{"id":39499,"date":"2026-08-27T09:27:00","date_gmt":"2026-08-27T13:27:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=39499"},"modified":"2026-08-21T08:42:40","modified_gmt":"2026-08-21T12:42:40","slug":"the-blockbusters-real-patent-is-the-weak-one-nobody-challenged","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/the-blockbusters-real-patent-is-the-weak-one-nobody-challenged\/","title":{"rendered":"The Blockbuster’s Real Patent Is the Weak One Nobody Challenged"},"content":{"rendered":"\n
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GSK’s Advair lost its core patent in 2010. Fourteen years later the inhaler was still bringing in \u00a3863 million \u2014 about $1.1 billion \u2014 in nine months alone, and the patent doing the protecting wasn’t a drug-substance claim at all. It was a narrow mechanical patent on the inhaler’s “actuation indicator,” a part that has nothing to do with fluticasone or salmeterol, the two molecules that actually treat asthma.[1]<\/sup> No generic company ever took that patent to trial. It fell only after a federal regulator wrote a letter.<\/p>\n\n\n\n

That pattern \u2014 a drug’s real commercial shield turning out to be a patent nobody rates highly enough to bother suing over \u2014 is not an Advair quirk. It is the default condition of dozens of Orange Book entries right now, and it explains why some of the best-selling drugs in America are still priced like they’re under patent long after the patent everyone assumes is doing the work has expired.<\/p>\n\n\n\n

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

Since November 2023, the Federal Trade Commission has disputed more than 400 Orange Book patent listings across three rounds of warning letters, targeting device and delivery-mechanism patents on drugs including Advair, EpiPen, Symbicort, Restasis, Spiriva, and Ozempic.[2][3][4]<\/sup> Patent lawyers, including litigators with two decades of Hatch-Waxman experience, say they have essentially never litigated a device patent because it has rarely been worth the cost.[5]<\/sup> When the FDA checked in on compliance in July 2025, nine of the ten most recently challenged listings were unchanged \u2014 companies had simply recertified that their patents were fine.[6]<\/sup> The one time a device patent actually went to trial, in Teva v. Amneal<\/em>, the brand company lost outright, and the Federal Circuit set a bright-line rule that should have gutted dozens of similar listings.[7][8]<\/sup> Most of those listings are still standing anyway, because a court ruling that applies in theory still has to be enforced patent by patent, drug by drug, and almost nobody has bothered.<\/p>\n\n\n\n

Device Patents vs. Drug-Substance Patents: Why the Distinction Matters<\/strong><\/h2>\n\n\n\n

The Orange Book is supposed to list three kinds of patents: drug-substance (the active ingredient), drug-product (the formulation), and method-of-use patents.[9]<\/sup> A patent on the mechanical parts of an inhaler, an injector pen, or a dropper bottle is not supposed to qualify unless it also recites the active ingredient. The FTC’s September 2023 policy statement said as much directly, warning that patents claiming “neither the reference listed drug nor a method of using it”<\/em> should not appear in the Orange Book at all.[9]<\/sup><\/p>\n\n\n\n

That distinction is the whole ballgame. A drug-substance patent on a genuinely novel molecule tends to be defensible \u2014 it survives litigation because there’s a real invention behind it. A dose-counter patent, an actuation-indicator patent, a bottle-tip patent has none of that depth. Patent attorneys describe these listings as the industry’s open secret: weak on the merits, but functionally strong, because a weak patent that nobody sues over blocks generic entry exactly as effectively as a strong one.<\/p>\n\n\n\n

The 30-Month Stay Is the Real Weapon<\/strong><\/h3>\n\n\n\n

Here is why a patent’s legal strength barely matters in practice. Under Hatch-Waxman, when a generic company files an Abbreviated New Drug Application with a Paragraph IV certification against a listed patent, the brand company can sue for infringement \u2014 and simply filing that suit triggers an automatic 30-month stay of FDA approval, regardless of how the litigation eventually turns out.[10]<\/sup> The stay fires the moment the patent is listed and asserted. Nobody has to prove the patent is valid first. That is what turns a legally fragile device patent into a real commercial asset: it doesn’t need to win in court to do its job. It only needs to exist on the list long enough to force a 30-month clock.<\/p>\n\n\n\n

Three Rounds, Four Hundred Patents: The FTC’s Orange Book Campaign<\/strong><\/h2>\n\n\n\n

The clearest evidence that “weak” and “unchallenged” are two different things comes from the FTC’s own multi-year campaign to dispute these listings administratively \u2014 a campaign that is not litigation, has no binding legal force, and has mostly failed to move brand manufacturers.<\/p>\n\n\n\n

Round<\/th>Date<\/th>Companies<\/th>Patents\/Listings Disputed<\/th>Products Named<\/th><\/tr>
1<\/td>Nov. 7, 2023<\/td>10 (incl. AbbVie, AstraZeneca, Boehringer Ingelheim, GSK, Kaleo, Mylan Specialty, Teva subsidiaries)<\/td>69 unique patents \/ 110+ listings<\/td>18 products, incl. Advair, EpiPen, Restasis, Symbicort, Spiriva[2][11]<\/sup><\/td><\/tr>
2<\/td>Apr. 30, 2024<\/td>10 (incl. Novo Nordisk, AstraZeneca, Boehringer Ingelheim, GSK, Teva, Novartis, Amphastar, Covis Pharma)<\/td>300+ listings<\/td>20 products, incl. Ozempic, Saxenda, Victoza, Bydureon[3][12]<\/sup><\/td><\/tr>
3<\/td>May 21, 2025<\/td>5\u20137 (incl. Novartis, Amphastar, Mylan Specialty, Covis Pharma, three Teva entities)<\/td>200+ listings<\/td>17 products, incl. EpiPen (again), ProAir, Tudorza Pressair, AirDuo[4][13]<\/sup><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Round One: The Products Everyone Already Knew<\/strong><\/h3>\n\n\n\n

