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【drug-news】仿制药上市变数多多
Generic pills are being welcomed with open arms by the market, but Big Pharma and the FDA may just be two of the roadblocks in the drugmakers' way.
In a recent interview, the director of the FDA's Office of Generic Drugs, Gary Buehler, said that the agency is having trouble keeping up with the number of submissions for generic drug applications. Their review process took about 19 months each in 2007, a two-month increase over 2006, and the government has been receiving a slew of new ones in recent years, with an expected total of 1,500 in 2008. But these lower-priced alternatives aren't just being held up by the FDA--the courts have a say, too.
Mylan's subsidiary Alphapharm and Barr Pharmaceuticals (nyse: BRL - news - people ) are in the process of launching generic versions of Ortho-McNeil's Alzheimer's drug Razadyne. The drug makers won a patent suit in the U.S. District Court for the District of Delaware on Thursday, effectively voiding one of Ortho's patents on Razadyne. Ortho was denied a request for a temporary restraining order by the court that would prevent Barr and Mylan from marketing their generic versions; the company plans to file an appeal.
Shares of Mylan were down 0.9%, or 11 cents, to close at $12.89 on Friday, while Barr was off 33 cents to trade at $67.54.
Ortho-McNeil, a unit of Johnson & Johnson (nyse: JNJ - news - people ), will be facing generic competition from Barr and Mylan almost immediately. Mylan (nyse: MYL - news - people ) said the U.S. Food and Drug Administration approved its application for generic Razadyne, allowing it to start selling 4 milligram, 8 milligram and 12 milligram tablets. The generic producers will have 180 days of marketing exclusivity on the generic versions.
"We are very pleased with the court's ruling on this first-to-file patent challenge, which once again continues to underscore our ability to effectively pursue and monetize Paragraph IV opportunities," said Mylan Vice Chairman Robert J. Coury. "This is yet another example of our continued and successful commitment to provide affordable medications to the patients who need them the most."
Razadyne is used for the treatment of mild dementia and had U.S. sales of $102.0 million for the year, ending June 2008. Razadyne's patent was set to expire in December 2008.
It is not unusual for generic companies to file a drug application with the FDA while the brand drug's patent is still valid. Larger pharmaceuticals will then file a patent suit; the decisions tend to be mixed.
In a victory for Big Pharma, Pfizer (nyse: PFE - news - people ) announced Friday that a Danish court-blocked generic Indian drugmaker Ranbaxy Laboratories from infringing on two of its patents for its blockbuster cholesterol drug Lipitor, which loses patent protection in 2011. Ranbaxy is battling with Pfizer to make a generic version of the world's top-selling drug in several other countries, including Spain and Portugal. Earlier this year, Pfizer and Ranbaxy settled their generic dispute in the U.S. by agreeing that the generic company could launch its copycat in November 2011.
Shares of Pfizer were off 16 cents to close at $19.11 on Friday. 仿制药上市变数多多
Generic pills are being welcomed with open arms by the market, but Big Pharma and the FDA may just be two of the roadblocks in the drugmakers' way.
虽然市场十分欢迎非专利药，但大制药公司和FDA可能会妨碍非专利药品的上市。
In a recent interview, the director of the FDA's Office of Generic Drugs, Gary Buehler, said that the agency is having trouble keeping up with the number of submissions for generic drug applications. Their review process took about 19 months each in 2007, a two-month increase over 2006, and the government has been receiving a slew of new ones in recent years, with an expected total of 1,500 in 2008. But these lower-priced alternatives aren't just being held up by the FDA--the courts have a say, too.
在近期一次采访中，FDA非专利药办公室主任Gary Buehler说，FDA无法处理那么多非专利药申请。2007年每项申请的审查过程需要19个月，比2006年增加了2个月，而且最近几年又有许多新申请，预计2008年总申请数会达1500项。但是，对于这些价廉的仿制药来说，不仅FDA会拖延其上市，法院也会对其造成一定的妨碍。
Mylan's subsidiary Alphapharm and Barr Pharmaceuticals (nyse: BRL - news - people ) are in the process of launching generic versions of Ortho-McNeil's Alzheimer's drug Razadyne. The drug makers won a patent suit in the U.S. District Court for the District of Delaware on Thursday, effectively voiding one of Ortho's patents on Razadyne. Ortho was denied a request for a temporary restraining order by the court that would prevent Barr and Mylan from marketing their generic versions; the company plans to file an appeal.
Mylan子公司Alphapharm 和Barr 制药公司正在申请仿制Ortho-McNeil公司的阿尔茨海默氏病治疗药Razadyne。该制药商周四在特拉华州联邦地方法院打赢了一场专利诉讼案，成功地避开Ortho公司对Razadyne的一项专利。Ortho提出的一项临时限制令申请被地方法院驳回，该限制令的目的旨在阻止Barr和Mylan公司的仿制药上市；目前Ortho公司打算提起上诉。
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作者:admin@医学,生命科学 2011-02-09 05:14
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