Pfizer Wins Lyrica Patent Extension
The US Food and Drug Administration (FDA) has granted pediatric exclusivity for Pfizer’s Lyrica, extending its US exclusive rights until Jun. 30, 2019. As the patent was due to expire at the end of 2018, the decision affords the US pharmaceutical giant a breather against competition.
Lyrica is currently approved in the US for fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults. It is also approved as adjunctive therapy for the treatment of partial onset seizures in patients four years of age and older.
The FDA based its pediatric exclusivity determination on data from Pfizer’s Pediatric Epilepsy Program, submitted in response to the agency’s request to evaluate its use as adjunctive therapy for the pediatric indication. The FDA also mandated post-marketing studies for the drug originally improved in 2004
Pfizer took in in nearly $3.5 billion from sales of Lyrica – its top-selling drug – in the US in 2017 and more than $5 billion globally. The US drugmaker had sought the six-month exclusivity extension to help bridge the gap between expiration of top-sellers and the launch of new products. It recently lost exclusivity on the erectile dysfunction treatment Viagra.
The company recently won FDA approval for a number of new products, including the acute myeloid leukemia drug Daurismo in certain patients 75 and older. It also received the regulator’s go-ahead for targeted lung cancer drug Vizimpro as well as Talzenna in breast cancer and Lorbrena in non-small cell lung cancer.
As regards Lyrica, Pfizer lost a recent patent fight in the UK, when the country’s Supreme Court ruled that the drug's neuropathic pain patent claims were invalid. The decision could allow the National Health Service (NHS) in England to seek to recoup £502 million from the drugmaker, reports say.