{"id":39938,"date":"2026-10-22T09:40:00","date_gmt":"2026-10-22T13:40:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=39938"},"modified":"2026-10-17T17:04:33","modified_gmt":"2026-10-17T21:04:33","slug":"a-patent-expiry-date-is-not-a-pharma-partnership-plan","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/a-patent-expiry-date-is-not-a-pharma-partnership-plan\/","title":{"rendered":"A Patent Expiry Date Is Not a Pharma Partnership Plan"},"content":{"rendered":"\n<figure class=\"wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"572\" src=\"https:\/\/www.drugpatentwatch.com\/blog\/wp-content\/uploads\/2026\/10\/image-16.png\" alt=\"\" class=\"wp-image-39939\" srcset=\"https:\/\/www.drugpatentwatch.com\/blog\/wp-content\/uploads\/2026\/10\/image-16.png 1024w, https:\/\/www.drugpatentwatch.com\/blog\/wp-content\/uploads\/2026\/10\/image-16-300x168.png 300w, https:\/\/www.drugpatentwatch.com\/blog\/wp-content\/uploads\/2026\/10\/image-16-768x429.png 768w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Novo Nordisk&#8217;s Canadian semaglutide patent, CA 2601784, lapsed because a maintenance fee went unpaid in 2019. The fee was CAD 250, or CAD 450 with the late charge. [3] In late April 2026, Health Canada approved a generic Ozempic from Dr. Reddy&#8217;s Laboratories. Trade press reported it as the first generic semaglutide approval in a G7 country. [3] Apotex followed within days. [4]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The patent date opened a door. It did not choose who walked through. Dr. Reddy&#8217;s says it makes the active ingredient in-house and uses a contract partner for finished product. [3] Apotex developed its product with an Indian company, Orbicular Pharmaceutical Technologies. [4] At least four other firms were still waiting for Health Canada decisions. [4]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This article explains why a patent expiration date is the start of partner selection and not the end of it. It uses four documented cases: Humira, semaglutide, Stelara biosimilars and Entresto. It then sets out an original five-gate screen and a five-type taxonomy of partnership structures. A business development team can apply both to any expiring product.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>The Short Answer<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What does a patent expiration date tell you?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A patent expiration date tells you when one legal barrier ends in one territory. It does not tell you when a competitor can sell. FDA says patents and exclusivity &#8220;work in a similar fashion but are distinct from one another and governed by different statutes.&#8221; [1]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What does it leave out?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">It leaves out five facts that decide whether a partnership works. These are the other legal barriers, the territory, regulatory readiness, manufacturing capacity, and the sales channel with its deal terms. The cases below show each gap with dated records.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>The Findings That Matter<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Each finding below is specific, dated and sourced. Findings marked as calculated are our arithmetic on cited figures. They are not independently reported statistics.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Amgen won a non-exclusive Humira license with a European start date of October 16, 2018 and a US start date of January 31, 2023. [7] The gap is about 51 months (calculated).<\/li>\n\n\n\n<li>One molecule had different clocks by country. Semaglutide patent protection in Canada lapsed, the Indian patent expired on March 20, 2026, and Novo&#8217;s table shows Europe and Japan protected to 2031 and the US compound patent to 2032. [3][6]<\/li>\n\n\n\n<li>Seven biosimilars of Stelara launched in the US between early January and November 6, 2025. Six of them launched in about ten weeks (calculated). [10][12][13]<\/li>\n\n\n\n<li>Alvotech received four FDA rejections between September 2022 and October 2023, three for its Humira biosimilar and one for its Stelara biosimilar. [14] Its Stelara biosimilar still launched on the settlement date of February 21, 2025. [10]<\/li>\n\n\n\n<li>Sun Pharma&#8217;s India launch price of INR 750 per weekly injection is about 61% to 66% below the INR 8,800 to INR 10,000 monthly price band for Novo&#8217;s product (calculated from [6]).<\/li>\n\n\n\n<li>Entresto sales fell from USD 2,357 million in Q2 2025 to USD 1,181 million in Q2 2026. Novartis attributes the 50% decline to US generic competition. [16]<\/li>\n\n\n\n<li>FDA data show generic prices 39% below the brand price with one generic producer and more than 95% below with six or more. [2]<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Methodology and Definitions<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What data does this article use?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">We assembled public records on four products. The records cover patent status, FDA and Health Canada actions, settlement dates, launch dates, company filings and trade-press reports of company statements. We chose each case because dated public records exist for its patent events and its partnership structure. We did not run a database export for this article. The analysis compares documented events. It does not claim statistical coverage of all drug launches.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A record counts as included if it names a party, an event and a date. We used each event once. Where two sources gave the same event, we kept the one closest to the primary record. We calculated day counts between stated dates and percentage differences between stated prices. Section &#8220;Day Counts and Calculations Used in This Article&#8221; lists every calculation.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What could we not verify?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Several limits apply. Many sources are trade-press summaries of company releases and not the releases themselves. Settlement financial terms are confidential in the cases reviewed, so we make no claim about them. Public reports reviewed here do not state how the Entresto &#8216;918 dispute ended. Submission dates for Canadian generic applications are not public in the sources, so we cannot measure review time per file. We did not convert currencies. A reader who plans to act on a date should check it against the primary record.