Pasireotide diaspartate
Pasireotide diaspartate: 1 brand, 0 generics; first approved Dec 14, 2012; on patent until Dec 14, 2026.
Protected until Dec 14, 2026 (earliest listed patent expiry).
Brand (NDA) products
- SIGNIFORRLDRECORDATI RARENDA 20067720123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML) SOLUTION SUBCUTANEOUS Rx - EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML) SOLUTION SUBCUTANEOUS Rx - EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML) SOLUTION SUBCUTANEOUS Rx -
Patent & exclusivity timeline
Listed patents
| Patent | Expires | In | Type |
|---|---|---|---|
| 7473761 | in 2 mo | SubstanceProduct |
Approval history
All 1 application were approved in 2012.
Pasireotide diaspartate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Assyro Intelligence
Ask anything about Pasireotide diaspartate
Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.
Evaluating for a team? Book a demo