Opportunity
Federal Register #FDA2025E3073; FDA2025E3074
FDA Notice: Regulatory Review Period for EMRELIS (telisotuzumab vedotin) Patent Extension
Buyer
Food and Drug Administration
Posted
April 03, 2026
Respond By
October 01, 2026
Identifier
FDA2025E3073; FDA2025E3074
This notice from the Food and Drug Administration (FDA) provides information on the regulatory review period for EMRELIS (telisotuzumab vedotin), supporting a patent extension application: - Government Buyer - Department of Health and Human Services, Food and Drug Administration (FDA) - OEMs and Vendors - AbbVie Manufacturing Management Unlimited Company (applicant for patent extension and manufacturer of EMRELIS) - Products/Services Referenced - EMRELIS (telisotuzumab vedotin): Human biological product for treatment of locally advanced or metastatic non-squamous non-small cell lung cancer with high cMet protein overexpression - Customer Service Satisfaction Surveys: Proposed information collection by FDA (not a procurement) - Unique or Notable Requirements - The notice is informational only and does not request procurement of products or services - Regulatory review period determined as 5,027 days (testing and approval phases) - Supports patent term extension application to the USPTO - Public comments and petitions regarding the review period are invited - Locations - FDA offices in Rockville and North Bethesda, Maryland - No procurement action is requested; this is a regulatory and patent-related notice
Description
The Food and Drug Administration (FDA) has determined the regulatory review period for the human biological product EMRELIS (telisotuzumab vedotin) and is publishing this notice as required by law. EMRELIS is approved for treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer with high cMet protein overexpression. The regulatory review period includes a testing phase starting August 11, 2011, and an approval phase ending May 14, 2025, totaling 5,027 days. This determination supports patent term extension applications submitted to the U.S. Patent and Trademark Office (USPTO) by AbbVie Manufacturing Management Unlimited Company.