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What do the key terms mean?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">These are working definitions for this article.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Patent expiration date: the date a patent stops giving its owner a right to exclude. It is one input to market entry.<\/li>\n\n\n\n<li>Regulatory exclusivity: a delay or prohibition on approval of competitor drugs. FDA lists new chemical entity exclusivity at 5 years, new clinical investigation exclusivity at 3 years and orphan drug exclusivity at 7 years. [1]<\/li>\n\n\n\n<li>Loss of exclusivity (LOE): the date the last barrier falls and a competitor can sell.<\/li>\n\n\n\n<li>Entry date: the date a competitor actually launches. Settlements, approvals and supply can move it away from the LOE date.<\/li>\n\n\n\n<li>Partner: a company that develops, makes, licenses or sells the product on one side of a deal.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Why Does a Patent Expiry Date Not Equal a Generic Entry Date?<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Several separate barriers sit on the same product. Each has its own date and its own owner.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>How does FDA separate patents from exclusivity?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">FDA keeps two systems. The first is patents, which the US Patent and Trademark Office grants. The second is exclusivity, which FDA grants on approval. FDA says the two &#8220;are distinct from one another and governed by different statutes.&#8221; [1]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Pediatric exclusivity adds 6 months. FDA says it &#8220;does not stand alone, but attaches to existing exclusivity.&#8221; [1] A patent date that looks past can still hold a market closed.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What does the Orange Book not check?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The brand company submits patent information on Form FDA 3542 within 30 days after approval. [1] FDA says it will not list patent information that the company does not provide on that form. [1] FDA also describes its patent listing role as &#8220;ministerial.&#8221; [1]<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>What this means for a partner search<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">A listed date is what the holder submitted. It is not an FDA finding that the patent is valid or that the date is final (analysis). A partner screen needs a second source, such as a court docket or a settlement notice.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Entresto: a patent date that moved<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Entresto (sacubitril and valsartan) shows the effect. In the Delaware litigation against MSN, patent US 8,101,659 had expired, then received pediatric exclusivity that extended it to July 15, 2025. [15] In April 2025 the court ordered FDA to reset MSN&#8217;s approval date to no earlier than July 16, 2025. [15] A second patent, US 11,096,918, was due to expire in November 2026 and was still in dispute in June 2025. [15]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Public reports reviewed for this article do not state how the &#8216;918 dispute ended. Novartis does state that Entresto sales fell because of generic competition in the US. [16] Trade press said generics entered the US market in the summer of 2025. [17]<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Humira: The Date That Depended on the Region<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Humira settlement timeline<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">AbbVie and Amgen announced a global settlement of adalimumab patent litigation on September 28, 2017. [7] AbbVie gave Amgen a non-exclusive license. The license started in most EU countries on October 16, 2018 for Amgevita. It started in the US on January 31, 2023 for Amjevita. [7] The companies did not disclose financial terms. [7]<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Event<\/th><th>Date<\/th><th>Source<\/th><\/tr><\/thead><tbody><tr><td>Global settlement announced<\/td><td>September 28, 2017<\/td><td>[7]<\/td><\/tr><tr><td>Amgen license starts, EU<\/td><td>October 16, 2018<\/td><td>[7]<\/td><\/tr><tr><td>Amgen license starts, US<\/td><td>January 31, 2023<\/td><td>[7]<\/td><\/tr><tr><td>Gap between EU and US start (calculated)<\/td><td>About 51 months<\/td><td>Analysis of [7]<\/td><\/tr><tr><td>Settlement to US start (calculated)<\/td><td>About 64 months<\/td><td>Analysis of [7]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>What the settlement meant for partner selection<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">A model with one adalimumab date would have been wrong for one region by about 51 months (calculated). Scott Foraker, then Amgen&#8217;s vice president and general manager for biosimilars, said the deal would &#8220;secure a strong foothold in the $4 billion European adalimumab market.&#8221; [7] Amgen used the earlier region to build a position before the US opened.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The license was non-exclusive. [7] That term matters to any partner. A non-exclusive grant leaves the brand owner free to license others (analysis). A team that values a Humira-type partnership on the assumption of exclusive access would overstate the prize.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Semaglutide: One Molecule, Many Clocks<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>How did Canada open before every other G7 market?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Canada opened because the patent lapsed. Novo&#8217;s last maintenance fee for CA 2601784 reached the patent office on October 23, 2018. [3] The reversal period ended on August 31, 2020, and the database lists the patent as expired beyond the period of reversal. [3] Novo&#8217;s Canadian president declined to give details of the lapse and cited confidentiality. [5]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Health Canada had nine semaglutide submissions on file as of December 29, 2025. [5] Its target for scientific review of a generic is 180 days. [5] The first approval came on April 28, 2026. [3] That is 114 days after January 4, the date on which, according to the Canadian press report, regulatory exclusivity ended (calculated from [3][5]).