Patents and Oncology Drugs

Patents are important in the development of oncology drugs.  They allow the maker of the drug to have exclusivity and hence charge high prices to recoup its investments.  Once a patent expires other companies can sell the medicine; this almost always leads to a drop in price.  Patents are granted by a legal authority, usually by a national government or super-region economic area.  The big pharmaceutical companies are global in scope, so they usually apply for patents in more than one jurisdiction.  The most important patents are those given in the US and the European Union.  In the US the usual pattern is that the inventor receive a patent for 20 years after submission.  Sometimes legal proceedings and court rulings make this time longer or shorter.

Generics

Once a patent expires, any company can manufacture the drug, although to be sold in the US drugs have to be made according to Current Good Manufacturing Practice (CGMP) regulations as defined by the FDA.  Some drugs have several manufacturers.  A difference between the two classes of new drugs – small molecule vs biologics – comes out here.  Pharmaceutical companies have the capability to exactly duplicate the active ingredient in small molecule drugs.  A generic form has exactly the same molecule as the original, although fillers and delivery systems may be different  But biologics are too complicated to be exactly duplicated and their composition reflects their method of production – a new maker will not be able to directly match the original.  The FDA and other regulatory agencies have procedures in place to certify “biosimilars” that act like the original drug.  The regulatory agencies will only certify biosimilars once the original patent has expired.

Expiration Dates

Here are some expected dates of US patent expiration for cancer drugs approved in the past 20 years:

Imatinib – June 2022

Fulvestrant – expired

Ibritumomab – expired

Bortezomib – 2022

Gefitinib – expired

Bevacizumab – expired

Erlotinib – expired

Histrelin – June 2026

Oxaliplatin – expired

Pemetrexed – May 2022

Capecitabine – expired

Exemestane – expired

Lenalidomide – expired

Nelarabine – expired

Sorafenib – expired

Dasatinib – Oct 2025

Sunitinib – expired

Lapatinib – Nov 2021

Nilotinib – July 2023

Bendamustine – Jan 2026

Degarelix – expired

Fludarabine Phosphate – expired

Cetuximab – expired

Pazopanib – Oct 2023

Pralatrexate – May 2025

Romidepsin – expired

Cabazitaxel – expired

Crizotinib – Nov 2026

Ruxolitinib – Dec 2027

Vandetanib – Oct 2023

Vemurafenib – Jun 2029

Axitinib – May 2028

Bosutinib – Nov 2026

Cabozantinib – Sept 2024

Ponatinib – Dec 2026

Afatinib – expired

Dabrafenib – Jan 2030

Ibrutinib – Dec 2026

Trametinib – Sept 2025

Idelalisib – expired

Regorafenib – July 2024