{"id":39944,"date":"2026-10-24T10:29:00","date_gmt":"2026-10-24T14:29:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=39944"},"modified":"2026-10-17T17:14:16","modified_gmt":"2026-10-17T21:14:16","slug":"on-time-delivery-metrics-miss-day-one-of-generic-entry","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/on-time-delivery-metrics-miss-day-one-of-generic-entry\/","title":{"rendered":"On-Time Delivery Metrics Miss Day One of Generic Entry"},"content":{"rendered":"\n
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Glenmark launched generic Zetia in the United States on December 12, 2016. IMS Health data cited in the company’s release put annual US sales of Zetia 10 mg at about $2.3 billion for the 12 months ending October 2016. [1] Glenmark and its partner Endo held 180-day exclusivity under section 505(j)(5)(B)(iv) of the FD&C Act. [1]<\/p>\n\n\n\n

Now take a supplier that serves the same wholesalers. It reports 98 percent on-time, in-full (OTIF) delivery for the year. Walmart set 98 percent as its OTIF target for suppliers in 2020. [2] That score cannot tell you whether the supplier shipped on the one date that set the value of the product.<\/p>\n\n\n\n

This article explains the gap. It uses FDA rules, court events, company filings and one FDA price study. It adds calculations, a taxonomy of day-one dates and four metrics that measure launch readiness. DrugPatentWatch tracks the patent and exclusivity records that fix these dates, and the last sections show how to use that kind of data in a launch calendar.<\/p>\n\n\n\n

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

On-time delivery (OTD) and OTIF metrics measure the share of orders that meet a date the customer set. Day one of generic entry is a date that a patent, a settlement, a court or FDA sets. A supplier can score 99.99 percent on OTIF and still miss it. The correct measure is a pass-or-fail readiness test for each launch, tied to the legal trigger and not to a purchase order.<\/p>\n\n\n\n

The Five Findings That Matter<\/strong><\/h2>\n\n\n\n
    \n
  1. One missed order line moves a 10,000-line OTIF score by 0.01 percentage points. A supplier that misses 150 routine lines scores 98.50 percent. A supplier that misses only the launch line scores 99.99 percent. (Analysis, worked example below.)<\/li>\n\n\n\n
  2. A first applicant for 180-day exclusivity can forfeit it by failing to market the drug within the statutory window. The window is the later of two dates, and one of them is 75 days after approval or a qualifying patent event. [3]<\/li>\n\n\n\n
  3. FDA data on 181 products show that median generic prices fall as producers enter. With one generic producer, the median generic price is 61.4 percent of the brand price (AMP basis). With five, it is 14.4 percent. [6]<\/li>\n\n\n\n
  4. FDA approved MSN’s generic Entresto on July 24, 2024. [11] Optum Rx reports the launch on July 22, 2025. [13] That is 363 days between approval and launch (analysis).<\/li>\n\n\n\n
  5. At the Zetia sales rate cited by Glenmark, one day of brand sales is about $6.3 million. A 180-day window covers about $1.13 billion of brand-equivalent sales. (Analysis based on [1].)<\/li>\n<\/ol>\n\n\n\n

    What the Data Shows About the Stakes<\/strong><\/h2>\n\n\n\n
    \n

    In 2024, generics and biosimilars accounted for 90 percent of US prescriptions filled and 12 percent of overall drug spending. Source: Association for Accessible Medicines and the Biosimilars Council, September 3, 2025. [7]<\/p>\n<\/blockquote>\n\n\n\n

    Those two numbers explain why the first weeks of generic entry matter. Volume moves to generics fast, and the price per unit falls in steps as more companies enter. The first entrant sells at the highest generic price it will ever see. The supply chain has to be ready for that window.<\/p>\n\n\n\n

    What Does an On-Time Delivery Metric Measure?<\/strong><\/h2>\n\n\n\n

    How Are OTD and OTIF Defined?<\/strong><\/h3>\n\n\n\n

    OTD is the share of orders delivered by a promised date. OTIF adds a second test: the full ordered quantity must arrive. Most buyers add a delivery window. A shipment that arrives inside the window passes. A shipment that arrives outside it fails. The metric covers a period, such as a month or a year, and reports one percentage.<\/p>\n\n\n\n

    Four features of this design matter for generic launches. The date comes from the customer. The metric treats every order line the same. The result is an average over many events. Nothing in the metric refers to a legal trigger.<\/p>\n\n\n\n

    Example: Walmart’s 98 Percent OTIF Rule<\/strong><\/h3>\n\n\n\n

    Walmart told suppliers in a September 1, 2020 memo that a 98 percent compliance target would apply from September 15, 2020. [2] Suppliers and carriers had to deliver orders as specified and by the must-arrive-by date. [2] Walmart set a fine of 3 percent of the cost of the goods for noncompliance. [2]<\/p>\n\n\n\n

    Before the change, the targets were lower. General merchandise had a 95 percent in-full target, and food and consumables had a 97.5 percent target. [2] Truckload carriers had an 87 percent on-time target for prepaid shipments and 95 percent for collect shipments. [2] Less-than-truckload carriers had a 70 percent target. [2]<\/p>\n\n\n\n

    What the Walmart Numbers Show<\/strong><\/h4>\n\n\n\n

    The rule is built for repeat flows. A retailer places thousands of similar orders, and a late truck costs a fixed share of the order value. The fine scales with the goods: on a $2 million order, a 3 percent fine is $60,000 (analysis). The fine does not scale with the strategic value of the date.<\/p>\n\n\n\n

    That design works for diapers and canned soup. It does not work for a launch, where the value of the shipment depends on the calendar day and not on the cost of the goods.<\/p>\n\n\n\n

    Why Do Averages Hide Single Events?<\/strong><\/h3>\n\n\n\n

    An average gives every event the same weight. A launch is one event with a weight far above the rest. Any percentage built over many orders will hide it.<\/p>\n\n\n\n

