{"id":36843,"date":"2026-03-17T09:46:00","date_gmt":"2026-03-17T13:46:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=36843"},"modified":"2026-03-08T13:48:03","modified_gmt":"2026-03-08T17:48:03","slug":"forecasting-generic-entry-combining-fda-orange-book-with-paragraph-iv-notice-letters","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/forecasting-generic-entry-combining-fda-orange-book-with-paragraph-iv-notice-letters\/","title":{"rendered":"Forecasting Generic Entry: Combining FDA Orange Book with Paragraph IV Notice Letters"},"content":{"rendered":"\n

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Pharmaceutical companies lose between $200 billion and $400 billion in annual revenue to patent expirations between 2025 and 2030. This revenue shift is not a gradual decline but a sharp cliff that requires precise forecasting for both investors and competitors. Predicting the exact date a generic drug hits the shelf involves more than checking an expiration date in a registry. It requires the synthesis of the FDA Orange Book data with the legal intelligence found in Paragraph IV notice letters. Professional analysts use this combination to identify the actual commercial launch date, which often falls years after the primary patent expires.<\/p>\n\n\n\n

The Economics of Patent Expiry<\/h2>\n\n\n\n

Generic drugs account for 90% of all prescriptions in the United States but represent only 20% of total drug spending.<\/sup> This gap exists because the patent system grants temporary monopolies to brand manufacturers to recover research costs. When these monopolies end, the market experiences a singularity. Historical brand performance stops being a reliable predictor of future revenue. The demand curve bifurcations occur instantly.<\/sup><\/p>\n\n\n\n

Branded firms prioritize extending these monopolies through life-cycle management. They build patent thickets that include secondary patents on formulations, methods of use, or specific chemical forms.<\/sup> These layers of protection aim to convert a sharp revenue cliff into a more manageable slope. For the generic challenger, the goal is to dismantle these layers as early as possible. This conflict is the primary driver of pharmaceutical valuation.<\/sup><\/p>\n\n\n\n

The financial impact of a successful patent challenge is significant. A generic firm that enters the market first can capture 60% to 80% of its total lifetime profits during the first six months.<\/sup> During this time, they often price their product at a 15% to 25% discount compared to the brand, maintaining high margins before the market becomes crowded.<\/sup><\/p>\n\n\n\n

Hatch-Waxman and the ANDA Pathway<\/h2>\n\n\n\n

The 1984 Hatch-Waxman Act created the modern generic industry. Before this law, generic manufacturers had to repeat the clinical trials already conducted by the brand company.<\/sup> This was expensive and delayed access to affordable medicine. The Act introduced the Abbreviated New Drug Application (ANDA), which allows generic firms to prove bioequivalence instead of safety and efficacy.<\/sup><\/p>\n\n\n\n

Bioequivalence requires the generic product to have the same active ingredient, dosage form, and strength as the brand drug.<\/sup> The rate and extent of absorption must not differ significantly. This streamlined process lowered the barrier to entry and moved the focus of competition from clinical data to patent law. To maintain a competitive edge, firms now monitor Paragraph IV filings to predict when their rivals might disrupt a therapeutic class.<\/sup><\/p>\n\n\n\n

Hatch-Waxman also established the “Orange Book,” the central registry for pharmaceutical patents. Branded firms must list patents that claim the drug or its approved uses.<\/sup> This transparency allows generic firms to identify which patents they must address. If a patent is not in the Orange Book, a generic firm can file a Paragraph I certification and potentially launch without a patent challenge.<\/sup><\/p>\n\n\n\n

The FDA Orange Book as a Strategic Map<\/h2>\n\n\n\n

The Orange Book is the starting point for any entry forecast. It lists the active ingredient, dosage forms, and strengths of approved drugs along with their associated patents.<\/sup> For an investigator, the Orange Book provides the statutory expiration dates that form the “base case” for a launch model. However, these dates are often modified by extensions like Patent Term Adjustments (PTA) or pediatric exclusivity.<\/sup><\/p>\n\n\n\n

