What MSN’s Entresto Court Win Did and Did Not Decide

In July 2025 a US district court found that Novartis had not proved MSN’s generic Entresto infringed one patent. The public record shows a longer sequence behind generic entry: FDA approved MSN’s application almost a year before the ruling, and ten generic applications show register dates before pediatric exclusivity ended. The reading is ours and is labelled as such.

The short account of generic Entresto goes like this: MSN took on Novartis, won in court, and a market opened. I set out to test it. The record I could read supports one part. On 11 July 2025 the US District Court for the District of Delaware found that Novartis had not proved that MSN’s product infringed one patent. The same record does not show that this ruling was what opened the market, and it shows the Federal Circuit ruling for Novartis on a separate patent on 10 January 2025.

This is a read of one molecule, sacubitril/valsartan (Entresto), and one company’s part in it. LOE Edge’s demo reads FDA data (Orange Book and drug label records via openFDA). It does not read court records, which this piece relies on. Novartis’s brand product is NDA 207620. I counted applications on the FDA register, read the court orders I could open, and kept a note of what I could not read.

Who and what does this page refer to?

• MSN means the three defendants named in the Federal Circuit caption: MSN Pharmaceuticals, Inc., MSN Laboratories Private Ltd. and MSN Life Sciences Private Ltd. On the FDA register the sponsor name for ANDA 213748 is “MSN”.

• Novartis: the court records name Novartis Pharmaceuticals Corporation. The FDA register names “NOVARTIS PHARMS CORP” (NDA 207620) and “NOVARTIS” (NDA 218591). Novartis’s own reports say “Novartis”.

• Novadoz: Optum Rx’s notice says Novadoz launched MSN’s generic. The openFDA record for ANDA 213748, whose sponsor is “MSN”, lists the labelled products under the manufacturer name “Novadoz Pharmaceuticals LLC”. The sources I read do not say how Novadoz relates to the MSN entities.

• Torrent: the Federal Circuit caption names Torrent Pharma Inc. and Torrent Pharmaceuticals Ltd. The register and Optum Rx’s notice say “Torrent”.

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.

Terms used on this page

• ANDA: an abbreviated new drug application, the route by which a generic maker asks FDA to approve a copy of an already approved drug.

• Pediatric exclusivity: a six-month period that FDA grants a brand company in exchange for FDA-requested studies in children. Novartis’s Supreme Court brief cites 21 U.S.C. §355a(c) for the period on Entresto.

• Register date: the date that the FDA register (openFDA and Drugs@FDA) gives for the approved status of an application’s original submission. It is not always the date FDA first approved the product (see Exhibit 2).

What did the court decide on 11 July 2025?

Judge Richard G. Andrews decided the infringement case on US 11,096,918 after a four-day bench trial in the District of Delaware, held from 10 to 13 December 2024. The opinion, dated 11 July 2025, describes the patent as directed to the amorphous solid form of sacubitril, valsartan and sodium cations. It finds that Novartis did not prove, by a preponderance of the evidence, that MSN’s generic application infringes it.

The conclusion rests on two things together. The reference Raman spectrum that Novartis compared against MSN’s product was found unreliable. The court also drew an adverse inference against Novartis for not producing the sample behind that reference spectrum. Raman spectroscopy is a laboratory method that identifies a compound from the way it scatters light.

The Delaware docket for that day records a trial opinion, a final judgment, and an order denying Novartis’s motion for injunctive relief. I read the opinion as page images, but not all of it: pages 1 to 2, 12 to 14, 19 and 21 to 22 of 22. I did not read the middle pages or open the judgment or the order.

Its conclusion states only the infringement finding on this one patent and says the court would enter a final judgment consistent with it. The opinion states that the ’918 patent is not listed in the Orange Book for Entresto. The Orange Book’s current view for NDA 207620 does not list it either. A current view does not show listings removed earlier, so this says only what is listed today.

Novartis appealed. On 15 July 2025 the Federal Circuit temporarily enjoined the three MSN defendants from selling their generic version (Nos. 2025-1927 and 2025-1928). Fish & Richardson dates the lifting of that block to 22 July 2025. IP Fray’s report of 23 July 2025 refers to the court’s decision “yesterday”, which points to the same date. I have not read the lifting order. Bloomberg Law reported it as without prejudice to the merits panel. I found no merits decision on that appeal.

