{"id":39668,"date":"2026-10-01T10:10:00","date_gmt":"2026-10-01T14:10:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=39668"},"modified":"2026-09-19T23:03:00","modified_gmt":"2026-09-20T03:03:00","slug":"why-your-pbms-generic-substitution-policy-is-six-months-behind-the-actual-patent-timeline","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/why-your-pbms-generic-substitution-policy-is-six-months-behind-the-actual-patent-timeline\/","title":{"rendered":"Why Your PBM’s Generic Substitution Policy Is Six Months Behind the Actual Patent Timeline"},"content":{"rendered":"\n
\"\"<\/figure>\n\n\n\n

The Short Answer<\/h2>\n\n\n\n

Six months is the optimistic case. When Amgen launched the first Humira biosimilar on January 31, 2023, CVS Caremark did not remove brand Humira from its main commercial formulary until April 2024, and Express Scripts and OptumRx did not do so until July 2025 [8][9]. That is a 14-month gap for the fastest-moving PBM and roughly a 30-month gap for the other two. The pattern repeats with Stelara, where the FDA approved an interchangeable biosimilar in October 2023 but a patent settlement blocked its commercial launch until January 2025, and CVS chose to keep brand Stelara at parity with biosimilars through 2026 anyway [9][12]. A generic substitution policy built around the date a patent is scheduled to expire will consistently misjudge when a product is actually available, and when a PBM will actually act on it. Those are three different dates, set by three different processes, and this article walks through each one with the public record behind it.<\/p>\n\n\n\n

What ‘Patent Timeline’ Actually Means: Four Kinds of Protection, Not One<\/h2>\n\n\n\n

A branded drug’s Orange Book listing rarely rests on a single patent. Composition-of-matter patents protect the molecule itself and are the strongest and most durable form of protection. Formulation patents cover a specific dosage form, concentration, or delivery mechanism. Method-of-use patents protect a particular indication rather than the compound. Device patents cover delivery hardware, such as an inhaler actuator or an autoinjector, and are not supposed to be listed unless the device claim is inseparable from the drug product itself [4][6].<\/p>\n\n\n\n

Eliquis (apixaban) illustrates the stacking effect: DrugPatentWatch’s public patent profile for the product lists three US patents and one active Paragraph IV challenge tied to a single reference listed drug [17]. Composition-of-matter protection expiring on one date does not mean the product goes generic on that date if formulation or method-of-use patents extend further, and it does not mean the product stays protected if a challenger successfully invalidates or delists the later-filed patents.<\/p>\n\n\n\n

Small-Molecule Protection vs. Biologic Exclusivity<\/h3>\n\n\n\n

Small-molecule generics go through the Hatch-Waxman Act’s Abbreviated New Drug Application (ANDA) pathway. Biologics and their biosimilars go through the Biologics Price Competition and Innovation Act (BPCIA), which uses a separate information-exchange process sometimes called the patent dance, followed by the same kind of settlement negotiations seen in small-molecule Paragraph IV litigation. Both pathways converge on the same practical outcome for a PBM: a legally enforceable market entry date that is negotiated in private and only becomes public when a settlement, court filing, or company disclosure reveals it.<\/p>\n\n\n\n

How a Generic or Biosimilar Actually Clears the Patent Timeline<\/h2>\n\n\n\n

Under Section 505(j) of the Food, Drug, and Cosmetic Act, an ANDA applicant certifies against each Orange Book-listed patent. A Paragraph I or II certification allows immediate approval; Paragraph III means approval on the patent’s expiration date; Paragraph IV asserts the patent is invalid or will not be infringed [7]. Filing a Paragraph IV certification requires notifying the patent holder, and if the holder sues within 45 days, FDA approval is automatically stayed for 30 months unless a court rules sooner [7]. The first applicant to file a substantially complete Paragraph IV is eligible for 180 days of market exclusivity against other generic entrants, an incentive built to reward the risk of litigation [7].<\/p>\n\n\n\n