Generic manufacturers analyze the Orange Book to find vulnerabilities. They categorize patents into “hard” and “soft” targets. Hard targets are typically composition-of-matter patents that cover the core molecule. Soft targets are secondary patents covering things like a specific crystalline form or a method of treating a specific patient sub-group.<\/sup><\/p>\n\n\n\n

Using DrugPatentWatch, analysts link these Orange Book listings to broader litigation data.<\/sup> This allows them to see not just when a patent expires, but whether any firm has already filed a Paragraph IV challenge against it. This intelligence is vital because a successful challenge can move the entry date forward by years.<\/p>\n\n\n\n

Paragraph IV Certification Mechanics<\/h2>\n\n\n\n

A Paragraph IV certification is a declaration by a generic firm that a listed patent is invalid, unenforceable, or will not be infringed by their product.<\/sup> This filing is an act of artificial infringement. It grants the brand manufacturer the right to sue the generic firm before any product is actually sold.<\/sup><\/p>\n\n\n\n

Once a generic firm files an ANDA with a Paragraph IV certification, a strict timeline begins. Within 20 days of the FDA acknowledging the application, the generic firm must send a notice letter to the patent holder.<\/sup> This letter is the first tactical move in a multi-year legal battle. It outlines the legal and scientific basis for the challenge.<\/p>\n\n\n\n

The number of Paragraph IV challenges has fluctuated. After peaking in 2014 and 2015, case filings dropped by 36% between 2017 and 2021.<\/sup> However, the strategic importance has not declined. In 2024, the industry saw a rebound with 312 complaints filed, up from 259 the previous year.<\/sup> This shows that firms are becoming more selective, targeting high-value blockbuster drugs where the return on litigation is highest.<\/sup><\/p>\n\n\n\n

Strategic Use of Notice Letters<\/h2>\n\n\n\n

The Paragraph IV notice letter is a critical piece of intelligence. It must contain a detailed statement of the factual and legal basis for the generic’s position.<\/sup> While these positions are not binding in court, they must be made in good faith. A weak notice letter can lead to penalties, including the payment of the brand’s attorney fees.<\/sup><\/p>\n\n\n\n

Generic firms often use the notice letter to influence the brand’s litigation strategy. A strong, detailed letter might convince a brand manufacturer that their patent is too weak to defend, leading to an early settlement. Conversely, a brief letter might be used to hide the challenger’s full legal strategy until the discovery phase of litigation begins.<\/sup><\/p>\n\n\n\n

Analysts look for the arrival of notice letters as a key forecasting signal. The median time for a Paragraph IV filing is 5.2 years after the brand drug’s approval.<\/sup> For a drug like Eliquis, which had peak sales over $10 billion, the arrival of multiple notice letters indicated that the market was preparing for a massive shift long before the patents neared expiration.<\/sup><\/p>\n\n\n\n

The Regulatory Stay and Litigation Timelines<\/h2>\n\n\n\n

If the brand manufacturer sues within 45 days of receiving a notice letter, the FDA automatically stays the approval of the generic drug for 30 months.<\/sup> This stay prevents the generic from entering the market while the court decides the case. It is a statutory protection for the brand’s monopoly.<\/p>\n\n\n\n

The 30-month stay acts as a provisional floor for any launch forecast.<\/sup> However, research shows the stay is rarely the final determinant of entry. Medians show that while the stay might expire 7.7 years after the brand’s approval, the actual generic launch often occurs at 14.1 years.<\/sup> This gap exists because of the complexity of the litigation and the time needed for final FDA approval.<\/p>\n\n\n\n

