1 June 2031
Settlements allow generic Vyndamax
Pfizer settled with every generic filer except Apotex in 2026; the date is subject to the outcome of the Apotex case.
When does Vyndaqel go off patent?
In the US, generics can launch from 2031. Vyndaqel is sold by Pfizer. April 2026 settlements extend the effective US patent expiry for Vyndamax to 1 June 2031, subject to a case against Apotex that is still going; Pfizer had expected US sales to start falling in 2029. Sales are the Vyndaqel family (Vyndaqel and Vyndamax), for a rare heart disease.
Vyndaqel's US exclusivity date is based on settlement / court date. Litigation settlements or a court ruling fix the earliest US entry date, which makes it one of the firmer dates in this tracker. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.
| Patent or protection | Covers | Expiry |
|---|---|---|
| US 7,214,695 | Tafamidis itself and the drug product (interim extension; Pfizer seeks 2028) | 19 December 2026 |
| US 9,770,441 | The crystalline form in Vyndamax | 31 August 2035 |
| Settlements on Vyndamax | Earliest generic launch for settled filers | 1 June 2031 |
Pfizer's basic patent, licensed from Scripps Research, runs to December 2026 under interim extensions, and Pfizer has applied to extend it to 2028. Pfizer owns a separate patent on the crystalline form used in Vyndamax, the main product, which runs to 2035. Pfizer settled the Vyndaqel case in March 2026 and three Vyndamax cases in April 2026, allowing generic Vyndamax from 1 June 2031; the case against Apotex is ongoing.
Sources: FDA Orange Book data files · Pfizer 10-K 2025 · Pfizer 10-Q, Q2 2026
| Year | Vyndaqel family (Vyndaqel, Vyndamax, Vynmac), Pfizer | US | Growth |
|---|---|---|---|
| 2023 | $3.32B | – | – |
| 2024 | $5.45B | $3.55B | +64% |
| 2025 | $6.38B | $3.83B | +17% |
Net sales as reported, with the US share. Source: Pfizer 10-K 2025
Filed with the FDA Several generic makers filed from June 2023 for both versions (Vyndaqel and Vyndamax), and Pfizer and Scripps Research sued. Pfizer settled with all of them except Apotex in March to May 2026: the Vyndamax settlements allow generics from 1 June 2031, subject to the outcome of other litigation. The case against Apotex over Vyndamax is ongoing.
| Company (product) | Stage |
|---|---|
| Apotex | Vyndamax: filed with the FDA; in litigation |
| Dexcel | Filed with the FDA; settled Apr 2026; US entry allowed from 1 Jun 2031 |
| Hikma | Filed with the FDA; settled Apr 2026; US entry allowed from 1 Jun 2031 |
| Cipla | Filed with the FDA; settled Apr 2026; US entry allowed from 1 Jun 2031 |
| Vyndaqel filer (not named by Pfizer) | Filed with the FDA; settled Mar 2026, terms confidential |
Checked October 2026. Sources: Pfizer 10-Q, Q2 2026 · Pfizer Q1 2026 results
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 →
| Scenario | 2025 US sales | Year 1 (about 2032) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | $3.83B | $0.00B0% | $0.00B0% | $0.03B1% |
| Median | $3.83B | $0.68B18% | $0.27B7% | $0.22B6% |
| Slowest past case | $3.83B | $1.84B48% | $0.95B25% | $0.67B17% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Vyndaqel's 2025 US sales, held flat until copies arrive in 2031. Year 1 is the first full year with copies on sale.
Vyndaqel is 10% of Pfizer's 2025 revenue ($6.4B of $62.6B). With Ibrance, Xtandi, Eliquis 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. Vyndaqel is highlighted.
Pfizer settled with every generic filer except Apotex in 2026; the date is subject to the outcome of the Apotex case.
Pfizer settled with Dexcel, Hikma and Cipla, extending the effective US patent expiry to 1 June 2031, subject to a case against Apotex. Pfizer had expected US sales to fall from 2029. Pfizer Q1 2026 results