    Worked Example: 10,000 Order Lines<\/strong><\/h4>\n\n\n\n

    Assume a supplier ships 10,000 order lines in a year. One line is the launch-day order for a first generic. The table shows two suppliers. Both numbers are calculations from the stated assumptions.<\/p>\n\n\n\n

    Supplier<\/th>Routine lines missed<\/th>Launch line missed<\/th>Total lines missed<\/th>OTIF score<\/th><\/tr><\/thead>
    A<\/td>150<\/td>No<\/td>150<\/td>98.50%<\/td><\/tr>
    B<\/td>149<\/td>Yes<\/td>150<\/td>98.50%<\/td><\/tr>
    C<\/td>0<\/td>Yes<\/td>1<\/td>99.99%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Suppliers A and B have the same score. One of them failed on the launch date and the other did not. Supplier C has the best score and failed on the only date that carried a legal clock. The metric cannot see the difference.<\/p>\n\n\n\n

    Why Is Day One of Generic Entry Different From Any Other Delivery Date?<\/strong><\/h2>\n\n\n\n

    Who Sets the Date for a Generic Launch?<\/strong><\/h3>\n\n\n\n

    Four parties set it. A patent owner sets it through the expiry dates of listed patents. A brand and a generic company set it through a settlement. A court sets it through a ruling on validity or infringement. FDA sets it through approval decisions and statutory clocks. A purchase order from a wholesaler comes after all four.<\/p>\n\n\n\n

    A date that comes from outside the customer relationship has no negotiating margin. A buyer can move a delivery window by two days. No buyer can move a court ruling.<\/p>\n\n\n\n

    Why Can a Late Day One Not Be Recovered?<\/strong><\/h3>\n\n\n\n

    Two forces work against recovery. One is the statutory clock, covered in the next section. The other is price. FDA’s data show that the generic price falls as producers enter, so the early period carries the highest price. [6] A competitor with product on hand also takes the orders that a late supplier cannot fill.<\/p>\n\n\n\n

    A late shipment on a routine order delays revenue by a few days. A late shipment on day one can cost the position in the market.<\/p>\n\n\n\n

    What Does FDA Mean by Commercial Marketing?<\/strong><\/h3>\n\n\n\n

    Under 21 C.F.R. 314.3(b), commercial marketing is “the introduction or delivery for introduction into interstate commerce of a drug product.” [4] The rest of the definition covers product moved outside the control of the ANDA applicant. It excludes shipments for investigational use under part 312 and transfers to parties named in the ANDA for reasons other than sale. [4]<\/p>\n\n\n\n

    Definition: Commercial Marketing<\/strong><\/h4>\n\n\n\n

    For supply planning, the key point is that the legal event is a commercial shipment. Production and warehouse stock do not meet the definition. A transfer between sites of the same company does not meet it either. This is a reading of the regulation for planning purposes. Regulatory counsel decides how it applies to a specific product.<\/p>\n\n\n\n

    Why the Definition Matters for Logistics<\/strong><\/h4>\n\n\n\n

    A launch plan that ends at “product in the warehouse” ends one step early. The plan has to include customer orders, carrier pickup, and a dated record of the first shipment. That record is the evidence that the clock started.<\/p>\n\n\n\n

    How Does 180-Day Exclusivity Turn a Supply Date Into a Legal Event?<\/strong><\/h2>\n\n\n\n

    What Is 180-Day Generic Exclusivity?<\/strong><\/h3>\n\n\n\n

    180-day exclusivity is a period in which FDA does not approve later applications for the same drug. It goes to a first applicant that meets the statutory conditions. Glenmark cited section 505(j)(5)(B)(iv) of the FD&C Act as the basis for its Zetia exclusivity. [1] The statute also lists the events that make an applicant forfeit it. [3]<\/p>\n\n\n\n

    What Are the Forfeiture Triggers Under 505(j)(5)(D)(i)?<\/strong><\/h3>\n\n\n\n

    The statute lists six forfeiture events. [3] The table summarizes them. The text of the statute controls, and the summary here follows a university law course summary of the statute. [3]<\/p>\n\n\n\n

    Forfeiture event<\/th>What triggers it<\/th>Supply relevance<\/th><\/tr><\/thead>
    Failure to market<\/td>The first applicant does not market the drug by the later of two dates. [3]<\/td>Direct. Product must ship by a fixed date.<\/td><\/tr>
    Withdrawal of application<\/td>The first applicant withdraws the application, or FDA treats it as withdrawn. [3]<\/td>Indirect. A quality failure can lead to this outcome.<\/td><\/tr>
    Amendment of certification<\/td>The first applicant amends or withdraws the certification for all qualifying patents. [3]<\/td>Low.<\/td><\/tr>
    Failure to obtain tentative approval<\/td>No tentative approval within 30 months after filing, with exceptions for changes in approval requirements. [3]<\/td>Indirect. Site readiness affects approval.<\/td><\/tr>
    Agreement with another party<\/td>An agreement with another applicant, the brand or a patent owner, followed by an FTC or Attorney General complaint and a final antitrust finding. [3]<\/td>Low.<\/td><\/tr>
    Expiration of all patents<\/td>All patents that qualified the applicant for exclusivity have expired. [3]<\/td>None.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Failure to Market: The Two-Date Test<\/strong><\/h4>\n\n\n\n

    The first applicant must market the drug by the later of two dates. [3] The first date is the earlier of 75 days after approval becomes effective or 30 months after the application was submitted. [3] The second date is 75 days after a qualifying patent event for each certified patent. [3] Qualifying events include a final court decision that the patent is invalid or not infringed, a settlement order or consent decree with such a finding, and withdrawal of the patent information. [3]<\/p>\n\n\n\n