Table 1: Median Milestones in Generic Entry<\/h2>\n\n\n\n
Milestone<\/strong><\/td>Years from Brand Approval<\/strong><\/td><\/tr><\/thead>
Paragraph IV Filing<\/strong><\/td>5.2 years<\/td><\/tr>
Stay Expiration<\/strong><\/td>7.7 years<\/td><\/tr>
FDA Approval (ANDA)<\/strong><\/td>11.5 years<\/td><\/tr>
Generic Product Launch<\/strong><\/td>14.1 years<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Source: Data synthesized from academic and industry analysis of Hatch-Waxman timelines.<\/sup><\/p>\n\n\n\n

The stay can be terminated early if a district court rules in favor of the generic firm or if the parties reach a settlement. On the other hand, the stay does not protect the brand from competition if the generic firm wins at trial before the 30 months are up.<\/sup><\/p>\n\n\n\n

The Commercial Value of 180-Day Exclusivity<\/h2>\n\n\n\n

The “brass ring” of the generic industry is the 180-day exclusivity period. This is awarded to the first generic applicant to file a substantially complete ANDA with a Paragraph IV certification.<\/sup> During this six-month window, the FDA cannot approve any other generic version of the drug.<\/p>\n\n\n\n

This exclusivity creates a temporary duopoly. The first generic filer can capture significant market share while charging a price close to the brand’s.<\/sup> For a blockbuster drug, this period can generate hundreds of millions of dollars in revenue for a single firm.<\/sup> This incentive is what drives generic firms to take the risk of multi-million dollar patent litigation.<\/sup><\/p>\n\n\n\n

Market share for a first entrant can reach 90% during this period and often persists even after more competitors arrive.<\/sup> The pricing dynamics are favorable because the brand manufacturer often avoids aggressive price competition during the exclusivity phase, knowing that a “race to the bottom” will occur once the 180 days expire.<\/sup><\/p>\n\n\n\n

Forfeiture Triggers and the Tentative Approval Deadline<\/h2>\n\n\n\n

180-day exclusivity is not a guarantee. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) introduced “use it or lose it” rules. These forfeiture triggers prevent generic firms from “parking” their exclusivity to block other competitors.<\/sup><\/p>\n\n\n\n

The most frequent cause of forfeiture is failing to obtain “tentative approval” from the FDA within 30 months of filing the ANDA.<\/sup> Tentative approval means the generic product is scientifically sound but cannot be sold yet due to patents. The FDA applies a strict rule: if the generic firm misses the 30-month window by even one day, they lose their exclusivity.<\/sup><\/p>\n\n\n\n

Table 2: Primary Exclusivity Forfeiture Triggers<\/h2>\n\n\n\n
Trigger<\/strong><\/td>Statutory Basis<\/strong><\/td>Mechanism<\/strong><\/td><\/tr><\/thead>
Failure to Market<\/strong><\/td>505(j)(5)(D)(i)(I)<\/td>Firm fails to launch within 75 days of a final court decision or approval. <\/sup><\/td><\/tr>
Failure to Obtain Approval<\/strong><\/td>505(j)(5)(D)(i)(IV)<\/td>Firm fails to get tentative approval within 30 months of filing. <\/sup><\/td><\/tr>
Withdrawal of Application<\/strong><\/td>505(j)(5)(D)(i)(II)<\/td>Firm voluntarily pulls their ANDA or fails to comply with FDA. <\/sup><\/td><\/tr>
Anticompetitive Agreement<\/strong><\/td>505(j)(5)(D)(i)(V)<\/td>A court or the FTC finds the settlement violates antitrust law. <\/sup><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Generic firms must maintain high regulatory precision to protect their exclusivity. Analysis of filings from 2020 to 2024 shows that nearly half of eligible applications were extinguished because firms failed to meet these milestones.<\/sup><\/p>\n\n\n\n

Settlement Dynamics and Reverse Payments<\/h2>\n\n\n\n

Most Paragraph IV disputes never reach a final court verdict. They are resolved through settlements. One study found that while generics win only about 48% of trials that go to a final decision, their overall success rate\u2014including favorable settlements\u2014is 76%.<\/sup><\/p>\n\n\n\n

