One Company, Two Anticoagulants, Two Different Records

Aurobindo holds US approvals for generic versions of Xarelto and Eliquis. On the public record, one has a product listed for sale and the other does not. The records give dates for each. They do not explain why the two differ.

The question this piece answers

Does an FDA approval tell you when a generic can be sold?

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No. An approval records that an application met the standard. It does not set a sale date. Aurobindo's generic rivaroxaban 2.5 mg was approved and listed for sale on 10 April 2025. Its generic apixaban was approved on 26 May 2023, and the records read on 26 October 2026 show no finished-dose product.

Five facts, each with its source

1. FDA approved Aurobindo's apixaban application (ANDA 210026, 2.5 mg and 5 mg) on 26 May 2023. Drugs@FDA lists its marketing status as "Discontinued". Source: Drugs@FDA, read 26 October 2026.

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2. The Bristol-Myers Squibb and Pfizer Alliance stated on 3 September 2021 that the earliest date generic manufacturers are permitted to launch apixaban is 1 April 2028, "subject to additional appeals and challenges". Source: Alliance press release, 3 September 2021.

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3. Pfizer's Form 10-K for 2025 says settlements permit a number of generic companies to launch a generic Eliquis on 1 April 2028, and that three other generic companies are not permitted to launch until the 2031 expiry of the formulation patent. It names no generic company. Source: Pfizer Inc. Form 10-K for 2025.

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4. Aurobindo Pharma USA announced final approval of rivaroxaban 2.5 mg on 10 April 2025. DailyMed lists NDC 59651-849 with a marketing start of 10 April 2025. Sources: Aurobindo Pharma USA release, 10 April 2025; DailyMed, read 26 October 2026.

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5. The Orange Book lists no patent or exclusivity against the Xarelto 2.5 mg product. It lists US 9,539,218 to 17 February 2034 against the 10, 15 and 20 mg products, with pediatric exclusivity to 17 August 2034. Source: FDA Orange Book, NDA 022406, read 26 October 2026.

Who and what does this page refer to?

"Aurobindo" here means the applicant that Drugs@FDA names on both applications, AUROBINDO PHARMA LTD. Aurobindo's US releases are issued by Aurobindo Pharma USA on behalf of Aurobindo Pharma Limited. "The Alliance" is the Bristol-Myers Squibb and Pfizer Alliance named in the 3 September 2021 release. Pfizer and Bristol-Myers Squibb are cited under the names their own filings use. "Xarelto" and "Eliquis" are the brand products that the generics reference. Court records name Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc. as separate defendants, and this page uses the name each record gives.

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.

Two approvals, one table

We read both records on the same day. Each shows an approval. Beyond that, they do not look alike.

Exhibit 1. Aurobindo's two anticoagulant applications, as the FDA records show them on 26 October 2026

Sources: Drugs@FDA; openFDA NDC endpoint; DailyMed; FDA Orange Book. Dates are as published. "None seen" means the record read shows no entry, not that no product exists. NPP is the Orange Book code for new patient population exclusivity. Pediatric entries add six months to the period they attach to.

This table is why the title says two different records. For rivaroxaban 2.5 mg, the register shows nothing standing in the way, and a product was listed on the approval date. For apixaban, the dates sit in other places: a patent listing, an exclusivity entry, and company statements. No line in the register reads 1 April 2028.

Rivaroxaban: the same application splits by strength

Aurobindo's rivaroxaban application covers four strengths. The records treat them differently.

Aurobindo Pharma Limited told the Indian exchanges on 12 April 2025 that the 2.5 mg strength had final approval and that the other strengths had tentative approval only. On Drugs@FDA, all four strengths now appear under marketing status "Prescription". The record also shows a second original submission dated 15 May 2025, 35 days after the first. We did not read what that submission covered, so we do not say.

Here are two records that sit side by side and do not obviously agree. The April 2025 letter says tentative approval for 10, 15 and 20 mg. The later Drugs@FDA listing carries those strengths as "Prescription". We have not reconciled them. We also found no NDC for 10, 15 or 20 mg under this application in the openFDA data, and that does not show whether they are sold.