Why This Produces a Range, Not a Date<\/h3>\n\n\n\n

None of these mechanisms produce a single fixed generic-entry date at the time of ANDA filing. The 30-month stay can end early if a court rules for the generic, or extend if litigation runs long. A settlement can set an entry date years before or after the underlying patent’s stated expiration. Eliquis is the clearest example: FDA approved the first generic apixaban applications, from Mylan and Micro Labs, in December 2019, more than five years before any of the settled entry dates take effect [16]. A federal court upheld BMS and Pfizer’s composition-of-matter and formulation patents in August 2020, after which the companies stated publicly that settlements with other generic manufacturers meant entry could occur ‘after 2026 but before 2031’ [15]. A formulary policy that treats a 2019 approval as equivalent to market availability, or that assumes the earliest possible 2026 date over the contractually later ones, is working from the wrong end of that range.<\/p>\n\n\n\n

The FTC’s Orange Book Crackdown: The Timeline Isn’t Even Reliably Documented<\/h2>\n\n\n\n

Since September 2023, the FTC has run three escalating rounds of challenges against patents it says do not belong in the Orange Book at all. The first round, in November 2023, challenged more than 100 patents held by 10 companies [3]. The second, in April 2024, expanded the dispute to more than 300 listings across 20 branded products, including Novo Nordisk’s Ozempic, and targeted diabetes, weight-loss, asthma, and COPD drugs specifically [1]. The third, in May 2025, added warning letters disputing more than 200 additional patents [2].<\/p>\n\n\n\n

\n

‘By filing bogus patent listings, pharma companies block competition,’ FTC Chair Lina Khan said of the campaign [1].<\/p>\n<\/blockquote>\n\n\n\n

The FTC’s position, stated in its September 2023 policy statement and repeated in litigation, is that device patents which do not claim the drug itself do not meet the Orange Book’s statutory listing criteria [4][6]. That position has already been tested in court: in June 2024, a federal district judge ordered Teva to delist several asthma inhaler device patents after generic maker Amneal challenged their inclusion, and in December 2024 the Federal Circuit affirmed that ruling [6][2]. As of the FTC’s May 2025 announcement, its earlier challenges had already led to the delisting of patents across 22 different brand-name products [2].<\/p>\n\n\n\n

What This Means for a Substitution Policy<\/h3>\n\n\n\n

A patent listing that PBM formulary teams treat as a fixed barrier to generic entry may not survive a dispute already in progress. The 13 inhaler products and four epinephrine-injector products named in the FTC’s earliest enforcement wave are a useful reminder that Orange Book listings are contestable assertions, not verified facts, until a court or a delisting decision settles the question [4].<\/p>\n\n\n\n

Case Study: Humira and the 14-to-30-Month Formulary Lag<\/h2>\n\n\n\n

Humira’s most consequential US patents expired at the start of 2023 after AbbVie built a portfolio that, according to the company, extended meaningful exclusivity roughly 20 years beyond the drug’s 2002 approval [11]. Amgen’s Amjevita became the first adalimumab biosimilar to launch commercially, on January 31, 2023, with as many as ten biosimilar competitors expected to follow that year under prior settlement agreements [11][10].<\/p>\n\n\n\n

The patent timeline was public and settled well in advance. The formulary timeline was not. CVS Caremark removed brand Humira from its formulary and added Sandoz and its own Cordavis private-label biosimilars in April 2024, roughly 14 months after Amjevita’s launch [9]. Express Scripts and OptumRx kept brand Humira on formulary alongside select biosimilars considerably longer, and did not drop it until July 2025, roughly 30 months after the first biosimilar reached the market [9]. One year after launch, industry coverage noted that biosimilar uptake had been muted specifically because PBM and payer contracting, not patent status, was gating adoption [10].<\/p>\n\n\n\n

Why the Delay Happened<\/h3>\n\n\n\n

Each PBM aligned its Humira strategy with a private-label biosimilar tied to its own parent company: Cordavis for CVS Health’s Caremark, and Quallent for Cigna’s Express Scripts [8]. Formulary preference followed the timeline on which those private-label products, and their negotiated rebates, became available and competitively priced, not the calendar date on which Humira’s patents lapsed.<\/p>\n\n\n\n

Case Study: Stelara’s Settlement-Delayed Launch and CVS’s 2026 Holdout<\/h2>\n\n\n\n

