Financial Daily from THE HINDU group of publications
Friday, Jun 21, 2002
Industry & Economy - IPR
Pfizer sues Dr Reddy's on hypertension drug
HYDERABAD, June 20
DR REDDY'S Laboratories said on Thursday it has been sued by global drug maker Pfizer Inc for allegedly infringing on its patent on anti-hypertension drug Norvasc.
The Hyderabad-based firm said Pfizer had notified it on Monday that a suit had been filed in a New Jersey court following Dr Reddy's filing for approval from the US Food and Drug Administration to sell a version of the drug - Amlodipine Maleate - in the US. The suit had been filed in connection with one of two patents that Pfizer holds for Norvasc which is also used in the treatment of angina, the company said in a notice to the Bombay Stock Exchange.
Dr Reddy's said Norvasc had sales of nearly $2.5 billion in the US in 2001. Global sales of Novarsc in 2001 are $3.7 billion, according to health information provider IMS Health.
Dr Reddy's has filed paragraph-IV certifications on two of the Orange Book patents listed in favour of Pfizer's.
The drug, Amoldipine Besylate, is a generic version of Pfizer and indicated for the treatment of hypertension and angina.
The product had brand sales of around $2.5 billion in the US market during the year 2001.
However, Pfizer did not file suit on the second patent.
According to the press release, Dr Reddy's had earlier filed a new drug application (NDA) for Amoldipine Maleate under Section 505 (b)(2) of the Federal Food, Drug and Cosmetic Act.
Though Dr Reddy's filing was done under the Paragraph-IV certification, it is not an abbreviated new drug application (ANDA), but an NDA since it is an innovation from the innovator's (Pfizer's) product. Dr Reddy's is said to be the first Indian company to file NDA under Section 505 (b)(2), which provides more upsides than a normal Paragraph-IV filing.
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