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 Otezla go off patent?
In the US, generics can launch from 2028. Otezla is sold by Amgen. A court barred generics until the key US patent expires on 16 February 2028, and Amgen says pediatric exclusivity on that patent runs to 16 August 2028. Amgen settled with other filers. A newer extended-release version has patents to 2042.
Otezla'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 7,427,638 | Apremilast itself and the drug product; upheld against Sandoz and Zydus | 16 February 2028 |
| Pediatric exclusivity | On the same patent, per Amgen | 16 August 2028 |
| Later patents listed with the FDA | Uses and a drug product patent, with pediatric exclusivity | 29 November 2034 |
| Otezla XR patents | Extended-release dosage forms and uses, per Amgen | 27 May 2042 |
Otezla's key US patent expires on 16 February 2028, and a court barred Sandoz and Zydus until then. Amgen says pediatric exclusivity on that patent runs to 16 August 2028. The FDA has approved generics from more than a dozen makers since 2021, but none has launched; Amgen settled with other filers on confidential terms. Otezla XR, the newer once-daily version, has patents to 2042. Medicare's negotiated price for Otezla takes effect in 2027.
Sources: FDA Orange Book data files · Amgen 10-K 2025
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | $2.25B | $1.80B | – |
| 2022 | $2.29B | $1.89B | +2% |
| 2023 | $2.19B | $1.78B | -4% |
| 2024 | $2.13B | $1.70B | -3% |
| 2025 | $2.27B | $1.84B | +7% |
Worldwide net sales as reported, with the US share. Sources: Amgen 10-K 2025 · Amgen 10-K 2023
Approved, waiting to launch The FDA has approved generic Otezla from more than a dozen makers since 2021, but none has launched. A court barred Sandoz and Zydus until the key patent expires on 16 February 2028; Amgen says pediatric exclusivity on that patent runs to 16 August 2028. Amgen settled with other filers on confidential terms.
| Company (product) | Stage |
|---|---|
| Alkem | FDA-approved 21 Sep 2021; settled 2021, terms confidential |
| Shilpa | FDA-approved 7 Apr 2023 |
| Annora | FDA-approved 26 Jul 2023 |
| Mankind | FDA-approved 7 Feb 2024 |
| MSN | FDA-approved 16 Dec 2024 |
| Sandoz | Filed with the FDA; barred by court until Feb 2028 |
| Zydus | Filed with the FDA; barred by court until Feb 2028 |
| Cipla | Filed with the FDA; settled 2021, terms confidential |
| Torrent | FDA-approved 20 Jun 2025, not marketed; settled 2021, terms confidential |
Checked October 2026. Sources: FDA Orange Book: MSN · Fierce Pharma · Amgen press release
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 2029) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | $1.84B | $0.00B0% | $0.00B0% | $0.01B1% |
| Median | $1.84B | $0.33B18% | $0.13B7% | $0.11B6% |
| Slowest past case | $1.84B | $0.88B48% | $0.46B25% | $0.32B17% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Otezla's 2025 US sales, held flat until copies arrive in 2028. Year 1 is the first full year with copies on sale.
Otezla was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2027, 65% below its list price. That is 1 year before US generics can launch, so Medicare revenue comes under pressure first. 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 →
Otezla is 6.2% of Amgen's 2025 revenue ($2.3B of $36.8B). With Prolia, Xgeva, Repatha and Enbrel, the drugs tracked here add up to 38% of Amgen's revenue losing US exclusivity by 2029.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Otezla is highlighted.
Discounts of 40% to 71% below list price for these drugs, before the rebates drugmakers already pay.
A court barred Sandoz and Zydus until the key patent expires on this date; Amgen says pediatric exclusivity on that patent runs to 16 August 2028. Amgen settled with other filers on confidential terms.