Pfizer secures six-month Lyrica extension in US
The US Food and Drug Administration (FDA) has granted Pfizer paediatric exclusivity for Lyrica (pregabalin), extending the period of US market exclusivity for the drug by six months.
Pfizer announced the news on Tuesday, November 27.
Lyrica is used to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults.
The FDA’s grant for paediatric exclusivity is based on data from Pfizer’s Lyrica paediatric epilepsy programme, which allowed the FDA to evaluate the use of Lyrica as an adjunctive therapy for partial onset seizures in paediatric epilepsy patients.
Pfizer’s market exclusivity for Lyrica is now due to expire on June 30, 2019, six months after the scheduled patent expiry next month.
In a recent article, LSIPR analysed how blockbuster drugs, including Lyrica, would fare after going off-patent.
It noted that Lyrica, which was first approved by the FDA in 2004, generated annual global sales of $5.1 billion in 2017 (with $3.46 billion coming from US sales). This contributed to Pfizer’s standing as the largest pharmaceutical company last year, according to prescription sales data.
Pfizer’s patents for Lyrica expired in the EU a few years ago and, as Pfizer did not pay the renewal fees to bring a supplementary protection certificate into force in May 2013, generic versions of pregabalin are already available in the EU.
Mylan and Teva both introduced generic versions of Lyrica into the market and Pfizer’s 2017 financial report said that, globally, Lyrica revenues decreased by 11% in 2017 year-on-year as a result of the drug going off-patent in Europe.
However, US-based sales of Lyrica increased by 10%, year-on-year, in 2017.
Earlier this year, Pfizer reported that it expected to lose $1.9 billion due to patent expirations in 2018.
But, this figure did not include projected losses for Lyrica, as Pfizer expected that the six-month patent-term extension would be granted by the FDA.
The FDA’s recently-granted extension means that generic competition in the US will be postponed until July 2019 at the earliest.
Meanwhile, in the UK, a Supreme Court decision delivered earlier this month found that Warner-Lambert’s (a Pfizer subsidiary) Lyrica patent claims were not sufficiently disclosed, in a win for generic pharmaceutical manufacturers Actavis and Mylan.
Lawyers told LSIPR that the ruling is disappointing for pharmaceutical innovators, and that it will make the enforcement of second medical use patents more challenging.
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