Launch of Generic Lyrica Delayed: Pfizer, Inc. Receives Patent Extension

Alan Rook, PharmD
Clinical Pharmacist

Lyrica (Pregabalin) is considered a first-line medication for the treatment of neuropathic pain, which is a chronic pain disorder commonly seen in workers’ compensation. This medication is one of few remaining single source brand name drugs of significance in workers’ compensation, and the expiration of its patent on December 30, 2018 had been widely anticipated as a significant source of cost-savings as generic alternatives became available. In fact, generic drug manufacturers Mylan, Teva and Novartis Sandoz had all received tentative FDA approval for pregabalin, the generic version of Lyrica. Unfortunately, the launch of these less expensive generic versions will be postponed until middle of 2019 as a result of Pfizer, Inc., the brand name manufacturer, receiving a six-month patent-term extension from the FDA for pediatric exclusivity. Although the pediatric exclusivity is not significant to workers’ compensation, the patent extension means the anticipated date for pregabalin to be available for any use will not be until June 30, 2019. The extension resulted from FDA approval of a supplemental new drug application filed in November 2017 by Pfizer for a new indication: adjunctive therapy in the treatment of partial onset seizures (POS) to include pediatric patients four to 16 years of age.

What does this mean to you:
• Brand name Lyrica will remain the only form of pregabalin available through June 30, 2019.
• For those of you participating in our step therapy program, gabapentin remains the preferred cost-effective alternative to Lyrica. If you are not enrolled in step therapy, Lyrica remains a significant target drug for our One Drug Review program.
• myMatrixx will automatically begin substituting pregabalin in all situations where it is legally appropriate to do so as soon as the generic is available.