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Do your own research. Dates are read automatically from public registers and company filings and may be incomplete or wrong. Not legal, regulatory or investment advice: check the primary source before relying on any date.
Loss of exclusivity · US · Canada · Europe

When drugs lose exclusivity

Patents, supplementary protection certificates and regulatory exclusivities for every drug in the FDA, EMA and Health Canada registers, read automatically and turned into one date per market. Each date shows where it comes from.

How dates are worked out

No single register says when a drug loses exclusivity. Each one holds a piece: a patent, a certificate, a regulatory exclusivity. The date shown for a market is built from those pieces with the rules below, and every piece is listed under it with a link to the register it came from.

Three kinds of date
  • Calculated: worked out from the registers with the rules on this page.
  • Company estimate: stated by the company in its annual report (10-K or 20-F). It replaces the calculated date because companies know about settlements and litigation that registers do not show. Each estimate is extracted twice, independently, and used only if both readings give the same date and the quoted passage is found word for word in the SEC filing. Anything else is set aside for a person to check.
  • Generic on market: a generic or biosimilar is already sold, so exclusivity has been lost whatever the registers say.
United States
  • Small molecules (FDA Orange Book): the later of the last patent on the drug substance, with any paediatric extension, and new chemical entity exclusivity. Formulation and method of use patents are listed but do not move the date, because they are the ones most often designed around or invalidated.
  • Biologics (FDA Purple Book): 12 years of reference product exclusivity. FDA fills this field for few products, so where it is empty it is calculated from the first approval date. Biologic patents are not in the Purple Book download: for the large products the company estimate covers them.
  • Patent challenges (Paragraph IV) from FDA's list are shown on each US drug, marked "challenged" in the list. They are the strongest sign that a generic will come: of the drugs challenged by March 2021, half had a generic by now, against 5% of the others. Where FDA reports the date the first challenger started marketing, that official date sets "generic on market".
  • Generics approved under an ANDA count only if they copy the same dosage form and route as the brand: hydrocortisone tablets say nothing about a paediatric granule. They are shown as an event, because approval is not launch: settlements can hold generics back for years.
European Union
  • EMA: 10 years of market protection (8 years of data exclusivity plus 2) from the first EU authorisation of the molecule by the same company, including its earlier brands of the same substance. Another company's product has its own protection. One more year is possible for a significant new indication, but registers do not say when it was granted. Orphan medicines get 10 years of market exclusivity, plus 2 with a paediatric plan.
  • Supplementary protection certificates are national. For the largest drugs the tracker reads the Italian (UIBM) and German (DPMA) registers. The EU date then becomes the earliest SPC expiry among those countries, if it is later than the regulatory protection.
  • Certificates on a combination with another drug are listed but not used.
Italy and Germany
  • The later of the EU regulatory protection and the national SPC, paediatric extension included. Where no SPC is found the country shows the EU date.
Canada
  • The later of data protection (Register of Innovative Drugs, 8 years plus 6 months for paediatric studies) and patent protection from the Patent Register. A certificate of supplementary protection is granted only on the patent covering the medicinal ingredient, so when there is one it is used. Without one, the earliest listed patent is used, which is usually the oldest.
  • If the Drug Product Database shows the same ingredients, in the same dosage form and route, marketed by another company, the drug is marked generic on market from the earliest such date. A brand that is not sold in Canada gets no Canadian date.
How accurate are the dates
  • We tested the rules on the past. Applied to the FDA Orange Book of March 2021, they gave a date for each drug; we then looked at when a generic actually reached the market (start of marketing in FDA's NDC Directory). For the 75 drugs that got a generic since then, the date was right within 6 months for 27% and within 12 months for 40%. Generics came earlier than the date in 53% of cases, a median of 9 months earlier, because patents fall in court or are settled; later in 20%. No other simple rule did better: the spread comes from litigation and settlements that registers do not show. Company estimates, where they exist, include them.
  • For biologics the 12-year date is the earliest possible: the first US biosimilar came a median of 5 years after it. In Canada the end of data protection is also a floor: generics came a median of 21 months later.
  • The test and its results are kept with the tracker's code, so it can be rerun on any past snapshot.
Limits
  • Settlements and court decisions only appear once a company reports them. Registers lag, and a patent can fall in court the day after the update.
  • Matching across registers uses the active ingredient and the brand name; different brand names are joined only when the products were approved within a few years of each other. A small number of drugs may still be split or merged wrongly.
  • Data is refreshed every three months. This is a research tool, not legal advice.
Sources