Before the July 2025 ruling. Novartis first sought a preliminary injunction on the ’918 patent. The Federal Circuit’s opinion of 4 December 2024 (Nos. 2024-2211 and 2024-2212, nonprecedential) affirmed the Delaware court’s denial of that injunction, which the opinion dates to 12 August 2024. The same opinion says FDA approved MSN’s application on 24 July 2024.

A District of Columbia court opinion of 13 August 2024 (Novartis Pharmaceuticals Corp. v. Becerra, No. 24-cv-02234) records the same approval date and denied Novartis’s motion for a preliminary injunction against that approval, without prejudice, finding Novartis had not shown likely irreparable harm. I could not find or read any Federal Circuit order of 15 August 2024 that blocked MSN’s sales, which the Delaware docket entries may refer to. The 4 December 2024 opinion, as I read it, mentions none, so this page states none.

Which Entresto patent did the courts decide against MSN?

US 8,101,659 claims the combination of valsartan and sacubitril. According to Novartis’s Form 6-K of 7 July 2023, the Delaware court found it invalid. The filing is dated 7 July 2023 and does not give the day of the ruling. On 10 January 2025 the Federal Circuit reversed the written-description ground and affirmed the district court’s rejection of the defendants’ other challenges (appeal No. 2023-2218). Torrent and the three MSN entities were among the defendants-appellees, as I read the caption through a summarising tool and have not re-checked.

The same 6-K gives 15 July 2025 as the date the patent expires, counting pediatric exclusivity. A Federal Circuit order of 13 June 2025 dismissed two related appeals (Nos. 2025-1722 and 2025-1723) by agreement, with each side bearing its own costs. The order gives no reasons and no terms, and I do not know what was agreed. The Supreme Court’s docket for No. 25-225 records MSN’s petition, filed on 22 August 2025 against the Federal Circuit decision of 10 January 2025 (No. 2023-2218), as denied on 15 December 2025. I did not open the order itself.

Exhibit 1. The Entresto sequence, in dates

Sourced entries only. Where a source is a secondary report, the outlet and date are named in the table and listed under Methodology and sources.

What does the FDA register show?

On 26 October 2026 the Drugs@FDA data on openFDA, last updated 23 October 2026, held 18 applications that list sacubitril. The 25 October pull gave the same count. Two are Novartis NDAs: 207620, approved 7 July 2015, and 218591. Sixteen are generic applications (ANDAs), and each comes from a different sponsor name. All sixteen carry the status code AP (approved) on a single original submission. MSN’s, ANDA 213748, shows a register date of 16 July 2025. FDA’s own approval letter for that application is dated 24 July 2024 (see below).

Ten of the 16 generic applications show a register date before 15 July 2025, the day pediatric exclusivity on US 8,101,659 ended. The earliest is 28 May 2024. Source: openFDA Drugs@FDA, read 26 October 2026. A count of applications, not of companies.

Exhibit 2. Register date for each of the 16 generic applications: the date the register gives for the approved status of the original submission, which is not always the date of first approval. MSN is highlighted, and its row shows FDA’s approval letter date beside the register date. Sponsor names are as the register prints them. Source: openFDA Drugs@FDA, read 26 October 2026.

Three cautions apply to Exhibit 2. First, I am counting applications and sponsor names. The register does not say which sponsors belong to the same group, so I do not count companies. Second, the register gives one date for each application, the date of the approved status on the original submission. It is not necessarily the date FDA first approved the product.

Third, MSN’s own row shows the problem. The register date is 16 July 2025. FDA’s approval letter for ANDA 213748 is dated 24 July 2024 and says the application is approved, effective on the date of the letter. A District of Columbia court opinion of 13 August 2024 and the Federal Circuit opinion of 4 December 2024 also give 24 July 2024. I do not know why the register differs, and I have not checked the other 15 applications against their approval letters.

Approval is a dated FDA record. Launch is a separate fact. The sources I read give two readings of when generic sales began, and I have not reconciled them.

• Reading A, July 2025. Optum Rx’s notice says Novadoz launched MSN’s generic on 22 July 2025 and Torrent launched on 24 July 2025. Endpoints News reported on 5 August 2025 that MSN and Torrent had completed what it called at-risk launches. Novartis’s Supreme Court brief says competitors including MSN began selling shortly after pediatric exclusivity expired in July 2025.

