Purple Book product · Biosimilar 351(k)
Ruxience
rituximab-pvvr
Jul 23, 2019
Approved
Biosimilar 351(k)
License type
Rx
Marketing
15
Listed patents
Sourced from the FDA Purple Book · verified Jul 02, 2026
Key dates
Approval
Approval date of this BLA submission.
Jul 23, 2019
7 yr 1 mo ago
Today
Pharmaceutical detail
Strength
100MG/10ML (10MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
2060
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of rituximab (Rituxan)
Patent list (15)
| Patent | Expires | In | Source |
|---|---|---|---|
| 7,485,704 | Mar 08, 2025 | 1 yr 5 mo ago | FDA |
| 7,976,838 | Jun 30, 2025 | 1 yr 1 mo ago | FDA |
| 10,450,379 | Nov 14, 2026 | in 4 mo | FDA |
| 10,654,940 | Nov 14, 2026 | in 4 mo | FDA |
| 10,759,866 | Jul 08, 2028 | in 2 yr | FDA |
| 8,574,869 | Jul 08, 2028 | in 2 yr | FDA |
| 8,460,895 | Aug 08, 2029 | in 3 yr 1 mo | FDA |
| 10,982,003 | Aug 06, 2030 | in 4 yr 1 mo | FDA |
| 9,714,293 | Aug 06, 2030 | in 4 yr 1 mo | FDA |
| 8,512,983 | Jan 04, 2031 | in 4 yr 6 mo | FDA |
| 10,662,237 | Aug 07, 2031 | in 5 yr 2 mo | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| 10,676,710 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 9 mo | FDA |
| 10,336,983 | Jul 31, 2035 | in 9 yr 2 mo | 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 Ruxience's patents expire?
The FDA Purple Book lists 15 published patents for Ruxience, with the last listed patent expiring Jul 31, 2035. Every patent below links to its FDA source record so you can verify the expiration date.
Is Ruxience a biosimilar?
Yes. Ruxience is a Biosimilar 351(k) referencing rituximab, licensed under a 351(k) BLA.
Is Ruxience interchangeable?
Ruxience 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 Ruxience's BLA number?
Ruxience is licensed under BLA 761103, held by Pfizer Ireland Pharmaceuticals Unlimited Company.
When was Ruxience approved by the FDA?
Ruxience was approved by the FDA on Jul 23, 2019.
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.
