Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The FDA has calculated the regulatory review period for the biologic drug EMRELIS (telisotuzumab vedotin), used to treat certain adults with advanced non-squamous non-small cell lung cancer showing high c-Met protein overexpression. The total regulatory review period is 5,027 days, consisting of a 4,797-day testing phase that began on August 11, 2011, and a 230-day approval phase from BLA submission on September 27, 2024, to approval on May 14, 2025. This determination sets the maximum possible patent term extension for two AbbVie patents. The applicant is seeking 727 days of extension. Comments challenging the dates must be submitted by June 2, 2026, and petitions regarding due diligence by September 30, 2026.
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Key Changes
- Total regulatory review period determined as 5,027 days
- Testing phase: 4,797 days starting August 11, 2011
- Approval phase: 230 days from September 27, 2024 to May 14, 2025
+ 3 more changes with Pro
Obligations
What this law requires
Submit comments challenging the accuracy of published regulatory review period dates by June 2, 2026, 11:59 p.m. Eastern Time via https://www.regulations.gov or written submission to FDA Dockets Management Staff
Include Docket Numbers FDA-2025-E-3073 and FDA-2025-E-3074 in all submissions regarding the EMRELIS patent extension determination
Submit petitions regarding whether the applicant for patent extension acted with due diligence during the regulatory review period by September 30, 2026
Mark and identify confidential information with a heading 'THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION' when submitting written/paper comments containing confidential data
Submit two copies of comments containing confidential information—one with confidential information included and one with it redacted—to Dockets Management Staff