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Lyrica® generic may be delayed

by Mary McNitt | Aug 21, 2018

According to the U.S. Food and Drug Administration (FDA), the patent for Lyrica® (pregabalin) was originally expected to expire at the end of 2018, making way for generic pregabalin to become available to consumers. Recent developments with pediatric clinical trials for Lyrica seem to indicate that the patent may be extended. Pfizer announced in May that a pediatric trial assessing the use of Lyrica solution for the treatment of partial onset seizures in pediatric patients had met a primary endpoint. Consequently, this information was expected to be submitted to the FDA for pediatric exclusivity determination. Therefore, pending approval by the FDA, generic competition for Lyrica in the U.S. may be delayed until June 2019.

The FDA refers to exclusivity as “a period of time when a brand-name drug is protected from generic drug competition.” When pediatric exclusivity is granted, six months of exclusivity is added to all existing patents for a brand-name medication. This means that a generic form of the brand-name medication may be delayed by at least six months from when the patent was expected to expire.

Although we originally anticipated generic pregabalin to become available in late December 2018, if pediatric exclusivity is obtained, pregabalin will not likely be on the U.S. market until summer 2019. We will continue to monitor this situation.

To learn more about patent and exclusivity rules, click here or on the links below.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

  1. Pfizer News. Pfizer reports second-quarter 2018 results. July 31, 2018. Available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizer_reports_second_quarter_2018_results-0.
  2. Pfizer Press Release. Lyrica® (pregabalin) Oral Solution CV Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint. May 17, 2018. Available at: https://investors.pfizer.com/default.aspx?SectionId=5cc5ecae-6c48-4521-a1ad-480e593e4835&LanguageId=1&PressReleaseId=708be4bc-1649-4d3b-a684-0ffb727b4d0c.
  3. Center for Drug Evaluation and Research. “Development & Approval Process (Drugs) - Frequently Asked Questions on Patents and Exclusivity.” U.S. Food and Drug Administration Home Page. May 2, 2018. Available at: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031.htm.
  4. Dunn, William H. “Letter of Supplement Approval.” Department of Health and Human Services, Food and Drug Administration. May 3, 2018. Available at: www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021446orig1s035,022488orig1s013ltr.pdf.

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