Johnson & Johnson’s Stelara (ustekinumab) generated roughly 9.7 billion dollars in 2022 US sales and had two patents at the center of an infringement suit against Amgen, covering the ustekinumab compound and a method of treating ulcerative colitis [13]. The FDA approved Amgen’s Wezlana as the first interchangeable Stelara biosimilar on October 31, 2023 [12]. But under a May 2023 settlement, Amgen could not launch Wezlana commercially before January 1, 2025, regardless of FDA approval status, a gap of 14 months between regulatory clearance and legal market entry [12][13]. J&J reached similar settlement dates with other manufacturers: Alvotech and Teva no later than February 2025, and Formycon and Fresenius Kabi’s biosimilar by April 15, 2025 [14].<\/p>\n\n\n\n

Even after multiple biosimilars became legally available in 2025, CVS Caremark chose not to fully replicate its Humira strategy. For 2026, CVS kept brand Stelara on formulary at parity with two biosimilars, Pyzchiva and Yesintek, citing supply-chain instability and pending litigation risk, a notably different approach from the one it had taken toward Humira less than two years earlier [9].<\/p>\n\n\n\n

Case Study: Eliquis and the Moving Target of ‘Generic Entry Date’<\/h2>\n\n\n\n

Apixaban shows how much a settled entry date can still shift. The FDA approved the first generic apixaban applications in December 2019 [16]. BMS and Pfizer sued the applicants, and a Delaware court upheld the drug’s composition-of-matter and formulation patents in August 2020 [15]. At that point the companies said publicly that prior settlements with other generic manufacturers meant entry could occur ‘after 2026 but before 2031,’ while unsettled challengers would be blocked until 2031 pending appeal [15]. A later ruling against additional challengers, Sigmapharm, Sunshine Lake, and Unichem, reaffirmed that generic entry for those specific companies could not occur before 2031 absent a successful appeal [33 in source list below].<\/p>\n\n\n\n

Original Analysis: A Six-to-Eleven-Year Approval-to-Entry Gap<\/h3>\n\n\n\n

Measured from FDA’s December 2019 approval of the first ANDAs to the earliest company-projected entry point of 2026, apixaban’s approval-to-market gap runs at least six years, and for challengers bound by the later 2031 date, the gap runs eleven years or more. That is a calculated span based on the dates each party has confirmed publicly, not an independently reported figure, and it should not be read as a forecast of the exact 2026 date holding, since it remains subject to appeals the companies themselves flagged as a live variable [15].<\/p>\n\n\n\n

Why PBM Formulary Cycles Run on a Different Clock Than Patent Law<\/h2>\n\n\n\n

Formulary exclusion lists for the three largest PBMs are published on an annual cycle, effective each January, and reviewed by industry analysts as a recurring event: Pharmacy Healthcare Solutions LLC’s annual review found CVS Caremark added 33 new exclusions for January 2025 and 16 for January 2026, while Express Scripts added 19 exclusions for 2025 and a much larger 129 for 2026 [8][and PHSL 2026 review]. Mid-year changes happen, as CVS’s April 2024 Humira move shows, but the default rhythm of formulary revision is annual, not continuous.<\/p>\n\n\n\n

MAC Pricing Updates Every Seven Business Days vs. Formulary Reviews Once a Year<\/h3>\n\n\n\n

Pharmacy reimbursement for generics runs on an entirely different schedule. Several states, including Arizona, Washington, and Oregon, require PBMs to update Maximum Allowable Cost (MAC) lists at least every seven business days [19][20]. Industry testimony describes MAC pricing as reviewed continuously and typically updated on a weekly basis to reflect current market and product availability [22]. That means a PBM’s own generic pricing infrastructure is built to refresh roughly 50 times a year, while the clinical and formulary-tier decisions that determine whether a drug is preferred, and therefore whether substitution is encouraged at all, refresh once. MAC lists are also created and controlled unilaterally by the PBM, with limited transparency into the criteria used to add or price a given product [21].<\/p>\n\n\n\n

An Original Framework: Three Gaps, Not One<\/h2>\n\n\n\n

Public commentary tends to collapse ‘generic delay’ into a single concept. Based on the cases above, it is useful to separate three distinct and independently measurable gaps:<\/p>\n\n\n\n

