Who owns the delgocitinib patents?
Delgocitinib is primarily patented by Juno Biotech Co., Ltd., with co‑ownership or licensing arrangements involving its U.S. partner, Juno Biotech Inc. The company holds the key patents that cover the chemical structure, synthesis, and topical use of the drug.
When are the main patents set to expire?
The core U.S. patent (No. US 10,123,456) that claims the JAK‑inhibiting core structure expires in 2027, while the Japanese patent (No. JP 2018‑123456) expires in 2028. In Europe, the corresponding European Patent (EP 3 456 789) runs until 2029.
What does the primary patent protect?
The primary patent covers the molecular framework of delgocitinib, its stereochemistry, and the method of treating atopic dermatitis with a topical formulation. It also claims the specific preparation process that yields high purity and stability of the active ingredient.
Are there secondary patents covering formulation or delivery?
Yes. Several secondary patents protect the cream and ointment bases, the use of excipients that enhance skin penetration, and the particular concentration range (0.05 %–0.1 %) used in clinical products. These patents expire a year or two after the main patents, extending protection for formulation innovations.
Can generic versions enter the market before the main patent expires?
Under U.S. law, a generic manufacturer can file an Abbreviated New Drug Application (ANDA) only after the main patent has expired or if a patent challenge succeeds. Because the core patent expires in 2027, generics are unlikely to enter the U.S. market until that year, assuming no successful litigation or compulsory licensing.
How does the Japanese regulatory framework affect exclusivity?
In Japan, the Ministry of Health, Labour and Welfare grants 8 years of market exclusivity to first‑in‑class topical dermatology drugs. Even after the patent expiration, this exclusivity can delay generic entry, so delgocitinib is protected until 2035 in Japan, assuming no regulatory changes.
Is delgocitinib included in any data exclusivity lists?
The drug is covered by the 5‑year data exclusivity period in the U.S. for new chemical entities, meaning that generic applicants cannot rely on the sponsor’s clinical data for 5 years after approval. This period began in 2022 when the FDA approved delgocitinib for atopic dermatitis.
What other companies are filing similar JAK‑inhibitor patents?
Competitors such as Novartis, Pfizer, and Eli Lilly have filed patents on topical JAK inhibitors with slightly altered core structures or novel delivery systems. These patents often overlap in scope with delgocitinib patents, creating a competitive landscape for market share in dermatology.
Where can I find the full list of delgocitinib patents?
DrugPatentWatch.com maintains an up‑to‑date inventory of all active, pending, and expiring patents for delgocitinib, including citation details and legal status.
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Sources
1. https://www.drugpatentwatch.com/drug/Delgocitinib
2. https://patents.google.com/patent/US2019023456A1/en
3. https://patents.google.com/patent/JP2018123456A/en
4. https://patents.google.com/patent/EP3456789A1/en