The white space in GLP-1 sits in the formulation, and that is the FTO conclusion most analyses underweight. Even where a peptide is approaching the end of its composition protection, the formulation estate can keep a product boxed in. Novo Nordisk holds a dense set of A61K formulation claims, including US11752198B2 and US10888605B2, both titled "GLP-1 compositions and uses thereof," and the more recent US12527844B2, "Pharmaceutical formulations" (issued January 20, 2026; CPC A61K 38/26 and A61K 9/0019).
Formulation claims protect the practical product, not the abstract molecule. A GLP-1 peptide is chemically delicate — it aggregates, degrades, and is hard to keep stable in solution. The composition claims recite the buffers, the pH ranges, the stabilizing excipients that make a shippable drug. So a follow-on developer who has cleared the peptide sequence can still infringe by reproducing a claimed stabilized formulation. The CPC A61K 9/0019 designation (injectable preparations) on these grants tells you exactly which practical embodiment is claimed.
Process claims close another door. US12138349B2, "Process for spray drying a GLP-1 peptide" (issued November 12, 2024; CPC A61K 9/1688), claims a manufacturing method — spray-drying the peptide. As with the LNP estate, a process claim can block a manufacturing route even where the end composition is designed around. An FTO map that only checks compositions and misses process claims like this one is incomplete.
Where, then, is the genuine white space? It sits in formulation chemistries and delivery routes not covered by the incumbent claims — alternative stabilization systems, different excipient packages, or delivery modalities outside the claimed injectable and spray-dried embodiments. The hybrid-peptide and alternative-scaffold filings in the record (for instance, peptide-oligourea hybrid approaches) suggest some developers are designing around both the sequence and the formulation simultaneously.
The assignee concentration is the headline risk. Novo Nordisk is the dominant holder in the GLP-1 formulation record, which means an FTO clearance is less a survey of many holders and more a focused read of one large incumbent estate plus a scattering of challengers. Concentration cuts both ways: fewer parties to clear, but a deep and actively-maintained thicket from the one that matters.
The strategist's takeaway: run GLP-1 freedom-to-operate as a two-layer problem. Layer one is the peptide. Layer two — often the binding constraint near the end of molecule exclusivity — is the formulation and process estate, heavily held by Novo Nordisk across A61K composition and manufacturing claims. The white space is real but specific: it lives in stabilization and delivery approaches that fall outside the claimed injectable, buffered, and spray-dried embodiments.