Pharma Patent Cliffby readouts.io
Change log · updated 24 October 2026

What changed

Every dated event that moved a loss-of-exclusivity date or changed a drug's outlook: settlements that pushed dates back, US generic and biosimilar launches, launches outside the US, Medicare price negotiation and acquisitions by the most exposed companies. Follow it with the RSS feed.

  1. Copies in the works
    Biocon settles with Genentech over its Perjeta biosimilar

    The settlement allows Biocon to launch Pebrilzo in the US from Q3 2028, and in Europe and the UK from early 2027. Henlius and Organon's Poherdy is already FDA-approved. Biocon

  2. Copies in the works
    FDA accepts the first Keytruda biosimilar application

    Formycon and Zydus's FYB206 is the first publicly announced Keytruda biosimilar under FDA review; a decision is expected in Q3 2027. Merck's primary US compound patent expires in December 2028. Formycon and Zydus

  3. US copies launched
    Celltrion launches the first US Xolair biosimilar

    Omlyclo, interchangeable with Xolair, launched at a list price about 15% lower, with a preferred spot on Optum's commercial formulary. Xolair's US sales were CHF 3.08B in 2025. Celltrion

  4. US copies launched
    FDA approves Teva's Xgeva biosimilar

    Degevma makes 10 approved Xgeva biosimilars; Teva expects to launch it, and its Prolia version, in the coming months. Teva

  5. Copies in the works
    Mylan sues to clear a newer Wegovy patent

    The patent, granted in February 2026 and running to 2038, covers weekly weight-loss dosing; Novo's compound patent still runs to 2032. Pearce IP

  6. Acquisition
    Eli Lilly completes its $2.8B AtaiBeckley acquisition

    AtaiBeckley brings treatments in development for treatment-resistant depression. Lilly has closed at least nine acquisitions in 2026. Lilly

  7. Copies in the works
    BMS and Ono sue Amgen to block its Opdivo biosimilar

    The suit asserts seven patents against Amgen's ABP 206, which is under FDA review with a decision expected by the end of 2026. Goodwin

  8. Copies in the works
    FDA gives final approval to a generic Imbruvica

    Hetero's capsules are approved, but AbbVie still expects no US generic before 30 March 2032. FDA Orange Book

  9. Acquisition
    AbbVie completes its $10.9B Apogee acquisition

    The deal adds zumilokibart, a long-acting antibody in development for atopic dermatitis. It is AbbVie's largest acquisition since 2023. AbbVie

  10. Copies in the works
    Takeda sues both Entyvio biosimilar filers

    Takeda sued Alvotech and Teva on 1 September and Polpharma on 26 August, asserting six patents against the two biosimilars now under FDA review. Pearce IP

  11. Acquisition
    Vertex completes its $10B Crinetics acquisition

    Crinetics brings Palsonify, an approved drug for acromegaly. It is Vertex's largest acquisition since 2023. Vertex

  12. Copies in the works
    Appeals court upholds Cabometyx patents against MSN

    MSN won FDA approval in August but cannot launch before 15 January 2030; Teva and Cipla's settlements allow generics from 1 January 2031. Exelixis

  13. Copies in the works
    More Descovy generics approved, none launched

    Natco joins Apotex, Lupin and Macleods with FDA approval; settlement terms are undisclosed and Gilead puts US exclusivity at 2031. FDA Orange Book

  14. Acquisition
    J&J completes its $1B Firefly Bio acquisition

    Firefly brings an early cancer platform. It is J&J's fifth acquisition of $1B or more since 2023. J&J

  15. Copies in the works
    FDA tentatively approves Natco's generic Lynparza

    Final approval cannot come before the compound patent expires in September 2027; AstraZeneca settled with Sandoz, another filer, in April. Natco

  16. Copies in the works
    Generic makers file to copy Mounjaro and Zepbound

    Lilly received notice that multiple companies had applied to sell generic tirzepatide before its patents expire, and said it intends to sue. Its US compound patent runs to 2036. Lilly 10-Q, Q2 2026