    The second date is the one that ties supply to the legal calendar. A court decision can start a 75-day clock. A supply team that waits for a purchase order before it builds stock starts that clock late.<\/p>\n\n\n\n

    Failure to Obtain Tentative Approval Within 30 Months<\/strong><\/h4>\n\n\n\n

    An applicant that does not obtain tentative approval within 30 months after filing forfeits exclusivity, unless a change in approval requirements caused the delay. [3] Manufacturing site readiness feeds into approval. A site that is not ready delays the application, and the delay can end the exclusivity. This is an analysis of how two rules connect.<\/p>\n\n\n\n

    What Is the 75-Day Rule for Competitive Generic Therapies?<\/strong><\/h3>\n\n\n\n

    Competitive generic therapy (CGT) exclusivity is a second 180-day exclusivity. Congress created it in the FDA Reauthorization Act of 2017, and it sits in section 506H of the FD&C Act (21 U.S.C. 356h). [5] The first approved applicant must commercially market the drug within 75 calendar days after ANDA approval. [5] FDA counts the 75 days from the day after the approval is made effective. [5] An applicant that misses the deadline loses eligibility. [5]<\/p>\n\n\n\n

    A drug qualifies for CGT designation when it has inadequate generic competition. That means no more than one approved drug in the active section of the Orange Book. [5] FDA issued final guidance in March 2020. [5]<\/p>\n\n\n\n

    The CGT rule states the supply requirement in plain terms: ship within 75 days.<\/p>\n\n\n\n

    A Taxonomy of Day-One Dates: Five Types<\/strong><\/h2>\n\n\n\n

    The five types below are an original framework for this article. FDA does not use this classification. The types are sorted by who controls the timing, because that controls how much warning a supply team gets.<\/p>\n\n\n\n

    Type<\/th>Trigger<\/th>Who controls timing<\/th>Example in this article<\/th>Main supply risk<\/th><\/tr><\/thead>
    A. Expiry date<\/td>A listed patent or exclusivity expires on its stated date<\/td>Patent owner and FDA records<\/td>None cited<\/td>Low surprise. Risk is build quality and timing.<\/td><\/tr>
    B. Settlement date<\/td>A brand and generic company agree on a date or volume schedule<\/td>The two companies<\/td>Lipitor and Ranbaxy [8]; Revlimid and Dr. Reddy’s [14]<\/td>Volume terms can make in-full a contract term.<\/td><\/tr>
    C. Court-triggered date<\/td>A ruling on validity or infringement opens or closes the window<\/td>A court<\/td>Entresto and MSN [11][12]<\/td>The date moves in hours. Stock must exist before the ruling.<\/td><\/tr>
    D. Regulatory-clock date<\/td>FDA approval starts a statutory deadline<\/td>FDA and the statute<\/td>CGT 75-day rule [5]<\/td>A fixed number of days to ship.<\/td><\/tr>
    E. Own-risk date<\/td>The applicant launches before litigation ends<\/td>The applicant<\/td>None cited<\/td>Inventory is built before the outcome is known.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Which Type Is Hardest to Supply?<\/strong><\/h3>\n\n\n\n

    Type C gives the least warning. In Type A, a team can plan against a date that is known years ahead. In Type C, the date depends on a decision that can arrive on any court day. The Entresto case below shows the pattern.<\/p>\n\n\n\n

    Case Study: Lipitor, Ranbaxy and a Launch With One Supply Path<\/strong><\/h2>\n\n\n\n

    Generic Lipitor Timeline, 2008 to 2012<\/strong><\/h3>\n\n\n\n
    Date<\/th>Event<\/th>Source<\/th><\/tr><\/thead>
    2008<\/td>FDA banned imports of products made at three Indian Ranbaxy facilities.<\/td>[9]<\/td><\/tr>
    February 2009<\/td>FDA invoked its Application Integrity Policy against Ranbaxy’s Paonta Sahib, India facility.<\/td>[8]<\/td><\/tr>
    October 2010<\/td>Analysts at BernsteinResearch, as reported by FDA Law Blog, rated an on-time Ranbaxy launch as the most likely outcome and a delay that holds other generics off the market as less likely.<\/td>[8]<\/td><\/tr>
    November 2011<\/td>Pfizer lost US exclusivity for Lipitor. Ranbaxy began selling atorvastatin made at Ohm Laboratories.<\/td>[10][9]<\/td><\/tr>
    April 2012<\/td>The import ban on Ranbaxy’s Mohali atorvastatin was lifted, and Ranbaxy began supplying the US from Mohali.<\/td>[9]<\/td><\/tr>
    May 2012<\/td>Multi-source generic competition began in the US.<\/td>[10]<\/td><\/tr>
    November 2012<\/td>Ranbaxy recalled about 40 batches of 10 mg, 20 mg and 40 mg atorvastatin tablets over possible glass particles.<\/td>[9]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    What the Timeline Shows<\/strong><\/h3>\n\n\n\n

    FDA Law Blog reported in October 2010 that Ranbaxy might launch in November 2011 under a patent settlement, which would trigger its pre-MMA 180-day exclusivity. [8] The same post said FDA invoked its Application Integrity Policy against the Paonta Sahib facility in February 2009. [8] The post said Ranbaxy’s atorvastatin ANDA was widely believed to use that facility, but Ranbaxy had never confirmed it. [8]<\/p>\n\n\n\n

    From February 2009 to November 2011 is 33 months (analysis). Ranbaxy had that time to resolve a site question before a date that the settlement fixed.<\/p>\n\n\n\n

    Pfizer states that it lost Lipitor exclusivity in the US in November 2011 and that multi-source generic competition began in May 2012. [10] The gap is about six months, which matches the 180-day window (analysis). Pfizer reported that worldwide Lipitor revenue fell by $5,629 million, or 59 percent, in 2012 compared with 2011. [10]<\/p>\n\n\n\n