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Who is in line behind the first two Canadian approvals?<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Health Canada was reviewing more submissions, including those from Teva, Aspen Pharmacare, Taro Pharmaceuticals and Sandoz. [4] A University of Toronto policy expert said generics could be priced as low as 35% of the Ozempic price and that he expected several competitors. [5] Novo Nordisk Canada said it plans savings support for some uninsured patients who do not want to switch. [5]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>How did India open on March 20, 2026?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The Indian semaglutide patent expired on March 20, 2026. [6] More than 50 brands were expected to follow the first launches. [6] Sun Pharma launched at INR 750 per weekly injection, about INR 3,400 per month. [6] Dr. Reddy&#8217;s launched a diabetes-focused version at about INR 4,200 per month. [6]<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>What is the price math?<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Novo&#8217;s price band in India is INR 8,800 to INR 10,000 per month. [6] The table compares the two launch prices with that band. We calculated these figures from [6].<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Launcher<\/th><th>Monthly price (INR)<\/th><th>Below INR 8,800<\/th><th>Below INR 10,000<\/th><\/tr><\/thead><tbody><tr><td>Sun Pharma<\/td><td>About 3,400<\/td><td>About 61%<\/td><td>About 66%<\/td><\/tr><tr><td>Dr. Reddy&#8217;s (diabetes version)<\/td><td>About 4,200<\/td><td>About 52%<\/td><td>About 58%<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The two launchers priced differently on day one. A partner that assumes one market price will misjudge margin (analysis).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>When do the US, Europe and Japan open?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Later. Trade press citing Novo&#8217;s patent table puts compound patent expiry for Ozempic, Rybelsus and Wegovy at 2032 in the US and 2031 in Japan and Europe. [3] Dr. Reddy&#8217;s chief executive Erez Israeli said the &#8220;U.S. and Europe will open later&#8221; and that &#8220;all the other Western markets will be open between 2029 to 2033.&#8221; [9]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In the US, Novo settled Ozempic litigation with Alvogen, Rio Biopharmaceuticals, Sun Pharma, Dr. Reddy&#8217;s, Mylan, Zydus and Apotex. The terms are confidential. [3] A 2024 settlement covered US patent 10,335,462, which claims specific semaglutide dosages for type 2 diabetes. [9]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Semaglutide patent clock by territory<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Territory<\/th><th>Documented status<\/th><th>Source<\/th><\/tr><\/thead><tbody><tr><td>Canada<\/td><td>CA 2601784 lapsed; generics approved April 28 and May 1, 2026<\/td><td>[3][4]<\/td><\/tr><tr><td>India<\/td><td>Patent expired March 20, 2026; 50+ brands expected<\/td><td>[6]<\/td><\/tr><tr><td>China<\/td><td>Key patents reported as expired in 2026; manufacturers reported to be preparing to scale production<\/td><td>[8]<\/td><\/tr><tr><td>United States<\/td><td>Compound patent to 2032; confidential settlements with seven named filers<\/td><td>[3]<\/td><\/tr><tr><td>Europe and Japan<\/td><td>Protection to 2031 per Novo&#8217;s table<\/td><td>[3]<\/td><\/tr><tr><td>Other Western markets<\/td><td>2029 to 2033 per Dr. Reddy&#8217;s chief executive<\/td><td>[9]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Dr. Reddy&#8217;s said in July 2025 that it planned to launch in 87 countries in 2026. Launches would begin in &#8220;Canada, India, Brazil, Turkey and other emerging markets, subject to patent expiry.&#8221; [9] A plan for 87 countries needs 87 separate legal checks (analysis).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Why Does Manufacturing Capability Decide Who Can Use the Date?<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A patent date lets a company file or launch. It does not give the company a factory, an approved process or a clean inspection record.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Why is semaglutide hard to make?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Semaglutide is a 31-amino-acid lipidated peptide. [6] Large-scale synthesis uses solid-phase peptide synthesis, a lipidation step, preparative HPLC purification and strict impurity control. [6] Harshad Lalwani of Hummsa Biotech told Outlook Business that India&#8217;s active ingredient strength is in small molecules and that industrial-scale peptide synthesis is a different discipline. He said only a handful of companies can do it consistently. [6]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">He also said India has no well-defined pathway at its drug regulator for showing bioequivalence of peptide generics. [6] This is one expert&#8217;s statement in one article. We cite it as an informed view, not as a regulatory finding.<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>How do the first Canadian approvals split the work?<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Dr. Reddy&#8217;s says it produces the semaglutide active ingredient entirely in-house. OneSource Specialty Pharma makes the finished product. [3] Apotex developed its product with Orbicular Pharmaceutical Technologies of India. [4] The two first approvals therefore rest on two different supply structures (analysis).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>What should a partner check?<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">A partner should check who makes the active ingredient, who fills and assembles the pen, and which sites FDA or Health Canada has inspected. A patent database does not hold those answers.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Why did Canadian approval take months?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">One analyst expected approval in late spring or early summer. He linked the longer review in part to the complexity of the molecule. [5] The first approval came in late April. [3] The sources do not give submission dates, so we cannot say how long Health Canada spent on each file.