The first letters, sent November 7, 2023, targeted 13 inhaler products and four epinephrine auto-injector products, plus AbbVie’s Restasis multidose eye-drop bottle.[11]<\/sup> The individual counts were granular: AbbVie for four listings covering Restasis Multidose, AstraZeneca for ten covering Symbicort, Boehringer Ingelheim for 22 across four products, GSK entities for 14 across Advair, Flovent, Arnuity, and Ventolin, Mylan Specialty for eight covering EpiPen and EpiPen Jr., and Teva Branded Pharmaceutical for 35 covering ProAir HFA, ProAir DigiHaler, and QVAR.[14]<\/sup><\/p>\n\n\n\n

Round Two: The Money Drugs<\/strong><\/h3>\n\n\n\n

Five months later the FTC widened the net to injectable diabetes and weight-loss drugs, disputing 17 device patents tied to Ozempic, Saxenda, and Victoza in a single letter to Novo Nordisk.[15][16]<\/sup> The timing put one of the best-selling drug franchises in history \u2014 Ozempic alone generated roughly $14 billion in global sales in 2023 \u2014 inside a dispute over patents that, by the agency’s own account, largely cover the mechanical parts of the injector pen rather than semaglutide itself.[17][16]<\/sup><\/p>\n\n\n\n

Round Three: The Ones That Didn’t Move<\/strong><\/h3>\n\n\n\n

By May 2025, under new leadership at the agency, the FTC went back to many of the same targets. Mylan Specialty was named again for EpiPen and EpiPen Jr. \u2014 the exact product it had been warned about eighteen months earlier.[13]<\/sup> Covis Pharma, Novartis, and Amphastar joined the list alongside three separate Teva entities covering ProAir HFA, ProAir DigiHaler, AirDuo Respiclick, and related products.[13]<\/sup> When the FDA’s Patent Listing Disputes page was updated two months later, in July 2025, only one of the ten targeted NDAs had actually changed. Nine had not moved at all.[6]<\/sup><\/p>\n\n\n\n

\n

Of the ten New Drug Applications named in the FTC’s May 2025 warning letters, nine showed no change to their Orange Book listings when the FDA updated its public dispute log in July 2025 \u2014 the same outcome as the agency’s April 2024 round, when none of the ten companies targeted delisted a single patent within the response window.[6][18]<\/sup><\/p>\n<\/blockquote>\n\n\n\n

The Five Findings That Matter<\/strong><\/h2>\n\n\n\n
    \n
  • Advair’s compound patent expired in 2010, yet the drug earned GSK roughly $1.1 billion in the first nine months of 2023 \u2014 protected by a device patent on the inhaler’s actuation indicator rather than by fluticasone or salmeterol.[1]<\/sup><\/li>\n\n\n\n
  • Across three FTC rounds since November 2023, more than 400 Orange Book patent listings have been formally disputed as improper, covering at least 55 branded products.[2][3][4]<\/sup><\/li>\n\n\n\n
  • In the most recent compliance check, 90% of targeted listings (nine of ten NDAs) remained unchanged two months after the FTC’s May 2025 warning letters.[6]<\/sup><\/li>\n\n\n\n
  • The only device-patent dispute to reach a full judicial decision \u2014 Teva v. Amneal<\/em> \u2014 ended in a unanimous loss for the patent holder, with the Federal Circuit ruling that a patent must claim the active ingredient itself to belong in the Orange Book at all.[7]<\/sup><\/li>\n\n\n\n
  • A litigator with more than 20 years of Hatch-Waxman experience has stated she has never personally litigated a device patent, underscoring how rarely generic challengers use the courtroom route the FTC’s letters are meant to substitute for.[5]<\/sup><\/li>\n<\/ul>\n\n\n\n

    Case Study: GSK’s Advair and the Patent That Outlived the Drug<\/strong><\/h2>\n\n\n\n

    Advair’s story is the cleanest illustration of the thesis. The compound patent \u2014 the one covering the actual medicines in the inhaler \u2014 expired in 2010.[1]<\/sup> Former GSK chief executive Andrew Witty predicted at the time that the drug would keep a long revenue tail anyway, specifically because of the device intellectual property surrounding it, not the drug itself.[1]<\/sup> He was right for thirteen years: Advair posted \u00a3863 million (about $1.1 billion) in revenue in just the first three quarters of 2023.[1]<\/sup><\/p>\n\n\n\n

    The patent doing that work was never tested in court. When the FTC’s November 2023 letter identified the “actuation indicator” patent \u2014 along with related listings on Flovent, Arnuity, and Ventolin \u2014 as improperly claiming a device component rather than the drug, GSK did not fight. By December 2023, it had removed four patents covering those four products from the Orange Book, citing changes in regulatory policy and case law.[19][20]<\/sup> No judge ruled the patent invalid. No generic manufacturer spent money proving it in court. GSK simply concluded, once a federal agency put it in writing, that the fight wasn’t worth having \u2014 which is itself a data point about how weak the company believed the patent to be.<\/p>\n\n\n\n

    Case Study: AstraZeneca’s Symbicort \u2014 the One That Didn’t Fold<\/strong><\/h2>\n\n\n\n

    Not every company reacted like GSK. AstraZeneca received its own 314.53(f) Patent Listing Dispute letter on November 16, 2023, identifying five Symbicort patents \u2014 including U.S. Patent No. 7,587,988 \u2014 as improperly or inaccurately listed.[21]<\/sup> Rather than withdrawing them, AstraZeneca sent a response to the FDA on December 14, 2023, formally confirming that it believed the five patents were correctly listed.[21]<\/sup> Symbicort, an asthma and COPD inhaler combining budesonide and formoterol, generated roughly $2.5 billion in sales in the year before the dispute.[22]<\/sup> As of the most recent public reporting reviewed for this piece \u2014 March 2025 \u2014 AstraZeneca was still listed among the companies that had not delisted the patents the FTC first challenged in November 2023.[23]<\/sup><\/p>\n\n\n\n

    That is a patent the FTC calls improperly listed, that the manufacturer has never taken to trial to defend, and that has now outlasted three separate rounds of federal scrutiny while still appearing in the Orange Book. Nobody has proven it invalid. Nobody has proven it valid, either. It simply sits there, doing its job.<\/p>\n\n\n\n

