Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO
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 product ENCELTO (revakinagene taroretcel-lwey), approved for treating adults with idiopathic macular telangiectasia type 2. The total regulatory review period is 7,903 days, consisting of a 7,581-day testing phase that began on July 18, 2003, and a 322-day approval phase from BLA submission on April 18, 2024, to approval on March 5, 2025. This determination sets the maximum possible patent term extension for U.S. Patent No. 10,195,140. The applicant is seeking 950 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 7,903 days
- Testing phase: 7,581 days beginning July 18, 2003
- Approval phase: 322 days from April 18, 2024 to March 5, 2025
+ 3 more changes with Pro
Obligations
What this law requires
Include Docket No. FDA-2025-E-1672 in all submissions regarding this determination
Submit petitions regarding whether the applicant acted with due diligence during the regulatory review period by September 30, 2026
Submit comments challenging the published dates for the regulatory review period by June 2, 2026, via regulations.gov or written submission to FDA Dockets Management Staff
Ensure electronic submissions do not contain confidential information, medical information, Social Security numbers, or confidential business information
Submit confidential information only as written/paper submissions with two copies: one marked as confidential and one with redactions