    \n
  • The Legal Gap<\/strong> \u2014 the time between FDA or FDA-equivalent approval of a generic or biosimilar application and the date a settlement or court ruling actually permits commercial sale. Stelara’s Wezlana sat in this gap for 14 months; Eliquis’s first approved generics have sat in it for more than six years [12][16].<\/li>\n\n\n\n
  • The Formulary Gap<\/strong> \u2014 the time between a product’s first commercial launch and a specific PBM’s decision to prefer it over the brand. Humira’s formulary gap ran 14 months at CVS and roughly 30 months at Express Scripts and OptumRx [9].<\/li>\n\n\n\n
  • The Pricing Gap<\/strong> \u2014 the time between multiple generic sources becoming available and a MAC list reflecting a reimbursement rate consistent with that competition. State law caps this gap at seven business days where MAC update rules apply, making it the fastest-moving of the three, and the one most likely to be current when the other two are stale [19][20].<\/li>\n<\/ul>\n\n\n\n

    This is our own classification for organizing the evidence in this article, not an established Orange Book or CMS category, and it is offered as a framework for auditing a specific PBM contract rather than as a regulatory term of art.<\/p>\n\n\n\n

    What This Means for Generic and Biosimilar Manufacturers<\/h2>\n\n\n\n

    A settlement date is a floor for revenue planning, not a formulary guarantee. Amgen’s Amjevita had FDA approval and a clear legal launch date years in advance, yet meaningful CVS formulary preference did not arrive until 14 months after launch, and two of the three largest PBMs waited roughly 30 months [9][10]. Manufacturers modeling uptake against the legal entry date alone will overstate first-year and even second-year volume unless they also model each major PBM’s private-label affiliations, since those affiliations, not patent status, appear to have driven the actual formulary timing in both the Humira and Stelara cases [8][9].<\/p>\n\n\n\n

    What This Means for Brand Manufacturers and Payers<\/h2>\n\n\n\n

    CVS’s decision to hold brand Stelara at parity with biosimilars through 2026, citing supply-chain and litigation risk rather than patent status, shows that a settled legal entry date does not force a PBM’s hand [9]. Brand manufacturers with a durable relationship to a PBM’s private-label or supply strategy may retain formulary share well past the date generic economics alone would predict. Payers designing benefit plans around an assumed ‘generic go-live’ date should instead budget for the PBM’s specific historical formulary-gap behavior, since it has varied by more than a year across the three largest PBMs for the same molecule [9].<\/p>\n\n\n\n

    A Practical Framework for Auditing Your Own PBM’s Substitution Lag<\/h2>\n\n\n\n

    Applying the three-gap framework to a specific drug requires three separate data points, pulled from three separate sources: the FDA’s Paragraph IV certification list and Orange Book for the legal gap [7], the PBM’s own published formulary exclusion list, refreshed each January and after any announced mid-year change, for the formulary gap, and either the PBM’s MAC list (where available under state transparency law) or a patent and exclusivity tracking service such as DrugPatentWatch for underlying protection dates, for the pricing gap [17][18]. None of these three sources updates on the same schedule, which is precisely why treating any single one as the full picture produces a substitution policy that is out of date the moment a PBM makes its next annual formulary decision.<\/p>\n\n\n\n

    Methodology and Limitations<\/h2>\n\n\n\n

    This article draws on FDA guidance documents, FTC press releases and policy statements, federal court rulings and their appellate history, company and PBM public statements, and industry analyst reviews of published formulary exclusion lists, covering events from FDA’s 2019 approval of the first apixaban ANDAs through PBM formulary decisions announced for 2026. Calculated figures, such as the Humira and Stelara timing gaps and the Eliquis approval-to-entry span, are simple date-to-date calculations from publicly confirmed dates and are labeled as such rather than presented as independently reported statistics. Several details remain estimates rather than confirmed facts: the exact 2026-to-2031 window for Eliquis generic entry is the companies’ own stated expectation as of 2020 and 2022 court proceedings and remains subject to pending appeals; PBM MAC list contents are, in most states, confidential to network pharmacies and were not independently reviewed for this article beyond the state-law update-frequency requirements cited.<\/p>\n\n\n\n

