sargramostim (Leukine)
sargramostim is an FDA-licensed reference biologic from Partner Therapeutics, Inc.. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
1991
Reference approved
Reference product
Leukine sargramostim
Partner Therapeutics, Inc.
- Approved
- Mar 05, 1991
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for sargramostim, in chronological order.
Reference approval
Approval date of the reference sargramostim product.
35 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr 2 mo ago
Frequently asked questions
Are there biosimilars approved for sargramostim (Leukine)?
No 351(k) biosimilars or interchangeable biosimilars referencing sargramostim are listed in the FDA Purple Book yet.
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