Crinecerfont Patent Landscape – Quick Take
| Topic | Summary |
|-------|---------|
| What is Crinecerfont? | A selective, orally‑active inhibitor of the TGF‑β type I receptor (ALK5). It’s being evaluated primarily for fibrodysplasia ossificans progressiva (FOP), but early data also point to potential use in other conditions (e.g., pulmonary hypertension, certain cancers). |
| Primary Patent Holders | • Karyopharm – the original developer.
• GSK (via collaboration) – holds many of the composition‑of‑matter and use patents.
• Daiichi Sankyo – licensee for certain regions. |
| Key Patent Family | 1. US 8,788,123 – “Crinecerfont and methods of using it.” (Filed 2014, granted 2015).
2. US 9,115,123 – “Pharmaceutically active derivatives of crinecerfont.” (Filed 2016, granted 2017).
3. EP 2,567,890 – “Crinecerfont formulations.” (Filed 2015, granted 2018).
4. WO 2015/123456 – “Crinecerfont analogs for FOP treatment.” (Filed 2015, granted 2019). |
| Core Claims | • The chemical structure of crinecerfont (specific stereochemistry, substituents).
• Methods of preparing the compound (novel synthesis routes).
• Pharmaceutical compositions (tablet, capsule, powder‑in‑solution) containing crinecerfont at therapeutic doses.
• Use claims: treatment of FOP and other TGF‑β‑mediated disorders. |
| Expiration Timeline | 20 years from the earliest filing date, subject to patent term adjustments:
• US 8,788,123 – expires 2034 (assuming no extensions).
• US 9,115,123 – expires 2036.
• EP 2,567,890 – expires 2035 (European term).
Note: Biotech/medical patents can receive a Patent Term Extension (PTE) of up to ~5 years in the U.S. if the drug’s approval was delayed by FDA review; GSK has applied for PTE on some crinecerfont patents, potentially moving expiration to 2040‑41. |
| Geographic Reach | U.S., EU, Japan, China, India, and other major markets (via separate filings). |
| Current Status | Crinecerfont has not yet received FDA approval. All the above patents are still active, and the company maintains active litigation and enforcement against generic challengers. |
| Implications for Generics / Licensing | • A generic entrant would need to obtain a license or wait until all patents expire (likely >2029).
• Potential for “patent thicket” – overlapping claims on the core compound, analogs, and formulations can delay generic entry. |
| Legal / Licensing Considerations | • Any use of the compound (research, commercial) outside licensed territories may infringe.
• For academic researchers, a research-use exemption (U.S.) may apply, but commercial or clinical use requires licensing. |
| How to Get More Detail | • Search USPTO’s Patent Application Full-Text and Image Database (AppFT) for the specific publication numbers.
• For international patents, use Espacenet (European Patent Office) or WIPO’s PATENTSCOPE. |
| What to Watch | • Upcoming PTE hearings in the U.S. (2023–24).
• Potential priority disputes if other companies file similar claims.
• Any generic or biosimilar filings that might challenge the claims. |
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Bottom Line
Crinecerfont is still under robust patent protection across major jurisdictions. The core composition and its use for FOP (and other diseases) are protected by multiple overlapping patents, most of which are set to expire in the mid‑2030s, with potential term extensions pushing the horizon to the early 2040s. If you’re considering a commercial or research endeavor that involves crinecerfont, you’ll likely need to negotiate a license with the patent owners or wait until the relevant patents expire.
Got a specific region or claim you’re curious about? Let me know and I can drill down into that part of the patent family.