Settlements often involve a compromise on the launch date. The brand firm allows the generic to enter early in exchange for the generic dropping its challenge against the patents. Historically, some of these deals involved “reverse payments,” where the brand paid the generic to delay entry.<\/sup> Since the Supreme Court’s Actavis<\/em> decision in 2013, these deals have faced heavy antitrust scrutiny.<\/sup><\/p>\n\n\n\n

Current settlements are more likely to include “quantity restrictions” or licenses to launch in foreign markets.<\/sup> In fiscal year 2021, the FTC reported 11 agreements that included quantity restrictions.<\/sup> These terms allow the generic to enter the market but limit how much they can sell, preventing an immediate price crash.<\/p>\n\n\n\n

Case Study: Revlimid and Volume-Limited Entry<\/h2>\n\n\n\n

The cancer drug Revlimid (lenalidomide) provides a clear example of how brand companies use settlements to manage a patent cliff. Celgene, the manufacturer, faced multiple generic challenges. Instead of a single launch date, they negotiated settlements with firms like Natco and Alvogen that included volume limits.<\/sup><\/p>\n\n\n\n

From March 2022 to January 2026, generics are allowed to sell Revlimid, but their market share is capped at single-digit percentages.<\/sup> These caps increase gradually until full, unlimited entry is permitted in February 2026.<\/sup> This structure preserved billions in revenue for the brand by preventing a 90% price drop on day one.<\/p>\n\n\n\n

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“A common settlement outcome is a license agreement that allows the generic to enter the market on a specific date, often months or even years before the last patent is set to expire. For the generic company, this is a massive financial victory.” <\/sup><\/p>\n<\/blockquote>\n\n\n\n

These volume-limited deals have faced antitrust lawsuits. Plaintiffs allege that the deals are “reverse payments” that kept prices high for patients.<\/sup> However, for the companies involved, the strategy successfully turned a patent cliff into a gradual slope.<\/sup><\/p>\n\n\n\n

Case Study: Eliquis and Global Patent Variance<\/h2>\n\n\n\n

Eliquis (apixaban) demonstrates how the U.S. patent system can delay generic entry compared to other countries. Bristol Myers Squibb and Pfizer obtained a patent term extension (PTE) for the core molecule patent, pushing its expiration from 2022 to late 2026.<\/sup> They also secured secondary formulation patents that expire in 2031.<\/sup><\/p>\n\n\n\n

While generic Eliquis is already available in Canada and the UK, U.S. patients must wait.<\/sup> Litigation settlements have established April 1, 2028, as the earliest legal entry date for generics in the U.S..<\/sup> The FDA has granted tentative approval to several manufacturers, including Micro Labs and Mylan, but they cannot sell the product until the patent issues are resolved in 2028.<\/sup><\/p>\n\n\n\n

This delay has a massive financial impact. Analysts estimate that the extra years of protection will generate $50.7 billion in additional U.S. revenue for the brand manufacturers.<\/sup> For a forecaster, Eliquis is a reminder that a drug’s scientific readiness (FDA approval) is secondary to its legal status.<\/p>\n\n\n\n

Quantitative Models for Launch Forecasting<\/h2>\n\n\n\n

Forecasting a generic launch requires a shift from linear to event-driven models. Standard econometric models often fail because they assume market continuity. A generic launch is a singularity\u2014a discontinuity where historical data becomes irrelevant.<\/sup><\/p>\n\n\n\n

Analog Forecasting<\/strong> This is the industry standard. Analysts select historical “twins”\u2014drugs that share characteristics with the target asset. If a previous blockbuster in the same therapeutic area saw a 20% price drop with three competitors, that curve is used as a proxy.<\/sup> Analysts adjust these curves based on the route of administration, as oral solids erode faster than complex injectables.<\/sup><\/p>\n\n\n\n

