16 December 2013Americas

FDA approves first generic versions of Lilly’s $5bn Cymbalta

The US Food and Drug Administration (FDA) has approved the first generic versions of antidepressant drug Cymbalta (duloxetine hydrochloride), after Eli Lilly’s primary patent covering the product expired on December 11.

Generic makers including Aurobindo Pharma, Dr. Reddy’s Laboratories and Teva Pharmaceuticals have all received approval to make and sell duloxetine hydrochloride in various strengths.

Cymbalta is Lilly’s biggest earning drug, generating $4.994 billion in revenue worldwide in 2012. In the same year, Lilly secured six months of paediatric exclusivity for the product in the US.

Lilly has  three patents, two of which remain in force, related to Cymbalta listed in the Orange Book, the FDA-published list of approved drugs. The patents cover delayed release duloxetine tablets in 20mg, 30mg and 60mg strengths.

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

She added: “Generic drugs offer greater access to health care for many people.”

In October 2013, Lilly’s chief financial officer Derica Rice said that in the medium term, the loss of the Cymbalta patent will stabilise revenue in the company’s Bio-Medicines division, though the company is hopeful that later in the decade, the division “could provide significant revenue growth through a combination of new molecules currently in Phase 3 development, including solanezumab, evacetrapib, baricitinib, ixekizumab, tabalumab and edivoxetine”.

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