Sun Pharma got final approval for Torsemide tablets
Sun Pharma announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application to market its generic version of Hoffman la Roche’s Demadex®, torsemide tablets.These generic torsemide tablets are therapeutic equivalents of Hoffman la Roche’s Demadex® Tablets and include four strengths: 5 mg, 10 mg, 20 mg and 100 mg. These strengths of torsemide tablets have annual sales of approximately USD 35 million in the US.Torsemide is a diuretic, indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Torsemide is also indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.The Company expects to reach the market shortly with these products.Demadex® is a registered trademark of Roche Therapeutics, Inc.
Gabapentin litigation
As reported yesterday Apotex Corp. has settled all outstanding patent infringement and antitrust litigation with Pfizer Inc. regarding that company's former blockbuster anticonvulsant Neurontin.Though terms of the settlement are confidential, Apotex said that it is free to market and sell the generic version as it has done since April 2005.The agreement ends almost a decade of litigation between the two companies.Pfizer added Neurontin to its drug stable when it purchased Warner-Lambert in February 2000. The drug had received approval from the U.S. Food and Drug Administration in January 1994.In 2005, the federal district court in New Jersey ruled that Pfizer was unable to prove infringement of its Neurontin patents by generic drug makers including Alpharma, Apotex, Teva Pharma and Eon Labs.
In September, an appeals court overturned portions of the 2005 decision and sent the case to a new trial after ruling that the district court erred in granting summary judgment of non-infringement.Afterward, Pfizer said it planned to pursue full damages due to the so-called at-risk launch of generic versions of Neurontin, the patent for which doesn't expire until 2017.Such a move is called an at-risk launch because, under U.S. law, the generic maker can be liable for triple the damages incurred by the branded-drug company if it ends up losing the patent case.Pfizer says sales of Neurontin were more than $2 billion a year, prior to the generic versions' launching.Pfizer offers a generic version of Neurontin through its unit Greenstone Ltd.
Barr confirms Para IV filing on Dutasteride
Barr Pharma confirmed that it has initiated a challenge of the patents listed by GlaxoSmithKline in connection with its Avodart(R) (Dutasteride) soft gelatin capsules, 0.5mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Avodart. Barr filed its ANDA containing a paragraph IV certification for a generic Avodart product with the U.S. Food & Drug Administration (FDA) in October 2007, and received notification of the application's acceptance for filing in January 2008. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.On February 25, 2008, GlaxoSmithKline filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.Avodart (dutasteride) had annual sales of approximately $362 million in the U.S., based on IMS sales data for the twelve-month period ending December 2007.
Pfizer Pulls Lipitor Ads
Pfizer Inc. (PFE) will stop running advertisements for cholesterol drug Lipitor featuring a doctor who invented an artificial heart, following criticism that the ads were misleading because the doctor isn't licensed to practice.
The New York drug company said in a press release Monday it would withdraw the ads featuring Robert Jarvik, saying "the way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions" from the goal of encouraging doctor-patient dialogue about heart disease. "We regret this," the company said.
Sun Pharma announced that USFDA has granted final approval for the Company’s Abbreviated New Drug Application to market its generic version of Hoffman la Roche’s Demadex®, torsemide tablets.These generic torsemide tablets are therapeutic equivalents of Hoffman la Roche’s Demadex® Tablets and include four strengths: 5 mg, 10 mg, 20 mg and 100 mg. These strengths of torsemide tablets have annual sales of approximately USD 35 million in the US.Torsemide is a diuretic, indicated for the treatment of edema associated with congestive heart failure, renal disease, or hepatic disease. Use of torsemide has been found to be effective for the treatment of edema associated with chronic renal failure. Torsemide is also indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.The Company expects to reach the market shortly with these products.Demadex® is a registered trademark of Roche Therapeutics, Inc.
Gabapentin litigation
As reported yesterday Apotex Corp. has settled all outstanding patent infringement and antitrust litigation with Pfizer Inc. regarding that company's former blockbuster anticonvulsant Neurontin.Though terms of the settlement are confidential, Apotex said that it is free to market and sell the generic version as it has done since April 2005.The agreement ends almost a decade of litigation between the two companies.Pfizer added Neurontin to its drug stable when it purchased Warner-Lambert in February 2000. The drug had received approval from the U.S. Food and Drug Administration in January 1994.In 2005, the federal district court in New Jersey ruled that Pfizer was unable to prove infringement of its Neurontin patents by generic drug makers including Alpharma, Apotex, Teva Pharma and Eon Labs.
In September, an appeals court overturned portions of the 2005 decision and sent the case to a new trial after ruling that the district court erred in granting summary judgment of non-infringement.Afterward, Pfizer said it planned to pursue full damages due to the so-called at-risk launch of generic versions of Neurontin, the patent for which doesn't expire until 2017.Such a move is called an at-risk launch because, under U.S. law, the generic maker can be liable for triple the damages incurred by the branded-drug company if it ends up losing the patent case.Pfizer says sales of Neurontin were more than $2 billion a year, prior to the generic versions' launching.Pfizer offers a generic version of Neurontin through its unit Greenstone Ltd.
Barr confirms Para IV filing on Dutasteride
Barr Pharma confirmed that it has initiated a challenge of the patents listed by GlaxoSmithKline in connection with its Avodart(R) (Dutasteride) soft gelatin capsules, 0.5mg. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for Avodart. Barr filed its ANDA containing a paragraph IV certification for a generic Avodart product with the U.S. Food & Drug Administration (FDA) in October 2007, and received notification of the application's acceptance for filing in January 2008. Following receipt of the notice from the FDA that Barr's ANDA had been accepted for filing, Barr notified the New Drug Application (NDA) and patent holder.On February 25, 2008, GlaxoSmithKline filed suit in the U.S. District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.Avodart (dutasteride) had annual sales of approximately $362 million in the U.S., based on IMS sales data for the twelve-month period ending December 2007.
Pfizer Pulls Lipitor Ads
Pfizer Inc. (PFE) will stop running advertisements for cholesterol drug Lipitor featuring a doctor who invented an artificial heart, following criticism that the ads were misleading because the doctor isn't licensed to practice.
The New York drug company said in a press release Monday it would withdraw the ads featuring Robert Jarvik, saying "the way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions" from the goal of encouraging doctor-patient dialogue about heart disease. "We regret this," the company said.
