A patent on three of Xarelto's four strengths is listed to 2034. Nineteen approved generic tablet applications cover those strengths.

Orange Book entries list patent 9,539,218, a method-of-use patent, against the 10 mg, 15 mg and 20 mg Xarelto tablets to 17 February 2034, or 17 August 2034 with the pediatric entry. FDA records show 19 approved tablet applications covering each of those strengths. Approval is not launch. Both statements are true, and the public record does not reconcile them.

Where does rivaroxaban stand? Five facts

26 ANDAs Distinct rivaroxaban abbreviated new drug applications on the FDA record, from 22 sponsors: 21 tablet applications with full approval (from 19 sponsors), 2 at tentative approval only, 3 for an oral suspension. Four NDAs are also on the record, including a Rosemont Pharms oral suspension approved 16 October 2026. Source: FDA Drugs@FDA via the openFDA API, retrieved 23 October 2026; openFDA last updated 22 October 2026

19 cover 10, 15 and 20 mg Approved tablet applications that list each of the 10 mg, 15 mg and 20 mg strengths. Sixteen of the nineteen list those strengths with FDA marketing status "Prescription"; three list them as discontinued. This is a count of applications, not of sponsors. Source: FDA Drugs@FDA via the openFDA API, retrieved 23 October 2026

17 Feb 2034 Expiry of patent 9,539,218 on the 10 mg, 15 mg and 20 mg tablets. With the pediatric entry the Orange Book date is 17 August 2034. Listed against method-of-use codes, flagged as neither drug substance nor drug product. Source: FDA Orange Book, NDA 022406, products 001 to 003, retrieved 23 October 2026

23 Sep 2025 Federal Circuit affirmed that claims 1 to 4 of US 10,828,310 are unpatentable, vacated as to claims 5 to 8 and remanded. J&J's 10-K states that the USPTO entered judgment against the petitioners upon remand in January 2026. Source: Bayer Pharma AG v. Mylan Pharmaceuticals Inc., Fed. Cir. No. 2023-2434; Johnson & Johnson Form 10-K for fiscal 2025

+0.7% Johnson & Johnson's (J&J) US Xarelto sales in the first nine months of fiscal 2026, $1,959m against $1,946m. For fiscal 2025 sales rose 11.0 per cent to $2,633m, which J&J's 10-K attributes primarily to Medicare Part D redesign and market growth, partly offset by continued share loss. Source: J&J Form 10-Q for the quarter ended 27 September 2026; J&J Form 10-K for fiscal 2025

What does the FDA record show for generic rivaroxaban?

Rivaroxaban is marketed as Xarelto in four tablet strengths under NDA 022406. Querying the FDA's own Drugs@FDA data for rivaroxaban returns 30 records on 23 October 2026: 26 abbreviated applications (ANDAs) and 4 new drug applications (NDAs). The 26 ANDAs come from 22 sponsors. Twenty-one are tablet applications with full approval, held by 19 sponsors. Two sit at tentative approval. Three cover an oral suspension.

The first tablet approvals are recorded on 3 March 2025, for Lupin and Taro. Nine applications record approval on 14 May 2025: Aiping, Ascent, Dr Reddy's, InvaGen, Alembic, Macleods, Sunshine, Biocon and Lupin, whose application ANDA208555 also records 3 March 2025. Breckenridge records 15 May 2025, and Aurobindo's application records two approval dates, 10 April and 15 May 2025. Further approvals run through 2025 and into 2026, the latest in this dataset being Micro Labs on 30 June 2026, Mankind on 1 July 2026 and Epic on 19 August 2026.

FDA's announcement of 4 March 2025 describes the first generic Xarelto approvals as 2.5 mg tablets, and Lupin announced the launch of its 2.5 mg tablets in the United States on 7 March 2025. Drugs@FDA does not record approval dates by strength, so the approvals of 14 May 2025 and later are not attributed to strengths here. No launch of a 10 mg, 15 mg or 20 mg generic is established in this brief.

