https://pharmapatentcliff.com/changes Loss-of-exclusivity changes for blockbuster drugs: settlements, US generic and biosimilar launches, and Medicare price negotiation. en https://pharmapatentcliff.com/opdivo pharmapatentcliff-2026-09-08-opdivo Tue, 08 Sep 2026 12:00:00 GMT Copies in the works The suit asserts seven patents against Amgen's ABP 206, which is under FDA review with a decision expected by the end of 2026. Source: Goodwin (https://www.goodwinlaw.com/en/insights/blogs/2026/09/bms-and-ono-file-bpcia-suit-against-amgen-for-nivolumab-biosimilar) https://pharmapatentcliff.com/ozempic pharmapatentcliff-2026-05-15-ozempic Fri, 15 May 2026 12:00:00 GMT Outside the US Dr. Reddy's launched the first generic in Canada, after generics reached India in the first quarter. US protection runs to 2032. Source: Dr. Reddy's (https://www.sec.gov/Archives/edgar/data/0001135951/000157587226000334/rdy0896_ex99-1.htm) https://pharmapatentcliff.com/farxiga pharmapatentcliff-2026-04-07-farxiga Tue, 07 Apr 2026 12:00:00 GMT US copies launched Several generic dapagliflozin makers were approved at once, ending US exclusivity. Source: FDA (https://www.fda.gov/drugs/drug-alerts-and-statements/fda-approves-first-generic-dapagliflozin-tablets) https://pharmapatentcliff.com/pomalyst pharmapatentcliff-2026-03-02-pomalyst Mon, 02 Mar 2026 12:00:00 GMT US copies launched Breckenridge launched generic pomalidomide under the settlement timeline, with Camber following. Source: Breckenridge (https://www.prnewswire.com/news-releases/breckenridge-launches-pomalidomide-capsules-strengthening-its-oncology-portfolio-302701181.html) https://pharmapatentcliff.com/changes pharmapatentcliff-2026-01-27-trulicity-biktarvy-cosentyx-entyvio Tue, 27 Jan 2026 12:00:00 GMT Medicare price Negotiated prices take effect in 2028. CMS must publish them by 30 November 2026. Source: CMS (https://www.cms.gov/files/document/factsheet-medicare-negotiation-selected-drug-list-ipay-2028.pdf) https://pharmapatentcliff.com/changes pharmapatentcliff-2025-11-ozempic-pomalyst-ibrance-xtandi Sat, 01 Nov 2025 12:00:00 GMT Medicare price From 2027: Ozempic 71%, Pomalyst 60%, Ibrance 50% and Xtandi 48% below list price. Source: CMS (https://www.cms.gov/files/document/fact-sheet-negotiated-prices-ipay-2027.pdf) https://pharmapatentcliff.com/biktarvy pharmapatentcliff-2025-10-06-biktarvy Mon, 06 Oct 2025 12:00:00 GMT Date pushed back Settlements with Lupin, Cipla and Laurus Labs bar generics before 1 April 2036, more than two years after Gilead's previous December 2033 estimate. Source: Fierce Pharma (https://www.fiercepharma.com/pharma/gilead-notches-settlements-three-generic-drugmakers-waylaying-us-biktarvy-copycats-until) https://pharmapatentcliff.com/rinvoq pharmapatentcliff-2025-09-11-rinvoq Thu, 11 Sep 2025 12:00:00 GMT Date pushed back AbbVie settled with every generic filer. Analysts had modeled US exclusivity ending in 2032. Source: Fierce Pharma (https://www.fiercepharma.com/pharma/abbvie-settles-generic-rinvoq-hopefuls-shielding-immunology-blockbusters-us-sales-until-2037) https://pharmapatentcliff.com/entresto pharmapatentcliff-2025-07-22-entresto Tue, 22 Jul 2025 12:00:00 GMT US copies launched MSN's generic launched through Novadoz, and Torrent followed two days later. Source: Optum Rx (https://business.optum.com/en/support/professionalrx-resources/newgeneric-entresto-073025.html) https://pharmapatentcliff.com/stelara pharmapatentcliff-2025-01-stelara Wed, 01 Jan 2025 12:00:00 GMT US copies launched Amgen's Wezlana launched in January 2025, and several more biosimilars followed during the year. Stelara sales fell 41% in 2025. Source: Center for Biosimilars (https://www.centerforbiosimilars.com/view/welcome-wezlana-the-first-stelara-biosimilar-to-launch-in-the-us) https://pharmapatentcliff.com/changes pharmapatentcliff-2024-08-eliquis-farxiga-entresto-enbrel-stelara Thu, 01 Aug 2024 12:00:00 GMT Medicare price From 2026: Farxiga 68%, Enbrel 67%, Stelara 66%, Eliquis 56% and Entresto 53% below list price. Source: CMS (https://www.cms.gov/files/document/fact-sheet-negotiated-prices-initial-price-applicability-year-2026.pdf) https://pharmapatentcliff.com/entyvio pharmapatentcliff-2022-01-entyvio Sat, 01 Jan 2022 12:00:00 GMT Date pushed back Takeda moved its assumption from May 2026 by three to five years, citing formulation, dosing and manufacturing patents. Source: Pharma Japan (https://pj.jiho.jp/article/245946)