    Site-of-Manufacture Risk<\/strong><\/h4>\n\n\n\n

    Ranbaxy supplied atorvastatin from Ohm Laboratories in late 2011 and began supplying from Mohali after the ban on that product lifted in April 2012. [9] Between launch and the Mohali start is about five months (analysis). During that period, the product came from Ohm Laboratories and not from Mohali.<\/p>\n\n\n\n

    An OTIF metric would record every on-time shipment from Ohm Laboratories as a success. It would not record that the launch depended on a site change.<\/p>\n\n\n\n

    The November 2012 Recall<\/strong><\/h4>\n\n\n\n

    Ranbaxy recalled about 40 batches, in thousands of 90-count and 500-count bottles, as a precaution against glass particles. [9] FDA suggested the recall could lead to a shortage of generic atorvastatin. [9] Ranbaxy said it remained the biggest-selling generic atorvastatin seller in the US even though its exclusivity had ended. [9] Earlier in 2012, the company had signed a five-year FDA consent decree covering its plants, and it had set aside $500 million for possible liabilities. [9]<\/p>\n\n\n\n

    The article does not state that the recalled batches came from a specific plant, so I draw no conclusion about the source. The case still shows that a single-site launch carries quality risk that a delivery metric does not measure.<\/p>\n\n\n\n

    Case Study: Entresto, MSN and 363 Days Between Approval and Launch<\/strong><\/h2>\n\n\n\n

    Generic Entresto Litigation Timeline<\/strong><\/h3>\n\n\n\n
    Date<\/th>Event<\/th>Source<\/th><\/tr><\/thead>
    2023<\/td>A decision invalidated one Entresto patent.<\/td>[12]<\/td><\/tr>
    July 24, 2024<\/td>FDA approved MSN’s generic Entresto.<\/td>[11]<\/td><\/tr>
    August 2024<\/td>Judge Richard Andrews of the US District Court for the District of Delaware denied Novartis’s request for a preliminary injunction and added a three-day stay so Novartis could appeal.<\/td>[11]<\/td><\/tr>
    July 2025 (the report gives weekdays, not dates)<\/td>The Federal Circuit reversed the 2023 decision. District courts in Washington and Delaware rejected requests for an immediate block. The D.C. Circuit issued a pause and lifted it the next day. The Federal Circuit issued a temporary order barring MSN from launching while it considered a longer ban.<\/td>[12]<\/td><\/tr>
    July 22, 2025<\/td>Novadoz launched MSN’s AB-rated generic Entresto.<\/td>[13]<\/td><\/tr>
    July 24, 2025<\/td>Torrent launched its generic Entresto.<\/td>[13]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    What Does the Entresto Sequence Show?<\/strong><\/h3>\n\n\n\n

    FDA approval on July 24, 2024 did not open the market. The launch came 363 days later (analysis, from [11] and [13]). Novartis said that the ruling that reversed the 2023 decision preserved its exclusive rights until July. [12] The judge in Delaware had already found in August 2024 that Novartis had not shown it was very likely to win on patent No. 11,096,918, which Novartis says protects crystalline forms of the active ingredients and runs until November 8, 2026. [11]<\/p>\n\n\n\n

    The report on the July 2025 sequence lists five court actions in two days: two district court denials, a D.C. Circuit pause, the lifting of that pause, and a Federal Circuit temporary order. [12] That count is my tally of the events in the report. In that period, the permitted launch status changed more than once.<\/p>\n\n\n\n

    Supply Implications of a Court-Triggered Date<\/strong><\/h4>\n\n\n\n

    A supplier with an approved product and a court-triggered date has to hold launch stock for an event that has no fixed day. A purchase-order-based metric does not start until a customer orders. In this case, the customer orders could follow only after the legal status allowed shipment.<\/p>\n\n\n\n

    The reports do not say how much inventory MSN, Novadoz or Torrent held. I make no claim about their stock levels. The lesson is about the planning problem: stock has to be released, packed and ready before the ruling arrives.<\/p>\n\n\n\n

    Case Study: Zetia, Glenmark and the Value of One Day<\/strong><\/h2>\n\n\n\n

    What Glenmark Said at Launch<\/strong><\/h3>\n\n\n\n

    Glenmark announced on December 12, 2016 that it was launching what it described as the first and only generic version of Zetia in the US. [1] The release cited annual US sales of about $2.3 billion for Zetia 10 mg for the 12 months ending October 2016, based on IMS Health data. [1] Glenmark and Endo were entitled to 180 days of exclusivity. [1]<\/p>\n\n\n\n

    How Much Is One Day Worth? A Calculation<\/strong><\/h3>\n\n\n\n

    Divide $2.3 billion by 365 days. The result is about $6.3 million of brand sales per day (analysis). Multiply by 180 days. The result is about $1.13 billion of brand-equivalent sales across the window (analysis).<\/p>\n\n\n\n

    These figures are brand sales, not generic revenue. They show the size of the market that moves to generic supply, and they set the scale for the scenario analysis below.<\/p>\n\n\n\n

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

    Settlement Terms Between Celgene and Dr. Reddy’s<\/strong><\/h3>\n\n\n\n

    Bristol Myers Squibb announced on September 17, 2020 that Celgene had settled its US patent litigation over Revlimid (lenalidomide) with Dr. Reddy’s. [14] The release said the volume-limited license begins some time after the March 2022 date that Celgene previously gave to Natco. [14] The specific date and the percentages are confidential. [14] An unlimited quantity license begins no earlier than January 31, 2026. [14]<\/p>\n\n\n\n

    Why In-Full Becomes a Contract Term<\/strong><\/h3>\n\n\n\n

    A volume-limited license sets a ceiling on units. A generic company can ship up to the ceiling and no more. In this structure, supply capacity and legal permission interact. A supplier that cannot ship its allowed volume wastes part of a right that took years of litigation to win. A supplier that ships beyond the ceiling may breach the settlement.<\/p>\n\n\n\n