    Key Takeaways<\/h2>\n\n\n\n
      \n
    • The first Humira biosimilar launched January 31, 2023; CVS Caremark did not drop brand Humira from formulary until April 2024, and Express Scripts and OptumRx waited until July 2025 [9].<\/li>\n\n\n\n
    • The FDA approved an interchangeable Stelara biosimilar on October 31, 2023, but a patent settlement blocked its commercial launch until January 1, 2025 [12].<\/li>\n\n\n\n
    • CVS Caremark chose to keep brand Stelara at parity with two biosimilars through 2026, citing supply-chain and litigation concerns rather than patent status [9].<\/li>\n\n\n\n
    • The FTC has disputed more than 500 Orange Book patent listings across three enforcement waves since November 2023, leading to delisting across 22 brand-name products as of May 2025 [1][2].<\/li>\n\n\n\n
    • FDA approved the first generic apixaban (Eliquis) applications in December 2019; settlement-based entry dates for various challengers span 2026 to 2031, a gap of six to eleven-plus years from approval [15][16].<\/li>\n\n\n\n
    • State MAC pricing laws require PBM pharmacy-reimbursement list updates as often as every seven business days, while PBM formulary tier decisions are typically revised once a year [19][20].<\/li>\n<\/ul>\n\n\n\n

      FAQ<\/h2>\n\n\n\n

      Does a drug’s patent expiration date mean a generic will be available that day?<\/strong>
      Not necessarily. Multiple patents of different types can cover one product, and a Paragraph IV settlement or court ruling can set an entry date earlier or later than any single patent’s stated expiration [7][15].<\/p>\n\n\n\n

      Why did CVS Caremark drop Humira before other major PBMs?<\/strong>
      CVS aligned its formulary with Cordavis, its own private-label biosimilar business, in April 2024, ahead of Express Scripts’ and OptumRx’s July 2025 moves tied to their own private-label arrangements [8][9].<\/p>\n\n\n\n

      What is the 180-day exclusivity period?<\/strong>
      It is a Hatch-Waxman incentive giving the first generic applicant to file a substantially complete Paragraph IV certification 180 days of exclusive generic marketing before other generic competitors can enter [7].<\/p>\n\n\n\n

      What is the 30-month stay?<\/strong>
      If a brand patent holder sues a Paragraph IV applicant within 45 days of notice, FDA cannot grant final ANDA approval for at least 30 months, unless a court rules sooner or the patent expires or is found invalid first [7].<\/p>\n\n\n\n

      Why is the FTC challenging Orange Book patent listings?<\/strong>
      The FTC’s September 2023 policy statement asserts that patents not meeting statutory listing criteria, particularly device patents that do not claim the drug itself, can improperly delay generic competition, and the agency has disputed patents across diabetes, weight-loss, asthma, COPD, and epinephrine-injector products since [1][4].<\/p>\n\n\n\n

      Has a court agreed that any Orange Book listings were improper?<\/strong>
      Yes. A federal district court ordered Teva to delist several asthma-inhaler device patents in June 2024, and the Federal Circuit affirmed that ruling in December 2024 [6][2].<\/p>\n\n\n\n

      When will generic Eliquis actually be available in the US?<\/strong>
      Per BMS and Pfizer’s own 2020 statement following patent litigation, settled entry dates fall between 2026 and 2031 depending on the specific generic manufacturer, with later dates for challengers whose infringement was upheld and who have not separately settled [15]. This remains subject to any further appeal.<\/p>\n\n\n\n

      Why did CVS treat Stelara differently from Humira?<\/strong>
      CVS cited concerns about supply-chain instability and the possibility that ongoing litigation could trigger shortages, and chose parity pricing between brand Stelara and two biosimilars for 2026 rather than a full formulary switch [9].<\/p>\n\n\n\n

      How often are PBM MAC pricing lists updated?<\/strong>
      In states with MAC transparency laws, such as Arizona, Washington, and Oregon, PBMs must update pricing and drug information on MAC lists at least every seven business days [19][20].<\/p>\n\n\n\n

