Purple Book product · Biosimilar 351(k)
Udenyca
pegfilgrastim-cbqv
Nov 02, 2018
Approved
Biosimilar 351(k)
License type
Rx
Marketing
1
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Nov 02, 2018
7 yr 10 mo ago
Today
Pharmaceutical detail
Strength
6MG/0.6ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
2105
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of pegfilgrastim (Neulasta)
Patent list (1)
| Patent | Expires | In | Source |
|---|---|---|---|
| 9,856,287 | Jun 21, 2030 | in 4 yr | FDA |
Source provenance
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
Change history
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Frequently asked questions
When do Udenyca's patents expire?
The FDA Purple Book lists 1 published patent for Udenyca, with the last listed patent expiring Jun 21, 2030. Every patent below links to its FDA source record so you can verify the expiration date.
Is Udenyca a biosimilar?
Yes. Udenyca is a Biosimilar 351(k) referencing pegfilgrastim, licensed under a 351(k) BLA.
Is Udenyca interchangeable?
Udenyca is a 351(k) biosimilar but does not carry an interchangeability designation in the Purple Book, so pharmacy-level substitution depends on state law.
What is Udenyca's BLA number?
Udenyca is licensed under BLA 761039, held by Accord BioPharma Inc..
When was Udenyca approved by the FDA?
Udenyca was approved by the FDA on Nov 02, 2018.
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.