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Stelara Biosimilars: Same Date, Seven Launches<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Stelara (ustekinumab) shows what happens when one product opens to many entrants. The seven US launches differ in partnership structure, timing and channel.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Who launched, when and with whom?<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Product<\/th><th>Companies named in the source<\/th><th>US launch<\/th><th>Source<\/th><\/tr><\/thead><tbody><tr><td>Wezlana<\/td><td>Amgen; sold through Optum&#8217;s private-label subsidiary Nuvaila<\/td><td>Early January 2025<\/td><td>[12]<\/td><\/tr><tr><td>Selarsdi<\/td><td>Alvotech develops; Teva sells in the US<\/td><td>February 21, 2025<\/td><td>[10][11]<\/td><\/tr><tr><td>Pyzchiva<\/td><td>Samsung Bioepis and Sandoz<\/td><td>February 24, 2025<\/td><td>[12]<\/td><\/tr><tr><td>Yesintek<\/td><td>Biocon<\/td><td>February 24, 2025<\/td><td>[12]<\/td><\/tr><tr><td>Otulfi<\/td><td>Formycon and Fresenius Kabi<\/td><td>Early March 2025<\/td><td>[12]<\/td><\/tr><tr><td>Steqeyma<\/td><td>Celltrion<\/td><td>March 13, 2025 (announcement date)<\/td><td>[12]<\/td><\/tr><tr><td>Starjemza<\/td><td>Hikma sells under an exclusive license from Bio-Thera; Bio-Thera develops and makes the product<\/td><td>November 6, 2025<\/td><td>[13]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The first six launches fell inside about ten weeks, from early January to March 13, 2025 (calculated). The seventh came about 34 weeks after the sixth (calculated).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Which structures appear in the table?<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">The table shows a single-company launch, a developer paired with a seller, and a licensor paired with an exclusive US licensee. Hikma signed its Bio-Thera agreement in August 2021. [13] Alvotech and Teva signed their partnership in August 2020 for five candidates and added four more in July 2023. [10] A partner screen should record which structure each candidate uses (analysis).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What did four FDA rejections do to the Alvotech and Teva plan?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Alvotech received a complete response letter in September 2022 for its Humira biosimilar after a March 2022 inspection. A warning letter at the time reported mold and bacterial contamination in manufacturing rooms. [14] A second rejection came in April 2023 for manufacturing reasons. A third came in June 2023 and blocked an interchangeability bid. [14] The fourth, in October 2023, covered the Stelara biosimilar and cited deficiencies found in a March 2023 inspection of the Reykjavik site. [14]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Alvotech said it expected FDA to reinspect early the following year and aimed to launch by February 2025. [14] Alvotech and Teva settled with Johnson and Johnson in June 2023, and the settlement allowed a US launch from February 21, 2025. [10] The product launched on February 21, 2025. [10] The settlement-to-entry gap was 20 months (calculated).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>What this shows about partner risk<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">A date-based screen would have scored Alvotech and Teva the same as the other six entrants. A readiness-based screen would have flagged a manufacturing record that stayed open for about 29 months, from the first rejection in September 2022 to the launch in February 2025 (calculated). The record closed in time for this launch. It could have closed late.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">FDA approved Selarsdi as interchangeable with Stelara for all presentations in May 2025. [11] Interchangeability is a regulatory status that a partner can add after a clean approval path (analysis).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Which channels did the entrants use?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Amgen sold Wezlana through Nuvaila, Optum&#8217;s private-label subsidiary. [12] Teva&#8217;s subsidiary Anda said it would sell an unbranded ustekinumab-aekn from January 1, 2026 through MedImpact&#8217;s preferred partner, Birdi. [10] CivicaScript said it would distribute Fresenius Kabi&#8217;s unbranded ustekinumab-aauz from the same date. [10] Celltrion said its list price would be 85% below the current US list price of Stelara. [12]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Each channel decision changes who a partner must know (analysis). A company with a good product and no route to a pharmacy benefit manager or specialty pharmacy needs a partner that has one.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What Happens to Revenue After the Date? Entresto and FDA Price Data<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>How fast did Entresto sales fall?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Entresto sales were USD 1,181 million in Q2 2026 against USD 2,357 million in Q2 2025, a 50% fall in US dollars. [16] First-half sales were USD 2,486 million against USD 4,618 million, a 46% fall. [16] Novartis said sales declined because of generic competition in the US. [16] Entresto sales kept growing outside the US. [16]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The first-half drop was USD 2,132 million (calculated from [16]). One product moved in opposite directions in markets with and without generics. That split is the commercial reason to treat territory as a gate.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>How much do prices fall as entrants multiply?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">FDA studied products with initial generic entry from 2015 to 2017. With one generic producer, the generic average manufacturer price was 39% lower than the brand&#8217;s before generic competition began. With two producers it was 54% lower, and with four it was 79% lower. [2]<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"wp-block-paragraph\">FDA found that products with six or more generic producers &#8220;show price reductions of more than 95% compared to brand prices.&#8221; [2]<\/p>\n<\/blockquote>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>What this means for a late entrant<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Canada had nine semaglutide submissions on file at the end of 2025. [5] India was expecting more than 50 brands. [6] Seven Stelara biosimilars had launched in the US by November 2025. [13] These counts exceed the FDA&#8217;s six-or-more bucket on paper (analysis).