BEGIN:VCALENDAR VERSION:2.0 PRODID:-//readouts.io//Pharma Patent Cliff//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:Patent cliff calendar X-WR-CALDESC:Generic and biosimilar entry dates\, patent expiries\, court \, FDA and Medicare dates for blockbuster drugs. From pharmapatentcliff. com by readouts.io. REFRESH-INTERVAL;VALUE=DURATION:P1D X-PUBLISHED-TTL:P1D BEGIN:VEVENT UID:2026-10-polpharma-ocrelizumab-biosimilar-starts-its-first-trial@pharm apatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20261001 DTEND;VALUE=DATE:20261002 SUMMARY:Polpharma ocrelizumab biosimilar starts its first trial (during O ctober) DESCRIPTION:Teva licensed the candidate in 2026 for the US and other mark ets.\nDrugs: Ocrevus\nSource: Teva press release https://ir.tevapharm.co m/news-and-events/press-releases/press-release-details/2026/Teva-and-Pol pharma-Biologics-Announce-Global-Licensing-Agreement-for-a-Biosimilar-Ca ndidate-to-Ocrevus-ocrelizumab-for-Multiple-Sclerosis/default.aspx\nhttp s://pharmapatentcliff.com/ocrevus URL:https://pharmapatentcliff.com/ocrevus TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2026-11-30-cms-publishes-medicare-negotiated-prices-for-2028@pharmapa tentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20261130 DTEND;VALUE=DATE:20261201 SUMMARY:CMS publishes Medicare negotiated prices for 2028 DESCRIPTION:Deadline for CMS to publish the negotiated prices for the dru gs selected for 2028. The prices take effect on 1 January 2028.\nDrugs: Trulicity\, Cosentyx\, Entyvio\, Biktarvy\, Kisqali and Verzenio\nSource : CMS: drugs selected for 2028 https://www.cms.gov/files/document/factsh eet-medicare-negotiation-selected-drug-list-ipay-2028.pdf\nhttps://pharm apatentcliff.com/calendar URL:https://pharmapatentcliff.com/calendar TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-01-medicare-negotiated-prices-for-2027-take-effect@pharmapate ntcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270102 SUMMARY:Medicare negotiated prices for 2027 take effect DESCRIPTION:Discounts of 40% to 71% below list price for these drugs\, be fore the rebates drugmakers already pay.\nDrugs: Pomalyst\, Ibrance\, Xt andi\, Ozempic\, Wegovy\, Calquence and Otezla\nSource: CMS: negotiated prices for 2027 https://www.cms.gov/files/document/fact-sheet-negotiated -prices-ipay-2027.pdf\nhttps://pharmapatentcliff.com/calendar URL:https://pharmapatentcliff.com/calendar TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-01-amgen-ocrelizumab-biosimilar-phase-3-results-expected@pharmap atentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20270101 DTEND;VALUE=DATE:20270102 SUMMARY:Amgen ocrelizumab biosimilar Phase 3 results expected (during Jan uary) DESCRIPTION:Amgen is the furthest along of the US-focused developers.\nDr ugs: Ocrevus\nSource: Biosimilars R&R https://biosimilarsrr.com/2025/10/ 21/the-early-outlook-for-ocrelizumab-biosimilars/\nhttps://pharmapatentc liff.com/ocrevus URL:https://pharmapatentcliff.com/ocrevus TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-03-ibrance-us-patent-extension-ends@pharmapatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20270301 DTEND;VALUE=DATE:20270302 SUMMARY:Ibrance US patent extension ends (during March) DESCRIPTION:Generic makers have filed since 2019\; Pfizer settled some ca ses on undisclosed terms.\nDrugs: Ibrance\nSource: Pfizer: patent extens ion https://www.pfizer.com/news/press-release/press-release-detail/pfize r-confirms-us-patent-term-extension-ibrancer\nhttps://pharmapatentcliff. com/ibrance URL:https://pharmapatentcliff.com/ibrance TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-04-calquence-patent-trial-against-cipla@pharmapatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20270401 DTEND;VALUE=DATE:20270402 SUMMARY:Calquence patent trial against Cipla (during April) DESCRIPTION:AstraZeneca settled with MSN in December 2025\; the case agai nst Cipla is set for trial.\nDrugs: Calquence\nSource: AstraZeneca 20-F 2025 https://www.sec.gov/Archives/edgar/data/901832/000110465926019130/a zn-20251231x20f.htm\nhttps://pharmapatentcliff.com/calquence URL:https://pharmapatentcliff.com/calquence TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-08-last-listed-xtandi-us-patent-expires@pharmapatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20270801 DTEND;VALUE=DATE:20270802 SUMMARY:Last listed Xtandi US patent expires (during August) DESCRIPTION:Generics from Sandoz and others are FDA-approved but have not launched while Pfizer and Astellas pursue patent suits.