ARIMA (Auto-Regressive Integrated Moving Average)<\/strong> This model is used to establish the pre-launch baseline. It captures seasonality and secular trends in the brand’s performance.<\/sup> However, ARIMA requires an external “eventing” input to predict the actual cliff. It cannot determine the launch date on its own; it can only model the erosion after a date is provided.<\/sup><\/p>\n\n\n\n

Bass Diffusion Model<\/strong> Modified for the pharmaceutical sector, this model tracks how quickly a market switches from a brand to a generic. Factors include the presence of “step therapy” protocols in insurance plans and state-level mandatory substitution laws.<\/sup><\/p>\n\n\n\n

Using Competitive Intelligence for Strategic Advantage<\/h2>\n\n\n\n

Platforms like DrugPatentWatch transform opaque legal filings into actionable data. For a business development team, this intelligence supports decisions on out-licensing and partnering.<\/sup> By tracking when a competitor’s drug faces a patent cliff, a firm can identify opportunities to fill that revenue gap with their own pipeline products.<\/sup><\/p>\n\n\n\n

Due diligence also relies on this data. If a firm is considering acquiring a drug, they must analyze the “last man standing”\u2014the specific patent that acts as the final legal barrier.<\/sup> This is often a method-of-use or formulation patent. If that patent is weak and already facing multiple Paragraph IV challenges, the asset is worth significantly less.<\/p>\n\n\n\n

ROI analysis for generic firms also depends on litigation tracking. The average cost of a patent case reached $3 million in 2023.<\/sup> A firm must determine if the potential market size justifies this investment. If a drug has ten expected generic entrants, the price will likely drop by 80% to 90% within three years, drastically reducing the potential profit for later filers.<\/sup><\/p>\n\n\n\n

Antitrust Scrutiny and FTC Enforcement<\/h2>\n\n\n\n

The Federal Trade Commission (FTC) is the primary monitor of patent settlements. Their goal is to prevent “pay-for-delay” deals that keep generic prices high. The FTC estimates these deals cost American consumers $3.5 billion per year.<\/sup><\/p>\n\n\n\n

In fiscal year 2020, the average litigation fee paid in a settlement was $1.591 million, rising to $3.082 million in 2021.<\/sup> The FTC tracks these fees and other forms of “possible compensation,” such as a brand’s promise not to launch an “authorized generic” (AG).<\/sup> A “no-AG” commitment is valuable because it preserves the first generic’s duopoly, allowing them to keep prices higher.<\/sup><\/p>\n\n\n\n

Table 3: FTC MMA Report Data (FY 2018\u20132021)<\/h2>\n\n\n\n
Metric<\/strong><\/td>FY 2018<\/strong><\/td>FY 2019<\/strong><\/td>FY 2020<\/strong><\/td>FY 2021<\/strong><\/td><\/tr><\/thead>
Total Settlements<\/strong><\/td>245<\/td>194<\/td>205<\/td>199<\/td><\/tr>
Products Involved<\/strong><\/td>111<\/td>104<\/td>111<\/td>86<\/td><\/tr>
Quantity Restrictions<\/strong><\/td>7<\/td>3<\/td>2<\/td>11<\/td><\/tr>
First-Filer Deals<\/strong><\/td>110<\/td>97<\/td>94<\/td>101<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Source: Compiled from FTC Bureau of Competition MMA reports.<\/sup><\/p>\n\n\n\n

Quantity restrictions are a major focus for the FTC. They argue these restrictions are de facto market allocations that allow companies to share monopoly profits.<\/sup> As settlements grow more complex, the agency continues to look for hidden forms of compensation that delay competition.<\/p>\n\n\n\n