Sixteen of the approved tablet applications cover the 2.5 mg strength. Nineteen cover each of the 10 mg, 15 mg and 20 mg strengths, and three of those nineteen list the strengths as discontinued. The two nineteens are different counts: 19 sponsors hold an approved tablet application, and 19 applications list each of the higher strengths.

The nineteen applications are the number that matters, because of what is still sitting in the Orange Book against those same strengths.

Which Xarelto patent is still listed in the Orange Book?

We pulled the Orange Book patent tables for NDA 022406 product by product on 23 October 2026, confirming on each returned page that the product number and strength matched the request. The method for reading these registers is set out on the LOE Edge methodology page.

Product 001, the 10 mg tablet, carries patent 9,539,218 expiring 17 February 2034, with a pediatric entry to 17 August 2034, against use codes U-1957, U-2143, U-2641 and U-3288. Product 002, the 15 mg tablet, carries the same patent and dates against use codes U-1953 and U-3289. Product 003, the 20 mg tablet, carries it against U-1953, U-1954, U-1955 and U-3285. Product 004, the 2.5 mg tablet, has no patent rows and no exclusivity rows.

On every one of those rows the drug substance and drug product columns are blank. This is a method-of-use patent. It is attached to indications and dosing regimens, not to the molecule or the formulation.

So the position as the FDA records it is this. A patent is listed to 2034 on three strengths. Nineteen approved applications cover each of those strengths. Both are true at the same time, and approval is not launch.

Exhibit 1. Rivaroxaban tablets under NDA 022406: listed patent against approved generic applications, by strength

Sources: FDA Orange Book patent and exclusivity data for NDA 022406, products 001 to 004, retrieved 23 October 2026, with the product number and strength confirmed on each returned page. Application counts derived from FDA Drugs@FDA records via the openFDA API, retrieved 23 October 2026 (openFDA last updated 22 October 2026). Ten, 15 and 20 mg each show 19 approved applications; three of the nineteen list those strengths as discontinued. FDA states that openFDA data is unvalidated and should not be used for medical decisions; the Orange Book and Drugs@FDA remain the authoritative views.

Exhibit 2. Rivaroxaban tablet ANDA approvals on the FDA record, March 2025 to August 2026

Source: FDA Drugs@FDA records via the openFDA API, retrieved 23 October 2026. Dates shown are submission status dates recorded as approvals. Where an application records two approval dates, both are reflected in the underlying data. This exhibit shows the shape of the approval sequence and is not a complete list of applicants; the full set is in the source data. Approval is not launch, and marketing status is a separate field.

Which patents are named in the Xarelto litigation?

Johnson & Johnson's annual report for fiscal 2025 lists two US patents as included in one or more of the Xarelto cases: 9,539,218 and 10,828,310. The filing states that Janssen Pharmaceuticals, Inc., Bayer Pharma AG, Bayer AG and Bayer Intellectual Property GmbH filed patent infringement suits from March 2021 against generic manufacturers that had filed ANDAs seeking approval before expiration of certain Orange Book listed patents. It does not say which patent was asserted against which defendant or strength.

The filing names these defendants: Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories, Ltd.; Lupin Limited and Lupin Pharmaceuticals, Inc.; Taro Pharmaceutical Industries Ltd. and Taro Pharmaceuticals U.S.A., Inc.; Teva Pharmaceuticals USA, Inc.; Mylan Pharmaceuticals Inc. and Mylan Inc.; Mankind Pharma Limited; Apotex Inc. and Apotex Corp.; Cipla Ltd. and Cipla USA Inc.; InvaGen Pharmaceuticals, Inc.; and Prinston Pharmaceuticals, Inc.

In December 2025 and January 2026, the cases against all of them were dismissed with prejudice, according to the same filing. In January 2026 the company entered into a confidential settlement agreement with Mankind Pharma Limited. The passage read describes no settlement with any other defendant and does not state why the other cases were dismissed.