\nDrugs: Xtandi\ nSource: Pfizer 10-Q\, Q2 2026 https://www.sec.gov/Archives/edgar/data/0 000078003/000007800326000095/pfe-20260628.htm\nhttps://pharmapatentcliff .com/xtandi URL:https://pharmapatentcliff.com/xtandi TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2027-09-lynparza-us-compound-patent-expires@pharmapatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20270901 DTEND;VALUE=DATE:20270902 SUMMARY:Lynparza US compound patent expires (during September) DESCRIPTION:None of the four generic filers challenges this patent\, so t his is the earliest the FDA can approve them.\nDrugs: Lynparza\nSource: Merck 10-K 2025 https://www.sec.gov/Archives/edgar/data/310158/000031015 826000063/mrk-20251231.htm\nhttps://pharmapatentcliff.com/lynparza URL:https://pharmapatentcliff.com/lynparza TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-01-01-medicare-negotiated-prices-for-2028-take-effect@pharmapate ntcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20280101 DTEND;VALUE=DATE:20280102 SUMMARY:Medicare negotiated prices for 2028 take effect DESCRIPTION:Prices are due from CMS by 30 November 2026.\nDrugs: Trulicit y\, Cosentyx\, Entyvio\, Biktarvy\, Kisqali and Verzenio\nSource: CMS: d rugs selected for 2028 https://www.cms.gov/files/document/factsheet-medi care-negotiation-selected-drug-list-ipay-2028.pdf\nhttps://pharmapatentc liff.com/calendar URL:https://pharmapatentcliff.com/calendar TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-02-16-court-bar-on-generic-otezla-ends@pharmapatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20280216 DTEND;VALUE=DATE:20280217 SUMMARY:Court bar on generic Otezla ends DESCRIPTION:A court barred Sandoz and Zydus until the key patent expires on this date\; Amgen settled with other filers on confidential terms.\nD rugs: Otezla\nSource: Fierce Pharma https://www.fiercepharma.com/pharma/ amgen-scores-otezla-patent-win-protecting-its-blockbuster-against-sandoz -and-zydus-copycats\nhttps://pharmapatentcliff.com/otezla URL:https://pharmapatentcliff.com/otezla TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-04-01-generic-eliquis-can-launch-in-the-us@pharmapatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20280401 DTEND;VALUE=DATE:20280402 SUMMARY:Generic Eliquis can launch in the US DESCRIPTION:Settlements let most of the original 25 generic filers launch from this date\; the three that lost in court must wait for a patent ex piring in 2031.\nDrugs: Eliquis\nSource: Pfizer 10-K 2025 https://www.se c.gov/Archives/edgar/data/78003/000007800326000026/pfe-20251231.htm\nhtt ps://pharmapatentcliff.com/eliquis URL:https://pharmapatentcliff.com/eliquis TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-06-first-jakafi-composition-patent-expires@pharmapatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20280601 DTEND;VALUE=DATE:20280602 SUMMARY:First Jakafi composition patent expires (during June) DESCRIPTION:The second expires in December 2028. Incyte has settled with five of nine challengers on confidential terms.\nDrugs: Jakafi\nSource: Incyte 10-Q\, Q2 2026 https://www.sec.gov/Archives/edgar/data/0000879169 /000087916926000056/incy-20260630.htm\nhttps://pharmapatentcliff.com/jak afi URL:https://pharmapatentcliff.com/jakafi TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-12-keytruda-primary-us-compound-patent-expires@pharmapatentcliff .com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20281201 DTEND;VALUE=DATE:20281202 SUMMARY:Keytruda primary US compound patent expires (during December) DESCRIPTION:No US biosimilar filing has been announced\; Samsung Bioepis has filed in Korea.\nDrugs: Keytruda\nSource: Merck 10-K https://www.sec .gov/Archives/edgar/data/310158/000031015826000063/mrk-20251231.htm\nhtt ps://pharmapatentcliff.com/keytruda URL:https://pharmapatentcliff.com/keytruda TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2028-12-second-jakafi-composition-patent-expires@pharmapatentcliff.co m DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20281201 DTEND;VALUE=DATE:20281202 SUMMARY:Second Jakafi composition patent expires (during December) DESCRIPTION:Incyte puts its minimum US market exclusivity at 2028.\nDrugs : Jakafi\nSource: Incyte 10-K 2025 https://www.sec.gov/Archives/edgar/da ta/879169/000087916926000010/incy-20251231.htm\nhttps://pharmapatentclif f.com/jakafi URL:https://pharmapatentcliff.com/jakafi TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2029-03-main-ocrevus-us-patent-protection-ends@pharmapatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20290301 DTEND;VALUE=DATE:20290302 SUMMARY:Main Ocrevus US patent protection ends (during March) DESCRIPTION:Biosimilars are in development\; Amgen is furthest along.