    This is the one setting in which OTIF has a close analog in a legal document. The metric that matters is the share of the permitted volume the supplier ships on the permitted dates. Standard OTIF does not measure it, because the denominator in OTIF is customer orders, not licensed volume.<\/p>\n\n\n\n

    Case Study: Humira Biosimilars and Two-Price Launches<\/strong><\/h2>\n\n\n\n

    Amgen announced on January 31, 2023 that Amjevita (adalimumab-atto), which it called the first biosimilar to Humira, was available in the US. [15] Amgen offered Amjevita at a list price 55 percent below the Humira list price and also at a list price 5 percent below it. [15] Amgen said it wanted to offer two options to health plans and pharmacy benefit managers. [15]<\/p>\n\n\n\n

    AbbVie reported that global Humira net revenue for 2023 was $14.4 billion, a 32 percent decrease from 2022. [16] AbbVie attributed the 9.6 percent decline in its immunology sector, to $26.1 billion, to Humira biosimilar competition. [16] BioSpace also reported that CVS Caremark said it would remove Humira from its national commercial template formularies and cover biosimilars instead. [16]<\/p>\n\n\n\n

    A two-price launch asks the commercial team to serve two offers on day one. That is my reading of the Amgen announcement. It adds a planning requirement that a delivery metric does not capture: the stock and the contracts for both offers have to be ready when the first payer chooses.<\/p>\n\n\n\n

    What Does Generic Entry Do to Price? What the FDA Data Show<\/strong><\/h2>\n\n\n\n

    FDA’s Generic Competition Study<\/strong><\/h3>\n\n\n\n

    Conrad and Lutter published an FDA report in December 2019 on generic prices. [6] The study covers products with initial generic entry from January 2015 through December 2017. It uses 181 unique products, 711 generic NDCs and 11,442 NDC-months. [6] The report gives medians. It states each ratio as the generic price divided by the pre-entry brand price. [6]<\/p>\n\n\n\n

    Number of generic producers<\/th>Product-months<\/th>Median AMP ratio (generic to pre-entry brand)<\/th>Median invoice ratio<\/th><\/tr><\/thead>
    1<\/td>1,231<\/td>0.614<\/td>0.696<\/td><\/tr>
    2<\/td>1,015<\/td>0.465<\/td>0.562<\/td><\/tr>
    3<\/td>482<\/td>0.322<\/td>0.447<\/td><\/tr>
    4<\/td>267<\/td>0.212<\/td>0.268<\/td><\/tr>
    5<\/td>170<\/td>0.144<\/td>0.152<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Source: Conrad and Lutter, FDA, December 2019. [6]<\/p>\n\n\n\n

    What the Ratios Imply for the First Entrant<\/strong><\/h3>\n\n\n\n

    The table below shows the change from one step to the next on the AMP basis. These are calculations from the FDA medians, not figures that FDA reports.<\/p>\n\n\n\n

    Step<\/th>Ratio change<\/th>Percentage decline (analysis)<\/th><\/tr><\/thead>
    1 to 2 producers<\/td>0.614 to 0.465<\/td>24.3%<\/td><\/tr>
    2 to 3 producers<\/td>0.465 to 0.322<\/td>30.8%<\/td><\/tr>
    3 to 4 producers<\/td>0.322 to 0.212<\/td>34.2%<\/td><\/tr>
    4 to 5 producers<\/td>0.212 to 0.144<\/td>32.1%<\/td><\/tr>
    1 to 5 producers<\/td>0.614 to 0.144<\/td>76.5%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

    Each added producer cuts the median price by about a quarter to a third. A company that enters on day one sells at the top of that curve. A company that enters later sells lower on the curve, and the late entrant cannot recover that gap.<\/p>\n\n\n\n

    The FDA report states the single-producer case in words: the generic AMP is 39 percent lower than the brand AMP before generic competition. [6] On invoice prices, the reduction is 31 percent. [6]<\/p>\n\n\n\n

    Scenario Analysis: What Is at Risk if Day One Slips?<\/strong><\/h2>\n\n\n\n

    Assumptions<\/strong><\/h3>\n\n\n\n

    This scenario is an illustration. It is not a forecast of any company’s results. I use four inputs.<\/p>\n\n\n\n

      \n
    • Brand run-rate: $2.3 billion per year, the Zetia figure in [1]. That is $6.30 million per day.<\/li>\n\n\n\n
    • Generic price: 0.614 of the brand price, the FDA median AMP ratio for one generic producer. [6]<\/li>\n\n\n\n
    • Generic share of volume during the window: 40, 60 or 80 percent. These shares are assumptions chosen to show a range. No source supports a specific share.<\/li>\n\n\n\n
    • Daily generic revenue equals the run-rate times the share times the price ratio.<\/li>\n<\/ul>\n\n\n\n

      Results<\/strong><\/h3>\n\n\n\n
      Exposure<\/th>40% share ($M)<\/th>60% share ($M)<\/th>80% share ($M)<\/th><\/tr><\/thead>
      One day<\/td>1.5<\/td>2.3<\/td>3.1<\/td><\/tr>
      7 days<\/td>10.8<\/td>16.2<\/td>21.7<\/td><\/tr>
      14 days<\/td>21.7<\/td>32.5<\/td>43.3<\/td><\/tr>
      30 days<\/td>46.4<\/td>69.6<\/td>92.9<\/td><\/tr>
      Full 180-day window<\/td>278.6<\/td>417.8<\/td>557.1<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

