Novartis today announced that the U.S. District Court for the District of Delaware issued a negative decision regarding the validity of a patent covering Entresto and combinations of sacubitril and valsartan, which expires in 2025 with its pediatric exclusivity. Novartis strongly believes the combination patent is valid and will appeal to the U.S. Court of Appeals for the Federal Circuit (CAFC) to reverse the District Court’s decision.
The company will continue to defend vigorously its intellectual property rights relating to Entresto, including the combination patent as well as multiple patents covering additional innovations. Currently no generic Entresto products have tentative or final FDA approval. If approved, any commercial launch of a generic Entresto product prior to the final outcome of Novartis appeal, or ongoing infringement litigations involving other patents, may be at risk of later litigation developments.
Novartis maintains its confidence in the growth and profitability outlook for both the short and mid-term, based on the future growth potential of other key brands including Kisqali, Pluvicto, Leqvio, Kesimpta, Scemblix and iptacopan.
Despite the potential for earlier-than-expected entry of generic Entresto products in the U.S., Novartis maintains its full-year 2023 group guidance1 to investors:
- Group Sales expected to grow mid-single digit (in cc)
- Group Core OpInc expected to grow high-single digit (in cc)
The company also maintains its mid-term outlook of +4% sales growth (in cc) 2022-2027 CAGR, with 40% Core OpInc margin for Novartis ex-Sandoz.
Novartis new focused strategy remains on track to deliver growth, driven by key in-market and launch brands, and a strong pipeline of high value innovative medicines.
Further information
The U.S. District Court for the District of Delaware issued a negative decision regarding the validity of U.S. Patent No. 8,101,659, one of the patents listed in the Orange Book for Entresto. This patent, with the associated pediatric exclusivity, expires on July 15, 2025.
Since October 2019, Novartis has been involved in patent infringement litigation with numerous Abbreviated New Drug Application (ANDA) filers who are seeking approval to market generic versions of Entresto. Currently, Entresto is protected by multiple Orange Book-listed patents which expire between 2023 and 2036 (including any pediatric exclusivity). Today’s decision does not impact the separate and ongoing litigation between Novartis and various ANDA filers concerning those and other U.S. patents:
| U.S. Patent | Expiration | |
| 8,101,659 | combinations of sacubitril and valsartan | July 15, 2025 |
| 11,096,918 | amorphous forms of sacubitril and valsartan | November 8, 2026 |
| 9,388,134 | crystalline forms of sacubitril and valsartan | May 8, 2027 |
| 8,877,938 | crystalline forms of sacubitril and valsartan | November 27, 2027 |
| 11,058,667 | dosage regimen for treating chronic heart failure | May 9, 2036 |
On July 6, 2023, the U.S. District Court for the Northern District of West Virginia issued a decision that the proposed generic Entresto products from Mylan Pharmaceuticals Inc. (“Mylan”) will infringe U.S. Patent Nos. 8,877,938 and 9,388,134. That decision only pertains to Mylan.
Novartis previously entered into settlement agreements with several ANDA filers that will be able to launch a generic version of Entresto in the United States on an agreed-upon date, or earlier in certain circumstances. Details of these settlements are confidential.
1 Novartis Group guidance, assuming Sandoz would remain within the Group for the entire FY 2023, in constant currencies.
Source: https://www.novartis.com/
