Milestone Pharma Patent Term Extension Application
Summary
FDA received a patent term extension application from Clark & Elbing LLP on behalf of Milestone Pharmaceuticals, Inc. The application seeks to extend patent protection for a drug product regulated by CDER. Patent term restoration may compensate for regulatory review time under applicable law.
What changed
FDA's CDER received a patent term extension application under 35 U.S.C. 156 for a pharmaceutical product. Clark & Elbing LLP filed on behalf of Milestone Pharmaceuticals, Inc. Patent term extension restores up to five years of marketing exclusivity lost during FDA regulatory review.
Pharmaceutical companies pursuing patent restoration should monitor competing applications on regulations.gov to identify potential overlapping extension claims. Generic and biosimilar applicants should review listed patents to assessOrange Book listing challenges.
What to do next
- Monitor FDA regulations.gov for related filings on FDA-2026-E-3815
- Review patent portfolio for overlapping regulatory review periods
Archived snapshot
Apr 10, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Attachments 1
Patent Term Extension Application from Clark & Elbing, LLP (on behalf of Milestone Pharmaceuticals, Inc)
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- Author(s) CDER
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Source document text, dates, docket IDs, and authority are extracted directly from Clark & Elbing.
The plain-English summary, classification, and "what to do next" steps are AI-generated from the original text. Cite the source document, not the AI analysis.
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