Takeda has sued two vedolizumab biosimilar developers on six patents that Google Patents records as sharing one 2011 priority date.

Three applications have been publicly announced, from two developers. Takeda's complaints, as published by Goodwin's Big Molecule Watch and dated August and September 2026, assert the same six US patents against both. In London, five biosimilar companies are reported to be challenging European patents and applications, and the three of those patents we checked carry the same 2011 priority date. Google Patents puts the anticipated expiry of the six US patents at a single day in 2032, which is an assumption rather than a confirmed term.

Where vedolizumab stands, in six facts

3 / 2 Publicly announced applications and the developers holding them. Alvotech has announced AVT16 and AVT80; PB016 was submitted by Polpharma Biologics S.A. Teva Pharmaceutical Industries Ltd. and Fresenius Kabi are commercialisation partners, not applicants. Source: Alvotech Forms 6-K, 8 June and 31 August 2026; Fresenius release, 31 July 2026; Polpharma Biologics International AG release, 31 July 2026

26 Aug 2026 Date of Takeda's complaint against Polpharma Biologics S.A. in the District of New Jersey. A second, against Alvotech hf and concerning AVT16 only, is dated 1 September 2026. In London, Fresenius Kabi, Advanz Pharma, Accord Healthcare, Samsung Bioepis and Celltrion are claimants against Millennium Pharmaceuticals. Trial is listed for April 2027 for the first four; Celltrion's later claim is reported as likely to be heard with them. Source: Takeda complaints as published by Big Molecule Watch (Goodwin); Pearce IP, 31 July 2026; JUVE Patent, 9 September 2026. Secondary; dockets not reached

2 May 2011 Priority date Google Patents records for all six patents asserted in both actions. Google Patents gives each an anticipated expiry of 2 May 2032, which it labels an assumption. Source: Google Patents. Term not checked against the USPTO

¥268.3bn Entyvio revenue for the three months to 30 June 2026, up 15.4 per cent at actual exchange rates and 3.8 per cent at constant rates. For the year to 31 March 2026 it was ¥958.0bn. Source: Takeda Forms 6-K, 30 July 2026 and 13 May 2026

27 Jan 2026 Date CMS selected Entyvio for Medicare price negotiation, for initial price applicability year 2028. Any agreed price takes effect on 1 January 2028, and CMS's deadline to publish any agreed prices is 30 November 2026. Source: CMS fact sheet, third cycle (IPAY 2028) selected drug list

blank The date of first licensure field on the FDA Purple Book record (the FDA's database of licensed biological products) for BLA 125476, the biologics licence application for Entyvio. That field governs the twelve-year period under 42 U.S.C. 262(k)(7)(A), so the period cannot be computed from the public record. Source: FDA Purple Book, BLA 125476, read 14 October 2026

Who and what does this page refer to?

Several companies on this page act through more than one legal entity. The table gives each name as the source we cite gives it, and the role that source gives it. Source numbers refer to the list at the end of the page.

Where a source gives a place, it is this: Alvotech, Reykjavik, Iceland (its Form 6-K datelines); Fresenius SE & Co. KGaA, which issued the Fresenius release, Bad Homburg, Germany; Polpharma Biologics International AG, Rotkreuz, Switzerland (its release). The other sources we read do not state a country for the companies above, and we have not added one.

Large companies operate through several legal entities, often one for each country or function. Press releases, court filings and regulatory records each name the entity that acted in that document, and these are not always the same one. This page uses the name each source gives. It does not treat two named entities as one company, or say that one controls the other, unless a source says so.

Where this page writes "Takeda" without naming an entity, it follows the source being cited: Takeda Pharmaceutical Company Limited in the filings of that company, and the plaintiffs named in the complaints in the litigation sections.

