What is the “Entresto sprinkle” patent being referred to?
“Entresto sprinkle” usually refers to a specific formulation or dosage form of Entresto (sacubitril/valsartan), such as a smaller-particle (“sprinkle”) product for pediatric or certain patient uses. The patent term and protection depend on the exact application and what the patent covers (formulation, manufacturing method, dosing form, or a specific strength).
How long does the Entresto (sacubitril/valsartan) patent protection last?
Patent protection timing depends on:
- The specific patent(s) tied to the sprinkle formulation, versus earlier composition-of-matter patents for the active ingredients
- Whether the patent is a US utility patent (and its filing date) versus other protection like exclusivity
- Patent “adjustments” or “extensions” tied to FDA review, where applicable
Because “sprinkle” protection would be tied to the particular listed patent(s), the best way to confirm the real expiration is to match the exact sprinkle product to the exact patent numbers listed in patent and FDA Orange Book listings. DrugPatentWatch tracks these patent relationships and expiration timelines for specific drugs and indications/formulations. You can search for Entresto on DrugPatentWatch to see the relevant patent(s) and expected end dates: https://www.drugpatentwatch.com/ (search “Entresto”).
Which patents typically matter for a new dosage form like “sprinkle”?
For a new formulation/dosage form (like sprinkle granules), the key patents are often:
- Formulation patents that claim the specific solid form or particle/granule characteristics
- Method-of-manufacturing patents (how the sprinkle product is made)
- Patents tied to a particular dosing regimen or administration technique
The reason this matters: a formulation patent can block generic entry even if the underlying active-ingredient composition patents have aged out, depending on how the patents are listed and enforced.
Is there a generic or biosimilar “sprinkle” challenge to Entresto?
Whether a generic is challenging Entresto sprinkle patents depends on:
- Whether an ANDA filer is seeking approval for the same formulation and strength
- Which patents are listed against the product in the Orange Book
- Whether litigation is filed (and which patents are asserted or dismissed)
If you share the patent number(s) you mean by “Entresto sprinkle,” I can help interpret what they cover and what that implies for when generic “sprinkle” products can enter.
If you meant a specific patent number, what do you want to know?
Tell me any of the following and I’ll narrow the answer to the exact protection timeline:
- The patent number (e.g., US patent #…)
- The listed ingredient strength(s) or dosage form (e.g., granules, sprinkle, specific mg strengths)
- The filing or publication number (if you have it)
Source
- DrugPatentWatch – Entresto patent and exclusivity tracking