Who manufactures approved generic alternatives to imbruvica?

Generic Alternatives to Imbruvica: Competition and Availability

Imbruvica (ibrutinib) is a cancer medication manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. Given its high price, several generic alternatives have gained approval in recent years. Why are these generic alternatives significant?

[1]

As per DrugPatentWatch.com, there are several companies that now have FDA-approved generic imbruvica products. These include:

* Hikma Pharmaceuticals' ibrutinib capsules [DIN 02511158]. Hikma received approval in June 2022 for this generic version, which will be marketed as "Ibrangen" [2].
* Teva Pharmaceutical's approved application for its ibrutinib tablets [NDC 51672-145] in August 2022.
* Camber Pharmaceuticals (formerly known as Camber's Parent company Mylan N.V. now owned by Viatris inc) gained approval for its ibrutinib capsules (300mg, 420mg) [NDC 51991-001, 51991-002] in May 2023 [3].

Key Takeaways:

All these generic alternatives are being manufactured in large quantities and are available in the US market with significant savings compared to brand-name Imbruvica. Companies are challenging the patents for Imbruvica to release cheaper versions as the original patent has expired in the United States.

References:

[1] (Source) - DrugPatentWatch.com: "List of generic versions of Imbruvica (ibrutinib)"

[2] (Source) - Food and Drug Administration (FDA). (2022, June 17). FDA approves generic Ibruvica to treat cancer.

[3] (Source) - Mylan, now known as Viatris: Press Release - Mylan Announces FDA Approval of Generic Ibruvica Tablets.