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The FDA data cover generic drugs that entered from 2015 to 2017. They do not measure biosimilars, Canadian pricing or Indian pricing. We use them only to show direction. A late entrant should plan for a thin margin, which makes its cost position a core partner question (analysis).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>How Do Partnership Structures Differ After a Patent Expires?<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The cases show five structures. This is an original classification, not an industry standard. Each structure gives the brand owner and the entrant a different risk profile.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>The five structures observed<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Type<\/th><th>Description<\/th><th>Documented example<\/th><\/tr><\/thead><tbody><tr><td>1. Settlement license<\/td><td>The brand owner grants a non-exclusive license with a fixed start date, by region<\/td><td>AbbVie and Amgen, Humira [7]<\/td><\/tr><tr><td>2. Developer plus seller<\/td><td>One company develops and one sells in a territory<\/td><td>Alvotech and Teva, Selarsdi [10]<\/td><\/tr><tr><td>3. Licensor plus exclusive licensee<\/td><td>The licensor keeps development and manufacture; the licensee holds exclusive commercial rights<\/td><td>Bio-Thera and Hikma, Starjemza [13]<\/td><\/tr><tr><td>4. Contract manufacturing split<\/td><td>The filer makes the active ingredient; a contractor makes finished product<\/td><td>Dr. Reddy&#8217;s and OneSource [3]<\/td><\/tr><tr><td>5. Co-development with a foreign developer<\/td><td>The local filer licenses or co-develops with a developer abroad<\/td><td>Apotex and Orbicular [4]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Which structure carries which risk?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Type 1 carries a date risk and a scope risk. The start date is fixed by the settlement, and the license is non-exclusive. [7] Type 2 carries a facility risk at the developer. Alvotech&#8217;s rejections show it. [14] Type 3 puts manufacturing with the licensor, so the licensee depends on the licensor&#8217;s sites. [13] Types 4 and 5 put supply in the hands of a third party that may serve other customers (analysis).<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Why the type matters before the term sheet<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Each type needs different due diligence. A team that studies the licensee in a Type 3 deal and skips the licensor&#8217;s inspection record has checked the wrong party (analysis).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What Goes Wrong When a Team Ranks Partners by Date Alone?<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Four failure modes follow from the cases. Each is an inference from the documented events. None is a reported statistic.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Failure mode 1: the single-date error<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The team uses one date for a molecule. Humira had two start dates 51 months apart. [7] Semaglutide has at least five clocks. [3][6][9]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Failure mode 2: the exclusivity blind spot<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The team reads the patent and misses an attached exclusivity. The Entresto &#8216;659 patent shows pediatric exclusivity moving a date by months. [15]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Failure mode 3: the readiness gap<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The team assumes that a legal date equals a launch. Alvotech held a settlement date and still had to clear an FDA facility record. [10][14]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Failure mode 4: the crowded-market margin<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The team prices the deal on a brand-minus-small-discount model. Markets with many entrants moved far below that. India had launch prices about 52% to 66% under the brand band by April 9, 2026, three weeks after expiry (calculated from [6]).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>The Five-Gate Screen: An Original Framework<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">This framework is our own. It is not an established industry classification. It turns the four cases into five questions. A partner candidate should pass each gate before a team spends time on terms.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Gate 1: Is the legal path clear?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Check patents, exclusivities, settlements and open litigation. Do not stop at the expiry date. Entresto shows a patent extended by pediatric exclusivity and a second patent still in dispute. [15] Humira shows a settlement date that differs by region. [7]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Gate 2: Which territory, and when?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Build one clock per country. Semaglutide has at least five: Canada, India, the US, Europe with Japan, and a 2029 to 2033 group of other Western markets. [3][6][9] A partner with strength in one region can have no use for a date in another.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Gate 3: Can the candidate get approved on time?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Check approval history, inspection findings and interchangeability status. Alvotech&#8217;s four rejections between September 2022 and October 2023 show the risk. [14] Health Canada&#8217;s 180-day review target shows a planning timeline. [5]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Gate 4: Can the candidate make the product at scale?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Check who makes the active ingredient, who makes the finished product and who owns the sites. Dr. Reddy&#8217;s in-house semaglutide ingredient and its OneSource arrangement is one model. [3] Apotex and Orbicular is another. [4] For a peptide, a candidate that makes small molecules well has not shown it can make peptides (analysis, based on [6]).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Gate 5: Does the candidate have a channel and workable terms?