• Reading B, October and November 2024. Drugs.com lists marketing-start dates of 16 October 2024 for Macleods, 4 November 2024 for Alembic and 11 November 2024 for Laurus Labs. The same page says FDA approval does not guarantee pharmacy availability.

I do not know what the Drugs.com dates measure. I found no dated source that names any other launch, so I state none.

Novartis reported global Entresto net sales of USD 1,181 million for the second quarter of 2026, down 50% in US dollars and 51% at constant currencies. Its interim report attributes the decline to generic competition in the US. Those are worldwide figures, and the third-quarter report is due on 27 October 2026.

What opened the market?

Our reading, not a sourced finding. The record I read contains four separate events in 2025. The Federal Circuit ruled on US 8,101,659 on 10 January 2025. Pediatric exclusivity on it ended on 15 July 2025. The Delaware court ruled on the ’918 patent on 11 July 2025. The Federal Circuit lifted its temporary injunction on 22 July 2025.

Novartis’s own brief to the Supreme Court says (page 10) that the ’659 patent expired in January 2025, that the six-month pediatric period expired in July 2025, and that shortly thereafter competitors including MSN began selling generic versions. FDA had approved MSN’s application almost a year earlier, on 24 July 2024, according to its approval letter, so approval did not wait for any of these events.

The ’918 ruling and the lifted injunction cleared MSN’s own path. I looked for a source tying any other launch to the ’918 ruling and found none. The ’918 case did not start with MSN alone. The court’s September 2023 opinion lists eleven defendants in its caption: three Alembic entities, Crystal, the three MSN entities, Mylan Laboratories, Mylan Pharmaceuticals, Viatris and Nanjing Noratech.

Its opinion of 31 May 2024 says Gerbera Therapeutics Inc. was joined on 26 April 2024. I did not read the complaint itself. The Delaware docket on CourtListener shows how each of the other nine left the case before the ruling. Crystal Pharmaceutical (Suzhou) Co., Ltd. ended by a consent judgment and order of injunction on 30 May 2023, and the three Alembic entities on 7 February 2024.

Mylan Laboratories Limited and Viatris Inc. were dismissed by stipulation on 27 November 2023, and Mylan Pharmaceuticals Inc. on 27 February 2024. Gerbera Therapeutics Inc. and Nanjing Noratech Pharmaceutical Co., Limited ended by a consent judgment on 17 June 2025. The 11 July opinion says Noratech went to trial with MSN, settled after trial, and had a consent judgment and injunction entered against it on 17 June 2025.

Several of those filings are sealed, so I do not state their terms. By 11 July 2025 only the MSN entities remained. On that record the ruling cannot have decided anyone else’s entry in that case. What the consent judgments allow, I cannot read. The register shows sponsor names ALEMBIC and CRYSTAL with register dates of 28 May 2024.

It does not say whether they are the same entities as those named in the court’s caption. A single court win is easy to credit with opening a market. On this molecule the record spreads the credit across several clocks, and it does not let me rank them.

Is this a litigation strategy?

I found no public statement from MSN that describes one. The record I read documents several MSN cases over two Entresto patents. It does not document a pattern across other molecules. I describe what MSN did in this case and do not describe a strategy.

What does the Orange Book not explain?

For all three strengths of Entresto, the Orange Book lists US 8,877,938 to 27 May 2027, with pediatric exclusivity to 27 November 2027, and US 9,388,134 to 8 November 2026, with pediatric exclusivity to 8 May 2027. It also lists patents to 2033 and 2036. Generic products are on the register and, by Optum Rx’s notice, on sale.

I found no court decision on the ’938 or ’134 patent in the sources I read, and no source that explains how the launches sit alongside those listings. I do not supply a reason. A listing is submitted by the brand holder. It is not a court finding.

That gap is the useful part. A reader who works from the patent register alone arrives at a different date from the one the market followed. How LOE Edge reads these registers is described on our methodology page. Read the rivaroxaban brief alongside this case.

What is sourced here, and what is our argument?

Sourced

• The 11 July 2025 ruling that Novartis had not proved infringement of US 11,096,918 (the opinion, pages 1 to 2, 12 to 14, 19 and 21 to 22 of 22, read directly; the rest unread).