Who has announced a filing, and what that count can and cannot show

Three applications have been publicly announced and they come from two developers. Alvotech holds two of them. Polpharma Biologics S.A. submitted the third. Alvotech's releases say Teva Pharmaceutical Industries Ltd. is responsible for commercialising both Alvotech candidates, without stating a territory, and the Fresenius release says Fresenius Kabi holds the PB016 commercialisation rights outside the Middle East and North Africa. That makes them partners to a filing rather than filers.

That count has a boundary worth stating before anything is built on it. Under 21 CFR 601.51, the FDA does not disclose that a biological product file exists before approval, "unless it has previously been publicly disclosed or acknowledged". The regulator will therefore not supply a list of pending biosimilar applications, and every count of who has filed on this molecule is assembled from company announcements. A developer that has filed without announcing would not appear in it.

The accurate form of the sentence is three publicly announced applications from two developers.

On the originator's side, FDA records retrieved on 14 October 2026 show three applications containing vedolizumab, all held by Takeda: BLA 125476, approved 20 May 2014, carrying the 300 mg intravenous product; and BLA 761133 and BLA 761359, each carrying both the 300 mg intravenous product and the 108 mg/0.68 mL subcutaneous presentation. As at that date the register lists no licensed biosimilar referencing vedolizumab. It does not list applications under review, so that says nothing about any application in progress.

Exhibit 1. Publicly announced vedolizumab applications, as at 14 October 2026

Sources: Alvotech Form 6-K exhibits furnished 8 June 2026 and 31 August 2026, read on SEC EDGAR; the Fresenius release and the Polpharma Biologics International AG release, both of 31 July 2026. The 31 August release states that Alvotech is responsible for development and manufacturing "while Teva is responsible for commercialization". This table lists what has been announced. Under 21 CFR 601.51 the FDA does not disclose pending applications, so it is not a complete list of what has been filed. Acceptance for review is not approval.

What each application covers, and why scope is the better benchmark

Two of the three announced applications are for the intravenous presentation. Only AVT80 covers subcutaneous administration, in a prefilled syringe and an autoinjector. Alvotech describes AVT16 as a proposed interchangeable biosimilar and states that biosimilarity and interchangeability have not been established by regulatory authorities and are not claimed.

Alvotech's release of 8 June 2026 says the FDA has accepted the AVT16 application for review and makes no claim to be first.

The dates themselves need care. Alvotech's August release dates the acceptance of AVT16 to May 2026, while the announcement came on 8 June.

The two New Jersey actions

Big Molecule Watch, Goodwin's biosimilars blog, publishes Takeda's complaints as PDFs alongside its own summaries. The first complaint is brought by Takeda Pharmaceuticals USA, Inc. and Takeda Pharmaceuticals International AG against Polpharma Biologics S.A. in the US District Court for the District of New Jersey and is dated 26 August 2026. The second, against Alvotech hf in the same court, is dated 1 September 2026. Goodwin reports that it concerns AVT16 only and that the injunction sought extends to any current or future version of AVT16.

Goodwin describes both as suits under the Biologics Price Competition and Innovation Act (BPCIA), the US statute that sets the information exchange and patent-litigation process for biosimilar applications. Both complaints assert the same six United States patents. Goodwin reports that the Polpharma complaint records a Notice of Commercial Marketing (the notice the BPCIA requires a biosimilar applicant to give at least 180 days before first commercial marketing) given on 18 June 2026, with Polpharma stating it intends to begin commercial marketing no earlier than 180 days after that date.

Goodwin also reports that Takeda alleges Polpharma announced a partnership with Fresenius Kabi USA, LLC in 2025 to commercialise PB016, and that Polpharma's counsel told Takeda's counsel that approval of Polpharma's application is expected in May 2027. Pearce IP (26 August 2026) reports the same statement. It is a second-hand account of what one party's lawyer said, and we do not rely on it.

In the Alvotech action, Goodwin reports that Takeda alleges it had not received Alvotech's application or manufacturing information. Goodwin also reports that Takeda alleges Alvotech's 2020 agreements for AVT16 were with Teva Pharmaceuticals International GmbH ("Teva Switzerland"), whereas Alvotech's Forms 6-K name Teva Pharmaceutical Industries Ltd. as its partner. No source we read says how the two Teva entities relate. Allegations in a complaint are one party's account and have not been tested.

