Hello guys!!!!!
Kindly attention generic pharma players please!!!
FDA has moved the path of Electronic Orange Book which is utilised to access patent data of approved drugs.
Here we have given the link to access Electronic Orange Book.
Check it out by your own.
The link is http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm
Saturday, May 30, 2009
Friday, May 29, 2009
Teva settles patent suit with Zydus Pharmaceuticals Inc on Coreg® (Carvedilol) in Round 2
Teva Pharmaceuticals, the Israel based generic major, has reportedly settled its patent litigation with the Ahmedabad-based Cadila Healthcare and its US-based subsidiary Zydus Pharmaceuticals Inc concerning the process of making carvedilol
First of all Teva sent enquiry letters to lot of companies and then sued some of them in round one and followed by the settlement. Teva purportedly settled first with DRL then Cadila and Torrent; but later, they sued a whole bunch of companies excluding DRL in round 2 including some of those who had settled in 1st round.
Teva has sent enquiry letters to some companies for Carvedilol and has already sued Zentiva for the same. This action should be worrying for other generic companies that are about to enter Carvedilol space
Teva is the drug manufacturer for the technology that goes into manufacturing carvedilol. The other companies included Ranbaxy Laboratories, Cadila Healthcare, Lupin and Orchid Chemicals. But Teva went ahead and withdrew the case against Dr Reddy’s as Dr Reddy’s had asked for a summary judgement from the New Jersey District Court. Now once the core patent against which Dr Reddy’s was sued is withdrawn by Teva, Dr Reddy’s will be able to sell this particular drug. It’s quite a big drug; now Zydus is also in the big list of Teva for the settlement.
Originally it is licensed by Roche to GSK in the US and it’s a very strong product as far as Teva is concerned. So there will be hindrances put by Teva for any other company which want to market that product.
It should be noted that the market size of the carvedilol would be upwards of USD 400 million.
So, war will be continued with other giants……..
First of all Teva sent enquiry letters to lot of companies and then sued some of them in round one and followed by the settlement. Teva purportedly settled first with DRL then Cadila and Torrent; but later, they sued a whole bunch of companies excluding DRL in round 2 including some of those who had settled in 1st round.
Teva has sent enquiry letters to some companies for Carvedilol and has already sued Zentiva for the same. This action should be worrying for other generic companies that are about to enter Carvedilol space
Teva is the drug manufacturer for the technology that goes into manufacturing carvedilol. The other companies included Ranbaxy Laboratories, Cadila Healthcare, Lupin and Orchid Chemicals. But Teva went ahead and withdrew the case against Dr Reddy’s as Dr Reddy’s had asked for a summary judgement from the New Jersey District Court. Now once the core patent against which Dr Reddy’s was sued is withdrawn by Teva, Dr Reddy’s will be able to sell this particular drug. It’s quite a big drug; now Zydus is also in the big list of Teva for the settlement.
Originally it is licensed by Roche to GSK in the US and it’s a very strong product as far as Teva is concerned. So there will be hindrances put by Teva for any other company which want to market that product.
It should be noted that the market size of the carvedilol would be upwards of USD 400 million.
So, war will be continued with other giants……..
Thursday, May 28, 2009
Cinacalcet (Sensipar®): Teva has fired off a suit accusing Amgen Inc. of infringing its patent by making and selling Sensipar®
Teva Pharmaceutical Industries Ltd. has fired off a suit accusing Amgen Inc. of infringing its patent by making and selling Sensipar®, a drug indicated for the treatment of secondary hyperparathyroidism in patients with chronic disease on dialysis.
Teva has filed patent infringement lawsuit against Innovator Company Amgen for Cinacalcet process patent infringement in District court for Eastern district of Pennsylvania.
Teva got following process patent issued on the date of Nov 11, 2008.US7449603 (Plaintiff: Teva): Which covers process for the synthesis of Cincalcet having independent claims 1, 10, 16, 32, 41 and 42
Earlier, M/s Amgen sued Barr (Now, subsidiary of Teva) for filing Para IV on Cinacalcet (Sensipar) 30, 60 and 90 mg tablets in March, 2008. Subsequently, M/s Amgen sued Teva and Barr in Delaware district court in July, 2008.
(The Brigham and Women’s Hospital, NPS Pharmaceuticals and Amgen filed the lawsuit in the U.S. District Court for the District of Delaware after receiving notices that Teva and Barr planned to make generic versions of Sensipar (cinacalcet HCl). Both firms’ generic Sensipar ANDAs contained Paragraph IV certifications on the ’244, ’146, ’068 and ’003 patents. The ’244 patent expires in October 2015, and the others expire in December 2016.
NPS is the sole owner of the ’244 patent and owns the other patents with the Brigham and Women’s Hospital. Amgen holds exclusive licenses for each of the patents.
The three plaintiffs asked the court to order that the effective date of any FDA approval of generic Sensipar be no earlier than the expiration of the patents or any later date of exclusivity.
Based on IMS data, Sensipar had annual sales of approximately $377 million in the U.S for the 12-month period ending in May, according to Barr. The drug was approved in March 2004 by the FDA after a priority review. )
Now, it will be interesting to monitor counter litigation strategy of Teva against M/s Amgen.
So wait and watch!!!!!!
Teva has filed patent infringement lawsuit against Innovator Company Amgen for Cinacalcet process patent infringement in District court for Eastern district of Pennsylvania.
Teva got following process patent issued on the date of Nov 11, 2008.US7449603 (Plaintiff: Teva): Which covers process for the synthesis of Cincalcet having independent claims 1, 10, 16, 32, 41 and 42
Earlier, M/s Amgen sued Barr (Now, subsidiary of Teva) for filing Para IV on Cinacalcet (Sensipar) 30, 60 and 90 mg tablets in March, 2008. Subsequently, M/s Amgen sued Teva and Barr in Delaware district court in July, 2008.
(The Brigham and Women’s Hospital, NPS Pharmaceuticals and Amgen filed the lawsuit in the U.S. District Court for the District of Delaware after receiving notices that Teva and Barr planned to make generic versions of Sensipar (cinacalcet HCl). Both firms’ generic Sensipar ANDAs contained Paragraph IV certifications on the ’244, ’146, ’068 and ’003 patents. The ’244 patent expires in October 2015, and the others expire in December 2016.
NPS is the sole owner of the ’244 patent and owns the other patents with the Brigham and Women’s Hospital. Amgen holds exclusive licenses for each of the patents.
The three plaintiffs asked the court to order that the effective date of any FDA approval of generic Sensipar be no earlier than the expiration of the patents or any later date of exclusivity.
Based on IMS data, Sensipar had annual sales of approximately $377 million in the U.S for the 12-month period ending in May, according to Barr. The drug was approved in March 2004 by the FDA after a priority review. )
Now, it will be interesting to monitor counter litigation strategy of Teva against M/s Amgen.
So wait and watch!!!!!!
Wednesday, May 27, 2009
Hello to all IP guys
Hi
I am Madhav, one of all.
I have masters in organic chemistry and bachelors in Law.
I am engaged in pharmaceutical IP field with a pharmaceutical company.
My fields of interest are chemistry and IP especially of generic pharmaceutical.
I am Madhav, one of all.
I have masters in organic chemistry and bachelors in Law.
I am engaged in pharmaceutical IP field with a pharmaceutical company.
My fields of interest are chemistry and IP especially of generic pharmaceutical.
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