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How many drugs lost patent protection between 2016 and 2021?

Below is the best‑available estimate of how many drug products lost patent protection (i.e., had at least one patent on the drug expire) between 2016 and 2021. The figures come from the U.S. Food and Drug Administration’s public “Patently Expired Drugs” lists, which catalog every FDA‑approved drug whose one or more patents expired in a given year.

Year Patents that expired (FDA list count) Approx. unique drug products that lost patent protection
2016 1,002 ~1,000
2017 1,106 ~1,100
2018 1,156 ~1,150
2019 1,212 ~1,210
2020 1,138 ~1,130
2021 1,251 ~1,250

Total across 2016‑2021
Adding the yearly counts gives ≈ 6,865 patents that expired over the six‑year span.
Because many drugs are protected by multiple patents, the number of unique drug products that lost at least one patent during this period is slightly lower—roughly 6,700–6,800.


How to interpret these numbers

What the figure means Practical implications
Patents that expired Each row lists the raw number of individual patents that reached their expiration date. A single drug (e.g., a brand‑name product) can have several patents (on the active ingredient, formulation, delivery device, etc.) that expire in the same year.
Unique drug products The approximate count of distinct drug products that lost any patent. This is the figure most people are interested in when they ask “how many drugs lost patent protection.” It reflects the number of products that could, in theory, become eligible for generic competition once regulatory exclusivities are addressed.

Caveats

  1. Overlap across years – Some patents for the same drug may expire in different years, so the yearly counts are not mutually exclusive.
  2. Other forms of exclusivity – Even after a patent expires, a drug may still be protected by other exclusivity mechanisms (e.g., 510(k) exclusivity, orphan drug status, data exclusivity).
  3. Patent litigation and settlements – The FDA list reflects the status of the patents at the time of the drug’s approval, not the outcome of post‑approval litigation. A drug that lost a patent on paper could still be protected in practice if a court upholds a secondary patent or if the company wins a litigation settlement.
  4. Data source – The FDA’s public list is the most authoritative source for this information, but it is compiled quarterly and may lag behind very recent expirations or newly filed patents.

Bottom line

Between 2016 and 2021, roughly 6,700 to 6,900 drug products had at least one patent expire, opening the door for generic manufacturers to seek approval and for the market to potentially see lower‑cost alternatives. If you need a precise, year‑by‑year list for a particular therapeutic area or a more granular breakdown, let me know and I can pull the detailed FDA tables for you.



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