These accounts rest on the complaints as published and on Goodwin's summaries, not on the court record. The first page of each complaint prints the civil action number: 3:26-cv-11002 for the Polpharma complaint and 2:26-cv-11301 for the Alvotech complaint. We have read these numbers from the complaints, not from the court docket.

Exhibit 2. The six patents asserted in both New Jersey actions. Priority date for all six: 2 May 2011

Source: Patent numbers, parties and the subject column from Takeda's complaints as published by Big Molecule Watch (complaints as published by Big Molecule Watch; the descriptions and representative claims in the Polpharma complaint were read directly on 14 October 2026, and the Alvotech complaint was not re-read for this column; the patents' own claims were not read). Titles, filing dates, grant dates and anticipated expiry from Google Patents, which states that the legal status and priority date are assumptions and not legal conclusions; all six carry a priority date of 2 May 2011. Anticipated expiry is Google's calculation, not a confirmed term. Patent term adjustment, patent term extension and terminal disclaimers have not been checked against the USPTO.

Three things in that table are worth separating from the headline.

The first is the shared priority date. All six trace to 2 May 2011 on Google Patents' record, yet the applications were filed across nine years, from July 2016 to June 2025, and granted between May 2017 and May 2026. The asserted estate is one 2011 priority maturing into six grants, four of them since August 2024. Whether the six also share a single expiry is a separate question, and on the evidence here it rests on Google Patents' assumption rather than on a term we have confirmed.

The second is claim type. Takeda's complaints describe all six as directed to methods of treatment, including US 9,663,579, whose title refers to a formulation. We have read the descriptions and representative claims as quoted in the Polpharma complaint, but not the patents' own claims, so this is Takeda's description of its own patents. The subjects differ: clinical response in Crohn's disease, remission in ulcerative colitis, a dosing regimen in ulcerative colitis, patients with an inadequate response or intolerance to azathioprine or 6-mercaptopurine, a mean trough serum concentration at the end of induction, and a stated proportion of patients remaining HAHA-negative.

Goodwin groups the six as dosing-regimen patents. Pearce IP's summary of the Polpharma complaint, dated 26 August 2026, describes them more broadly, as covering the molecule, its use, its formulation and its manufacture. The sources disagree and the claims would settle it. On any reading the six should not be treated as interchangeable barriers.

The third is Takeda's own statement. Its Form 20-F says it expects certain patents covering various aspects of Entyvio to expire in 2032, and the six asserted patents carry an anticipated 2032 expiry. The two statements are consistent. Neither is a confirmed term.

London, where European patents are attacked from the other side

The United States is not the only forum, and the posture there is the reverse of the American one.

Pearce IP reported on 31 July 2026 that Fresenius Kabi, Advanz Pharma, Accord Healthcare and Samsung Bioepis had brought proceedings in the Patents Court in England and Wales against Millennium Pharmaceuticals, which Pearce IP describes as a Takeda subsidiary. JUVE Patent reported on 9 September 2026 that Celltrion has since brought a fifth claim, which the court is likely to hear with the other four.

JUVE does not say which patents Celltrion challenges. The claimants seek revocation of various patents, together with declarations of non-infringement or Arrow declarations (which Pearce IP describes as declarations that a product or process was obvious at the relevant priority date), with the stated aim of clearing the way for a United Kingdom launch of their biosimilars.

Pearce IP lists six European items. On dosing regimens: EP (UK) 3329965 and EP 3311834, both granted, and EP4378484 and EP4438625, described as pending applications. On formulations: EP (UK) 2704798 and EP 4403579, both granted. Trial is listed for April 2027. A judgment of 31 July 2026 in those proceedings concerned the confidentiality regime for information about Advanz's formulations and decided nothing on validity.

