Purple Book product · Biosimilar 351(k)
Ennumo
pegfilgrastim-pccg
May 07, 2026
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.
May 07, 2026
2 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
- v3Jul 02, 2026
- v2Jul 02, 2026
- v1Jul 02, 2026
Frequently asked questions
When do Ennumo's patents expire?
The FDA Purple Book lists 1 published patent for Ennumo, 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 Ennumo a biosimilar?
Yes. Ennumo is a Biosimilar 351(k) referencing pegfilgrastim, licensed under a 351(k) BLA.
Is Ennumo interchangeable?
Ennumo 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 Ennumo's BLA number?
Ennumo is licensed under BLA 761147, held by Accord BioPharma Inc..
When was Ennumo approved by the FDA?
Ennumo was approved by the FDA on May 07, 2026.
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.