      How to Read the Table<\/strong><\/h4>\n\n\n\n

      A delay does not erase days from a 180-day window by itself, because the period runs from first commercial marketing. The table shows the value exposed if a forfeiture event removes the window, if a rival compresses it, or if lost volume does not return. The FDA single-producer ratio is a median across product-months and does not describe pricing during any one exclusivity period. The shares are assumptions. Use the table to size the stakes, not to predict revenue.<\/p>\n\n\n\n

      Compare the exposure with a retail fine. On a $2 million launch order, Walmart’s 3 percent fine is $60,000 (analysis from [2]). The scenario exposure for a single day at a 60 percent share is $2.3 million. The two numbers differ by a factor of about 38 (analysis). A penalty clause sized for routine goods does not match the risk in a launch.<\/p>\n\n\n\n

      What Else a Missed Day One Can Do<\/strong><\/h4>\n\n\n\n

      The 2010 FDA Law Blog post, citing BernsteinResearch, described a less likely scenario in which a failed Ranbaxy launch delays the Lipitor market in a way that holds other generics off. [8] That outcome follows from how exclusivity works. A first applicant that does not launch can block others without selling product. The forfeiture rules exist to limit that outcome. [3]<\/p>\n\n\n\n

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

      This article draws on public documents. I read FDA regulations, a law course summary of the forfeiture statute, an FDA price report, court-related news reports, company press releases, an SEC exhibit and trade press. I did not query a patent database for the calculations. The records are listed in the references.<\/p>\n\n\n\n

        \n
      • Time period: 2008 to September 2025 for events, and January 2015 to December 2017 for the FDA price data.<\/li>\n\n\n\n
      • Selection: I picked five launches that illustrate different trigger types. The sample is a set of examples. It is not a random sample, and it supports no statement about how often launches fail.<\/li>\n\n\n\n
      • Calculations: Day counts use calendar days. Percent changes use the FDA medians as published. The scenario multiplies a stated run-rate by an assumed share and a published median price ratio.<\/li>\n\n\n\n
      • Duplicates: Each event appears once in the timelines. Where two sources report the same event, I cite the one that gives more detail.<\/li>\n\n\n\n
      • Included events: A launch is included if a company or a regulator source reports a date. A court event is included if a news report dates it.<\/li>\n<\/ul>\n\n\n\n

        Limits. Several sources are news reports and not court opinions. The reports on the Entresto Federal Circuit sequence do not state exact dates for each order, so the table gives the sequence and not a date for each step. The Ranbaxy sources do not tie the 2012 recall to a specific plant. The 2019 FDA price data predate the launches discussed here, so the ratios describe a past sample. Where I calculate, I mark the figure as analysis.<\/p>\n\n\n\n

        Which Metrics Measure Day-One Readiness?<\/strong><\/h2>\n\n\n\n

        The four metrics below are my proposals. No regulator or standards body defines them. Each one is tied to a legal trigger and not to a customer order.<\/p>\n\n\n\n

        Day-One Fill Rate<\/strong><\/h3>\n\n\n\n

        Day-one fill rate is the units shipped against launch-day orders within 24 hours of first commercial marketing, divided by the units ordered in that window. It is a measure of the one date. Report it as a number for each launch, not as an average across launches.<\/p>\n\n\n\n

        Launch Inventory Coverage<\/strong><\/h3>\n\n\n\n

        Launch inventory coverage is the released, saleable units on hand one day before the trigger, divided by the forecast units demanded until the first replenishment lot ships. A value below 1.0 means the supply plan runs out before it refills.<\/p>\n\n\n\n

        Why Release Status Matters<\/strong><\/h4>\n\n\n\n

        Count only units that quality has released for sale. Units in quarantine or in pending testing cannot ship. In a court-triggered launch, this rule matters most, because the ruling can arrive before the lot release does.<\/p>\n\n\n\n

        Time to First Commercial Shipment<\/strong><\/h3>\n\n\n\n

        Time to first commercial shipment is the number of hours between the legal trigger and the first shipment that meets the definition of commercial marketing. [4] For a regulatory-clock date, record it against the 75-day limit. [3][5] For a court-triggered date, record it against the hour of the ruling.<\/p>\n\n\n\n

        Site Readiness Flag<\/strong><\/h3>\n\n\n\n

        The site readiness flag is a yes-or-no test: does every site named in the application have the regulatory standing to ship? The Lipitor case shows why. The launch began from Ohm Laboratories, and supply from Mohali started only after the April 2012 end of the import ban on that product. [9] A flag set to no on launch day is a launch risk that no delivery rate reflects.<\/p>\n\n\n\n

        Pairing the Flag With a Tentative-Approval Clock<\/strong><\/h4>\n\n\n\n

        The 30-month tentative approval limit is also a site readiness issue. [3] A team can track the months remaining and the open items at each site in the same report.<\/p>\n\n\n\n

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

        Treat each Paragraph IV launch as a project with a legal trigger, not as a product in the order book. Set the build date from the trigger type in the taxonomy above. For a Type C date, build and release stock before the ruling. For a Type D date, count back from the 75-day limit. [5]<\/p>\n\n\n\n

        Keep a dated record of the first commercial shipment, because that event can start the exclusivity clock. [4] Review every site on the application for regulatory standing before the trigger.<\/p>\n\n\n\n

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

        The brand side sees the same dates from the other direction. The Entresto timeline shows a brand that fought for a court order in the final days before the date. [12] The Humira revenue decline shows how large a single year of biosimilar competition can be. [16] Brand teams need their own day-one plan for supply, contracts and any authorized generic, because the price curve in the FDA data starts to fall the day the first generic ships. [6]<\/p>\n\n\n\n

        What This Means for Biosimilar Developers<\/strong><\/h2>\n\n\n\n

        Biosimilar launches add a payer layer. Amgen’s two list-price offers for Amjevita show that the commercial plan can include more than one product offer on day one. [15] The supply plan has to cover each offer and each contract. A launch-day fill rate for a biosimilar should be measured by offer, not only in total.<\/p>\n\n\n\n