We read three of those European patents on Google Patents. EP 3329965 (granted 19 March 2025), EP 3311834 (granted 11 March 2026) and EP 2704798 (granted 12 July 2017) each carry a priority date of 2 May 2011 and a filing date of 2 May 2012, matching the priority date of the United States patents. Google titles EP 3311834 "Formulation for anti-alpha4beta7 antibody", although Pearce IP lists it among the dosing-regimen patents. The other three named could not be read in this pass, and no source states that the European and United States patents form one family.

Two observations follow, and they are ours rather than any source's.

In the United States, Takeda is the plaintiff and the developers are defending. In London, the biosimilar companies are the claimants and Millennium Pharmaceuticals is defending. Anyone modelling this estate as a single global risk is modelling two different fights.

The party lists also differ, though less than a first count suggests. Accord Healthcare, Samsung Bioepis and Celltrion appear in London and on no announced United States application. Advanz Pharma appears in London and, per Pearce IP, is the UK, EU and Swiss commercialisation partner for Alvotech's AVT16, so it is a partner of an announced developer rather than an unconnected name.

Fresenius Kabi appears in London as a claimant and as the PB016 commercialisation partner. The sources name it as Fresenius Kabi in both places and, in Takeda's complaint, as Fresenius Kabi USA, LLC; none says these are the same legal entity, and we do not treat them as one. A list built from United States announcements alone names two developers and two partners; the London proceedings add three companies with no announced United States application, and Advanz Pharma.

What Takeda reports, at the level it reports it

Takeda does not report intravenous and subcutaneous revenue separately. It reports Entyvio, by region, and it credits the subcutaneous formulation in its commentary.

For the most recent quarter, the three months to 30 June 2026, Entyvio revenue was JPY 268.3 billion, up 15.4 per cent at actual exchange rates and 3.8 per cent at constant rates. United States revenue was JPY 169.5 billion, up 8.4 per cent at actual rates, an increase Takeda attributes to favourable exchange rates, "accompanied by growth of the subcutaneous formulation".

Europe was JPY 63.5 billion, up 21.2 per cent at actual rates, which Takeda also ties to favourable exchange rates, complemented by continued patient gains through increased use of the subcutaneous formulation. Takeda gives no constant-rate figure for either region in that report, so both regional growth rates include currency.

Takeda also reclassified its geography in that report. Canada now sits within Other rather than with Europe, so the Europe figure is not comparable with the Europe and Canada line reported earlier. Takeda reports a single operating segment, so this is a change of geographic classification rather than of segment.

For the full year to 31 March 2026, Entyvio was JPY 958.0 billion, up 4.8 per cent at actual rates and 4.2 per cent at constant rates, with the United States at JPY 623.7 billion, up 0.7 per cent, and Europe and Canada at JPY 256.7 billion, up 12.9 per cent. Takeda's Form 20-F for that year names Entyvio as its highest-selling product.

Our reading, not Takeda's: the gap between the two growth rates is mostly currency. At constant rates the quarter grew 3.8 per cent against 4.2 per cent for the year, so the underlying growth rate looks broadly similar, and the 15.4 per cent figure includes the effect of the yen. Anyone building a baseline should state which of the two rates they use.

On exclusivity, the 20-F says Entyvio "will face loss of regulatory exclusivity in the latter half of this decade". It gives no specific year.

The Medicare clock, and the rule that switches it off

CMS announced the third-cycle selected drug list on 27 January 2026, and Entyvio is on it, for initial price applicability year 2028. CMS's timeline has the negotiation period ending on 1 November 2026 and sets 30 November 2026 as the deadline to publish any agreed-upon maximum fair prices (MFPs). Any agreed price becomes effective on 1 January 2028. Takeda's 20-F warns that the negotiation could materially affect Entyvio sales through Medicare.

The part that matters for a challenger is the exit rule rather than the price. CMS says a selected drug stops being subject to negotiation under certain circumstances, and names two as examples. In one, FDA approves a generic that names a product in the selected drug as its reference-listed drug. In the other, FDA licenses a biosimilar that names such a product as its reference product. In each case the generic or biosimilar has to be marketed under that approval or licence. Because CMS introduces the two as examples, we do not treat them as a closed list.