US 10,828,310, titled "Reducing the Risk of Cardiovascular Events", covers methods of reducing cardiovascular risk in coronary artery disease or peripheral artery disease by administering rivaroxaban with aspirin. That is the therapeutic territory of the 2.5 mg strength. It does not appear in the current Orange Book tables for NDA 022406. We have not retrieved its listing history, and we do not state whether it was ever listed.

On 10 December 2021 the Judicial Panel on Multidistrict Litigation centralised five actions as MDL No. 3017, captioned In re Xarelto (Rivaroxaban) ('310) Patent Litigation, before Judge Richard G. Andrews in the District of Delaware. Four actions were pending in Delaware and one in the Northern District of West Virginia. The plaintiffs were Bayer Pharma AG, Bayer AG and Janssen Pharmaceuticals.

The defendants named in the order were Lupin, Dr Reddy's, Taro, Teva and Mylan. The panel's order states that "All of the actions are Hatch-Waxman patent infringement lawsuits" and that they concern the defendants' filings to sell generic Xarelto 2.5 mg tablets. The Panel's report of recently terminated MDLs lists MDL 3017 as terminated on 3 February 2026.

Separately, the patent was challenged at the Patent Trial and Appeal Board in inter partes review proceedings IPR2022-00517, IPR2022-01513 and IPR2022-01515. The Board found claims 1 and 2 anticipated and claims 1 to 8 obvious. Bayer appealed. On 23 September 2025 the Federal Circuit affirmed the judgment that claims 1 to 4 are unpatentable, vacated the judgment as to claims 5 to 8, and remanded for the Board to reconsider under a narrower construction of the term "first product", which the court held requires a single dosage form containing both rivaroxaban and aspirin.

J&J's 10-K states that in January 2026 the USPTO entered judgment against the petitioners upon remand. We have not read that decision, so its effect on claims 5 to 8 is not stated here.

Both patents therefore appear in J&J's own list of patents in the Xarelto cases. The record read here does not show which was asserted against which strength, and nothing in it explains the approvals on the higher strengths.

Exhibit 3. Rivaroxaban status by strength and by patent, as at 23 October 2026

Source: Compiled from the sources named in each row and verified on 23 October 2026. Statements about litigation are drawn from the court's own opinion, the Judicial Panel's transfer order and terminated-MDL report, and J&J's Form 10-K. Nothing in this table predicts the outcome of the remanded claims.

What does the record not explain about the higher-strength approvals?

A method-of-use patent listed against three strengths, and approvals on those strengths. The obvious question is how.

We are not going to answer it, because the sources checked do not. Several routes exist in principle for an abbreviated application to proceed where a method-of-use patent is listed, and the public record we pulled does not show which, if any, was used by which applicant. J&J's 10-K reports dismissals with prejudice and one confidential settlement, with Mankind Pharma Limited, and states no terms. Establishing the route would need the certifications filed with each application and the terms of any settlements. These are generally not public.

We read the current labels on DailyMed on 25 October 2026. Three generic labels list 10 mg, 15 mg and 20 mg alongside 2.5 mg: Alembic Pharmaceuticals Limited (label revised 10/2025), Changzhou Pharmaceutical Factory (2/2026) and Indoco Remedies (11/2025). The Alembic and Changzhou labels carry the same section 1 indication headings as the Xarelto label (revised 3/2026), 1.1 to 1.10; for Indoco we confirmed headings 1.1 to 1.8 and did not read 1.9 and 1.10. The other 15 generic tablet labels in the DailyMed rivaroxaban results that day list 2.5 mg only, with the coronary and peripheral artery disease indications.

Lupin's DailyMed label for NDC 68180-709 is one of those 2.5 mg labels. We found no Lupin label for 10 mg, 15 mg or 20 mg in the DailyMed search. Lupin's own release of 15 May 2025 lists eight indications for those strengths, and a press release is not the label.

These are current labels, not the labels as approved. We compared section headings and read the text of subsections 1.1 and 1.8, not every sentence, and we have not matched any indication to the use codes on the Orange Book rows. No carve-out is visible in the three labels. That does not show how the approvals were reached.