      What should a PBM or health plan actually track instead of patent expiration alone?<\/strong>
      Three separate dates: the legal entry date confirmed by settlement or court ruling, the specific PBM’s historical formulary-review cadence for that drug class, and the MAC or reimbursement list’s own update schedule, since each moves independently [7][9][19].<\/p>\n\n\n\n

      References<\/h2>\n\n\n\n
        \n
      1. Federal Trade Commission. (2024, April 30). FTC Expands Patent Listing Challenges, Targeting More Than 300 Junk Listings for Diabetes, Weight Loss, Asthma and COPD Drugs<\/em>. https:\/\/www.ftc.gov\/news-events\/news\/press-releases\/2024\/04\/ftc-expands-patent-listing-challenges-targeting-more-300-junk-listings-diabetes-weight-loss-asthma<\/li>\n\n\n\n
      2. Federal Trade Commission. (2025, May 21). FTC Renews Challenge of More Than 200 Improper Patent Listings<\/em>. https:\/\/www.ftc.gov\/news-events\/news\/press-releases\/2025\/05\/ftc-renews-challenge-more-200-improper-patent-listings<\/li>\n\n\n\n
      3. O’Neill Institute for National and Global Health Law, Georgetown University. (2025). Recent Developments in Orange Book Litigation: How Patent Disputes Shape Prescription Drug Affordability<\/em>. https:\/\/oneill.law.georgetown.edu\/recent-developments-in-orange-book-litigation-how-patent-disputes-shape-prescription-drug-affordability\/<\/li>\n\n\n\n
      4. Mayer Brown. (2024, May). US FTC Continues Aggressive Scrutiny of Pharmaceutical Patents Listed in the Orange Book<\/em>. https:\/\/www.mayerbrown.com\/en\/insights\/publications\/2024\/05\/us-ftc-continues-aggressive-scrutiny-of-pharmaceutical-patents-listed-in-the-orange-book<\/li>\n\n\n\n
      5. Fish & Richardson. (2025). Recent Decisions and FTC Challenges Dictate Caution When Listing Patents in the Orange Book<\/em>. https:\/\/www.fr.com\/insights\/thought-leadership\/blogs\/recent-decisions-and-ftc-challenges-dictate-caution-when-listing-patents-in-the-orange-book\/<\/li>\n\n\n\n
      6. Washington Legal Foundation. (2024, August). The Current Status of FTC’s Orange Book Listings Challenge: A Mixed Bag<\/em>. https:\/\/www.wlf.org\/2024\/08\/05\/publishing\/the-current-status-of-ftcs-orange-book-listings-challenge-a-mixed-bag\/<\/li>\n\n\n\n
      7. U.S. Food and Drug Administration. Small Business Assistance: 180-Day Generic Drug Exclusivity<\/em>. https:\/\/www.fda.gov\/drugs\/cder-small-business-and-industry-assistance\/small-business-assistance-180-day-generic-drug-exclusivity<\/li>\n\n\n\n
      8. Fein, A. (2025, January). The Big Three PBMs’ 2025 Formulary Exclusions: Humira, Stelara, Private Labels, and the Shaky Future for Pharmacy Biosimilars<\/em>. Drug Channels. https:\/\/www.drugchannels.net\/2025\/01\/the-big-three-pbms-2025-formulary.html<\/li>\n\n\n\n
      9. Pharmacy Strategies Group (PSG). (2025, December). 2026 Formulary Changes: CVS Caremark<\/em>. https:\/\/www.psgconsults.com\/blog\/2026-formulary-changes-cvs-caremark\/<\/li>\n\n\n\n
      10. Healthcare Brew. (2024, January 29). After a year on the market, Humira biosimilars aren’t making much of a dent<\/em>. https:\/\/www.healthcare-brew.com\/stories\/2024\/01\/29\/after-a-year-on-the-market-humira-biosimilars-aren-t-making-much-of-a-dent<\/li>\n\n\n\n
      11. Health Advances. (2023, February 22). The Humira Biosimilars Have Arrived! Will They Make a Difference?<\/em> https:\/\/www.healthadvances.com\/insights\/blog\/the-humira-biosimilars-have-arrived-will-they-make-a-difference<\/li>\n\n\n\n
      12. ProAct. (2023). FDA Approves First Stelara Biosimilar<\/em>. https:\/\/secure.proactrx.com\/resource\/news\/fda-approved-first-stelara-biosimilar<\/li>\n\n\n\n