The programme is therefore not a permanent fixture around a molecule. For a biologic such as Entyvio, the biosimilar route is the one that applies, in our reading.

CMS's table shows both routes in use. It lists Stelara and NovoLog (with Fiasp) for removal effective 1 January 2027; these are biologics, so the biosimilar route in our reading. It lists Entresto and Xarelto for the same date; these are small molecules, so the generic route in our reading. It lists Xeljanz and Xeljanz XR for 1 January 2029. CMS's table does not state the route for each drug, and that mapping is ours.

What none of this establishes is a sequence for Entyvio. No regulator has published a date on which a vedolizumab biosimilar will be licensed. The one expectation in the sources we read is second-hand: Takeda's complaint against Polpharma Biologics S.A., as reported by Goodwin and Pearce IP, says Polpharma's counsel told Takeda's counsel that approval is expected in May 2027.

We do not rely on it, and this brief does not estimate a date. Any agreed price takes effect on 1 January 2028; whether it is ever the price a biosimilar competes against depends on a licensure date no regulator has published. CMS's fact sheet also says the list excludes certain biologics that qualify for delayed selection because a biosimilar is highly likely to enter within a specified time, and that all 15 selected drugs would have been selected without that provision. It names no drug as delayed. Entyvio was selected, so its selection was not delayed.

What the public record does not settle

Three gaps are worth stating plainly, because each one is a place where a reader could reasonably expect an answer and the record does not provide one.

The twelve-year period cannot be computed. The Purple Book record for BLA 125476, read on 14 October 2026, shows applicant Takeda Pharmaceuticals U.S.A., Inc. and an original approval date of 20 May 2014, but it leaves date of first licensure blank, and it shows no exclusivity expiry. The twelve-year reference product exclusivity under 42 U.S.C. 262(k)(7)(A) runs from the date of first licensure, which is a defined term and not the same thing as the approval date.

With that field empty, the end of the period is not on the public record, and substituting the approval date would be arithmetic rather than a finding.

Nothing can be read from the absence of a licensed biosimilar. The register lists what has been licensed. All three announced applications were accepted for review between May and August 2026, and none has been decided. The absence of a licensure is not evidence of a stall, and under 21 CFR 601.51 it is not evidence about what is under review either.

Patent term is unconfirmed. Every expiry date in this brief is Google Patents' anticipated expiry. We have not pulled patent term adjustment, extensions or terminal disclaimers from the USPTO for any of the six, and Google's pages mention none of them. Four of the six were granted since August 2024, and two were filed in 2016, so adjustment cannot be ruled out.

How to read this if you are assessing your own position

• Count filers, not filings, and say where the count comes from. Three announced applications, two developers. The FDA will not disclose pending applications, so any public count is a count of announcements.
• Benchmark on scope. Filing order tells you who moved early. Presentation coverage tells you what share of the market each application can address, and the originator credits subcutaneous for its growth in both regions it reports.
• Read the patent family, not the patent count. Six asserted patents sound like six barriers. All six trace to one 2011 priority date, were filed across nine years, and are described by Takeda as method-of-treatment patents on different subjects.
• Treat an anticipated expiry as a lead. Google's date is an assumption. If a date is load-bearing in your model, pull the term from the USPTO.
• Check both forums. The United States answer and the United Kingdom answer to "who is working on this" differ by three companies with no announced US application, plus one partner of an announced developer, and the party bringing the case differs too.
• The Medicare price is conditional. CMS removes a selected drug once a qualifying generic or biosimilar is marketed, so any negotiated price is a condition of the market a challenger enters, not a fixed feature of it.

Further reading on this site: LOE Edge and how it reads FDA registers on the LOE Edge methodology page. For other biologics with a blank date of first licensure on the Purple Book, see Pembrolizumab loss of exclusivity; for a biologic with licensed US biosimilars, see Denosumab biosimilars.