    Case Study: EpiPen \u2014 Three Rounds, Same Product, Still Listed<\/strong><\/h2>\n\n\n\n

    No product illustrates institutional persistence better than EpiPen. Mylan Specialty (later folded into Viatris) was named in the FTC’s very first round of letters in November 2023, over eight listings covering four unique patents on the EpiPen and EpiPen Jr. autoinjector devices.[24][11]<\/sup> EpiPen generated $378 million in revenue in 2022, a fraction of its peak but still a meaningful franchise for a product whose active ingredient \u2014 epinephrine \u2014 has been off-patent for decades.[22]<\/sup><\/p>\n\n\n\n

    Mylan Specialty did not delist. As of March 2025, it remained on the list of companies that had rebuffed the FTC’s original warning letter.[23]<\/sup> Then, in the FTC’s third round on May 21, 2025, Mylan Specialty was named again \u2014 for the same two products, EpiPen and EpiPen Jr. \u2014 eighteen months after the first warning.[13]<\/sup> No generic challenger has taken the specific EpiPen device patents to a Hatch-Waxman trial the way Amneal did with Teva’s inhaler patents. The listings remain in place not because anyone has found them defensible, but because nobody with standing to sue has spent the money to find out.<\/p>\n\n\n\n

    Case Study: AbbVie’s Restasis Multidose Bottle<\/strong><\/h2>\n\n\n\n

    AbbVie’s Restasis, a cyclosporine ophthalmic emulsion for chronic dry eye, has already been through one of the more unusual patent fights in pharmaceutical history \u2014 the 2017 attempt by Allergan (later acquired by AbbVie) to shield its Restasis compound patents from inter partes review by assigning them to the Saint Regis Mohawk Tribe, a maneuver the Federal Circuit rejected in 2018. The four patents the FTC challenged in November 2023 are a separate estate entirely: patents covering the Restasis Multidose bottle, the dropper mechanism rather than the cyclosporine formulation itself.[24][11]<\/sup> As of March 2025, AbbVie had not delisted them.[23]<\/sup> Like the AstraZeneca and Mylan Specialty listings, they remain administratively disputed and judicially untested \u2014 a second, independent example of a formulation-adjacent company choosing to sit on a challenged listing rather than either defend it in court or give it up.<\/p>\n\n\n\n

    Case Study: Novo Nordisk’s Ozempic, Saxenda, and Victoza Pens<\/strong><\/h2>\n\n\n\n

    Novo Nordisk’s semaglutide compound patent \u2014 U.S. Patent No. 8,431,582 \u2014 carries a patent term extension that pushes its expiration to April 20, 2031.[25]<\/sup> That is a real, substantive patent covering the active molecule, and it has already survived a 2023 inter partes review petition from Mylan without being invalidated.[26]<\/sup> The 17 patents the FTC disputed in April 2024 are a different animal: device patents on the FlexTouch and related injector pens used to deliver Ozempic, Saxenda, and Victoza, most of which do not appear to require semaglutide or liraglutide in their claims at all.[15][27]<\/sup><\/p>\n\n\n\n

    Unlike AstraZeneca or Mylan Specialty, Novo Nordisk eventually folded. By early 2025 \u2014 roughly a year after the April 2024 letter, and after the Federal Circuit’s ProAir ruling had made clear how such patents would fare in court \u2014 Novo Nordisk requested delisting of the challenged device patents covering Ozempic, Victoza, and Saxenda.[23]<\/sup> Company disclosures describe semaglutide’s remaining protection window running toward 2031 in the U.S. via the compound patent, though some market commentary has cited 2032 as the effective cutoff \u2014 a discrepancy that is itself a reminder that “patent cliff” dates are estimates until a settlement or ruling fixes them, not settled facts.[28][25]<\/sup> Either way, the device patents that briefly sat alongside the compound patent were never the strong part of the estate, and the record suggests Novo Nordisk knew it: it gave them up without a fight once the legal weather turned, rather than defending them the way AstraZeneca defended Symbicort’s.<\/p>\n\n\n\n

    What Happens When Somebody Actually Sues: Teva v. Amneal<\/em><\/strong><\/h2>\n\n\n\n

    The exception that proves the pattern is Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC<\/em> \u2014 the one case in this entire saga where a generic challenger actually put a device patent’s Orange Book listing in front of a judge rather than waiting for a regulator’s letter to do the work.<\/p>\n\n\n\n

    Nine Patents, Then Five<\/strong><\/h3>\n\n\n\n

    Teva’s ProAir HFA, an albuterol sulfate inhaler approved under NDA No. 021457 in October 2004, had nine unexpired patents listed in the Orange Book.[29]<\/sup> After Amneal filed an Abbreviated New Drug Application with a Paragraph IV certification against all nine in August 2023, Teva sued for infringement \u2014 then narrowed its claims to five: U.S. Patent Nos. 8,132,712, 9,463,289, 9,808,587, 10,561,808, and 11,395,889, covering the inhaler’s dose counter and canister.[29][30]<\/sup> None of the five claimed albuterol sulfate.[30][31]<\/sup><\/p>\n\n\n\n

    The District Court Ruling<\/strong><\/h3>\n\n\n\n

    Amneal counterclaimed for delisting. On June 10, 2024, District Judge Stanley Chesler of the District of New Jersey granted Amneal’s motion for judgment on the pleadings, ordering Teva to delist all five patents because they did not claim the active ingredient the applicant had submitted for approval.[32]<\/sup> The FTC had already filed an amicus brief in March 2024 backing Amneal’s position.[33]<\/sup><\/p>\n\n\n\n

    The Federal Circuit’s Bright-Line Rule<\/strong><\/h3>\n\n\n\n

    Teva appealed and won a temporary stay, but on December 20, 2024, the Federal Circuit affirmed Chesler’s order in full.[7][34]<\/sup> The court’s holding was unambiguous: to be listed in the Orange Book, a patent must claim the drug for which the application was approved, and to claim that drug, it must claim at least the active ingredient.[34][35]<\/sup> Patents covering only device components \u2014 a dose counter, a canister \u2014 do not qualify, no matter how central those components are to how the product actually works.[34]<\/sup> Teva sought en banc rehearing; the full Federal Circuit declined to take the case, leaving the panel’s ruling as the governing law.[36]<\/sup><\/p>\n\n\n\n

