HYDERABAD, Feb. 24. DR Reddy's Laboratories Ltd has announced that it had filed a lawsuit seeking declaratory judgment against Pfizer in the US district court of New Jersey regarding its abbreviated new drug application (ANDA) for Sertraline Hcl.

Sertraline Hcl is the generic version of Pfizer's Zoloft, indicated for use in the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder and premenstrual dysphoric disorder.

The product had US brand sales of $2.4-billion during the last calendar year.

In a press release here on Monday, Dr Reddy's said the lawsuit seeks a declaratory judgment that the claims of certain Pfizer patents were invalid and were not infringed.

The company had filed an ANDA with the US Food and Drug Administration (USFDA) for Sertraline Hcl tablets, equivalent to 25, 50 and 100 mg base, with a Paragraph-IV certification on four of the five patents listed on the Orange Book.

Subsequently, Dr Reddy's had notified Pfizer of the filing.

However, Pfizer did not file a lawsuit against Dr Reddy's within the 45-day period prescribed by the Hatch-Waxman Act.

Dr Reddy's which is currently engaged in the research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection, has so far filed 30 ANDAs with the USFDA, of which 17 were Para-IV filings.

At present, 19 ANDAs filed by Dr Reddy's were pending approval with the USFDA.

According to Dr Reddy's, 14 of these were Para-IV filings which address a total market value of $12.7 billion.

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