Frequently asked questions

Related reading

• Pembrolizumab loss of exclusivity: two FDA licences, two sets of Merck-listed dates.
• Denosumab biosimilars: US biosimilar entries and Amgen's sales.
• Apixaban loss of exclusivity: a small-molecule comparison.

See where your molecule stands

LOE Edge reads US FDA records for a molecule: the Orange Book and openFDA for small molecules, and the Purple Book for biologics such as vedolizumab. It does not include court dockets or patent term. Book a demo and we will show you what the FDA records say for a molecule from your own portfolio.

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Methodology and sources

Filing facts come from the developers' own announcements, two of them filed with the SEC. Revenue and exclusivity language comes from Takeda's own filings. Litigation details come from Takeda's complaints as published by Big Molecule Watch and from law-firm reporting, and are labelled secondary throughout, because we have not reached the dockets. Patent dates come from Google Patents and are anticipated rather than confirmed. No syndicated market research forecast is used anywhere in this brief and no market size has been estimated.

1. Alvotech, Form 6-K furnished 8 June 2026, on FDA acceptance of the application for AVT16: intravenous lyophilised vial, proposed interchangeable status, Teva Pharmaceutical Industries Ltd. as commercialisation partner, and no first-to-file claim. SEC EDGAR.
2. Alvotech, Form 6-K furnished 31 August 2026, on acceptance for AVT80: subcutaneous prefilled syringe and autoinjector, the statement that AVT16 was accepted in May 2026, and the statement that Teva Pharmaceutical Industries Ltd. is responsible for commercialisation, with no territory stated. SEC EDGAR.
3. Fresenius SE & Co. KGaA, investor news of 31 July 2026 on behalf of Fresenius Kabi, on FDA and EMA acceptance of PB016, the intravenous scope, Polpharma Biologics S.A. as the submitting company, and Fresenius Kabi's commercialisation rights outside the Middle East and North Africa. fresenius.com.
4. Polpharma Biologics International AG, press release of 31 July 2026, on FDA and EMA acceptance of PB016. BioSpace.
5. Takeda Pharmaceutical Company Limited, Form 6-K of 30 July 2026, for Entyvio revenue for the three months ended 30 June 2026 by region, the actual and constant-rate growth, Takeda's attributions, the geographic reclassification and the single operating segment. SEC EDGAR.
6. Takeda Pharmaceutical Company Limited, Form 6-K of 13 May 2026, for Entyvio revenue for the year ended 31 March 2026 by region. SEC EDGAR.
7. Takeda Pharmaceutical Company Limited, Form 20-F for the year ended 31 March 2026, for the exclusivity and 2032 patent language, the description of Entyvio as highest-selling product, and the Medicare statement. SEC EDGAR.
8. US Centers for Medicare and Medicaid Services, selected drugs and negotiated prices page, for the circumstances in which a selected drug ceases to be selected and the removal table. cms.gov.
9. US Centers for Medicare and Medicaid Services, fact sheet on the selected drug list for initial price applicability year 2028, for Entyvio's selection on 27 January 2026, the 1 January 2028 effective date and the Biosimilar Delay provision. cms.gov.
10. FDA Purple Book, BLA 125476, read 14 October 2026, for applicant, the original approval date of 20 May 2014, and the blank date of first licensure field. purplebooksearch.fda.gov.
11. 21 CFR 601.51, for the rule that the FDA does not disclose the existence of a biologics file before approval unless it has previously been publicly disclosed or acknowledged. eCFR.
12. FDA Drugs@FDA via the openFDA API, count by application number, retrieved 14 October 2026: BLA 125476, 761133 and 761359, one each. openFDA.
13. Google Patents, US 9,663,579: title, filing date, grant date, priority date and anticipated expiry. Google labels anticipated expiry and legal status as assumptions. Google Patents.
14. Google Patents, US 10,004,808: title, filing date, grant date, priority date and anticipated expiry. Google labels anticipated expiry and legal status as assumptions. Google Patents.
