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 11 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
1 yr 4 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.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.