    Notably, Teva had already stopped manufacturing branded ProAir HFA in October 2022, continuing to sell only an authorized generic version.[37]<\/sup> It fought a two-year legal battle, through a district court and an appeal, to defend patents on a product it had already effectively exited commercially \u2014 a sign of how much residual value even a “weak” device patent can represent once it is the only thing standing between a company and generic price competition on an adjacent authorized-generic revenue stream.<\/p>\n\n\n\n

    The Precedent Trilogy: Lantus, Avadel, and ProAir<\/strong><\/h2>\n\n\n\n

    The ProAir ruling did not emerge from nowhere. It joined two earlier appellate decisions that had already put brand manufacturers on notice that device- and system-adjacent patents face real delisting risk if anyone bothers to litigate them. In In re Lantus Direct Purchaser Antitrust Litigation<\/em>, the First Circuit held in 2020 that a patent on Sanofi’s SoloSTAR injector pen device should not have been listed in the Orange Book for the insulin product Lantus.[38]<\/sup> In Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC<\/em>, the Federal Circuit ruled in February 2023 that a patent covering the computerized risk evaluation and mitigation strategy (REMS) system for Xyrem \u2014 not the drug itself \u2014 likewise did not belong in the Orange Book.[38][39]<\/sup> Three different appellate circuits, three different device- or system-adjacent patent types, one consistent outcome: when a challenger actually sues, these patents tend to lose. The gap between that legal reality and the hundreds of similar listings still sitting unchallenged in the Orange Book is the entire subject of this piece.<\/p>\n\n\n\n

    What the Critics Get Right<\/strong><\/h2>\n\n\n\n

    It would be a mistake to treat every disputed device patent as obviously worthless. Critics of the FTC’s campaign make a point worth taking seriously: for drug-device combination products, the device is not incidental. An inhaler’s particle size determines how deep medication travels into the lungs; an autoinjector’s needle mechanism determines whether a panicking patient in anaphylactic shock actually receives a dose. Even after Teva secured permission to sell a generic EpiPen, the company reportedly needed multiple attempts and roughly two years to get FDA approval, illustrating how hard these devices are to replicate even without patent obstacles.[40]<\/sup> Some commentary on the FTC’s third round of letters has also pointed out that the agency’s warning letters contain no finding that any specific challenged listing has actually deterred, delayed, or blocked a generic entrant \u2014 the letters allege improper listing, not proven competitive harm.[41]<\/sup> Those are legitimate limits on how far this analysis should be read. A patent can be a poor fit for Orange Book listing under the statute’s narrow “claims the active ingredient” test and still cover genuine, safety-relevant engineering.<\/p>\n\n\n\n

    Why Nobody Challenges a Patent Everyone Calls Weak<\/strong><\/h2>\n\n\n\n

    The economics explain the gap better than the law does. A Paragraph IV challenge against an Orange Book patent is expensive \u2014 millions of dollars in litigation costs before a generic company sees a dollar of revenue. A generic manufacturer choosing where to spend that money will target the patent standing between it and the largest addressable market, which is usually the drug-substance patent, not a secondary device claim that a court is likely to find irrelevant to infringement anyway if the generic simply uses a different delivery mechanism. Litigating a device patent to delist it only pays off if the challenger specifically needs to use the same device architecture \u2014 as Amneal did, because building an equivalent metered-dose inhaler from scratch is itself a regulatory and engineering project. For everyone else, designing around a weak device patent is cheaper than proving it invalid, which means the patent survives not on its merits but because contesting it was never anybody’s most profitable move.<\/p>\n\n\n\n

    An Original Taxonomy: Four Ways a Weak Patent Meets Its End<\/strong><\/h2>\n\n\n\n

    Reviewing how each disputed listing in this dataset was ultimately resolved \u2014 or wasn’t \u2014 surfaces four distinct outcomes, useful as a framework for tracking any future Orange Book dispute.<\/p>\n\n\n\n

    Category<\/th>Definition<\/th>Example<\/th><\/tr>
    Untested-and-standing<\/strong><\/td>FTC-disputed, never litigated by any actual generic challenger, still listed as of the most recent public record<\/td>AstraZeneca’s Symbicort patents; Mylan Specialty’s EpiPen patents; AbbVie’s Restasis Multidose patents[21][23][13]<\/sup><\/td><\/tr>
    Administratively conceded<\/strong><\/td>Withdrawn voluntarily after a regulatory letter alone, with no court ever ruling on validity<\/td>GSK’s original Advair, Flovent, Arnuity, and Ventolin delistings[19][20]<\/sup><\/td><\/tr>
    Precedent-conceded<\/strong><\/td>Withdrawn only after a similar patent lost in court elsewhere \u2014 the company waited to see the legal weather before folding<\/td>Novo Nordisk’s 2025 Ozempic, Saxenda, and Victoza device-patent delistings, requested after the ProAir ruling[23]<\/sup><\/td><\/tr>
    Judicially tested<\/strong><\/td>Actually litigated to a binding ruling on Orange Book listability<\/td>Teva’s five ProAir HFA patents; Sanofi’s Lantus SoloSTAR patent; Jazz’s Xyrem REMS patent[34][38]<\/sup><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Of these four categories, only the last one produces a legally settled answer about whether the patent actually deserved its place in the Orange Book. The other three all leave the question open \u2014 which, for a brand manufacturer weighing whether to keep listing a marginal patent, is precisely the point.<\/p>\n\n\n\n

    Original Analysis: The Compliance Rate Behind the Headlines<\/strong><\/h2>\n\n\n\n

    Pulling the response data from all three FTC rounds together shows a pattern that gets lost in any single round’s press coverage: compliance was front-loaded, voluntary, and largely limited to products the manufacturer had less riding on.<\/p>\n\n\n\n