One cross-check, and it is not independent. Drugs.com's generic Xarelto availability page, last updated on 10 September 2026, draws on FDA data. It lists Aurobindo for 2.5 mg only in its marketing table, with a start date of 10 April 2025. It lists approvals for 10, 15 and 20 mg dated 15 May 2025, with no marketing entry.

The Orange Book is the other half. It lists no patent or exclusivity against the 2.5 mg product. It lists US 9,539,218 against the three higher strengths. A patent date such as 17 February 2034 is a date on a register. By itself, it does not say what FDA has approved or what is on sale.

The court record also shows a Delaware case over the patent listed against the 10, 15 and 20 mg products. On 28 April 2017 Bayer Intellectual Property GmbH, Janssen Pharmaceuticals, Inc. and Bayer AG sued Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc. over US 9,539,218 (No. 1:17-cv-00483). The docket's ANDA form gives the patent's expiry as 17 February 2034.

The case was consolidated on 13 November 2017 into lead case No. 1:17-cv-00462, administratively closed on 30 November 2017, and closed on 22 December 2020 by reference to entry 230 in the lead case. That entry, dated 2 September 2020, is an order granting a stipulation of dismissal between Bayer and InvaGen Pharmaceuticals, Inc. The Aurobindo docket shows no judgment, settlement or dismissal entry of its own, and no ruling on the patent. We did not read how the Aurobindo case was resolved, and we do not say.

Apixaban: an approval from 2023 and no finished-dose listing

Aurobindo Pharma USA announced final FDA approval for apixaban 2.5 mg and 5 mg on 26 May 2023. The release does not give a launch date.

Drugs@FDA now lists the application as "Discontinued". That word is easy to misread. In a Federal Register notice of 28 August 2024, FDA wrote that never marketing an approved drug product is equivalent to withdrawing it from sale, and listed that product in the Orange Book's "Discontinued Drug Product List" section. So a Discontinued entry can describe a product that was sold and stopped, or one that was never sold.

We read that rule in an FDA notice about a different drug. We have not read the Drugs@FDA field definition, so we treat the link between that section and the "Discontinued" marketing status as likely, not confirmed.

The openFDA National Drug Code data, last updated on 23 October 2026, shows only a bulk-ingredient listing for Aurobindo and apixaban. That is one point-in-time search. It shows no listing. It is not proof that no sale ever happened.

We looked for a sales source and found none. Aurobindo's earnings call transcripts for Q4 FY26 (22 May 2026) and Q1 FY27 (6 August 2026) do not mention apixaban or rivaroxaban. Its Q1 FY27 presentation says the company launched 10 products in the US in the quarter and names none of them.

The dates in the company filings

The Alliance wrote on 3 September 2021 that the earliest date generic manufacturers are permitted to launch apixaban is 1 April 2028, and that this is "subject to additional appeals and challenges".

Pfizer's Form 10-K for 2025 gives more. It says that Pfizer and Bristol-Myers Squibb settled patent litigation with a number of generic companies, permitting their launch on 1 April 2028. It says Pfizer continued to litigate against three remaining generic companies and, after the litigation resolved in Pfizer's favour, those three are not permitted to launch until the 2031 expiry of the formulation patent.

It also lists ways an earlier launch could arise, including a launch on 21 November 2026 for the settled companies if the formulation patent were held invalid or not infringed in future litigation, through appeal. Pfizer says it cannot predict the outcome of any such litigation.

The filing names no generic company in this passage. A search of the whole filing found Aurobindo named only in an unrelated Nurtec passage, and not in any Eliquis passage. So the public record we read does not say whether Aurobindo is among the settled companies, among the three remaining, or neither. The Orange Book carries NPP exclusivity to 17 April 2028, a different day from 1 April 2028. We do not say how the two relate.

1,772 days

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The gap between FDA's approval of Aurobindo's apixaban application (26 May 2023) and the 1 April 2028 launch date that the Alliance and Pfizer state for generic companies. This is our arithmetic on two dated records. One is an FDA date. The other is a company statement that names no generic company, so we do not say it applies to Aurobindo.

The court record on Aurobindo and Eliquis

Aurobindo appears in the US court record for Eliquis. On 5 April 2017 Bristol-Myers Squibb Company and Pfizer Inc. sued Aurobindo Pharma USA Inc. in the US District Court for the District of Delaware (No. 1:17-cv-00374). The report to the Patent and Trademark Office on that docket lists US 6,967,208 and US 9,326,945. The action was consolidated with other Eliquis actions before one judge.

