FDA opens US to Lyrica generics
The US Food and Drug Administration (FDA) last week approved nine applications for the first generic versions of Pfizer’s Lyrica (pregabalin).
Lyrica, which is used to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults, was first approved in 2004. In 2017, it generated annual global sales of $5.1 billion (with $3.5 billion coming from US sales).
Pfizer was seemingly prepared for the patent cliff—in its fourth-quarter earnings report (issued in January this year) Pfizer warned investors of little revenue growth to come in 2019, owing partly to expiring exclusivity rights on drugs including Viagra and Lyrica.
Expiring market exclusivity on products is expected to hit revenues by $2.6 billion in 2019, due to competition from new generic and biosimilar products.
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 were already available in the EU.
Both Mylan and Teva introduced generic versions of Lyrica into the EU market and Pfizer’s 2017 financial report stated that, globally, Lyrica revenues decreased by 11% in 2017 year-on-year as a result of the drug going off-patent in Europe.
In November 2018, Pfizer secured paediatric exclusivity for Lyrica (pregabalin), extending the period of US market exclusivity for the drug by six months, expiring on June 30, 2019.
Last week, the FDA granted approval to Teva, along with Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, and Sciegen Pharmaceuticals.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said: “Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower-cost, high-quality generic medicines.”
Last year, LSIPR analysed how blockbuster drugs, including Lyrica, would fare after going off-patent.
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