Abemaciclib manufacturers

About abemaciclib

Abemaciclib manufacturers are currently limited to the originator, Eli Lilly, which sells it as Verzenio (Verzenios in the EU), while generic companies such as Cipla have filed US applications. Abemaciclib is an oral CDK4/6 inhibitor for hormone receptor-positive, HER2-negative breast cancer. It is used both in early breast cancer at high risk of recurrence and in advanced or metastatic disease. Its only US Orange Book patent expires in September 2031. Pharmaceutical companies can prepare abemaciclib tablet and API dossiers for launch after patent expiry.

Abemaciclib key facts

Abemaciclib manufacturers and licensing history

Eli Lilly developed abemaciclib, and the FDA approved Verzenio on 28 September 2017 for advanced breast cancer. In October 2021, the FDA approved it as the first CDK4/6 inhibitor for adjuvant treatment of high-risk early breast cancer, based on the monarchE trial.

Abemaciclib competes with palbociclib (Ibrance) and ribociclib (Kisqali). It can be taken continuously, without the one-week break needed for the other two.

The only US Orange Book patent for Verzenio, covering the compound, expires in September 2031. In June 2026, Lilly sued Cipla over its ANDA for generic 50, 100, 150 and 200 mg tablets. Buyers should confirm the API's crystal form, GMP status and freedom to operate before choosing a dossier partner.

Abemaciclib dosage forms and dossier types

Abemaciclib is approved as 50, 100, 150 and 200 mg tablets. Generic developers develop all four strengths.

Abemaciclib regulatory and patent status

The FDA approved abemaciclib on 28 September 2017, and for adjuvant use in October 2021. The EU approved it in 2018. The only US Orange Book patent expires in September 2031, and generic companies have been able to challenge it since September 2021. Lilly sued Cipla in June 2026. Check the FDA Orange Book, litigation status and EU registers before planning a launch.

Abemaciclib mechanism of action and therapeutic use

Abemaciclib blocks CDK4 and CDK6, enzymes that drive cancer cells from one growth phase to the next. This stops cell division in hormone receptor-positive breast cancer. It is taken twice daily, usually with endocrine therapy such as an aromatase inhibitor or fulvestrant. The most common side effect is diarrhoea.

Abemaciclib licensing and sourcing

Abemaciclib suppliers and licensing partners typically offer dossier development, API supply or technology transfer, timed for patent expiry. Buyers usually compare GMP status, oncology manufacturing capability, patent position and territory availability. Current offers and supplier contacts are listed among the abemaciclib manufacturers on Pipelinepharma.

Frequently asked questions about abemaciclib

Who manufactures abemaciclib? Eli Lilly is the only manufacturer in the US and EU and sells abemaciclib as Verzenio (Verzenios in the EU).

When can generic abemaciclib launch in the US? The only US Orange Book patent expires in September 2031. Lilly sued Cipla over its generic application in June 2026.

What is abemaciclib used for? Abemaciclib is used for HR-positive, HER2-negative breast cancer, both in high-risk early disease and in advanced or metastatic disease.

What forms and strengths of abemaciclib are available? Abemaciclib is available as 50, 100, 150 and 200 mg tablets.

How is abemaciclib different from palbociclib and ribociclib? All three are CDK4/6 inhibitors. Abemaciclib is taken continuously twice daily, while palbociclib and ribociclib are usually taken for three weeks followed by one week off.