CD10

Novartis has filed a lawsuit against the FDA after the agency approved a generic version of its top-selling product Entresto. Two weeks ago, Novartis CEO Vas Narasimhan referred to the initial wave of drug pricing effects tied to the Inflation Reduction Act (IRA) as “manageable.”What the company appears to be finding unmanageable, however, is potential near-term generic competition to its heart failure blockbuster Entresto.On Wednesday afternoon in federal court in Washington, D.C., the Swiss company filed a lawsuit against the FDA, claiming that the U.S. regulator’s approval of a generic version of Entresto is unlawful.The complaint comes a week after the FDA approved an Entresto generic from MSN Laboratories. The agency also rejected a Novartis-orchestrated Citizen Petition, which asked it to block the entry of generic versions of Entresto.The petition, which was submitted in September 2022, had asked the agency to deny the approval of any Entresto generic until Feb. 16 of this year. It also petitioned to prevent the FDA from approving any Entresto generics that would violate Novartis patents due to expire in 2033 and 2036. The FDA rejected the first request because it has already passed. The second and third requests were denied because the agency said that generics can avoid infringement simply by adjusting their labels.Novartis is seeking to preserve U.S. exclusivity for Entresto as long as possible. The company owns a series of patents on the drug, with some expiring in 2025, 2026 and 2027, according to FDA records.In 2026, government-negotiated prices Entresto will kick in. Those prices are set to be published Sept. 1 of this year. Entresto was approved by the FDA in 2015. The oral treatment is a combination of the neprilysin inhibitor sacubitril and the angiotensin II receptor blocker valsartan.In its complaint, Novartis alleges the FDA’s conduct is unlawful because it encourages labeling that “inappropriately rewrites Entresto’s approved indication.” Novartis also argues that MSN’s label for its generic “deletes critical safety information contained in the Entresto labeling.” Further, the company contends that the FDA, in denying Novartis’ petition, has “bound itself to approved generics that do not have identical active ingredients to Entresto.” This is another in Novartis’ attempts to derail generic competition for Entresto. In 2022, the company filed a lawsuit against generic drug makers Viatris, Alembic, Crystal and Nanjing Noratech, as well as MSN. In that complaint, the company claimed infringement against a patent due to expire in November 2026.That suit followed an infringement claim against generics maker Torrent Pharma, which was filed in December 2021.In addition to reaching confidential settlements with "several" generics filers, the company has had mixed success in other court cases against generic drug makers.Entresto is Novartis’ top-selling product, raking in revenue of $6 billion last year and $3.8 billion in the first half of this year.

RSS Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that Novartis Pharma K.K. (Novartis Pharma) has launched Entresto® Granular Tablets for Pediatric Use 12.5 mg / 31.25 mg (generic name: sacubitril valsartan sodium hydrate, hereinafter referred to as "Entresto Granular Tablets"), an angiotensin receptor neprilysin inhibitor (ARNI) and a formulation dedicated for pediatric patients with chronic heart failure. In Japan, activities to provide information on Entresto to healthcare professionals will be conducted by Novartis Pharma and Otsuka based on a co-promotion agreement. About Entresto Entresto is classified as an angiotensin receptor neprilysin inhibitor (ARNI) with a mechanism of action that simultaneously inhibits neprilysin (NEP) and the renin-angiotensin-aldosterone system (RAAS). In Japan, Entresto Tablets was approved for the indication of chronic heart failure and hypertension in June 2020 and September 2021, respectively. The indication, dosage and administration of Entresto Tablets for the treatment of chronic heart failure in pediatric patients were approved in February 2024. Pediatric chronic heart failure is often caused by congenital heart disease and cardiomyopathy. Patients may not only experience symptoms such as difficulty breathing, but also develop aggravated cardiac hypertrophy and cardiomegaly with the disease progression, which may result in arrhythmia and sudden death. Therefore, early diagnosis and appropriate treatment are essential.1,2,3 Reference

RSS Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that Novartis Pharma K.K. (Novartis Pharma) has received approval for Entresto® Granular Tablets for Pediatric Use 12.5 mg / 31.25 mg (generic name: sacubitril valsartan sodium hydrate, hereinafter referred to as Entresto Granular Tablets), an angiotensin receptor neprilysin inhibitor (ARNI). In Japan, activities to provide information on Entresto to healthcare professionals will be conducted by Novartis Pharma and Otsuka based on a co-promotion agreement. About Entresto Entresto is classified as an angiotensin receptor neprilysin inhibitor (ARNI) with a mechanism of action that simultaneously inhibits neprilysin (NEP) and the renin-angiotensin-aldosterone system (RAAS). In Japan, Entresto Tablets was approved for the indication of chronic heart failure and hypertension in June 2020 and September 2021, respectively. The indication, dosage and administration of Entresto Tablets for the treatment of chronic heart failure in pediatric patients were approved in February 2024. Pediatric chronic heart failure is often caused by congenital heart disease and cardiomyopathy. Patients may not only experience symptoms such as difficulty breathing, but also develop aggravated cardiac hypertrophy and cardiomegaly with the disease progression, which may result in arrhythmia and sudden death. Therefore, early diagnosis and appropriate treatment are essential.1,2,3 Reference 1. Mitsunori Nishiyama, "Diagnosis and Initial Treatment of Pediatric Heart Failure," Pediatric Clinical Practice 2012; 65(7):1621-6. 2. Sharma M, Nair M, Jatana SK, et al. "Congestive Heart Failure in Infants and Children." Med J Armed Forces India; 59(3): 2003, 228-33. 3. Andrews RE, Fenton MJ, Ridout DA, et al. "New-onset heart failure due to heart muscle disease in childhood: a prospective study in the United Kingdom and Ireland." Circulation; 2008, 117(1):79-84.