      \n
    • Round 1 compliance (Nov. 2023):<\/strong> 4 of the 10 letter recipients \u2014 GSK’s two entities, Kaleo, and Impax Laboratories \u2014 delisted patents within roughly six weeks.[3][20]<\/sup> That is a 40% company-level compliance rate, achieved entirely without litigation.<\/li>\n\n\n\n
    • Round 2 compliance (Apr. 2024):<\/strong> None of the 10 companies delisted a single patent in the immediate response window; every recipient instead recertified its listings as accurate.[42]<\/sup> That is a 0% immediate compliance rate.<\/li>\n\n\n\n
    • Round 3 compliance (May 2025, checked July 2025):<\/strong> 1 of 10 targeted NDAs changed. 9 did not.[6]<\/sup> A 10% compliance rate roughly two months after the letters went out.<\/li>\n<\/ul>\n\n\n\n

      Read together, the trend line is not one of accelerating deterrence \u2014 if anything, it runs the other way. The manufacturers most willing to fold were the ones facing the smallest first wave, before the pattern of “certify and wait” had been established by peers. By the third round, the strategy of simply recertifying and waiting for a court, rather than a letter, to force the issue, had become the default. This is calculated analysis by DrugChatter based on the compliance figures reported across the cited FTC press releases and law-firm trackers; it is not an official FTC metric.<\/p>\n\n\n\n

      What This Means for Generic Challengers<\/strong><\/h2>\n\n\n\n

      The lesson from Teva v. Amneal<\/em> is not “device patents are always weak” \u2014 it’s “device patents are weak specifically against a challenger who needs to use the same device architecture and is willing to litigate.” A generic company evaluating an Orange Book entry should treat every FTC-disputed device patent as a candidate for a delisting counterclaim rather than a barrier to design around by default, particularly now that three separate appellate courts have set precedent in the challenger’s favor. The Federal Circuit’s bright-line “must claim the active ingredient” test gives any Paragraph IV filer a template that did not exist before December 2024.[34]<\/sup> Firms tracking Orange Book patent-family composition \u2014 including through DrugPatentWatch’s patent and exclusivity data \u2014 can flag device-only claims for early legal review rather than treating every listed patent as equally load-bearing.<\/p>\n\n\n\n

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

      For originator companies, the AstraZeneca and Mylan Specialty pattern \u2014 recertify, hold, and wait to see whether anyone actually sues \u2014 has so far outperformed the GSK pattern of early voluntary delisting, at least in terms of preserving nominal patent-life protection. But Teva v. Amneal<\/em> raises the cost of that bet materially: a manufacturer that recertifies a device-only listing and is later sued by a generic willing to litigate risks not just losing that patent, but doing so via a published appellate decision that other challengers can cite against every other device patent in the portfolio. The safer long-term position, for patents that genuinely cannot be defended on a “claims the active ingredient” test, is closer to Novo Nordisk’s \u2014 concede early, on your own terms, rather than be the next published opinion.<\/p>\n\n\n\n

      What This Means for Policymakers and Payers<\/strong><\/h2>\n\n\n\n

      The compliance data undercuts the premise that administrative “naming and shaming” alone can fix improper Orange Book listings. Three rounds and 400-plus disputed patents later, the FDA’s own dispute log shows the overwhelming majority of challenged listings unchanged.[6]<\/sup> The mechanism that has actually moved patents off the list \u2014 litigation resulting in a binding court order \u2014 remains available only to a generic company with the specific commercial incentive and legal budget to pursue it, which by definition excludes most of the smaller device patents quietly sitting on smaller-volume drugs that never attract an ANDA filer’s attention at all.<\/p>\n\n\n\n

      Methodology<\/strong><\/h2>\n\n\n\n

      This analysis draws on FTC press releases and warning letters (November 2023, April 2024, May 2025), FDA Orange Book Patent Listing Dispute records, Federal Circuit and district court opinions in Teva v. Amneal<\/em>, In re Lantus<\/em>, and Jazz v. Avadel<\/em>, company SEC and regulatory filings, and law-firm and industry-press coverage of each development, current through the FDA’s July 2025 dispute-log update \u2014 the most recent comprehensive compliance snapshot publicly available as of this writing. Compliance percentages in the “Original Analysis” section were calculated by the author from the response counts each cited source reported for its respective round; they are original calculations, not figures published by the FTC itself. Revenue figures are as reported by each company or cited outlet for the period specified and are not adjusted for inflation or converted between currencies unless noted. Orange Book listing status can change at any time; readers evaluating a specific patent’s current status should verify it directly against the FDA’s Orange Book or a real-time tracking source such as DrugPatentWatch rather than relying on the snapshot dates cited here.<\/p>\n\n\n\n

      Key Takeaways<\/strong><\/h2>\n\n\n\n
        \n
      • Advair’s core compound patent expired in 2010; the drug’s continued $1.1 billion nine-month revenue run in 2023 rested on a device patent, not a drug patent.[1]<\/sup><\/li>\n\n\n\n
      • The FTC has disputed more than 400 Orange Book listings across three rounds since November 2023, but nine of ten targeted listings in the most recent round remained unchanged two months after the warning letters went out.[6]<\/sup><\/li>\n\n\n\n
      • The only device patent dispute to reach a full appellate ruling, Teva v. Amneal<\/em>, resulted in a unanimous loss for the patent holder and a new bright-line test for Orange Book listability.[7][34]<\/sup><\/li>\n\n\n\n
      • AstraZeneca’s Symbicort, Mylan Specialty’s EpiPen, and AbbVie’s Restasis Multidose bottle patents remain disputed but unlitigated and unresolved as of the most recent public record reviewed.[23][13]<\/sup><\/li>\n\n\n\n
      • Compliance with the FTC’s letters has trended downward, not upward, across the three rounds \u2014 40% company-level compliance in round one, 0% immediate compliance in round two, 10% in round three.[3][42][6]<\/sup><\/li>\n<\/ul>\n\n\n\n