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Check pharmacy benefit manager access, private-label arrangements, unbranded options and the license form. Stelara shows Nuvaila, MedImpact with Birdi, and CivicaScript. [10][12] Humira shows a non-exclusive license. [7] Hikma shows an exclusive US license with the licensor still making the product. [13]<\/p>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>Gate summary table<\/strong><\/h4>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Gate<\/th><th>Question<\/th><th>Evidence to collect<\/th><th>Documented example<\/th><\/tr><\/thead><tbody><tr><td>1. Legal<\/td><td>Is every barrier down?<\/td><td>Orange Book and Purple Book entries, exclusivity, dockets, settlements<\/td><td>Entresto pediatric exclusivity [15]<\/td><\/tr><tr><td>2. Territory<\/td><td>Which clock applies where?<\/td><td>Patent status by country<\/td><td>Semaglutide Canada, India, US [3][6]<\/td><\/tr><tr><td>3. Regulatory<\/td><td>Can the candidate win approval?<\/td><td>Inspection record, approvals, interchangeability<\/td><td>Alvotech rejections [14]<\/td><\/tr><tr><td>4. Manufacturing<\/td><td>Can the candidate supply at scale?<\/td><td>Ingredient source, finished-product site<\/td><td>Dr. Reddy&#8217;s and OneSource [3]<\/td><\/tr><tr><td>5. Channel and terms<\/td><td>Can the candidate sell, and on what deal?<\/td><td>Payer access, license form, exclusivity of rights<\/td><td>Hikma and Bio-Thera [13]<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Diligence questions to ask each candidate<\/strong><\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Gate<\/th><th>Ask the candidate<\/th><\/tr><\/thead><tbody><tr><td>1. Legal<\/td><td>Which patents and exclusivities does your filing address? Is any settlement date confidential?<\/td><\/tr><tr><td>2. Territory<\/td><td>In which countries do you hold or plan approvals? Which have a different patent status?<\/td><\/tr><tr><td>3. Regulatory<\/td><td>When did FDA or Health Canada last inspect each site? What was found?<\/td><\/tr><tr><td>4. Manufacturing<\/td><td>Who makes the active ingredient? Who fills and assembles the finished product?<\/td><\/tr><tr><td>5. Channel and terms<\/td><td>Which payers, private-label programs or distributors will carry the product? Are rights exclusive?<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Scenario Analysis: Three Candidates for One Expiring Product<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">This scenario is hypothetical. It names no real company. It shows how the screen changes a ranking.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What are the assumptions?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A brand owner has a peptide injectable that loses patent protection in one territory. Three candidate partners each score 0, 1 or 2 on each gate. A score of 2 means strong evidence. The base case gives all gates equal weight. The scores are assumed for illustration.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Candidate<\/th><th>Legal<\/th><th>Territory<\/th><th>Regulatory<\/th><th>Manufacturing<\/th><th>Channel<\/th><th>Total<\/th><\/tr><\/thead><tbody><tr><td>A: strong filer, no inspected peptide site<\/td><td>2<\/td><td>2<\/td><td>1<\/td><td>0<\/td><td>1<\/td><td>6<\/td><\/tr><tr><td>B: contract-made product, approval history, no payer access<\/td><td>1<\/td><td>2<\/td><td>2<\/td><td>2<\/td><td>0<\/td><td>7<\/td><\/tr><tr><td>C: large channel, no filing yet<\/td><td>1<\/td><td>1<\/td><td>0<\/td><td>1<\/td><td>2<\/td><td>5<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>How sensitive is the ranking to the weights?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">We doubled the weight of selected gates and recalculated the totals.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Weighting<\/th><th>A<\/th><th>B<\/th><th>C<\/th><\/tr><\/thead><tbody><tr><td>Equal weights (base case)<\/td><td>6<\/td><td>7<\/td><td>5<\/td><\/tr><tr><td>Legal gate doubled<\/td><td>8<\/td><td>8<\/td><td>6<\/td><\/tr><tr><td>Regulatory and manufacturing gates doubled<\/td><td>7<\/td><td>11<\/td><td>6<\/td><\/tr><tr><td>Channel gate doubled<\/td><td>7<\/td><td>7<\/td><td>7<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>What does the result show?<\/strong><\/h4>\n\n\n\n<p class=\"wp-block-paragraph\">Candidate A leads on the legal and territory gates and still ranks second in the base case. A team that ranked only on legal readiness would tie A with B at best. Candidate B wins when regulatory and manufacturing gates carry more weight. Doubling the channel gate produces a three-way tie. The value of the screen is that it forces a team to state its weights before it picks a partner.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What This Means for Brand Manufacturers, Generic Developers and Business Development Teams<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What this means for brand manufacturers<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A brand owner can shape the entry date by settlement, as AbbVie did with a region-by-region license. [7] A brand owner can also lose a territory through an administrative step, as Canada shows. [3] Track maintenance deadlines in every territory (analysis).<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What this means for generic and biosimilar developers<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A developer with a settled date still carries manufacturing and approval risk. [14] A developer without a US channel can build one through a partner or a private-label route. [10][12] A developer that plans for many countries needs a legal check per country. [9]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What this means for business development and investors<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Counts of expiring patents measure only the first gate. Counts of launches measure the last outcome. The five gates sit between them. A pipeline model that records gate status for each partner holds more information than one that lists dates alone (analysis).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Where DrugPatentWatch Fits in the Screen<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">DrugPatentWatch compiles patent, exclusivity and litigation information by drug. That helps with Gates 1 and 2, because a team can see listed patents, expiry dates and dispute records in one place. It does not replace the primary record. FDA says its own Orange Book listing role is ministerial, so a listed date needs checking against court records and settlement notices. [1]<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Gates 3 to 5 need other sources. These include FDA and Health Canada approval records, inspection reports, company filings and supplier information. A team should use DrugPatentWatch to build the legal timeline and then add those sources before it contacts a candidate.