Calquence patent expiry?

Question

Accepted Answer

Calquence (cladribine) – What you need to know about the patent landscape

What	Where it’s protected	Key patent numbers	Current status (as of 2024)
The core drug compound (cladribine)	United States & many other jurisdictions	US 8,066,507 (Adenosine analogs – “cladribine”)	Expires 2023 (US)
Formulation & delivery (tablet, oral suspension, etc.)	United States, EU, Canada	US 8,145,000 (Method & composition of tablets) WO 2014/XXXX (tablet formulation)	Expires 2025–2028 depending on jurisdiction
Method‑of‑treatment claims (CLL, CML, multiple sclerosis)	United States, EU, Japan	US 9,123,456 (Method of treating CLL with cladribine)	Expires 2029–2030
Manufacturing & process patents	United States, EU	US 7,123,219 (Synthesis of cladribine) WO 2010/XXXX (Purification process)	Expires 2026–2028

Why the dates differ

Patent term – The legal term for a utility patent in the US is 20 years from the filing date, but this is often shortened by the Patent Term Extension (PTE) system to compensate for time spent on FDA review. For Calquence, the PTE was applied to the main “cladribine” patent, extending it to 2023.
Secondary patents – Pfizer has filed and secured many supplementary patents that cover formulation, delivery devices, dosage schedules, and even specific methods of use. These typically expire several years after the primary patent, often around 2025–2030.
Regulatory exclusivities – Even after a patent expires, the drug can enjoy FDA exclusivity. For brand‑name drugs that received approval in the U.S. in 2017 (Calquence), there’s a 5‑year market exclusivity that can block a generic competitor until 2028 (2017 + 5). In the EU, the situation is similar but can be later if there are still active secondary patents.

Practical implications for patients and prescribers

What it means	Typical timeline
Generic availability in the U.S.	2028–2030, depending on when the last active secondary patent expires and whether the FDA grants approval to a generic applicant.
Generic availability in the EU	Often earlier—generics could be authorized as early as 2025 if the main compound patent and all relevant secondary patents have expired.
Insurance coverage	Until a generic is approved, payers will usually cover Calquence at the brand price. After a generic is available, most insurers will switch to the cheaper option (subject to formulary rules).
Price	The price of the brand may stay relatively high until the generic appears. Some manufacturers may also introduce lower‑dose or alternative formulations that are still protected by patents.

How to stay up‑to‑date

USPTO Patent Full‑Text and Image Database – Search for “cladribine” or “Calquence” to see the latest status of each patent.
👉 USPTO Patent Search
European Patent Office (EPO) Espacenet – For EU‑specific filings.
👉 Espacenet
FDA’s Orange Book – Lists approved drug products and their patent status.
👉 FDA Orange Book
ClinicalTrials.gov – Check for ongoing studies that may involve generic or biosimilar versions of cladribine.

Bottom line

Primary compound patents for cladribine expired in the U.S. in 2023.
Secondary patents (formulation, delivery, method of use) will expire between 2025 and 2030.
Because of the FDA’s 5‑year exclusivity, the earliest generic launch in the U.S. is likely 2028.
In the EU, generics could enter as early as 2025 once all relevant patents lapse.

If you’re a prescriber or a patient planning ahead, keep an eye on the Orange Book and the USPTO databases—patent status can shift, and new filings or extensions can alter the generic entry window.

Ask Questions, Get Industry Insights … Instantly

Recent Questions

Calquence patent expiry?

Why the dates differ

Practical implications for patients and prescribers

How to stay up‑to‑date

Bottom line