On 26 August 2019 the plaintiffs and both Aurobindo defendants, Aurobindo Pharma USA Inc. and Aurobindo Pharma Limited, filed a stipulation of dismissal. It dismisses all claims and counterclaims without prejudice, has each side bear its own costs, and says it finally resolves the action between those parties. The stipulation does not use the word settlement and states no terms.

Two points follow, and no more. A dismissal without prejudice is not a ruling on the patents. And the public record we read does not say whether Aurobindo is among the settled companies in Pfizer's Form 10-K, or among the three remaining ones. The 10-K names no company and the stipulation names no settlement, so we cannot join the two. The dockets are CourtListener's copy of the federal court record, which says it may not be up to date.

The part that is actually our argument

What is sourced. Every date, strength, application number and marketing status above comes from a named record and is dated. The 1,772-day gap is arithmetic on two of those dates.

What is ours. We make three points.

1. An approval date is not a sale date. Aurobindo's rivaroxaban 2.5 mg approval and listing fall on the same day. Its apixaban approval is more than three years old, and the records read show no finished-dose product.
2. The dates that matter sit in different kinds of record for each molecule. For rivaroxaban 2.5 mg, the register lists nothing. For apixaban, the dates sit in a patent listing, an exclusivity entry and a company statement.
3. A company-level view hides this. Even within one rivaroxaban application, the strengths sit in different positions. A portfolio view needs a row for each molecule, each strength and each record.

We hold this at medium confidence. We read these registers once, on one day. Points 1 and 2 follow directly from the records. Point 3 is a judgement about what a planner needs, and it comes from how the records read, not from a test.

This is not a prediction. We do not say when Aurobindo will or will not sell apixaban, or what any court or company will do.

What would change our mind

• A dated source showing a finished-dose Aurobindo apixaban product on sale in the US. That would break the central contrast. We looked in the openFDA NDC data, the Drugs@FDA marketing status, Aurobindo's two releases and its last two earnings calls, and found none.
• A source that places Aurobindo among the settled companies, or among the three remaining ones. That would turn an open question into a known one. The 2019 stipulation of dismissal does not do this, because it states no terms and does not mention the 10-K's settlements.
• An NDC listing for rivaroxaban 10, 15 or 20 mg under Aurobindo's application. That would remove the strength split.
• Evidence that the "Discontinued" status on ANDA 210026 is a records lag. That would change how the apixaban row reads.

Questions the public record does not answer

How to read this if you are planning a multi-molecule portfolio

• Read approval and sale as two facts. Check the marketing status and the NDC data for each strength.
• Read the register and the company statement separately. They can carry different dates for the same molecule.
• Treat "Discontinued" as a flag to investigate, not as a reason.
• Check the strength. One application can hold strengths in different positions.
• Date every record you rely on. These move.

LOE Edge puts these FDA records in one view for a molecule. The LOE Edge methodology page describes how the Orange Book is read. Two companion pieces cover each molecule in full: apixaban and rivaroxaban.

Frequently asked questions

Related reading

• Apixaban loss of exclusivity: what the FDA records show
• Rivaroxaban loss of exclusivity: what the FDA records show
• How LOE Edge reads the Orange Book

See these records for your own molecules

LOE Edge brings FDA records for a molecule into one view: approvals, applications, and the patents and exclusivity listed in the Orange Book. Book a demo and we will walk through a molecule with you.

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Methodology and sources

How we read these records. We read ANDA 208544 and ANDA 210026 on Drugs@FDA through the openFDA drugsfda endpoint. We read marketing start dates on DailyMed and finished-dose listings in the openFDA National Drug Code endpoint, whose data was last updated on 23 October 2026. We read patents and exclusivity on the Orange Book for NDA 022406 (Xarelto) and NDA 202155 (Eliquis).

We read company statements in the sources below. For Pfizer's Form 10-K, we read the full text of the Eliquis footnote and searched the whole filing for Aurobindo. All reads were on 26 October 2026. The FDA records were read directly in a browser pane and through the openFDA application programming interface. We read the Delaware dockets on CourtListener, which copies the federal court record and says its copy may not be up to date, and the 26 August 2019 stipulation in full.