        What This Means for Contract Manufacturers and Distributors<\/strong><\/h2>\n\n\n\n

        A contract manufacturer that reports 98 percent OTIF to a generic customer has told the customer very little about launch risk. Ask for the four launch metrics instead, and ask for the release date of the launch lots. A distributor should ask how many days of stock the manufacturer has released for the date and not how often past orders arrived on time.<\/p>\n\n\n\n

        How Can DrugPatentWatch Data Support a Day-One Calendar?<\/strong><\/h2>\n\n\n\n

        DrugPatentWatch compiles patent, exclusivity and litigation records for pharmaceutical products. A supply team can use that kind of data to build the first draft of a launch calendar: listed patents and their expiry dates, exclusivity periods, and Paragraph IV litigation. The platform is a starting point and not a legal authority.<\/p>\n\n\n\n

        Which Sources Should Confirm a Date?<\/strong><\/h3>\n\n\n\n

        Confirm each date against the primary source. Use the Orange Book and FDA records for exclusivity and approval status. Use the court docket or opinion for litigation events. Use company filings and press releases for announced settlement terms. Where a settlement keeps a date confidential, as in the Revlimid case, no public database can supply it. [14]<\/p>\n\n\n\n

        A Simple Calendar Structure<\/strong><\/h3>\n\n\n\n

        List each product with four fields: the trigger type from the taxonomy, the earliest possible date, the latest plausible date, and the next legal event that can move the date. Add the build-complete date and the release date for launch lots. A gap between the build date and the earliest possible date is a warning.<\/p>\n\n\n\n

        Key Takeaways<\/strong><\/h2>\n\n\n\n
          \n
        • OTD and OTIF measure orders against customer-set dates. Day one of generic entry is set by a patent, a settlement, a court or FDA.<\/li>\n\n\n\n
        • A 10,000-line supplier that misses only the launch line scores 99.99 percent OTIF (analysis).<\/li>\n\n\n\n
        • The statute can end 180-day exclusivity if the first applicant does not market in time. [3] The CGT rule sets a 75-day marketing deadline after approval. [5]<\/li>\n\n\n\n
        • FDA’s median generic-to-brand AMP ratio falls from 0.614 with one producer to 0.144 with five. [6]<\/li>\n\n\n\n
        • FDA approved MSN’s generic Entresto on July 24, 2024. Reported launches came on July 22 and July 24, 2025. [11][13]<\/li>\n\n\n\n
        • At the Zetia run-rate cited by Glenmark, one day of brand sales is about $6.3 million (analysis from [1]).<\/li>\n\n\n\n
        • A launch needs four measures: day-one fill rate, launch inventory coverage, time to first commercial shipment and a site readiness flag. These are original proposals.<\/li>\n<\/ul>\n\n\n\n

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

          What is the difference between OTD and OTIF?<\/strong><\/h3>\n\n\n\n

          OTD counts orders that arrive by the promised date. OTIF counts orders that arrive by the promised date and in the full ordered quantity. Walmart’s 98 percent target applies to the second kind of measure. [2]<\/p>\n\n\n\n

          Does a generic company lose 180-day exclusivity if it misses its launch date?<\/strong><\/h3>\n\n\n\n

          It can. The statute lists failure to market as a forfeiture event, and the deadline is the later of two dates. [3] The answer depends on the facts of each application, so regulatory counsel should review any specific case.<\/p>\n\n\n\n

          What is competitive generic therapy exclusivity?<\/strong><\/h3>\n\n\n\n

          It is a 180-day exclusivity for the first approved applicant for a drug with inadequate generic competition. It comes from the FDA Reauthorization Act of 2017 and section 506H of the FD&C Act. [5]<\/p>\n\n\n\n

          How long does a CGT applicant have to launch after approval?<\/strong><\/h3>\n\n\n\n

          The applicant has 75 calendar days, counted from the day after the approval is made effective. [5] A missed deadline forfeits eligibility for the exclusivity. [5]<\/p>\n\n\n\n

          What counts as commercial marketing for exclusivity purposes?<\/strong><\/h3>\n\n\n\n

          FDA’s regulation defines it as the introduction or delivery for introduction into interstate commerce of a drug product. [4] It excludes shipments for investigational use and transfers to named parties for reasons other than sale. [4]<\/p>\n\n\n\n

          How much do generic prices fall as more companies enter?<\/strong><\/h3>\n\n\n\n

          In FDA’s 2019 analysis, the median generic AMP was 61.4 percent of the pre-entry brand price with one producer and 14.4 percent with five. [6] The decline between steps was 24 to 34 percent in my calculation from those medians.<\/p>\n\n\n\n

          How did Amgen price the biosimilar to Humira at launch?<\/strong><\/h3>\n\n\n\n

          Amgen offered Amjevita at a list price 55 percent below Humira’s and at a list price 5 percent below it. [15] The company said it aimed to give health plans and pharmacy benefit managers two options. [15]<\/p>\n\n\n\n

          Why did generic Entresto launch a year after FDA approval?<\/strong><\/h3>\n\n\n\n

          Approval of the ANDA did not settle the patent dispute. A Delaware court denied Novartis a preliminary injunction in August 2024. [11] The Federal Circuit later reversed a 2023 decision on one patent, and court orders in July 2025 decided when MSN could ship. [12] Optum Rx reports launches on July 22 and July 24, 2025. [13]<\/p>\n\n\n\n

          What is a volume-limited license in a patent settlement?<\/strong><\/h3>\n\n\n\n

          It is a license that lets a generic company sell up to a stated quantity during a set period. In the Revlimid settlement with Dr. Reddy’s, the volume-limited start date and percentages are confidential, and the unlimited license begins no earlier than January 31, 2026. [14]<\/p>\n\n\n\n

          Which metrics should a supply team track for a generic launch?<\/strong><\/h3>\n\n\n\n

