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.
When does Pomalyst go off patent?
It already has. Pomalyst is sold by Bristol Myers Squibb. US generics launched March 2026 under settlements.
Pomalyst's US exclusivity date is based on generics launched. US generics have already launched, so the loss of exclusivity is under way. 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 generic entry under settlements | Generics on sale from March 2026 | March 2026 |
| Patents still listed with the FDA | Formulation and drug substance patents, with pediatric exclusivity | 21 December 2031 |
| FDA orphan exclusivity | One approved use, with pediatric exclusivity | 14 November 2027 |
| Europe | Generics already on sale, per BMS | Expired |
| Japan | Minimum market exclusivity, per BMS | 2026 |
Under settlements, US generics of Pomalyst could launch from the first quarter of 2026, and several did in March, even though patents on the formulation and drug substance stay listed with the FDA until 2031. An orphan exclusivity on one use runs to November 2027. In Europe generics are already on sale; in Japan, BMS put minimum exclusivity at 2026. In its first full quarter with generics, US sales fell to 21% of the last quarter before them.
Sources: FDA Orange Book data files · BMS 10-K 2025
| Year | Pomalyst/Imnovid, BMS | US | Growth |
|---|---|---|---|
| 2022 | $3.50B | $2.44B | – |
| 2023 | $3.44B | $2.36B | -2% |
| 2024 | $3.54B | $2.69B | +3% |
| 2025 | $2.73B | $2.34B | -23% |
US generics launched in March 2026. Net sales as reported, with the US share. Sources: BMS 10-K 2025 · BMS 10-K 2023
Copies on the US market Ten companies hold active FDA approvals. Several were approved years earlier but, under settlements, could only launch from March 2026.
180-day exclusivity: 6 generic applications were filed on the first day patents could be challenged (8 Feb 2017), and a first filer began selling on 2 Mar 2026. The FDA has not decided whether exclusivity applies. FDA Paragraph IV list (28 Sep 2026)
| Company (product) | Stage |
|---|---|
| Breckenridge | FDA-approved 30 Oct 2020; launched Mar 2026; first filer; FDA has not decided whether it keeps 180-day shared exclusivity |
| Eugia | FDA-approved 30 Oct 2020; first filer; FDA has not decided whether it keeps 180-day shared exclusivity |
| Teva | FDA-approved 4 May 2022; launched Mar 2026 |
| Apotex | FDA-approved 11 Jun 2024; launched 2 Mar 2026 |
| Hetero | FDA-approved 26 Sep 2024; launched 3 Mar 2026. Sells as Camber in the US |
| Cipla | FDA-approved 31 Aug 2026 |
| Dr. Reddy's | FDA-approved 31 Aug 2026 |
| Sandoz | FDA-approved 31 Aug 2026 |
| Sun Pharma | FDA-approved 31 Aug 2026 |
| MSN | FDA-approved 2 Sep 2026 |
| Mylan (Viatris) | FDA-approved 26 Jan 2022; discontinued |
Approval dates are from the FDA's own lists. A maker shows as launched only when its own release or filing confirms it; FDA-approved means a launch is not confirmed, not that the copy is off the market. Checked October 2026. Sources: FDA Orange Book data files · Breckenridge launch · FDA approval letter, ANDA 210111 · FDA Paragraph IV list (28 Sep 2026) · FDA approval letter, ANDA 210249 · Teva 10-Q, Q1 2026 (launches) · Apotex new-drug report to the Vermont Attorney General, pomalidomide · Camber (Hetero): pomalidomide launch
In Q2 2026, US sales were $131M, 21% of the $624M in Q4 2025, the last full quarter before copies.
Settlements let generic makers launch from March 2026; Q2 2026 was the first full quarter, with US sales down 78% on a year earlier.
| Quarter | US sales | vs Q4 2025 |
|---|---|---|
| Q4 2024 | $685M | 110% |
| Q1 2025 | $537M | 86% |
| Q2 2025 | $584M | 94% |
| Q3 2025 | $596M | 96% |
| Q4 2025 | $624M | 100% |
| Q1 2026 · copies launch | $439M | 70% |
| Q2 2026 | $131M | 21% |
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 →
Pomalyst was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2027, 60% below its list price. US generics had already launched by then. 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 →
Pomalyst is 5.7% of Bristol Myers Squibb's 2025 revenue ($2.7B of $48.2B). With Eliquis, Opdivo and Reblozyl, the drugs tracked here add up to 61% of Bristol Myers Squibb's revenue losing US exclusivity by 2031.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Pomalyst is highlighted.
Discounts of 40% to 71% below list price for these drugs, before the rebates drugmakers already pay.
Breckenridge launched generic pomalidomide under the settlement timeline, with Camber following. Breckenridge