We read the lead-case order of 2 September 2020 only as far as its docket description. The 1,772-day gap and the 35-day gap are our arithmetic on dated records.

What these records do not show. Drugs@FDA lists approved applications, and for ANDAs tentatively approved ones. It does not list applications under review. The NDC data lists products that companies have listed with FDA. It does not show sales. Neither source says why a product is or is not on sale. A docket lists what was filed. It does not give settlement terms unless they were filed publicly, and a dismissal entry does not say why a case ended.

Licensed data. We use no licensed sales figures.

1. FDA. Drugs@FDA, ANDA 208544, rivaroxaban tablets, AUROBINDO PHARMA LTD. Drugs@FDA overview, ApplNo 208544. Read 26 October 2026.
2. FDA. Drugs@FDA, ANDA 210026, apixaban tablets, AUROBINDO PHARMA LTD. Drugs@FDA overview, ApplNo 210026. Read 26 October 2026.
3. FDA. openFDA National Drug Code endpoint, data last updated 23 October 2026. openFDA drug NDC. Read 26 October 2026.
4. National Library of Medicine. DailyMed, NDC 59651-849, rivaroxaban 2.5 mg, Aurobindo. DailyMed search. Read 26 October 2026.
5. FDA. Orange Book, NDA 022406 (Xarelto), patent and exclusivity listings. Orange Book patent information. Read 26 October 2026.
6. FDA. Orange Book, NDA 202155 (Eliquis), patent and exclusivity listings. Orange Book patent information. Read 26 October 2026.
7. Aurobindo Pharma USA. Release of 26 May 2023, apixaban tablets 2.5 mg and 5 mg, final approval. Aurobindo Pharma USA news. Read 26 October 2026.
8. Aurobindo Pharma USA. Release of 10 April 2025, rivaroxaban tablets 2.5 mg, final approval. Aurobindo Pharma USA news. Read 26 October 2026.
9. Aurobindo Pharma Limited. Letter to the NSE and BSE of 12 April 2025 on the rivaroxaban approvals. Disclosure letter (PDF). Read 26 October 2026.
10. Bristol-Myers Squibb and Pfizer Alliance. Press release of 3 September 2021 on the Federal Circuit decision, as published by Pfizer. Pfizer announcements. Read 26 October 2026.
11. Pfizer Inc. Form 10-K for the year ended 31 December 2025, footnote 5 to the US patent expiration table, and the legal proceedings note. SEC EDGAR. Read 26 October 2026.
12. FDA. Federal Register notice of 28 August 2024, 89 FR 68910, on fentanyl citrate injections and the Discontinued Drug Product List. Federal Register (PDF). Read 26 October 2026.
13. Aurobindo Pharma Limited. Earnings presentation for Q1 FY27. Earnings presentation (PDF). Read 26 October 2026.
14. Aurobindo Pharma Limited. Earnings conference call transcript for Q1 FY27, 6 August 2026. Transcript (PDF). Read 26 October 2026.
15. Aurobindo Pharma Limited. Earnings conference call transcript for Q4 FY26, 22 May 2026. Transcript (PDF). Read 26 October 2026.
16. Drugs.com. Generic Xarelto availability, last updated 10 September 2026. Secondary source that draws on FDA data. Drugs.com availability page. Read 26 October 2026.
17. US District Court for the District of Delaware. Bristol-Myers Squibb Company v. Aurobindo Pharma USA Inc., No. 1:17-cv-00374, docket as copied on CourtListener. CourtListener docket. Read 26 October 2026.
18. Same case, document 612, stipulation of dismissal filed 26 August 2019, read in full. CourtListener, document 612. Read 26 October 2026.
19. US District Court for the District of Delaware. Bayer Intellectual Property GmbH v. Aurobindo Pharma Limited, No. 1:17-cv-00483, docket as copied on CourtListener. CourtListener docket. Read 26 October 2026.
20. US District Court for the District of Delaware. Bayer Intellectual Property GmbH v. Taro Pharmaceutical Industries Ltd., No. 1:17-cv-00462 (lead case), entry 230 of 2 September 2020, docket description only. CourtListener, entry 230. Read 26 October 2026.

This page describes public regulatory records. It does not predict any company's launch, any court's decision or any commercial outcome, and it is not investment advice.