15. Google Patents, US 12,053,526: title, filing date, grant date, priority date and anticipated expiry. Google labels anticipated expiry and legal status as assumptions. Google Patents.
16. Google Patents, US 12,171,832: title, filing date, grant date, priority date and anticipated expiry. Google labels anticipated expiry and legal status as assumptions. Google Patents.
17. Google Patents, US 12,544,445: title, filing date, grant date, priority date and anticipated expiry. Google labels anticipated expiry and legal status as assumptions. Google Patents.
18. Google Patents, US 12,622,969: title, filing date, grant date, priority date and anticipated expiry. Google labels anticipated expiry and legal status as assumptions. Google Patents.
19. Google Patents, EP 3329965: priority date, filing date and grant date. Google labels legal status as an assumption. Google Patents.
20. Google Patents, EP 3311834: priority date, filing date and grant date. Google labels legal status as an assumption. Google Patents.
21. Google Patents, EP 2704798: priority date, filing date and grant date. Google labels legal status as an assumption. Google Patents.
22. Secondary. Takeda's complaint against Polpharma Biologics S.A., 26 August 2026, as published by Big Molecule Watch, for parties, court, date, the six asserted patents and Takeda's description of each. Big Molecule Watch.
23. Secondary. Takeda's complaint against Alvotech hf, 1 September 2026, as published by Big Molecule Watch, for parties, court, date and the six asserted patents. Big Molecule Watch.
24. Secondary. Goodwin, Polpharma post, for the Notice of Commercial Marketing, the named plaintiffs, the Fresenius Kabi USA, LLC allegation, the statement by Polpharma's counsel about expected approval and the relief sought. Goodwin.
25. Secondary. Goodwin, Alvotech post, for Takeda's allegation about Alvotech's application, the Teva Pharmaceuticals International GmbH allegation and the relief sought. Goodwin.
26. Secondary. Pearce IP, 31 July 2026, for the London proceedings, the four claimants then named, Millennium Pharmaceuticals as a Takeda subsidiary, Advanz Pharma as the UK, EU and Swiss commercialisation partner for AVT16, Intas as the parent of Accord Healthcare, European patent numbers, the claimants' stated aim, the April 2027 trial listing and the 31 July judgment. Pearce IP.
27. Secondary. Pearce IP, 26 August 2026, for its description of the six US patents, Advanz Pharma as Alvotech's UK and EU partner, and the statement by Polpharma's counsel about expected approval. Pearce IP.
28. Secondary. JUVE Patent, 9 September 2026, for Celltrion as a fifth claimant that filed a revocation action, and for its statement that it does not know which patents Celltrion challenges. JUVE Patent.

Open items, stated rather than filled. The civil action numbers (3:26-cv-11002 and 2:26-cv-11301) are taken from the first page of each complaint, not from the court docket. Date of first licensure for BLA 125476 is blank on the Purple Book, so the twelve-year period cannot be computed. Patent term adjustment, extensions and terminal disclaimers have not been pulled from the USPTO for any of the six patents, so every expiry here is anticipated.

The claims of the asserted patents have not been read; the claim types given are Takeda's description in its complaints. Three of the six European patents named in the London proceedings (EP4378484, EP4438625 and EP 4403579) could not be read, and the patents Celltrion challenges are not stated in the source. Pearce IP and the complaints differ on what the US patents cover.

Whether any pediatric extension applies to Entyvio is unverified. The legal entity behind the London claimant Fresenius Kabi, and how the two Teva entities relate, are not stated in the sources we read.

Nothing in this brief is investment advice or a recommendation regarding any security. Company names appear as the subject of cited public filings, announcements and litigation reporting. Allegations in a complaint are the pleading party's account and have not been tested; nothing here predicts an outcome, a licensure date or a launch date. Acceptance for regulatory review is not approval, and no biosimilar referencing vedolizumab is on the register as at the date of this brief.