\nDr ugs: Ocrevus\nSource: Roche FY2025 https://www.roche.com/investors/updat es/inv-update-2026-01-29\nhttps://pharmapatentcliff.com/ocrevus URL:https://pharmapatentcliff.com/ocrevus TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2029-04-court-upheld-patents-stop-blocking-enbrel-biosimilars@pharmap atentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20290401 DTEND;VALUE=DATE:20290402 SUMMARY:Court-upheld patents stop blocking Enbrel biosimilars (during Apr il) DESCRIPTION:Two biosimilars are FDA-approved but cannot launch until then .\nDrugs: Enbrel\nSource: GaBI https://www.gabionline.net/biosimilars/ne ws/etanercept-biosimilars-delayed-until-2029-in-us\nhttps://pharmapatent cliff.com/enbrel URL:https://pharmapatentcliff.com/enbrel TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2029-08-27-repatha-us-antibody-patent-expires@pharmapatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20290827 DTEND;VALUE=DATE:20290828 SUMMARY:Repatha US antibody patent expires DESCRIPTION:A methods-of-treatment patent runs to May 2032. No confirmed US biosimilar filing yet.\nDrugs: Repatha\nSource: Amgen 10-K 2025 https ://www.sec.gov/Archives/edgar/data/318154/000031815426000010/amgn-202512 31.htm\nhttps://pharmapatentcliff.com/repatha URL:https://pharmapatentcliff.com/repatha TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2030-01-15-earliest-launch-for-msn-s-generic-cabometyx@pharmapatentcl iff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20300115 DTEND;VALUE=DATE:20300116 SUMMARY:Earliest launch for MSN's generic Cabometyx DESCRIPTION:MSN has FDA approval\, but an appeals court upheld Exelixis's patents in August 2026.\nDrugs: Cabometyx\nSource: Exelixis: appeal rul ing\, Aug 2026 https://ir.exelixis.com/news-releases/news-release-detail s/exelixis-announces-update-patent-litigation-trial-appeal-msn\nhttps:// pharmapatentcliff.com/cabometyx URL:https://pharmapatentcliff.com/cabometyx TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2031-01-01-teva-and-cipla-licensed-to-sell-generic-cabometyx@pharmapa tentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20310101 DTEND;VALUE=DATE:20310102 SUMMARY:Teva and Cipla licensed to sell generic Cabometyx DESCRIPTION:Under settlements with Exelixis.\nDrugs: Cabometyx\nSource: F ierce Pharma: Teva settlement https://www.fiercepharma.com/pharma/exelix is-teva-settle-cabometyx-patent-litigation-2031-license-launch-generic\n https://pharmapatentcliff.com/cabometyx URL:https://pharmapatentcliff.com/cabometyx TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2031-03-28-extended-dupixent-us-patent-expires@pharmapatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20310328 DTEND;VALUE=DATE:20310329 SUMMARY:Extended Dupixent US patent expires DESCRIPTION:Sanofi plans to defend exclusivity beyond this date. Biosimil ars are in early development.\nDrugs: Dupixent\nSource: Fierce Pharma ht tps://www.fiercepharma.com/pharma/sanofi-expects-extend-its-loe-dupixent -beyond-2031\nhttps://pharmapatentcliff.com/dupixent URL:https://pharmapatentcliff.com/dupixent TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2032-03-30-earliest-us-generic-imbruvica-per-abbvie@pharmapatentcliff .com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20320330 DTEND;VALUE=DATE:20320331 SUMMARY:Earliest US generic Imbruvica\, per AbbVie DESCRIPTION:After a 2021 court ruling and settlements\, assuming pediatri c exclusivity. Hetero already has FDA approval.\nDrugs: Imbruvica\nSourc e: AbbVie 10-K 2025 https://www.sec.gov/Archives/edgar/data/1551152/0001 55115226000008/abbv-20251231.htm\nhttps://pharmapatentcliff.com/imbruvic a URL:https://pharmapatentcliff.com/imbruvica TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2036-04-01-settlements-allow-us-generic-biktarvy@pharmapatentcliff.co m DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20360401 DTEND;VALUE=DATE:20360402 SUMMARY:Settlements allow US generic Biktarvy DESCRIPTION:Gilead settled with all three generic filers in October 2025. \nDrugs: Biktarvy\nSource: Fierce Pharma https://www.fiercepharma.com/ph arma/gilead-notches-settlements-three-generic-drugmakers-waylaying-us-bi ktarvy-copycats-until\nhttps://pharmapatentcliff.com/biktarvy URL:https://pharmapatentcliff.com/biktarvy TRANSP:TRANSPARENT END:VEVENT BEGIN:VEVENT UID:2037-04-settlements-allow-us-generic-rinvoq@pharmapatentcliff.com DTSTAMP:20260928T000000Z DTSTART;VALUE=DATE:20370401 DTEND;VALUE=DATE:20370402 SUMMARY:Settlements allow US generic Rinvoq (during April) DESCRIPTION:AbbVie settled with every generic filer in September 2025\, a ssuming pediatric exclusivity.\nDrugs: Rinvoq\nSource: AbbVie 10-K 2025 https://www.sec.gov/Archives/edgar/data/1551152/000155115226000008/abbv- 20251231.htm\nhttps://pharmapatentcliff.com/rinvoq URL:https://pharmapatentcliff.com/rinvoq TRANSP:TRANSPARENT END:VEVENT END:VCALENDAR