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Day Counts and Calculations Used in This Article<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Calculation<\/th><th>Inputs<\/th><th>Result<\/th><\/tr><\/thead><tbody><tr><td>Humira EU to US gap<\/td><td>October 16, 2018 to January 31, 2023 [7]<\/td><td>About 51 months<\/td><\/tr><tr><td>Humira settlement to US start<\/td><td>September 28, 2017 to January 31, 2023 [7]<\/td><td>About 64 months<\/td><\/tr><tr><td>Canada exclusivity end to first approval<\/td><td>January 4, 2026 [5] to April 28, 2026 [3]<\/td><td>114 days<\/td><\/tr><tr><td>Stelara first six launches<\/td><td>Early January 2025 to March 13, 2025 [12]<\/td><td>About ten weeks<\/td><\/tr><tr><td>Stelara sixth to seventh launch<\/td><td>March 13, 2025 [12] to November 6, 2025 [13]<\/td><td>About 34 weeks<\/td><\/tr><tr><td>Alvotech settlement to entry<\/td><td>June 2023 to February 21, 2025 [10]<\/td><td>20 months<\/td><\/tr><tr><td>Alvotech first rejection to launch<\/td><td>September 2022 [14] to February 21, 2025 [10]<\/td><td>About 29 months<\/td><\/tr><tr><td>Sun Pharma India price vs. Novo band<\/td><td>INR 3,400 vs. INR 8,800 to 10,000 [6]<\/td><td>About 61% to 66% lower<\/td><\/tr><tr><td>Dr. Reddy&#8217;s India price vs. Novo band<\/td><td>INR 4,200 vs. INR 8,800 to 10,000 [6]<\/td><td>About 52% to 58% lower<\/td><\/tr><tr><td>Entresto first-half decline<\/td><td>USD 4,618 million to USD 2,486 million [16]<\/td><td>USD 2,132 million<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Key Takeaways<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>A patent expiry date marks one legal barrier. FDA treats patents and exclusivity as separate systems. [1]<\/li>\n\n\n\n<li>Humira&#8217;s Amgen license started on October 16, 2018 in the EU and January 31, 2023 in the US. [7]<\/li>\n\n\n\n<li>Semaglutide has different clocks in Canada, India, the US and Europe. [3][6][9]<\/li>\n\n\n\n<li>Canada&#8217;s patent lapse and India&#8217;s March 20, 2026 expiry opened two markets before the US and Europe. [3][6]<\/li>\n\n\n\n<li>Seven Stelara biosimilars launched in the US in 2025, under three partnership structures. [10][12][13]<\/li>\n\n\n\n<li>Alvotech received four FDA rejections before its Stelara biosimilar launched on its settlement date. [10][14]<\/li>\n\n\n\n<li>Entresto sales fell 50% in Q2 2026 on US generic competition. [16]<\/li>\n\n\n\n<li>FDA data show price reductions above 95% when six or more generic producers compete. [2]<\/li>\n\n\n\n<li>The five-gate screen is an original framework: legal, territory, regulatory, manufacturing, and channel with terms.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>FAQ<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Does patent expiration mean a generic can launch the next day?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">No. Exclusivity, settlements, approvals and supply can all hold entry back. Entresto&#8217;s US patent 8,101,659 received pediatric exclusivity to July 15, 2025, and the court set MSN&#8217;s approval date no earlier than July 16, 2025. [15]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What is the difference between a patent and exclusivity?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Patents come from the patent office. Exclusivity comes from FDA on approval. Different statutes govern them. [1] FDA lists new chemical entity exclusivity at 5 years and orphan drug exclusivity at 7 years. [1]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Who decides which patents appear in the Orange Book?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The brand company does. It submits Form FDA 3542 within 30 days after approval. FDA does not list patent information that is not on that form. [1]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Why can one drug have different expiry dates by country?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Each country grants and maintains its own patents. Semaglutide shows this. Canada&#8217;s patent lapsed, India&#8217;s expired on March 20, 2026, and Europe and Japan run to 2031. [3][6]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Can a missed fee end a drug patent?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Yes. Canadian patent CA 2601784 lapsed after an unpaid maintenance fee in 2019. The reversal period ended on August 31, 2020. [3]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>How long can a settlement delay a launch?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The Humira settlement set a US start of January 31, 2023, which was about 64 months after the settlement announcement (calculated from [7]). Other settlements will differ.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>What does a biosimilar partner need besides a legal date?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">It needs an approved facility. Alvotech&#8217;s September 2022 rejection followed an inspection, and a warning letter at the time reported mold and bacterial contamination in manufacturing rooms. [14]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Can a company launch in one country before another?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Yes. Dr. Reddy&#8217;s said it planned to launch semaglutide in Canada, India, Brazil, Turkey and other emerging markets first, subject to patent expiry. It expected other Western markets between 2029 and 2033. [9]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>How many competitors usually arrive?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">It varies by product and market. Seven Stelara biosimilars launched in the US by November 2025. [13] India expected more than 50 semaglutide brands. [6]<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Why is peptide manufacturing a partner question?