Patent/Application: US 11357820 B2
Filing Date: June 14, 2019
Assignee: Eli Lilly and Company
Family: Part of a broader worldwide patent family covering formulations and compositions of tirzepatide and related dual agonist peptides
What the Patent Covers
This patent relates to pharmaceutical compositions comprising a GIP/GLP-1 co-agonist peptide such as tirzepatide, combined with agents like sodium chloride, propylene glycol, and phosphate buffers to produce stable, injectable formulations suitable for clinical use.
- The invention focuses on how tirzepatide is formulated (e.g., with specific excipients for stability and patient tolerability) and methods of administration using these compositions.
- The patent family includes multiple continuation and priority filings that extend intellectual property protection into various countries and through future patent terms (anticipated expiration around 2039 in the U.S. for some claims).
Why It’s Important & Lucrative
1. Foundation of Blockbuster Products
Tirzepatide and its formulations are the basis for Mounjaro and Zepbound, two of Lilly’s most commercially successful products. These medicines have driven substantial revenue growth for the company since their approvals by treating type 2 diabetes and obesity—two massive global markets.
2. Patent Protection Extends Revenue Lifespan
By securing broad composition and formulation patents filed in 2019, Lilly has created a “patent thicket” around tirzepatide that blocks generic competition not just on the active drug itself but also on how it’s formulated and delivered. This extends effective market exclusivity, delaying biosimilar competition and increasing long-term revenue.
3. Strategic Timing to Maximize Lifecycle
Filing in mid-2019 positioned Lilly to build layers of intellectual property before U.S. FDA approval, enabling multi-year exclusivity protections tied to both composition and use patents.
Summary
- Patent: US 11357820 B2 – GIP/GLP-1 agonist compositions
- Date Filed: June 14, 2019
- Focus: Stable injectable compositions of tirzepatide, protecting how the drug is formulated and administered
- Importance: Underlies the commercial success of Mounjaro and Zepbound; helps preserve exclusivity and maximize long-term revenue.
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