Givosiran sodium
As of the edition of 20 October 2026, Givosiran sodium is an oligonucleotide: marketed, first approved in 2019 (US); acts on ALAS1; US protection ends in 2034.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Oligonucleotide
- Brand name
- Givlaari
- First approved
- 20 November 2019 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Alnylam Pharmaceuticals; 2 holders in all
US protection
US protection ends in 2034.
The last listed US drug-substance patent ends in 2034. The application that gives this date is held by Alnylam Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product8 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Givosiran sodium.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| ALAS1 | 5-aminolevulinate synthase, non-specific, mitochondrial | P13196 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Alnylam Pharmaceuticals | Originator and Applicant | 2019 to now |