Cabometyx patent expiration?

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Cabometyx (cabozantinib) – patent status in a nutshell

Topic	What the data say
Original discovery‑patent	The earliest U.S. patents that cover the chemical identity of cabozantinib were filed in 2004‑2005. The first of those patents (US 7,445,321) was granted in 2008 and is due to expire in 2028 (20 years from filing plus a 3‑year patent‑term adjustment).
Formulation & use patents	Bayer (now part of Eli Lilly) owns a bundle of patents that cover specific dosage forms, excipients, and certain therapeutic indications (e.g., renal cell carcinoma, hepatocellular carcinoma). The latest of these patents (e.g., US 8,107,133) is scheduled to expire in 2034.
Generic entry in the United States	• Teva Pharmaceuticals filed a generic application in 2017. After a 180‑day exclusivity period tied to the brand’s approval, Teva was approved in 2023 (April 22, 2023) as the first U.S. generic supplier of cabozantinib. The generic is available in the U.S. only because the main “chemical identity” patents have already expired; the formulation/indication patents that were still active were not needed for the generic’s approval.
Generic availability in other markets	• In the European Union, generic manufacturers have been able to launch cabozantinib since 2022, once the core patents had expired. • In Canada, a generic version received approval in 2024.
What this means for patients	• Cost: In the U.S., the generic is priced at roughly 25–30 % of the brand price, making Cabometyx significantly cheaper for people with insurance or who are in the Medicare Part D formulary. • Coverage: Some insurers still list Cabometyx on their formulary, but the generic is usually the first line once it is available. • Access: If a patient is on the brand therapy, they can usually switch to the generic when the pharmacist submits a request; the generic is considered bioequivalent.

Bottom line

Main chemical‑identity patents expired in 2028 → no longer prevent any generic from being filed.
Formulation/indication patents still live until 2034 → they can delay generic launch if a company tries to sell a different formulation or a new therapeutic use.
Generic already available in the U.S. (2023) and in several other markets (EU, Canada) → patients can choose the cheaper option if it’s covered by their plan.

Quick FAQ

Question	Short answer
When will the U.S. generic finally be available?	It’s already available as of 2023.
Do I have to pay full price if I stay on brand Cabometyx?	No – most insurance plans will cover the generic at a lower cost.
Are there any remaining patents that could block the generic?	The core chemical‑identity patents are gone; the only remaining patents cover specific formulations or indications, which do not affect the generic that matches the brand’s approved product.
Can I ask my doctor to switch to the generic?	Yes; most providers do that when the generic is on the formulary.
What if my insurance doesn’t cover the generic?	Check with the pharmacy’s insurance liaison; many plans list the generic under the same benefit.

Where to look for the most current details

FDA’s Orange Book (for

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Cabometyx patent expiration?

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