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

        Why would a company keep a patent listed if the FTC calls it improper?<\/strong><\/h3>\n\n\n\n

        Because the FTC’s dispute process carries no binding legal force. A 314.53(f) letter only requires the manufacturer to certify, under penalty of perjury, that the listing is accurate \u2014 or withdraw it.[43]<\/sup> Certifying costs nothing and preserves the 30-month-stay leverage until an actual court says otherwise.[6]<\/sup><\/p>\n\n\n\n

        Has any device patent actually been proven invalid in court?<\/strong><\/h3>\n\n\n\n

        Courts have ruled several device- and system-adjacent patents improperly listed \u2014 including Teva’s ProAir HFA patents, Sanofi’s Lantus SoloSTAR patent, and Jazz’s Xyrem REMS patent \u2014 but these rulings addressed Orange Book listability under the statute, not patent validity in the broader sense.[34][38]<\/sup><\/p>\n\n\n\n

        What is the difference between delisting and invalidation?<\/strong><\/h3>\n\n\n\n

        Delisting removes a patent from the Orange Book, ending its ability to trigger an automatic 30-month stay against a specific ANDA filer. It does not necessarily mean the patent is invalid \u2014 a delisted patent can still be asserted in ordinary infringement litigation outside the Hatch-Waxman framework.<\/p>\n\n\n\n

        Why did GSK delist its Advair patents so quickly while AstraZeneca kept fighting for Symbicort’s?<\/strong><\/h3>\n\n\n\n

        Public statements differ by company, but the pattern is consistent with GSK judging the specific actuation-indicator claims indefensible once challenged, while AstraZeneca formally certified its Symbicort patents as accurately listed in a December 2023 response to the FDA.[19][21]<\/sup> Neither company’s reasoning has been tested in court.<\/p>\n\n\n\n

        Does the Teva v. Amneal ruling apply automatically to every other inhaler or injector patent?<\/strong><\/h3>\n\n\n\n

        No. The ruling sets binding precedent within the Federal Circuit’s jurisdiction over similar fact patterns, but each individual patent listing still requires its own challenge \u2014 typically a Paragraph IV certification and litigation \u2014 before it is formally delisted.[34]<\/sup><\/p>\n\n\n\n

        How much revenue is riding on these disputed listings?<\/strong><\/h3>\n\n\n\n

        The individual products span a wide range: EpiPen reported $378 million in 2022 revenue, Symbicort roughly $2.5 billion the year before its dispute, and Ozempic roughly $14 billion in global 2023 sales, though only a portion of each product’s protection comes from the disputed device patents specifically.[22][17]<\/sup><\/p>\n\n\n\n

        Why don’t generic companies just sue to delist every weak patent they find?<\/strong><\/h3>\n\n\n\n

        Litigation is expensive, and delisting a device patent only clears the way to market if the generic’s own product uses a similar device architecture that the patent would otherwise block. A generic using a different delivery mechanism often has no need to litigate a device patent it isn’t infringing in the first place.<\/p>\n\n\n\n

        Is the FTC’s Orange Book campaign likely to result in actual antitrust enforcement?<\/strong><\/h3>\n\n\n\n

        As of the most recent reporting reviewed, the FTC has used the dispute process and amicus briefs rather than filing its own antitrust suit over a specific listing, and some legal commentary has noted the warning letters do not themselves establish that any listing caused competitive harm.[41][44]<\/sup><\/p>\n\n\n\n

        Do “weak” device patents ever get challenged proactively, before a generic files an ANDA?<\/strong><\/h3>\n\n\n\n

        Rarely. The FTC’s administrative dispute process is the main proactive mechanism, and it has produced far lower compliance in its later rounds than in its first.[6]<\/sup> Litigated delistings have so far all arisen from ordinary Hatch-Waxman infringement suits, not standalone pre-emptive challenges.<\/p>\n\n\n\n

        What should a generic manufacturer do differently after the ProAir ruling?<\/strong><\/h3>\n\n\n\n

        Treat FTC-disputed device patents in a target drug’s Orange Book listing as a specific line item for early legal diligence \u2014 assessing whether the listed claims recite the active ingredient \u2014 rather than assuming every listed patent carries equal litigation risk.<\/p>\n\n\n\n

