Five companies get US regulators approval for Cymbalta generic

Five Indian generic drug makers — Sun Pharmaceuticals, Aurobindo Pharma, Lupin, Torrent Pharmaceuticals and Dr. Reddy’s Labs — have got approval from the US Food and Drug Administration for selling the generic version of antidepressant Cymbalta (duloxetine delayed-release capsules), one of the most widely prescribed treatments for depression, anxiety and other related disorders in the US.

 

“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, acting director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research.

Cymbalta, the fifth largest selling drug in the world, is US drug maker Eli Lilly’s best-selling drug, with an annual sales of $4.7 billion. The drug’s patent expired on Wednesday. Launched in 2004, Cymbalta accounted for 22 per cent of Lilly’s $22.6 billion in revenue last financial year.

Sun Pharmaceuticals will soon start marketing the drug’s 20 mg, 30 mg and 60 mg dosages in the US. Mumbai-based Lupin said it has launched its generic version of Cymbalta in the US. Apart from Indian companies, Israel’s Teva Pharmaceuticals has also received an FDA nod for the drug’s generic.

Sun Pharma shares closed at Rs 575.35 on BSE, down 1.5 per cent, while Lupin closed at Rs 877.4, up 0.2 per cent on Thursday. Dr. Reddy’s shares were down 1.6 per cent to close at Rs 2,403.75.

Duloxetine and other antidepressant drugs have a boxed warning describing the increased risk of suicidal thinking and behavior during initial treatment in children, adolescents, and young adults of ages 18 to 24, said the FDA statement. Common adverse reactions reported by people taking Cymbalta include nausea, dry mouth, drowsiness, fatigue, decreased appetite, increased sweating, and dizziness.

During last 2 years, the US-based Lilly has lost patent protection for a few of its top selling drugs such as the antipsychotic Zyprexa, which had global sales of over $5 billion per year.

Earlier this year, Lilly also lost US patent protection for its diabetics drug – Humalog, which had annual sales of $2.4 billion in the US.

Grabbing a small pie of the largest selling drug could be a boost to the US revenue of the Indian pharma companies. A few of the Indian companies are still struggling to retain their US revenue after the FDA has banned import from their plants in India which are under the scanner.

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