  17. Acquisition
    Eli Lilly completes its $6.3B Centessa acquisition

    Centessa brings orexin agonists in development for narcolepsy and other sleep disorders. Lilly

  18. Copies in the works
    FDA accepts the first Entyvio biosimilar application

    Alvotech's AVT16, to be sold in the US by Teva, is under review with a decision expected in the first quarter of 2027. Takeda's patents running to 2032 still stand in the way of launch. Alvotech

  19. Outside the US
    Generic semaglutide launched in Canada

    Dr. Reddy's launched the first generic in Canada, after generics reached India in the first quarter. US protection runs to 2032. Dr. Reddy's

  20. Acquisition
    Merck completes its $6.7B Terns acquisition

    Terns brings TERN-701, an oral drug in development for chronic myeloid leukemia. Merck

  21. Date pushed back · 2028 → 2031
    Settlements push Vyndamax's US generic entry to June 2031

    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

  22. Acquisition
    Gilead completes its $7.8B Arcellx acquisition

    Gilead takes full ownership of anito-cel, a CAR-T therapy for multiple myeloma it already co-developed with Arcellx. Gilead

  23. Copies in the works
    FDA approves Sandoz's generic Xtandi tablets

    Launch still waits on patents: the last listed Xtandi patent expires in August 2027. FDA Orange Book

  24. US copies launched
    FDA approved the first US generics of Farxiga

    Several generic dapagliflozin makers were approved at once, ending US exclusivity. FDA

  25. US copies launched
    US generics of Pomalyst launched

    Breckenridge launched generic pomalidomide under the settlement timeline, with Camber following. Breckenridge

  26. Acquisition
    Novartis completes its $12B Avidity acquisition

    Avidity brings late-stage RNA drugs for neuromuscular diseases. It is Novartis's largest acquisition since 2023. Novartis

  27. Medicare price
    Trulicity, Biktarvy, Cosentyx and Entyvio selected for Medicare price negotiation

    Negotiated prices take effect in 2028. CMS must publish them by 30 November 2026. CMS

  28. Acquisition
    Merck completes its $9.2B Cidara acquisition

    Cidara brings CD388, a long-acting antiviral in development to prevent flu. Merck

  29. Medicare price
    Stelara, Entresto and Xarelto leave Medicare negotiation in 2027

    CMS found generics or biosimilars on sale, so their negotiated prices apply through 31 December 2026 only. CMS

  30. Medicare price
    Medicare prices set for Ozempic, Pomalyst, Ibrance and Xtandi

    From 2027: Ozempic 71%, Pomalyst 60%, Ibrance 50% and Xtandi 48% below list price. CMS

  31. Date pushed back · 2033 → 2036
    Settlements push Biktarvy's US generic entry to April 2036

    Settlements with Lupin, Cipla and Laurus Labs bar generics before 1 April 2036, more than two years after Gilead's previous December 2033 estimate. Fierce Pharma

  32. Date pushed back · 2032 → 2037
    Settlements push Rinvoq's US generic entry to April 2037

    AbbVie settled with every generic filer. Analysts had modeled US exclusivity ending in 2032. Fierce Pharma

  33. US copies launched
    First US generics of Entresto launched

    MSN's generic launched through Novadoz, and Torrent followed two days later. Optum Rx

  34. US copies launched
    First US biosimilars of Stelara launched

    Amgen's Wezlana launched in January 2025, and several more biosimilars followed during the year. Stelara sales fell 41% in 2025. Center for Biosimilars

  35. Medicare price
    First Medicare prices set, including Eliquis, Farxiga, Entresto, Enbrel and Stelara

    From 2026: Farxiga 68%, Enbrel 67%, Stelara 66%, Eliquis 56% and Entresto 53% below list price. CMS

  36. Date pushed back · 2026 → 2032
    Takeda pushes its assumed US biosimilar entry for Entyvio to 2032

    Takeda moved its assumption from May 2026 by three to five years, citing formulation, dosing and manufacturing patents. Pharma Japan