        References<\/h2>\n\n\n\n
          \n
        1. BioPharma Dive. (2023, November 8). FTC challenges patents held by nine big drugmakers, citing unfair competition.<\/em> https:\/\/www.biopharmadive.com\/news\/ftc-orange-book-patent-advair-epipen-restasis\/699132\/<\/li>\n\n\n\n
        2. Federal Trade Commission. (2023, November 7). FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book.<\/em> https:\/\/www.ftc.gov\/news-events\/news\/press-releases\/2023\/11\/ftc-challenges-more-100-patents-improperly-listed-fdas-orange-book<\/li>\n\n\n\n
        3. 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
        4. IPWatchdog. (2025, May 22). FTC Renews Campaign to Remove ‘Junk’ Inhaler and Device Patents from Orange Book Listings.<\/em> https:\/\/ipwatchdog.com\/2025\/05\/22\/ftc-renews-campaign-remove-junk-inhaler-device-patents-orange-book-listings\/<\/li>\n\n\n\n
        5. American Conference Institute. (2024, July 10). FTC’s Targeting of Orange Book Patents Won’t Impede Hatch-Waxman Litigation.<\/em> Paragraph IV Disputes. https:\/\/www.americanconference.com\/paragraph-iv-disputes-master-symposium\/ftcs-targeting-of-orange-book-patents-wont-impede-hatch-waxman-litigation\/<\/li>\n\n\n\n
        6. National Law Review \/ Polsinelli. (2025). Device Patents in the Orange Book: May 21, 2025, FTC Warning Letters Appear to Have Minimal Impact.<\/em> https:\/\/natlawreview.com\/article\/device-patents-orange-book-may-21-2025-ftc-warning-letters-appear-have-minimal<\/li>\n\n\n\n
        7. Federal Trade Commission. (2024, December 20). FTC Statement on Appellate Court Decision Ordering Delisting of Teva Inhaler Patents.<\/em> https:\/\/www.ftc.gov\/news-events\/news\/press-releases\/2024\/12\/ftc-statement-appellate-court-decision-ordering-delisting-teva-inhaler-patents<\/li>\n\n\n\n
        8. Cooley LLP. (2025, January 2). Teva v. Amneal Ruling Interprets Orange Book Listing Statute, Affirms Delisting of Device Patents.<\/em> https:\/\/www.cooley.com\/news\/insight\/2025\/2025-01-02-teva-v-amneal-ruling-interprets-orange-book-listing-statute-affirms-delisting-of-device-patents<\/li>\n\n\n\n
        9. Federal Trade Commission. (2023, September). Policy Statement Concerning Brand Drug Manufacturers’ Improper Listing of Patents in the Orange Book.<\/em> https:\/\/www.ftc.gov\/system\/files\/ftc_gov\/pdf\/p239900orangebookpolicystatement092023.pdf<\/li>\n\n\n\n
        10. Congressional Research Service. (2026, January 21). Patent Listing in FDA’s Orange Book.<\/em> Congress.gov. https:\/\/www.congress.gov\/crs-product\/IF12644<\/li>\n\n\n\n
        11. Wilson Sonsini Goodrich & Rosati. (2023, November). FTC Disputes Patent Listings of 10 Brand Drug Makers as Improperly Listed in FDA’s Orange Book.<\/em> https:\/\/www.wsgr.com\/en\/insights\/ftc-disputes-patent-listings-of-10-brand-drug-makers-as-improperly-listed-in-fdas-orange-book.html<\/li>\n\n\n\n
        12. Bloomberg Law. (2024, April 30). Novo’s Blockbuster Ozempic Among FTC’s Latest Patent Targets.<\/em> https:\/\/news.bloomberglaw.com\/ip-law\/novos-blockbuster-ozempic-among-ftcs-latest-patent-targets<\/li>\n\n\n\n
        13. IPWatchdog. (2025, May 22). Warning letter recipient list, Covis Pharma, Teva entities, and Mylan Specialty for EpiPen and EpiPen Jr. https:\/\/ipwatchdog.com\/2025\/05\/22\/ftc-renews-campaign-remove-junk-inhaler-device-patents-orange-book-listings\/<\/li>\n\n\n\n
        14. IPWatchdog. (2023, November 9). FTC’s Orange Book Challenge Creates Uncertainty for Pharma Patent Listings.<\/em> https:\/\/ipwatchdog.com\/2023\/11\/09\/ftcs-orange-book-challenge-creates-uncertainty-pharma-patent-listings\/<\/li>\n\n\n\n
        15. MedEsthetics. (2024, June 6). FTC Warns Novo Nordisk on Inaccurate Patents for Ozempic.<\/em> https:\/\/www.medestheticsmag.com\/research\/injectables\/news\/22911792\/ftc-warns-novo-nordisk-on-inaccurate-patents-for-ozempic<\/li>\n\n\n\n
        16. NBC Los Angeles \/ CNBC. (2024, April 30). FTC challenges ‘junk’ patents held by 10 drugmakers, including for Novo Nordisk’s Ozempic.<\/em> https:\/\/www.cnbc.com\/2024\/04\/30\/ftc-challenges-patents-held-by-drugmakers-including-for-ozempic.html<\/li>\n\n\n\n
        17. Lexology \/ CHIP Law Group. (2025, March 18). Novo Nordisk Settles Ozempic Patent Case.<\/em> https:\/\/www.lexology.com\/library\/detail.aspx?g=2917bc04-1eae-469c-bbfe-151c59331bae<\/li>\n\n\n\n
        18. Crowell & Moring LLP. (2024, June 27). The FTC Strikes Out: Drug Manufacturers Refuse to Play Ball and Delist Orange Book Patents in Response to FTC Warning Letters.<\/em> https:\/\/www.crowell.com\/en\/insights\/client-alerts\/the-ftc-strikes-out-drug-manufacturers-refuse-to-play-ball-and-delist-orange-book-patents-in-response-to-ftc-warning-letters<\/li>\n\n\n\n
        19. Fierce Pharma. (2023, December 21). GSK, Amneal and Kaleo pull patents from FDA database after FTC challenge.<\/em> https:\/\/www.fiercepharma.com\/pharma\/gsk-amneal-and-kaleo-pull-patents-fda-listing-after-ftc-challenge<\/li>\n\n\n\n
        20. Fierce Pharma. (2024, June 12). Teva notches loss in inhaler patent case against Amneal.<\/em> https:\/\/www.fiercepharma.com\/pharma\/teva-takes-flak-improperly-listed-inhaler-patents-amid-ongoing-ftc-orange-book-crackdown<\/li>\n\n\n\n
        21. Senator Elizabeth Warren. Drug Companies’ Responses to Warren re Orange Book Patents.<\/em> https:\/\/www.warren.senate.gov\/imo\/media\/doc\/Drug%20Companies’%20Responses%20to%20Warren%20re%20Orange%20Book%20Patents.pdf<\/li>\n\n\n\n
        22. pharmaphorum. (2023, November). FTC challenges dozens of ‘improper’ US drug patents.<\/em> https:\/\/pharmaphorum.com\/news\/ftc-challenges-dozens-improper-us-drug-patents<\/li>\n\n\n\n
        23. The Capitol Forum. (2025, March 25). Teva: Drugmaker Requests Delisting of Inhaler Patents from Orange Book in Response to Court Order; Boehringer Ingelheim, Novo Nordisk Have Also Asked FDA to Pull Disputed Drug-Device Patents.<\/em> https:\/\/thecapitolforum.com\/teva-inhaler-patents-orange-book\/<\/li>\n\n\n\n