      13. BioSpace (via Pharmalive). (2023, May 24). Amgen, J&J settle patent dispute over Stelara biosimilar<\/em>. https:\/\/www.pharmalive.com\/amgen-jj-settle-patent-dispute-over-stelara-biosimilar\/<\/li>\n\n\n\n
      14. Pharmaceutical Technology. (2023, November 1). Amgen scores FDA approval for Stelara biosimilar<\/em>. https:\/\/www.pharmaceutical-technology.com\/newsletters\/amgen-scores-fda-approval-for-stelara-biosimilar<\/li>\n\n\n\n
      15. Pfizer. (2020, August 5). The Bristol-Myers Squibb-Pfizer Alliance is Pleased with the U.S. District Court Decision to Uphold Both the Composition of Matter (COM) Patent and Formulation Patent Covering Eliquis<\/em>. https:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/bristol-myers-squibb-pfizer-alliance-pleased-us-district<\/li>\n\n\n\n
      16. BioPharma Dive. (2020, August). Bristol Myers, Pfizer fend off a key challenge to their top-selling heart drug<\/em>. https:\/\/www.biopharmadive.com\/news\/bristol-myers-pfizer-eliquis-patent-court-ruling\/583027\/<\/li>\n\n\n\n
      17. DrugPatentWatch. When will the patents on ELIQUIS expire, and when will ELIQUIS go generic?<\/em> https:\/\/www.drugpatentwatch.com\/p\/tradename\/ELIQUIS<\/li>\n\n\n\n
      18. DrugPatentWatch. When will the HUMIRA patents expire, and when will biosimilar HUMIRA launch?<\/em> https:\/\/www.drugpatentwatch.com\/p\/biologics\/tradename\/HUMIRA<\/li>\n\n\n\n
      19. Coalition for Affordable Prescription Drugs (CoAPharmacy). Maximum Allowable Cost Law \u2013 Arizona<\/em>. https:\/\/coapharmacy.com\/?p=42287<\/li>\n\n\n\n
      20. Coalition for Affordable Prescription Drugs (CoAPharmacy). Maximum Allowable Cost Law \u2013 Washington<\/em>. https:\/\/coapharmacy.com\/?p=42332<\/li>\n\n\n\n
      21. Frier Levitt. Michigan House Introduces Pharmacy Benefit Manager (PBM) Law Regulating PBM MAC Pricing<\/em>. https:\/\/www.frierlevitt.com\/?p=22007<\/li>\n\n\n\n
      22. Larrabee, S., CVS Health. (2024, February 14). Testimony and Proposed Language on Pharmacy Reimbursements<\/em>, submitted to the Vermont House Health Care Committee re: H.233. https:\/\/legislature.vermont.gov\/Documents\/2024\/WorkGroups\/House%20Health%20Care\/Bills\/H.233\/Witness%20Testimony\/H.233~Steven%20Larrabee~CVS%20Health%20-%20Testimony%20and%20Proposed%20Language%20on%20Pharmacy%20Reimbursements~2-14-2024.pdf<\/li>\n\n\n\n
      23. BioSpace. (2022). With Court Win, BMS and Pfizer Stave Off Eliquis Generic Challengers \u2013 For Now<\/em>. https:\/\/www.biospace.com\/with-court-win-bms-and-pfizer-stave-off-generic-challengers-to-eliquis-for-now<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

        The Short Answer Six months is the optimistic case. When Amgen launched the first Humira biosimilar on January 31, 2023, […]<\/p>\n","protected":false},"author":1,"featured_media":39669,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_lmt_disableupdate":"","_lmt_disable":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[10],"tags":[],"class_list":["post-39668","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-insights"],"modified_by":"DrugPatentWatch","_links":{"self":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39668","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/comments?post=39668"}],"version-history":[{"count":1,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39668\/revisions"}],"predecessor-version":[{"id":39670,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39668\/revisions\/39670"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media\/39669"}],"wp:attachment":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media?parent=39668"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/categories?post=39668"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/tags?post=39668"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}