http://www.patentbaristas.com/archives/2009/02/06/bill-introduced-to-prohibit-the-marketing-of-authorized-generic-drugs/?utm_source=rss&utm_medium=rss&utm_campaign=bill-introduced-to-prohibit-the-marketing-of-authorized-generic-drugs Freshly Brewed Bio/Pharma Chat. Served Up Daily. Tue, 07 Feb 2012 11:57:58 +0000 hourly 1 http://wordpress.org/?v=3.3.1 http://www.patentbaristas.com/archives/2009/02/06/bill-introduced-to-prohibit-the-marketing-of-authorized-generic-drugs/comment-page-1/#comment-69501 DOJ Hits Pfizer with $2.3B Bill | Technology Boss Thu, 03 Sep 2009 07:15:28 +0000 http://www.patentbaristas.com/archives/2009/02/06/bill-introduced-to-prohibit-the-marketing-of-authorized-generic-drugs/#comment-69501 [...] Bill Introduced to Prohibit the Marketing of Authorized Generic Drugs The 1984 Hatch-Waxman Act combined the 180-day duration of exclusivity… [...] [...] Bill Introduced to Prohibit the Marketing of Authorized Generic Drugs The 1984 Hatch-Waxman Act combined the 180-day duration of exclusivity… [...]

]]> http://www.patentbaristas.com/archives/2009/02/06/bill-introduced-to-prohibit-the-marketing-of-authorized-generic-drugs/comment-page-1/#comment-65548 Senthilkumar Sat, 07 Feb 2009 09:27:00 +0000 http://www.patentbaristas.com/archives/2009/02/06/bill-introduced-to-prohibit-the-marketing-of-authorized-generic-drugs/#comment-65548 While the bills addressed two aspects of circumventing the Hatch-Waxmann act namely Reverse Payments, and Authorized Generics, the are other unjustified means of delaying the generic entry. At the end of patent expiry, certain brand companies introduce minor modification of the original formulation, get approval from the agency, withdraw the original formulation from market, and file a petition with FDA that the generic formulation referencing the original formulation should no longer be approved. Hence, there would be substantial delay from the agency to conclude on the petition, during which time the monopoly is maintaine by the brand, as no generic was approved even after the expiry of the patent. Since the new formulation with minor change in formulation is patented, it would amount to extending the monopoly for several years ! While the bills addressed two aspects of circumventing the Hatch-Waxmann act namely Reverse Payments, and Authorized Generics, the are other unjustified means of delaying the generic entry. At the end of patent expiry, certain brand companies introduce minor modification of the original formulation, get approval from the agency, withdraw the original formulation from market, and file a petition with FDA that the generic formulation referencing the original formulation should no longer be approved. Hence, there would be substantial delay from the agency to conclude on the petition, during which time the monopoly is maintaine by the brand, as no generic was approved even after the expiry of the patent. Since the new formulation with minor change in formulation is patented, it would amount to extending the monopoly for several years !

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