Lyrica® Patent Extended


By Dr. Nahla D. Rizkallah, MSCC Senior Clinical Pharmacist

Lyrica has been a hot-button topic for claims involving Medicare Set Asides.  Medicare’s Workers’ Compensation Review Contractor (WCRC) has been far more aggressive in incorporating Lyrica into Medicare Set Asides (MSAs) where submitters had been previously more successful in making “off-label” arguments to include MSAs.  Underlying those changes has been the fact that Pfizer’s patent on Lyrica was expected to expire on December 30, 2018.

Now, in a win for Pfizer, the exclusive patent on the drug has been extended for six months through June 30, 2019. The drugmaker accomplished this by gaining FDA approval when Lyrica succeeded in phase 3 trials for pediatric epilepsy.

Anticonvulsants or anti-epilepsy drugs, such as Lyrica® (pregabalin) are recommended by the Official Disability Guidelines as first-line therapy for the treatment of neuropathic pain conditions and as an adjunct to opioid medications to provide opioid-sparing effects.

Lyrica® is FDA approved for the following indications:  pain related to diabetic peripheral neuropathy, fibromyalgia, neuropathic pain related to spinal cord injury, adjunct to treatment of partial seizures and postherpetic neuralgia. The Centers for Medicare and Medicaid Services has recently been accepting of the inclusion of Lyrica® in Workers Compensation Medicare Set-Aside for some neuropathic-related conditions.

Worth noting, Pfizer did not succeed in a longstanding patent battle in the United Kingdom.  In a judgment, the UK’s Supreme Court ruled that Lyrica’s neuropathic pain patent claims were invalid. This is a costly loss which the UK can recoup up to £502 million on overspending of the drug.

Lyrica is one of Pfizer’s biggest selling drugs; bringing in approximately $5 billion in the past year.

ExamWorks Clinical Solutions best practices is to continually monitor for the launch of therapeutically equivalent generic agents onto the market and in utilizing evidence based guidelines to ensure first-line cost-effective agents are utilized for inclusion or exclusion of a drug under the Part D benefit. For questions about medications, please contact Nahla D. Rizkallah, PharmD, MSCC at 678.256.5086 or

About Nahla Rizkallah

Nahla D. Rizkallah, PharmD, MSCC, is Senior Clinical Pharmacist at ExamWorks Clinical Solutions (ECS). In this capacity, she performs quality assurance on pharmacy reports, prescription analysis to optimize drug therapy using evidence-based guidelines and national guidelines and participates in physician outreaches to implement the recommendations. She has 29 years of experience in various area of pharmacy practice including review of Part D medications on Medicare Set-Aside Allocations, Pharmacy and Therapeutics Committee, Pharmacy Manager for a closed mental health facility, Pharmacy Manager for the indigent, staff/clinical pharmacist for assisted-living facilities (ALFs), medication audits for ALFs, drug information center, clinical pathways, staff education, and surgical/medical pharmacy satellite at All Children’s Hospital. Dr. Rizkallah received her Doctorate from the University of Florida in Gainesville followed by a one-year American Society of Health-System Pharmacists accredited residency.