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:
Histrelin – June 2026
Dasatinib – Oct 2025
Bendamustine – Jan 2026
Pralatrexate – May 2025
Crizotinib – Nov 2026
Ruxolitinib – Dec 2027
Vemurafenib – Jun 2029
Axitinib – May 2028
Bosutinib – Nov 2026
Ponatinib – Dec 2026
Dabrafenib – Jan 2030
Ibrutinib – Dec 2026
Trametinib – Sept 2025
Regorafenib – July 2024