What can be said from the record is narrower and still useful. The patent is listed against use codes and carries no drug substance or drug product flag, so it is attached to specific indications and dosing regimens rather than to the molecule. That is the category of patent for which carve-out and certification routes exist. Which route applied here is not established.

Anyone sizing this molecule should treat that gap as the finding rather than as a hole to fill with an assumption. The approvals are a matter of record. The mechanism is not.

What do Johnson & Johnson's filings say about Xarelto sales?

J&J reported US Xarelto sales of $2,633m for fiscal 2025 against $2,373m for 2024, growth of 11.0 per cent on both a reported and an operational basis. For the first nine months of fiscal 2026, to 27 September 2026, sales were $1,959m against $1,946m, up 0.7 per cent on both bases. Third-quarter sales were $653m against $635m, up 2.7 per cent; J&J calculates its percentages from unrounded figures, so the rounded dollar amounts give a slightly different result.

J&J's tables show no international Xarelto sales, so its worldwide and US figures are the same number. J&J's 10-K describes Xarelto as co-developed with Bayer HealthCare AG.

The 10-K states that the growth of Xarelto sales in 2025 was primarily driven by the impact of Medicare Part D redesign and market growth, partially offset by continued share loss. For the fiscal third quarter of 2026, the 10-Q states that Xarelto sales rose primarily on favourable patient mix, partially offset by continued share erosion.

The 10-Q also states that there are potential generic entrants in 2027 in the US, which will likely result in a reduction in future sales. It does not say which strengths or which companies. Nothing in the passages read links the 2025 or 2026 sales movement to the approvals in the FDA record, and none is inferred here.

Exhibit 4. US Xarelto sales through the year of first generic approvals

Source: Johnson & Johnson Form 10-K for fiscal 2025 and Form 10-Q for the quarter ended 27 September 2026, key product sales schedules. Reported and operational growth were both 11.0 per cent for 2025 and both 0.7 per cent for the nine months. J&J reports Xarelto sales in the US only. The causes shown in the text are the company's own statements.

How does the Medicare negotiation programme apply to Xarelto?

J&J's 10-K states that CMS published the first Selected Drug List in 2023, that it includes Xarelto, and that selected products are subject to a government-established price for the Medicare population beginning in 2026. CMS's own page records a deselection determination for Xarelto with timing of October 2025 and a removal effective date of 1 January 2027. The 10-K states that CMS has indicated it will remove Xarelto from the Selected Drug List from 2027.

CMS states the general rule: a selected drug ceases to be a selected drug under certain circumstances, such as when FDA has approved a generic that identifies a product in the selected drug as its reference-listed drug and the generic is marketed under that approval. The page gives no Xarelto-specific reason. CMS's fact sheet on negotiated prices for initial price applicability year 2026 (page dated 15 August 2024) lists Xarelto at a list price of $517 per 30-day supply for calendar year 2023 and a negotiated maximum fair price of $197 per 30-day supply for calendar year 2026, a 62 per cent discount from list. The selected drugs page also links a document titled "MFP Explanation for Xarelto", which we have not read.

The first rivaroxaban tablet approvals in the FDA record, on 3 March and 14 May 2025, precede the October 2025 determination. We state the sequence without asserting that one caused the other, because CMS does not say so for this product.

What is the status of the European dosing patent?

The European patent at issue on dosing is EP 1 845 961, "Treatment of thromboembolic disorders with rivaroxaban", held by Bayer Intellectual Property GmbH, filed 19 January 2006 and granted 22 April 2015. Google Patents records an anticipated expiry of 19 January 2026 and a legal status of expired, and labels its own status data an assumption rather than a legal conclusion.

That date is more than nine months in the past.

Bayer's release of 29 October 2021 states that the European Patent Office reversed a first-instance decision and maintained EP 1 845 961 for once-daily dosing at 10, 15 and 20 mg, and that Bayer regards the patent as valid until mid-January 2026. JUVE Patent reported on 30 July 2025 that the German Federal Patent Court revoked EP 1 845 961 for lack of inventive step in case 3 Ni 11/22; we have not read the judgment or any appeal.

