Dr Reddy’s loses schizophrenia drug Zyprexa generic litigation to Eli Lilly in UK

India’s leading generic company Dr Reddy’s has another setback on schizophrenia drug Zyprexa generic as the UK Court of Appeal upheld the validity of Eli Lilly’s patent.
Zyprexa contains olanzapine an antispychotic drug to treat schizophrenia symptoms.

UK court ruling upheld the validity of the key composition of matter patent protecting Zyprexa, or olanzapine, from generic competition, Lilly said.

Dr Reddy’s lost a similar case to gain control of the Zyprexa generic earlier in a US district court as it upheld Eli Lilly’s patents thus defeating the challenge by generic drug companies, Dr Reddy’s, Ivax and Teva Pharmaceuticals.

Dr. Reddy’s Laboratories and Ivax have decided to appeal the ruling by an Indiana federal court.

“We are disappointed by the court decision and will appeal the decision to the Federal Circuit. Despite adverse ruling, our strategy remains unchanged,” Dr Reddy’s and Ivax saiad in a combined statement.

Zyprexa has a share of the $4-billion market.

Dr Reddy’s filed an abbreviated new drug application (ANDA) with the USFDA but lost the case in both the district and federal courts.

During April 2005, the US district court for the southern district of Indiana had ruled against Dr Reddy’s Labs along with Ivax and Teva by upholding the validity of Eli Lilly’s patent on Zyprexa upto 2011.

In December 2006, the Federal Circuit also affirmed district court verdict over generic Zyprexa. In 2001, Lilly filed a lawsuit in the US district court against Dr Reddy’s, seeking to stop it from selling the generic equivalent of Zyprexa.

Zyprexa is also linked to some side-effects including weigh gain in patients. It was reported that the Lilly has agreed to pay $1.2 billion to settle 28,500 lawsuits from people who alleged that the use of Zyprexa caused diabetes and various other diseases.

Global generic sales drove Dr. Reddy’s Laboratories’ earnings to more than double for the quarter ending on September 30 2009.

Dr Reddy’s consolidated net profit for the July-September quarter rose to 2.17 billion rupees ($46.6 million) from 1.05 billion rupees last year. Consolidated revenue increased 14% to 18.37 billion rupees from 16.15 billion rupees a year ago.

The growth in revenues is largely driven by global generics, Dr Reddy’s said in a statement announcing quarterly results.

Dr Reddy’s revenue from its global generics business rose 14% from a year earlier to 12.7 billion rupees, led by the key markets of North America, Russia and India.

Revenue from the North America market surged 39% to 4.3 billion rupees, driven by high volume growth across existing products and product launches in the past 12 months.

Dr Reddy’s has filed 141 filings for generic formulations –abbreviated new drug applications (ANDA) with US FDA. 62 ANDAs are pending approval at USFDA of which 27 are Para IVs and 16 are first to files (FTFs).

Revenues from Europe fell 13% at Rs. 2.8 billion ($59 million) in Q2 FY10 as against Rs. 3.3 billion ($68 million) in Q2 FY09.

Headquartered in Hyderabad, southern India, Dr. Reddy’s Laboratories produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. Dr Reddy’s conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.