193 | 4 | 3§ | NA | |
Lenalidomide | Celgene | 17/01/2008 | 06/06/2013 | 1967 | 1 | 1 | NA | |
Levodopa/carbidopa | AbbVie | 01/03/2007 | 12/03/2014 | 2568 | 2 | 2 | NA | |
Pregabalin | Pfizer | 09/11/2007 | 29/06/2010 | 963 | 1 | 1 | NA | |
Recombinant factor VIIa | Novo Nordisk | 12/02/1999 | 19/03/2006 | 2319 | 1 | 1 | NA | |
Riluzole† | Sanofi-Aventis | 30/08/2000 | 29/11/2007 | 2647 | 1 | NA | 1 | |
Sorafenib | Bayer | 28/06/2006 | 12/06/2009 | 1050 | 3 | 2§ | NA | |
Sunitinib | Pfizer | 17/08/2006 | 23/04/2010 | 1345 | 3‡ | 3‡ | NA | |
01/05/2008 | 23/04/2010 | 722 | 1‡ | 1‡ | NA | |||
Zanamivir | GlaxoSmithKline | 02/11/1999 | 26/08/2003 | 1393 | 1 | 1 | NA | |
Total no. of distinct confirmatory studies/publications | 34 studies | 29 publications (31 studies) | 1 publication (1 study) | 2 studies | ||||
Company did not respond | ||||||||
Aztreonam | Merck (Gilead) | 17/06/2009 | 17/05/2011 | 669 | 1 | NA | 1 | |
Delavirdine | ViiV Healthcare | 22/07/1998 | 22/07/2003 | 1826 | 5¶ | NA | 1‡ | 4¶ |
25/04/2000 | 22/07/2003 | 1183 | 5¶ | NA | 1‡ | 4¶ | ||
Imatinib | Novartis | 20/09/2001 | 29/12/2004 | 1196 | 7 | NA | 6 | 1 |
08/10/2003 | 17/06/2010 | 2444 | 1 | NA | 1 | |||
24/05/2007 | 21/02/2013 | 2100 | 1 | NA | 1 | |||
Letrozole | Novartis | 01/04/2005 | 17/12/2010 | 2086 | 2 | NA | 2 | |
06/10/2006 | 17/12/2010 | 1533 | 1 | NA | 1 | |||
Nilotinib | Novartis | 09/09/2008 | 30/11/2011 | 1177 | 1 | NA | 1 | |
22/07/2010 | 18/08/2011 | 392 | 1 | NA | 1 | |||
Raltegravir | Merck | 27/11/2007 | 04/03/2009 | 463 | 2 | NA | 1§ | |
Tenofovir | Merck (Gilead) | 18/03/2003 | 20/07/2005 | 855 | 2 | NA | 2 | |
Total no. of distinct confirmatory studies/publications | 24 studies | NA | 18 publications (19 studies) | 5 studies |
Note: NOC/c = Notice of Compliance with conditions.
*No company response or publication not confirmed by company.
†Company responded but did not confirm all studies.
‡One study or publication in common.
§Two studies in 1 publication.
¶All studies or publications in common.