Policy Shifts: The BLOCKING Act and 2026 Regulations<\/h2>\n\n\n\n

Policymakers are actively trying to clear bottlenecks in the generic market. One proposed solution is the BLOCKING Act. This legislation would allow the FDA to approve a subsequent generic applicant if the first filer has not received final approval within a certain timeframe.<\/sup> This aims to prevent “parking” exclusivity, but critics argue it could weaken the incentive for firms to challenge patents.<\/sup><\/p>\n\n\n\n

The Consolidated Appropriations Act of 2026 includes measures to increase transparency. The FDA is now allowed to disclose specifically why a generic application is not “qualitatively and quantitatively” (Q1\/Q2) similar to the brand drug.<\/sup> This helps generic manufacturers fix formulation issues faster, potentially shortening the time to market.<\/p>\n\n\n\n

Also included in recent policy shifts is a “legislative fix” for orphan drug exclusivity. Following the Catalyst<\/em> decision, exclusivity is now tied specifically to the “approved use or indication” rather than the entire rare disease.<\/sup> This prevents a brand from using one orphan approval to block competition across an entire therapeutic class.<\/p>\n\n\n\n

Key Takeaways<\/h2>\n\n\n\n

Predicting generic entry requires a synthesis of regulatory and legal signals. The “base case” comes from the Orange Book, but the actual launch date is dictated by Paragraph IV litigation and settlements. Analysts must monitor tentative approvals and 30-month deadlines, as missing these milestones is the most common reason for exclusivity forfeiture.<\/p>\n\n\n\n

Market erosion is driven by competitor count. A single generic entrant typically results in a 15% to 25% price drop, but ten or more entrants can push prices down by over 95%.<\/sup> First-to-file exclusivity remains the most lucrative goal, but firms must navigate an increasingly complex settlement environment where quantity restrictions are replacing cash payments.<\/p>\n\n\n\n

Case studies like Revlimid and Eliquis show that brand manufacturers are successfully using secondary patents and volume-limited settlements to soften the blow of the patent cliff. For investors and competitors, the ability to read these legal “tea leaves” in notice letters and court dockets is the difference between a successful market entry and a multi-million dollar mistake.<\/p>\n\n\n\n

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

How does a Paragraph IV notice letter differ from a patent opinion?<\/strong> A patent opinion is a private document shared between an attorney and a client, protected by attorney-client privilege.<\/sup> A Paragraph IV notice letter is a public disclosure sent to a brand manufacturer. While it reflects the legal opinion, it is subject to discovery in litigation and is used to establish the “good faith” basis of the generic firm’s challenge.<\/sup><\/p>\n\n\n\n

What happens if a generic firm wins a trial before the 30-month stay ends?<\/strong> If a district court rules that the patent is invalid or not infringed before the 30-month stay expires, the stay is terminated.<\/sup> The FDA can then grant final approval to the generic drug, allowing for a commercial launch. This is the primary goal for aggressive generic challengers.<\/p>\n\n\n\n

Why is 180-day exclusivity often called a “brass ring”?<\/strong> It is a congressionally mandated period of market protection that allows a generic firm to act as a temporary monopolist.<\/sup> For blockbuster drugs, the profit margins during these six months are so high that they often account for the majority of the product’s lifetime earnings, making it the most sought-after prize in the sector.<\/sup><\/p>\n\n\n\n

Can a brand company prevent a generic launch even after all patents expire?<\/strong> Yes, through regulatory exclusivities. These are separate from patents and are granted by the FDA for things like pediatric studies or orphan drug designations.<\/sup> These can extend a brand’s monopoly by six months or more even after the underlying patents have naturally lapsed.<\/p>\n\n\n\n

What is the “generics paradox” in brand pricing?<\/strong> The generics paradox refers to the observation that brand manufacturers sometimes raise their prices right before or after a generic enters the market.<\/sup> This is often done to harvest maximum profit from the remaining brand-loyal patient base as the broader market shifts to lower-cost generic alternatives.<\/p>\n","protected":false},"excerpt":{"rendered":"

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