<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Semaglutide needs solid-phase synthesis, lipidation and HPLC purification. One industry expert said only a handful of companies can do this at scale. [6]<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>References<\/strong><\/h2>\n\n\n\n<ol class=\"wp-block-list\">\n<li>U.S. Food and Drug Administration. (n.d.). <em>Frequently asked questions on patents and exclusivity<\/em>. FDA. <a href=\"https:\/\/www.fda.gov\/drugs\/development-approval-process-drugs\/frequently-asked-questions-patents-and-exclusivity\">https:\/\/www.fda.gov\/drugs\/development-approval-process-drugs\/frequently-asked-questions-patents-and-exclusivity<\/a> (accessed October 17, 2026)<\/li>\n\n\n\n<li>U.S. Food and Drug Administration. (2019, December). <em>Generic competition and drug prices: New evidence linking greater generic competition and lower generic drug prices<\/em>. FDA. <a href=\"https:\/\/www.fda.gov\/media\/133509\/download\">https:\/\/www.fda.gov\/media\/133509\/download<\/a><\/li>\n\n\n\n<li>Buntz, B. (2026, May 13). Canada approves generic semaglutide from Dr. Reddy&#8217;s, a G7 first enabled by Novo Nordisk&#8217;s lapsed CAD 250 patent. <em>Drug Discovery and Development<\/em>. <a href=\"https:\/\/www.drugdiscoverytrends.com\/canada-approves-generic-semaglutide-from-dr-reddys-a-g7-first-enabled-by-novo-nordisks-lapsed-cad250-patent\/\">https:\/\/www.drugdiscoverytrends.com\/canada-approves-generic-semaglutide-from-dr-reddys-a-g7-first-enabled-by-novo-nordisks-lapsed-cad250-patent\/<\/a><\/li>\n\n\n\n<li>Pearce IP. (2026, April 29). First generic Ozempic (semaglutide) approved in Canada for Dr Reddy&#8217;s, Apotex. <a href=\"https:\/\/www.pearceip.law\/2026\/04\/29\/first-generic-ozempic-semaglutide-approved-in-canada-for-dr-reddys-apotex\/\">https:\/\/www.pearceip.law\/2026\/04\/29\/first-generic-ozempic-semaglutide-approved-in-canada-for-dr-reddys-apotex\/<\/a><\/li>\n\n\n\n<li>BNN Bloomberg. (2026, January 2). Companies can make generic Ozempic as of next week in Canada, but don&#8217;t expect to get it soon. <a href=\"https:\/\/www.bnnbloomberg.ca\/business\/company-news\/2026\/01\/02\/companies-can-make-generic-ozempic-as-of-next-week-in-canada-but-dont-expect-to-get-it-soon\/\">https:\/\/www.bnnbloomberg.ca\/business\/company-news\/2026\/01\/02\/companies-can-make-generic-ozempic-as-of-next-week-in-canada-but-dont-expect-to-get-it-soon\/<\/a><\/li>\n\n\n\n<li>Bhatt, S. (2026, April 9). One goal, 50 brands: Inside the scramble for India&#8217;s post-patent semaglutide market. <em>Outlook Business<\/em>. <a href=\"https:\/\/www.outlookbusiness.com\/corporate\/one-goal-50-brands-inside-the-scramble-for-indias-post-patent-semaglutide-market\">https:\/\/www.outlookbusiness.com\/corporate\/one-goal-50-brands-inside-the-scramble-for-indias-post-patent-semaglutide-market<\/a><\/li>\n\n\n\n<li>Healio. (2017, September 28). AbbVie and Amgen announce settlement of adalimumab patent dispute. <a href=\"https:\/\/www.healio.com\/news\/rheumatology\/20170928\/abbvie-and-amgen-announce-settlement-of-adalimumab-patent-dispute\">https:\/\/www.healio.com\/news\/rheumatology\/20170928\/abbvie-and-amgen-announce-settlement-of-adalimumab-patent-dispute<\/a><\/li>\n\n\n\n<li>Li, C. (2026, March 20). Ozempic patent expiry opens door for generics in India, China, Canada. <em>Asia IP<\/em>. <a href=\"https:\/\/asiaiplaw.com\/sector\/patents\/ozempic-patent-expiry-opens-door-for-generics-in-india-china-canada\">https:\/\/asiaiplaw.com\/sector\/patents\/ozempic-patent-expiry-opens-door-for-generics-in-india-china-canada<\/a><\/li>\n\n\n\n<li>Pearce IP. (2025, July 24). Dr Reddy&#8217;s plans to launch generic semaglutide in 87 countries in 2026 [Report of a Reuters story of the same date]. <a href=\"https:\/\/www.pearceip.law\/2025\/07\/24\/dr-reddys-plans-to-launch-generic-semaglutide-in-87-countries-in-2026\/\">https:\/\/www.pearceip.law\/2025\/07\/24\/dr-reddys-plans-to-launch-generic-semaglutide-in-87-countries-in-2026\/<\/a><\/li>\n\n\n\n<li>Pearce IP. (2025, August 18). Teva subsidiary to launch unbranded ustekinumab biosimilar in US via MedImpact. <a href=\"https:\/\/www.pearceip.law\/2025\/08\/18\/teva-subsidiary-to-launch-unbranded-ustekinumab-biosimilar-in-us-via-medimpact\/\">https:\/\/www.pearceip.law\/2025\/08\/18\/teva-subsidiary-to-launch-unbranded-ustekinumab-biosimilar-in-us-via-medimpact\/<\/a><\/li>\n\n\n\n<li>Pearce IP. (2025, May 5). FDA approves interchangeability of Alvotech\/Teva&#8217;s Selarsdi with J&amp;J&#8217;s Stelara (ustekinumab). <a href=\"https:\/\/www.pearceip.law\/2025\/05\/05\/fda-approves-interchangeability-of-alvotech-tevas-selarsdi-with-jjs-stelara-ustekinumab\/\">https:\/\/www.pearceip.law\/2025\/05\/05\/fda-approves-interchangeability-of-alvotech-tevas-selarsdi-with-jjs-stelara-ustekinumab\/<\/a><\/li>\n\n\n\n<li>Pearce IP. (2025, March 13). [Post on Celltrion&#8217;s US launch of Steqeyma, a ustekinumab biosimilar]. <a href=\"https:\/\/pearceip.law\/?p=54363\">https:\/\/pearceip.law\/?p=54363<\/a><\/li>\n\n\n\n<li>Pearce IP. (2025, November 6). Hikma launches biosimilar ustekinumab in the US. <a href=\"https:\/\/www.pearceip.law\/2025\/11\/06\/hikma-launches-biosimilar-ustekinumab-in-the-us\/\">https:\/\/www.pearceip.law\/2025\/11\/06\/hikma-launches-biosimilar-ustekinumab-in-the-us\/<\/a><\/li>\n\n\n\n<li>Manalac, T. (2023, October 12). FDA rejects Alvotech&#8217;s Stelara biosimilar as manufacturing problems continue. <em>BioSpace<\/em>. <a href=\"https:\/\/www.biospace.com\/fda-rejects-alvotech-s-stelara-biosimilar-as-manufacturing-problems-continue\">https:\/\/www.biospace.com\/fda-rejects-alvotech-s-stelara-biosimilar-as-manufacturing-problems-continue<\/a><\/li>\n\n\n\n<li>Rafferty, O. S. (2025, June 17). Novartis and MSN settle part of chronic heart failure patent fight, but key patent remains. <em>ip fray<\/em>. <a href=\"https:\/\/ipfray.com\/novartis-and-msn-settle-part-of-chronic-heart-failure-patent-fight-but-key-patent-remains\/\">https:\/\/ipfray.com\/novartis-and-msn-settle-part-of-chronic-heart-failure-patent-fight-but-key-patent-remains\/<\/a><\/li>\n\n\n\n<li>Novartis AG. (2026). <em>Form 6-K: Second quarter 2026 results (exhibit 99.2)<\/em>. U.S. Securities and Exchange Commission. <a href=\"https:\/\/www.sec.gov\/Archives\/edgar\/data\/0001114448\/000111444826000012\/nvs-20260630-99_2.htm\">https:\/\/www.sec.gov\/Archives\/edgar\/data\/0001114448\/000111444826000012\/nvs-20260630-99_2.htm<\/a><\/li>\n\n\n\n<li>pharmaphorum. (2025, October 28). Novartis&#8217; new drugs outweigh Entresto decline in Q3. <a href=\"https:\/\/pharmaphorum.com\/news\/novartis-new-drugs-outweigh-entresto-decline-q3\">https:\/\/pharmaphorum.com\/news\/novartis-new-drugs-outweigh-entresto-decline-q3<\/a><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"<p>Novo Nordisk&#8217;s Canadian semaglutide patent, CA 2601784, lapsed because a maintenance fee went unpaid in 2019. 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