• How each of the other defendants in the ’918 case left it before that ruling, from the Delaware docket.

• The 10 January 2025 Federal Circuit ruling for Novartis on US 8,101,659.

• The 16 register dates and the 18-application count, read from the register, and MSN’s FDA approval letter date of 24 July 2024.

• Launch dates of 22 and 24 July 2025, from Optum Rx (secondary; undated page), and the 5 August 2025 Endpoints News report of at-risk launches by MSN and Torrent.

• Novartis’s Q2 2026 Entresto sales and its stated cause.

• Novartis’s statement, on page 10 of its Supreme Court brief, that competitors including MSN began selling shortly after pediatric exclusivity expired in July 2025 (a party’s characterisation).

• The Supreme Court’s denial of MSN’s petition on 15 December 2025, from the Supreme Court docket.

Ours

• That the market opened through several events and not through the ’918 ruling alone.

• That the record does not let anyone rank those events.

• That one company’s cases on one molecule do not show a strategy.

• That the gap between FDA approval dates and launch dates is the thing worth tracking.

What would change this reading?

• The terms of the consent judgments with Crystal, the Alembic entities, Gerbera and Noratech, if they show that entry dates were tied to MSN’s ruling.

• A dated source naming other launches in July 2025 and tying them to the 11 July ruling.

• A statement by MSN describing how it chooses which patents to litigate, together with cases on other molecules.

• The district court opinion itself, if it holds more than the summaries say.

Which questions are still open?

Exhibit 3. Standing questions

How was this record read, and what are its limits?

I read the Orange Book pages and the openFDA records directly on 25 October 2026, and re-read the openFDA records and the Drugs@FDA approval history for ANDA 213748 in the built-in browser on 26 October 2026. I read the Supreme Court docket for No. 25-225 and page 10 of Novartis’s brief in opposition directly on 26 October 2026.

I read the Federal Circuit orders of 13 June and 15 July 2025 directly, the second through a copy hosted by IP Fray. I read the Federal Circuit opinions of 10 January 2025 and 4 December 2024, the Delaware opinions of September 2023 and 31 May 2024, the District of Columbia opinion of 13 August 2024 and FDA’s approval letter for ANDA 213748 through a summarising tool, which is a way of locating text and not a close read.

I read the Delaware docket for the ’918 case on CourtListener, a copy that may not be up to date, and I did not open the filings behind the entries. I read the Delaware trial opinion of 11 July 2025 as page images in the built-in browser on 26 October 2026, but only pages 1 to 2, 12 to 14, 19 and 21 to 22 of 22: the opening, part of the Raman analysis, the adverse-inference discussion and the conclusion.

I did not read its middle pages, and I did not open the judgment. Some Bloomberg Law and Endpoints News pages were paywalled, so I name what I could read.

The FDA register lists approved applications. It does not list applications under review, so it says nothing about a filing in progress. A check against the current Orange Book view does not show listings that were removed earlier. The register’s date for an application is a status date and can differ from the date of first approval, as it does for MSN.

Frequently asked questions

Related reading

• Rivaroxaban: loss of exclusivity

• Apixaban: loss of exclusivity

See how LOE Edge reads the FDA Orange Book

The demo shows listed patents with expiry dates for a small-molecule brand, pediatric-extension pairs collapsed into one row, decoded exclusivity codes and a confidence breakdown for each estimate. It reads FDA data only. It does not include court records, EU5 or India data, or a forecast.

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Methodology and sources

1. FDA Orange Book, patent and exclusivity pages for NDA 207620, products 001, 002 and 003 (Entresto), read 25 October 2026. Source

2. openFDA, Drugs@FDA endpoint, applications listing sacubitril (18 applications; data last updated 23 October 2026), read 25 October 2026. Source

3. Novartis, Form 6-K of 7 July 2023, on the Delaware ruling on US 8,101,659 and the patent’s expiry date including pediatric exclusivity. Source

4. US Court of Appeals for the Federal Circuit, In re Entresto, Nos. 2023-2218 and related appeals, opinion of 10 January 2025. Source

5. US Court of Appeals for the Federal Circuit, Nos. 2025-1722 and 2025-1723, order of 13 June 2025 (dismissal by agreement). Source

