Lyrica® generic delayed until summer 2019 and Pfizer to increase drug prices

This is a cross-post from our Optum Insights blog. The U.S. Food and Drug Administration’s (FDA) recent decision to grant pediatric exclusivity for Lyrica® ― as it may be used as an adjunctive therapy for partial onset seizures in pediatric epilepsy patients ― extends the period of market exclusivity in the U.S. by an additional … Read moreLyrica® generic delayed until summer 2019 and Pfizer to increase drug prices

Trends affecting Workers’ Compensation Medicare Set-Aside Allocations

Capitol Bridge, LLC, the newest Workers’ Compensation Review Contractor (WCRC) for the Centers for Medicare and Medicaid Services (CMS), officially took over on March 19, 2018. Since that time, the Medicare Set-Aside (MSA) industry has noticed aggressive changes in the Workers’ Compensation Medicare Set-Aside (WCMSA) review process, resulting in an increase in WCMSA allocations. At … Read moreTrends affecting Workers’ Compensation Medicare Set-Aside Allocations

The Battle over Generic Lyrica

On Thursday, July 19, 2012, Pfizer Pharmaceuticals along with Northwestern University won the first legal battle over the release of pregabalin, the generic formulation of Lyrica.  Lyrica is an anticonvulsant which is approved to treat diabetic neuropathy, post herpetic neuralgia, partial onset seizures in adults and fibromyalgia.  Recently, the FDA also approved its use for the treatment of neuropathic pain associated with spinal cord injuries. 

Pfizer Pharmaceuticals and Northwestern University own the patents for the active ingredient pregabalin and its indications. Collectively, they filed patent infringement lawsuits in 2009 against several companies which applied to the FDA for approval to market a generic version of Lyrica before expiration of the patents.  These defendant companies included TEVA of Israel, Lupin LTD and Sun Pharmaceuticals of India as well as Mylan and Watson from the United States.  A trial was held in October of 2011 before Judge Sleet of the U.S. District Court of Delaware, but no decision was rendered at that time. The pharmaceutical companies involved reached an agreement not to put generic products on the market before July 20, 2012 or until Judge Sleet had rendered a decision, whichever came first. 

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FDA Approves Lyrica for Treatment of Neuropathic Pain Associated with Spinal Cord Injury

Lyrica is currently a commonly prescribed medication approved for the treatment of diabetic nerve pain, post herpetic neuralgia (pain after shingles), fibromyalgia, and partial onset seizures. On June 21, 2012, the FDA announced that Lyrica (capsules CV) would additionally be approved for the treatment of neuropathic pain associated with a spinal cord injury. The drug … Read moreFDA Approves Lyrica for Treatment of Neuropathic Pain Associated with Spinal Cord Injury