Pharma Patent Cliffby readouts.io
Loss of exclusivity · Oncology

Ibrance patent expiration

When does Ibrance go off patent?

In the US, generics can launch from 2027. Ibrance is sold by Pfizer. US patent term extended to March 2027, and pediatric exclusivity to September 2027.

What the date means

Ibrance's US exclusivity date is based on patent-expiry estimate. It is estimated from patent expiry rather than a fixed entry date, so it may move as patents are challenged or extended. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.

Patents and sales historyPatent and exclusivity dates, sales by year

Ibrance patents and exclusivity

Patent or protectionCoversExpiry
US RE47,739Palbociclib itself, with patent term extension5 March 2027
Pediatric exclusivityAdds six months to the patent5 September 2027
US 10,723,730Solid forms of palbociclib, with pediatric exclusivity8 August 2034
Later drug product patentWith pediatric exclusivity19 February 2037
Europe and Japan basic patentsIbrance, per Pfizer2028

Ibrance's basic US patent, extended to 5 March 2027, now carries six months of pediatric exclusivity, to 5 September 2027. Patents on solid forms and the drug product run to 2034 and 2037. Generic makers have filed since 2019 and Pfizer has settled some cases on undisclosed terms. Pfizer lists 2028 for Europe and Japan, and generics have already entered some markets outside the US.

Sources: FDA Orange Book data files · Pfizer 10-K 2025

Ibrance sales by year

YearWorldwideUSGrowth
2022$5.12B$3.37B–
2023$4.75B$3.15B-7%
2024$4.37B$2.85B-8%
2025$4.12B$2.71B-6%

Worldwide net sales as reported, with the US share. Sources: Pfizer 10-K 2025 · Pfizer 10-K 2023

Who's lined up to copy Ibrance

Filed with the FDA Generic makers have filed since 2019. Pfizer settled some cases on undisclosed terms, and its patent extension runs to March 2027 and pediatric exclusivity to September 2027.

Company (product)Stage
Several generic makers (not named by Pfizer)Filed with the FDA

Checked October 2026. Sources: Pfizer 10-Q, Q3 2021 · Pfizer: patent extension

What past cliffs suggest

Among past small-molecule drugs facing unrestricted generics, US sales in the first full year after copies arrived were a median 18% of the last full year before (range 0% to 48%, 10 drugs), and 6% by the third year (8 drugs). Where settlements limit generic volumes, as with Revlimid, the decline is slower. Every drug is different: settlements, how many copies launch, and pricing all change the curve. See the erosion benchmarks →

Scenario2025 US salesYear 1 (about 2028)Year 2Year 3
Median$2.71B$0.48B18%$0.19B7%$0.16B6%

An illustration, not a forecast: it applies the past-cliff benchmarks to Ibrance's 2025 US sales, held flat until copies arrive in 2027. Year 1 is the first full year with copies on sale.

Medicare price negotiation

Ibrance was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2027, 50% below its list price. That is the same year US generics can launch. The discount is measured against list price, before the rebates drugmakers already pay, and applies to Medicare only, so the revenue impact is smaller than the headline number. See every negotiated Medicare price →

What's at stake for Pfizer

Ibrance is 6.6% of Pfizer's 2025 revenue ($4.1B of $62.6B). With Xtandi, Eliquis, Vyndaqel and Prevnar 20, the drugs tracked here add up to 43% of Pfizer's revenue losing US exclusivity by 2035. Eliquis and Xtandi are Pfizer's reported alliance and product revenue ($8.0B, $2.2B).

Bars show each company's tracked drugs as a share of its total 2025 revenue. Ibrance is highlighted.

Coming up for Ibrance

1 January 2027

Medicare negotiated prices for 2027 take effect

Discounts of 40% to 71% below list price for these drugs, before the rebates drugmakers already pay.

5 September 2027

Ibrance US patent protection ends, including pediatric exclusivity

The extended basic patent runs to 5 March 2027 and pediatric exclusivity to 5 September 2027. Generic makers have filed since 2019; Pfizer settled some cases on undisclosed terms.

See every upcoming date on the patent cliff calendar →

What changed for Ibrance

  1. Medicare price
    Medicare prices set for Ozempic, Pomalyst, Ibrance and Xtandi

    From 2027: Ozempic 71%, Pomalyst 60%, Ibrance 50% and Xtandi 48% below list price. CMS