We have not read the EPO Register or other national registers, so the status of the patent in other countries, and any supplementary protection certificates, is not stated here.

How should you read this if you are deciding whether to build?

• Read the application register, not only the patent register. The patent table on this molecule points one way and the approval record points the other. Only one of them records what has been approved. LOE Edge shows the patent listings and the generic application record for a molecule, each figure with its source.
• A method-of-use listing is not a wall. Patent 9,539,218 is listed against use codes with no drug substance or drug product flag, and approvals on the strengths it covers are on the record. Whether a given applicant carved out, certified or settled is a separate question needing separate evidence.
• Check which patents were litigated. J&J lists both 9,539,218 and 10,828,310 as included in one or more of the Xarelto cases, which were dismissed with prejudice in December 2025 and January 2026. The filing does not tie either patent to a strength.
• Separate approval, marketing status and launch. FDA marketing status of "Prescription" is a regulatory field, not evidence of pharmacy availability. The only launch established here is Lupin's 2.5 mg launch, announced on 7 March 2025; launches by strength and company are otherwise not established in this brief. The apixaban brief reads a second small-molecule record the same way, and Denosumab biosimilars sets approved, permitted and launched dates side by side for a biologic.
• Read the company's stated reasons, and no further. J&J attributes the 2025 US Xarelto growth primarily to Medicare Part D redesign and market growth, and nine-month 2026 sales were up 0.7 per cent. Whether approvals affect those figures is not stated by the company.

Frequently asked questions

Related reading

• Apixaban loss of exclusivity: a second small-molecule record, with a company-stated date that is not on the Orange Book.
• Denosumab biosimilars: US biosimilar entries from June 2025 on reported settlement dates, and Amgen's sales.
• Pembrolizumab loss of exclusivity: two FDA licences, two sets of Merck-listed dates.

Read the same FDA record for your own molecule

LOE Edge shows the Orange Book entries and the FDA application record for a molecule, each figure with its source, method and confidence. Request a walkthrough with a molecule that matters to your portfolio. The demo reads FDA records: for small molecules the Orange Book and application data, and for biologics the Purple Book.

Request a walkthrough

Methodology and sources

This brief was last updated on 25 October 2026. FDA, CMS and J&J figures were pulled on 23 October 2026. The Orange Book patent and exclusivity screens and the DailyMed labels were read on 25 October 2026; the Orange Book home page then stated "Current through October 2026". No syndicated market research forecast is used anywhere in this piece, and no market size has been estimated.

Open items. Launches by strength and company other than Lupin's 2.5 mg launch of 7 March 2025; the certifications and settlement terms behind each higher-strength approval; any Lupin label for 10 mg, 15 mg and 20 mg; the 1.9 and 1.10 indication text of the Indoco label; the original approved labels; the Orange Book listing history and enforceable term for US 10,828,310; the content of the USPTO's January 2026 remand judgment, by claim (searched for on 23 October 2026, not found); the EPO Register and the German judgment's appeal status; and which strengths J&J means by potential US generic entrants in 2027. None of these is asserted in the text.

Nothing in this brief is investment advice or a recommendation regarding any security. Orange Book and Drugs@FDA records are point-in-time and change without notice. Statements about litigation are drawn from the courts' own documents, describe filings and judgments only, and predict no outcome.