        24. BioPharma Dive. (2023, November 8). Patent counts for EpiPen and Restasis Multidose. https:\/\/www.biopharmadive.com\/news\/ftc-orange-book-patent-advair-epipen-restasis\/699132\/<\/li>\n\n\n\n
        25. DrugPatentWatch. When do the patents on OZEMPIC expire, and when will generic OZEMPIC be available?<\/em> https:\/\/www.drugpatentwatch.com\/p\/alphasignals\/tradename\/OZEMPIC<\/li>\n\n\n\n
        26. DrugPatentWatch. How to bypass the GLP-1 patent lock.<\/em> https:\/\/www.drugpatentwatch.com\/blog\/how-to-bypass-the-glp-1-patent-lock\/<\/li>\n\n\n\n
        27. Markman Advisors. (2025, February 7). What is the patent landscape for Novo Nordisk’s semaglutide products, Ozempic, Wegovy and Rybelsus?<\/em> https:\/\/www.markmanadvisors.com\/blog\/2025\/2\/7\/what-is-the-patent-landscape-for-novo-nordisks-semaglutide-products-ozempic-wegovy-and-rybelsus<\/li>\n\n\n\n
        28. Lexology \/ CHIP Law Group. (2025, March 18). U.S., EU, Japan, and China semaglutide expiration estimates. https:\/\/www.chiplawgroup.com\/novo-nordisk-settles-ozempic-patent-case\/<\/li>\n\n\n\n
        29. Justia \/ U.S. Court of Appeals for the Federal Circuit. (2024, December 20). Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC<\/em>, No. 24-1936. https:\/\/law.justia.com\/cases\/federal\/appellate-courts\/cafc\/24-1936\/24-1936-2024-12-20.html<\/li>\n\n\n\n
        30. Patent Docs. (2025, September 25). Teva Pharms. Inc. v. Amneal Pharms. LLC (D.N.J. 2024).<\/em> https:\/\/patentdocs.org\/2024\/10\/17\/teva-pharms-inc-v-amneal-pharms-llc-dnj-2024\/<\/li>\n\n\n\n
        31. Alston & Bird. (2024, December 23). Patent Case Summaries, Week Ending December 20, 2024.<\/em> https:\/\/www.alston.com\/en\/insights\/publications\/2024\/12\/patent-case-summaries-week-ending-december-20-2024<\/li>\n\n\n\n
        32. DLA Piper. (2024, October 17). Teva ordered to delist inhaler patents from FDA Orange Book.<\/em> https:\/\/www.dlapiper.com\/en\/insights\/publications\/synthesis\/2024\/teva-ordered-to-delist-inhaler-patents-from-fda-orange-book<\/li>\n\n\n\n
        33. Sheppard Mullin Richter & Hampton LLP. (2024). FTC’s Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA.<\/em> https:\/\/www.sheppard.com\/insights\/blogs\/ftcs-campaign-against-improper-orange-book-listings-continues-with-amicus-brief-in-tevas-challenge-of-amneal-asthma-inhaler-anda<\/li>\n\n\n\n
        34. Patently-O. (2024, December 20). Orange Book Device Patent Listings: Understanding Teva v. Amneal.<\/em> https:\/\/patentlyo.com\/patent\/2024\/12\/orange-listings-understanding.html<\/li>\n\n\n\n
        35. Fed Circuit Blog. (2025, January 15). Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC.<\/em> https:\/\/fedcircuitblog.com\/other-cases\/teva-branded-pharmaceutical-products-rd-inc-v-amneal-pharmaceuticals-of-new-york-llc\/<\/li>\n\n\n\n
        36. JD Supra. Federal Circuit Denies Teva’s Request for En Banc Rehearing in Orange Book Patent Dispute.<\/em> https:\/\/www.jdsupra.com\/authors\/sheena-wang\/orange-book<\/li>\n\n\n\n
        37. Fierce Pharma. (2024, June 12). Note on Teva discontinuing branded ProAir HFA manufacturing in October 2022. https:\/\/www.fiercepharma.com\/pharma\/teva-takes-flak-improperly-listed-inhaler-patents-amid-ongoing-ftc-orange-book-crackdown<\/li>\n\n\n\n
        38. Congressional Research Service. (2026, January 21). Discussion of In re Lantus<\/em> and Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals.<\/em> Congress.gov. https:\/\/www.congress.gov\/crs-product\/IF12644<\/li>\n\n\n\n
        39. Haug Partners LLP. (2025, July 2). FTC Issues a Third Round of Warning Letters Over Improper Orange Book Listings.<\/em> https:\/\/haugpartners.com\/article\/ftc-issues-a-third-round-of-warning-letters-over-improper-orange-book-listings\/<\/li>\n\n\n\n
        40. Center for Intellectual Property x Innovation Policy, George Mason University. (2024, November 18). What the FTC Gets Wrong About the FDA’s Orange Book.<\/em> https:\/\/cip2.gmu.edu\/2024\/11\/18\/what-the-ftc-gets-wrong-about-the-fdas-orange-book\/<\/li>\n\n\n\n
        41. Hogan Lovells. (2025, May 23). Republican FTC renews challenges to Orange Book patent listings.<\/em> https:\/\/www.hoganlovells.com\/en\/publications\/republican-ftc-renews-challenges-to-orange-book-patent-listings<\/li>\n\n\n\n
        42. Crowell & Moring LLP. (2024, June 27). Compliance data for the April 2024 round. https:\/\/www.crowell.com\/en\/insights\/client-alerts\/the-ftc-strikes-out-drug-manufacturers-refuse-to-play-ball-and-delist-orange-book-patents-in-response-to-ftc-warning-letters<\/li>\n\n\n\n
        43. Fish & Richardson. (2025, March 3). 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
        44. Georgetown O’Neill Institute. (2025, November 6). 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<\/ol>\n","protected":false},"excerpt":{"rendered":"

          GSK’s Advair lost its core patent in 2010. Fourteen years later the inhaler was still bringing in \u00a3863 million \u2014 […]<\/p>\n","protected":false},"author":1,"featured_media":39500,"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-39499","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\/39499","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=39499"}],"version-history":[{"count":1,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39499\/revisions"}],"predecessor-version":[{"id":39501,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39499\/revisions\/39501"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media\/39500"}],"wp:attachment":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media?parent=39499"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/categories?post=39499"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/tags?post=39499"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}