Taj Pharmaceuticals Announces Issuance of US Patent for Terfenadine
Taj Pharma India, Extends exclusivity to Terfenadine Generic Patent used for antihistamine formerly used for the treatment of allergic conditions
June 5, 2011 (Newswire.com) -
Today Taj Pharma India was given the official Issuance of Patent for the controversial drug Terfenadine in US. The drug was brought to market by Hoechst Marion Roussel (Sanofi-Aventis) but the clinical trials were due with a patent on a changed compound.
Taj Pharmaceuticals today announced allowance by the United States Patent and Trademark Office of Patent Application Terfenadine. This follows the UK issuance which was granted in October of 2010 adding to the extensive patent estate.
"This U.S. allowance comes at a strategic time for Taj Pharma India and said to be part of major strategic alignment and turnaround in the international patent pool. The company's Chief Executive Officer Mr.A.K.Singh said," We believe Terfenadine may help address the significant need to improve outcomes for the thousands of people suffering from allergic conditions. But Taj Pharma India also considers that the new drug fexofenadine has been developed in 1990's due to the risk of cardiac arrhythmia caused by QT interval prolongation.
Although the company has been manufacturing Generic formulations since decades but the clinical trial has been done now and the company now holds the patent till 2029, and this allows the company to recoup the cost of developing that particular drug. After the patent on a drug expires, any pharmaceutical company can manufacture and sell it; only manufacturing cost will be incurred, which is a small fraction of the cost of original testing and development the drug.
In the U.S., the Patient Protection and Affordable Care Act, which President Obama signed on March 23, 2010, authorized the Food and Drug Administration to approve generic versions of biologic drugs and grant biologics manufacturers 12 years of exclusive use before generics can be developed.
The company's R & D department reported that the company's patent for the new drug Fexofenadine is pending and the clinical trials are still in process as it a time taking process.
The announcement led to an increase in the share price in bearish Indian Market with is suffering from the political and economical instability in the country.