1. FDA Orange Book, patent and exclusivity data for NDA 022406, products 001 to 004, retrieved 23 October 2026, with product number and strength confirmed on each returned page. accessdata.fda.gov.
2. FDA Drugs@FDA records via the openFDA API, rivaroxaban abbreviated and new drug applications, retrieved 23 October 2026 (openFDA last updated 22 October 2026). FDA states this data is unvalidated and not for medical decisions. api.fda.gov.
3. Bayer Pharma Aktiengesellschaft v. Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA, Inc., InvaGen Pharmaceuticals Inc., United States Court of Appeals for the Federal Circuit, No. 2023-2434, decided 23 September 2025, on appeal from IPR2022-00517, IPR2022-01513 and IPR2022-01515. cafc.uscourts.gov.
4. In re Xarelto (Rivaroxaban) ('310) Patent Litigation, MDL No. 3017, United States Judicial Panel on Multidistrict Litigation transfer order of 10 December 2021. govinfo.gov.
5. United States Judicial Panel on Multidistrict Litigation, Recently Terminated MDLs report, January 1 2026 to March 2 2026, for the termination date of MDL No. 3017. jpml.uscourts.gov.
6. Johnson & Johnson, Form 10-K for the fiscal year ended 28 December 2025, filed 11 February 2026, for US Xarelto sales of $2,633m in 2025 and $2,373m in 2024, the company's stated reasons for the 2025 movement, the Xarelto patent litigation paragraph, and the Medicare Drug Price Negotiation statements. sec.gov.
7. Johnson & Johnson, Form 10-Q for the quarter ended 27 September 2026, for US Xarelto sales for the third quarter and first nine months of fiscal 2026, the company's stated reasons, its statement on potential US generic entrants in 2027, and the note that percentages are calculated from unrounded figures. sec.gov.
8. U.S. Food and Drug Administration, FDA Roundup, 4 March 2025, for the description of the first generic Xarelto approvals as 2.5 mg tablets. fda.gov.
9. Lupin Limited, press release of 7 March 2025, Lupin launches Rivaroxaban Tablets USP, 2.5 mg, in the United States. lupin.com.
10. Centers for Medicare & Medicaid Services, Medicare Drug Price Negotiation Program, selected drugs and negotiated prices page, retrieved 23 October 2026, for the Xarelto deselection determination of October 2025, the removal effective date of 1 January 2027, and the general deselection rule. cms.gov.
11. Centers for Medicare & Medicaid Services, Medicare Drug Price Negotiation Program: Negotiated Prices for Initial Price Applicability Year 2026, fact sheet, for the Xarelto list price and negotiated price per 30-day supply. cms.gov.
12. Google Patents, EP1845961B1, retrieved 23 October 2026, for filing, grant and anticipated expiry of 19 January 2026, which Google labels an assumption rather than a legal conclusion. patents.google.com.
13. Bayer AG, press release of 29 October 2021, European Patent Office maintained Bayer patent on the once-daily administration of rivaroxaban. bayer.com.
14. JUVE Patent, report of 30 July 2025 on the German Federal Patent Court decision on EP 1 845 961, case 3 Ni 11/22. Trade press, secondary; the judgment was not read. juve-patent.com.
15. Lupin Limited, press release of 15 May 2025, Lupin receives approval from U.S. FDA for Rivaroxaban Tablets USP, 10 mg, 15 mg and 20 mg, for the indications Lupin lists. Company release, not the approved label. lupin.com.
16. DailyMed, National Library of Medicine, Xarelto (Janssen) drug label, revised 3/2026, read 25 October 2026, for the indications and strengths. dailymed.nlm.nih.gov.
17. DailyMed, Alembic Pharmaceuticals Limited rivaroxaban label, revised 10/2025, read 25 October 2026, 2.5, 10, 15 and 20 mg. dailymed.nlm.nih.gov.
18. DailyMed, Changzhou Pharmaceutical Factory rivaroxaban label, revised 2/2026, read 25 October 2026, 2.5, 10, 15 and 20 mg. dailymed.nlm.nih.gov.
19. DailyMed, Indoco Remedies rivaroxaban label, revised 11/2025, read 25 October 2026, 2.5, 10, 15 and 20 mg. dailymed.nlm.nih.gov.
20. DailyMed, Lupin Pharmaceuticals rivaroxaban label (NDC 68180-709), revised 4/2026, read 25 October 2026, 2.5 mg only. dailymed.nlm.nih.gov.