6. US Court of Appeals for the Federal Circuit, Nos. 2025-1927 and 2025-1928, order of 15 July 2025 (copy hosted by IP Fray). Source

7. US District Court for the District of Delaware, In re Entresto (Sacubitril/Valsartan) Patent Litigation, trial opinion of 11 July 2025. Trial opinion in Nos. 20-md-2930-RGA and 22-cv-1395-RGA (primary), read as page images in the built-in browser on 26 October 2026: pages 1 to 2, 12 to 14, 19 and 21 to 22 of 22 only. The two law-firm summaries below are secondary and were used to locate it. Source

8. Robins Kaplan, Generically Speaking Hatch-Waxman Bulletin, Q3 2025 (secondary). Source

9. Carlton Fields, “Court Finds MSN Does Not Infringe Novartis’s Patent and Clears the Way for Generic Entresto”, 2025 (secondary). Source

10. IP Fray, report of 23 July 2025 on the Federal Circuit lifting its temporary injunction (secondary). Source

11. Fish & Richardson, “Lessons for Biopharma From the Battle of Entresto”, 27 October 2025 (secondary; used for the 22 July 2025 date only). Source

12. Bloomberg Law, 4 December 2024, on the Federal Circuit affirming the denial of a preliminary injunction on US 11,096,918 (secondary; paywalled, summary read). Source

13. SCOTUSblog, case page for MSN Pharmaceuticals Inc. v. Novartis Pharmaceuticals Corp., No. 25-225 (secondary; states certiorari denied on 15 December 2025). Source

14. CourtListener, docket for Novartis Pharmaceuticals Corporation v. MSN Pharmaceuticals Inc., 1:22-cv-01395 (D. Del.), docket entries and parties page, read 25 October 2026 (a RECAP copy; the page says it may not be up to date, and many entries after mid-2025 carry no description). Source

15. Bloomberg Law, 15 December 2025, on the Supreme Court declining MSN’s petition (secondary; paywalled, summary read). Source

16. Supreme Court of the United States, No. 25-225, Novartis brief in opposition, 7 November 2025 (a party’s brief; Novartis’s characterisation; page 10 read directly on 26 October 2026). Source

17. Optum Rx, notice on generic Entresto (secondary; the page carries no date in its text). Source

18. Endpoints News, 5 August 2025 (secondary; only the opening text was readable). Source

19. Novartis, events page for third-quarter 2026 results, dated 27 October 2026 (the page’s metadata mentions 2025; the date in its body is 27 October 2026). Source

20. Novartis, Q2 2026 results release, Form 6-K of 21 July 2026. Source

21. Novartis, Second Quarter and Half Year 2026 Condensed Interim Financial Report (read through a summarising tool). Source

22. Supreme Court of the United States, docket for No. 25-225, MSN Pharmaceuticals, Inc. v. Novartis Pharmaceuticals Corporation, read 26 October 2026 (primary). Source

23. FDA, approval letter for ANDA 213748 (MSN), signed 24 July 2024 (primary; read through a summarising tool). Source

24. FDA, Drugs@FDA overview page for ANDA 213748, approval history read on 26 October 2026. Source

25. US Court of Appeals for the Federal Circuit, Nos. 2024-2211 and 2024-2212, opinion of 4 December 2024, nonprecedential (read through a summarising tool). Source

26. US District Court for the District of Columbia, Novartis Pharmaceuticals Corp. v. Becerra, No. 24-cv-02234, memorandum opinion of 13 August 2024 (read through a summarising tool). Source

27. US District Court for the District of Delaware, memorandum opinion of September 2023 in No. 22-1395, for the defendants in its caption (read through a summarising tool; the day of the month was not legible in the copy read). Source

28. US District Court for the District of Delaware, memorandum opinion of 31 May 2024 (document 194) in No. 22-cv-1395, on a Justia copy (read through a summarising tool). Source

29. Biosimilars IP, 18 July 2025, on the 11 July 2025 ruling (secondary; read through a summarising tool). Source

30. Drugs.com, generic Entresto availability page (secondary; the first 100,000 of about 123,000 characters read through a summarising tool). Source

Nothing on this page is investment advice. Litigation is reported in the past tense and attributed to the courts and parties that recorded it. Phontix AI Private Limited. Last updated 26 October 2026.