http://onthepharm.net/2006/05/fda-bottleneck.html Life on the pharm Sat, 13 Mar 2010 17:06:35 -0800 http://wordpress.org/?v=2.8.6 hourly 1 http://onthepharm.net/2006/05/fda-bottleneck.html/comment-page-1#comment-109 OnThePharm Sat, 08 Jul 2006 02:01:13 +0000 http://onthepharm.net/2006/05/fda-bottleneck/#comment-109 [...] On the other hand, you wonder why one of the parties has to be a spoil-sport and ruin the party by trying to bend the rules to their further benefit. Given that any single member of the one group has more resources than all the opposition put together*, this often makes for a pretty lobsided game. Especially when one party begins exploiting safeguards put in place by the government to work on behalf of the People. Some at the FDA, as well as leaders in the generic drug industry, complain that “citizen petitions” — requests for agency action that any individual, group or company can file — are being misused by brand-name drugmakers to stave off generic competition. [...] [...] On the other hand, you wonder why one of the parties has to be a spoil-sport and ruin the party by trying to bend the rules to their further benefit. Given that any single member of the one group has more resources than all the opposition put together*, this often makes for a pretty lobsided game. Especially when one party begins exploiting safeguards put in place by the government to work on behalf of the People. Some at the FDA, as well as leaders in the generic drug industry, complain that "citizen petitions" — requests for agency action that any individual, group or company can file — are being misused by brand-name drugmakers to stave off generic competition. [...]

]]> http://onthepharm.net/2006/05/fda-bottleneck.html/comment-page-1#comment-77 Novartis as the next-gen pharmaceutical company? …It’s possible. :: OnThePharm Mon, 26 Jun 2006 18:22:19 +0000 http://onthepharm.net/2006/05/fda-bottleneck/#comment-77 [...] This would allow them to skip creating an “authorized” generic if they chose. Authorized generics are exactly the same as their brand-name drugs, and can be sold during that 180 day window — which of course drives the generic manufacturer batty because they don’t quite have that total monopoly. This, of course, cuts into their profits, for reasons I’ve elucidated before. [...] [...] This would allow them to skip creating an "authorized" generic if they chose. Authorized generics are exactly the same as their brand-name drugs, and can be sold during that 180 day window — which of course drives the generic manufacturer batty because they don't quite have that total monopoly. This, of course, cuts into their profits, for reasons I've elucidated before. [...]

]]> http://onthepharm.net/2006/05/fda-bottleneck.html/comment-page-1#comment-57 OnThePharm » Generic Proscar approved; Propecia loses patent protection today. Tue, 20 Jun 2006 03:14:42 +0000 http://onthepharm.net/2006/05/fda-bottleneck/#comment-57 [...] Teva has gotten its generic finasteride tablets approved by the FDA. They will begin shipping the new generic for Merck’s Proscar immediately. They have a 6-month monopoly on the sale of the new generic, and I wouldn’t be surprised to hear about them filing the ANDA for Propecia as well, assuming they haven’t already. (Propecia is a low-dose finasteride (1mg) used to treat male pattern baldness that also lost patent protection today.) [...] [...] Teva has gotten its generic finasteride tablets approved by the FDA. They will begin shipping the new generic for Merck's Proscar immediately. They have a 6-month monopoly on the sale of the new generic, and I wouldn't be surprised to hear about them filing the ANDA for Propecia as well, assuming they haven't already. (Propecia is a low-dose finasteride (1mg) used to treat male pattern baldness that also lost patent protection today.) [...]

]]> http://onthepharm.net/2006/05/fda-bottleneck.html/comment-page-1#comment-20 OnThePharm » Teva’s potential windfalls: Cozaar and Zocor Tue, 30 May 2006 17:54:55 +0000 http://onthepharm.net/2006/05/fda-bottleneck/#comment-20 [...] Teva will not be able to sell their generic Cozaar until April 2010, when Merck’s patent expires, but they are the first to get this FDA Good Housekeeping Seal of Approval, so it looks like they’re going to get that six-month lock on sales of the generic forms of the drug provided Merck doesn’t do some wheeling-and-dealing. Predicting what Merck will do in 2010 is impossible: will they have a successor to Cozaar by then? Will Cozaar even be a super-profitable at that time? These are the biggest two questions that will determine whether Merck will buy themselves that extra six months when the time comes. [...] [...] Teva will not be able to sell their generic Cozaar until April 2010, when Merck's patent expires, but they are the first to get this FDA Good Housekeeping Seal of Approval, so it looks like they're going to get that six-month lock on sales of the generic forms of the drug provided Merck doesn't do some wheeling-and-dealing. Predicting what Merck will do in 2010 is impossible: will they have a successor to Cozaar by then? Will Cozaar even be a super-profitable at that time? These are the biggest two questions that will determine whether Merck will buy themselves that extra six months when the time comes. [...]

]]> http://onthepharm.net/2006/05/fda-bottleneck.html/comment-page-1#comment-16 OnThePharm » Generic Plavix shenanigans Sun, 28 May 2006 20:29:44 +0000 http://onthepharm.net/2006/05/fda-bottleneck/#comment-16 [...] It’s a clear victory for Big Pharma, and a loss for consumers and any company that’s not Sanofi-Aventis or BMS. Plavix was #2 on the top 200 list in 2005, with sales totaling $5.2 billion. Had Apotex been successful and not settled out of court, there would have been a generic Plavix available relatively quickly. Unfortunately they settled for the guaranteed money, and exclusive rights for 8 months. As I’ve said before, the value of the generic drug market is tiny compared to Big Pharma — by taking the settlement BMS, S-A, and Apotex all win. (Personally if I was Apotex, I’d have pushed for a higher figure, just because Plavix is so valuable.) [...] [...] It's a clear victory for Big Pharma, and a loss for consumers and any company that's not Sanofi-Aventis or BMS. Plavix was #2 on the top 200 list in 2005, with sales totaling $5.2 billion. Had Apotex been successful and not settled out of court, there would have been a generic Plavix available relatively quickly. Unfortunately they settled for the guaranteed money, and exclusive rights for 8 months. As I've said before, the value of the generic drug market is tiny compared to Big Pharma — by taking the settlement BMS, S-A, and Apotex all win. (Personally if I was Apotex, I'd have pushed for a higher figure, just because Plavix is so valuable.) [...]

]]>