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 – Jan 2021 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 – Feb 2021 Lapatinib – Nov 2021 Nilotinib – July 2023 Bendamustine – Jan 2026 Degarelix – May 2021 Fludarabine Phosphate – expired Cetuximab – expired Pazopanib – Oct 2023 Pralatrexate – May 2025 Romidepsin – Aug 2021 Cabazitaxel – Mar 2021 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 – Apr 2021 Regorafenib – July 2024