          Track day-one fill rate, launch inventory coverage, time to first commercial shipment and a site readiness flag. These are the framework proposed in this article. Report each as a value for one launch, not as an average.<\/p>\n\n\n\n

          References<\/strong><\/h2>\n\n\n\n
            \n
          1. Glenmark Pharmaceuticals. (2016, December 12). Glenmark launches first and only generic version of Zetia (ezetimibe) in the United States [Press release, reproduced by New Drug Approvals, 2016, December 13]. https:\/\/newdrugapprovals.org\/2016\/12\/13\/glenmark-launches-first-and-only-generic-version-of-zetia-ezetimibe-in-the-united-states<\/li>\n\n\n\n
          2. Solomon, M. (2020, September 11). Walmart tightens on-time, in-full requirements. FreightWaves. https:\/\/www.freightwaves.com\/news\/walmart-tightens-on-time-in-full-requirements<\/li>\n\n\n\n
          3. Berkeley Law. (2024). 180 day generic drug exclusivity: Forfeiture [Course materials summarizing 21 U.S.C. 355(j)(5)(D)(i)]. University of California, Berkeley. https:\/\/law.berkeley.edu\/wp-content\/uploads\/2024\/05\/180-Day-Generic-Drug-Exclusivity-\u2013-Forfeiture.pdf<\/li>\n\n\n\n
          4. Definitions, 21 C.F.R. 314.3. Legal Information Institute, Cornell Law School. https:\/\/www.law.cornell.edu\/cfr\/text\/21\/314.3<\/li>\n\n\n\n
          5. Arnall Golden Gregory LLP. (2020, June 1). Competitive generic therapies: FDA issues final guidance. https:\/\/www.agg.com\/news-insights\/publications\/competitive-generic-therapies-fda-issues-final-guidance\/<\/li>\n\n\n\n
          6. Conrad, R., & Lutter, R. (2019, December). Generic competition and drug prices: New evidence linking greater generic competition and lower generic drug prices. U.S. Food and Drug Administration. https:\/\/fda.gov\/media\/133509\/download<\/li>\n\n\n\n
          7. Association for Accessible Medicines. (2025, September 3). Generic and biosimilar medicines save $467 billion in 2024 [Press release]. https:\/\/accessiblemeds.org\/resources\/press-releases\/generic-and-biosimilar-medicines-save-467-billion-in-2024\/<\/li>\n\n\n\n
          8. Karst, K. R. (2010, October 12). Generic LIPITOR: The brass ring of all brass rings for 180-day exclusivity; how will exclusivity resolve? FDA Law Blog. https:\/\/www.thefdalawblog.com\/2010\/10\/generic-lipitor-the-brass-ring-of-all-brass-rings-for-180-day-exclusivity-how-will-exclusivity-resol\/<\/li>\n\n\n\n
          9. Taylor, P. (2012, November 27). Glass particles force recall of Ranbaxy Lipitor. Pharmafile. https:\/\/pharmafile.com\/news\/glass-particles-force-recall-ranbaxy-lipitor\/<\/li>\n\n\n\n
          10. Pfizer Inc. (2013). 2012 financial report (Exhibit 13 to Form 10-K for fiscal year 2012). U.S. Securities and Exchange Commission. https:\/\/www.sec.gov\/Archives\/edgar\/data\/0000078003\/000007800313000006\/pfe-12312012xex13.htm<\/li>\n\n\n\n
          11. Taylor, P. (2024, August 13). Judge rebuffs Novartis bid to block generic Entresto. PharmaPhorum. https:\/\/pharmaphorum.com\/news\/judge-rebuffs-novartis-bid-block-generic-entresto<\/li>\n\n\n\n
          12. DrugStore News. (2025). US appeals court reinstates pause on MSN’s generic of Novartis’ Entresto. https:\/\/drugstorenews.com\/us-appeals-court-reinstates-pause-msns-generic-novartis-entresto<\/li>\n\n\n\n
          13. Optum Rx. (2025). Entresto (sacubitril\/valsartan): First-time generic. RxNews. https:\/\/business.optum.com\/en\/support\/professionalrx-resources\/newgeneric-entresto-073025.html<\/li>\n\n\n\n
          14. Bristol Myers Squibb. (2020, September 17). Bristol Myers Squibb announces settlement of U.S. patent litigation for Revlimid (lenalidomide) with Dr. Reddy’s [Press release, reproduced by BioSpace]. https:\/\/www.biospace.com\/bristol-myers-squibb-announces-settlement-of-u-s-patent-litigation-for-revlimid-lenalidomide-with-dr-reddy-s<\/li>\n\n\n\n
          15. Amgen. (2023, January 31). AMJEVITA (adalimumab-atto), first biosimilar to Humira, now available in the United States [Press release]. https:\/\/amgen.com\/newsroom\/press-releases\/2023\/01\/amjevita-adalimumabatto-first-biosimilar-to-humira-now-available-in-the-united-states<\/li>\n\n\n\n
          16. BioSpace. (2024). AbbVie gets Q4 beat, sees 2023 sales decline in oncology, immunology. https:\/\/www.biospace.com\/article\/abbvie-gets-q4-revenue-beat-sees-2023-sales-decline-in-oncology-immunology\/<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

            Glenmark launched generic Zetia in the United States on December 12, 2016. IMS Health data cited in the company’s release […]<\/p>\n","protected":false},"author":1,"featured_media":39945,"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-39944","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\/39944","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=39944"}],"version-history":[{"count":1,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39944\/revisions"}],"predecessor-version":[{"id":39946,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/posts\/39944\/revisions\/39946"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media\/39945"}],"wp:attachment":[{"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/media?parent=39944"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/categories?post=39944"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.drugpatentwatch.com\/blog\/wp-json\/wp\/v2\/tags?post=39944"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}