Olaparib manufacturers

About olaparib

Olaparib manufacturers include the originator AstraZeneca, which sells Lynparza with Merck (MSD), and generic developers such as Natco, which received US tentative approval in July 2026. Olaparib is an oral PARP inhibitor that blocks DNA repair in cancer cells with BRCA mutations or other repair defects. It is used for ovarian, breast, prostate and pancreatic cancer. Pharmaceutical companies can prepare olaparib tablet and API dossiers for markets where patents allow.

Olaparib key facts

Olaparib manufacturers and licensing history

KuDOS Pharmaceuticals discovered olaparib, and AstraZeneca acquired KuDOS in 2006. The FDA approved Lynparza capsules on 19 December 2014 for BRCA-mutated ovarian cancer, as the first PARP inhibitor. Tablets replaced capsules from 2017. In 2017, AstraZeneca formed a global partnership with Merck (MSD) to co-develop and co-commercialise Lynparza.

Approvals expanded to breast, prostate and pancreatic cancer, including adjuvant treatment of high-risk early breast cancer and combination with abiraterone for prostate cancer.

Natco, Sandoz and Cipla filed US ANDAs challenging Lynparza patents. In July 2026, Natco received FDA tentative approval for 100 and 150 mg tablets, with Alembic as its US marketing partner, but launch depends on ongoing litigation. Buyers should confirm the API's crystal form, GMP status and freedom to operate before choosing a dossier partner.

Olaparib dosage forms and dossier types

Olaparib is approved as 100 mg and 150 mg film-coated tablets. Generic developers develop both strengths.

Olaparib regulatory and patent status

The FDA approved olaparib on 19 December 2014 and the EU in 2014. Lynparza has 17 listed US patents, with expiry dates from 2027 to 2041. Natco received FDA tentative approval in July 2026, but final approval and launch depend on ongoing paragraph IV litigation. Check the FDA Orange Book and national registers before planning a launch.

Olaparib mechanism of action and therapeutic use

Olaparib blocks PARP enzymes, which help repair single-strand breaks in DNA. Cancer cells with BRCA mutations or other homologous recombination defects cannot repair the resulting damage and die. This is called synthetic lethality. Olaparib is used for ovarian, breast, prostate and pancreatic cancers with these genetic changes, confirmed by testing.

Olaparib licensing and sourcing

Olaparib 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 olaparib manufacturers on Pipelinepharma.

Frequently asked questions about olaparib

Who are the main olaparib manufacturers? AstraZeneca makes Lynparza and co-commercialises it with Merck (MSD). Natco, Sandoz and Cipla are developing US generics.

Is there a generic version of olaparib? Natco received US tentative approval in July 2026, but launch depends on ongoing patent litigation.

What is olaparib used for? Olaparib is used for BRCA-mutated or similar ovarian, breast, prostate and pancreatic cancers.

What forms and strengths of olaparib are available? Olaparib is available as 100 mg and 150 mg film-coated tablets.

What does tentative approval mean? Tentative approval means the FDA has found a generic meets its standards, but cannot grant final approval until patents or exclusivities expire or are resolved.