Purple Book product · Biosimilar 351(k)
Ruxience
rituximab-pvvr
At a glance
Jul 23, 2019
Approved
Biosimilar 351(k)
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Jul 23, 2019
7 yr 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
U
Reference product family
View full familyBiosimilar of rituximab (Rituxan)
- 1997RituxanReference 351(a)
rituximab · Genentech, Inc.
- 2002RituxanReference 351(a)
rituximab · IDEC Pharmaceuticals Corp.
- 1997RituxanReference 351(a)
rituximab · Genentech, Inc.
- 2002RituxanReference 351(a)
rituximab · IDEC Pharmaceuticals Corp.
- 2019RuxienceBiosimilar 351(k)
rituximab-pvvr · Pfizer Ireland Pharmaceuticals Unlimited Company
Patent list (15)
| Patent | Expires | In | Source |
|---|---|---|---|
| 7,485,704 | Mar 08, 2025 | 1 yr 3 mo ago | FDA |
| 7,976,838 | Jun 30, 2025 | 11 mo ago | FDA |
| 10,450,379 | Nov 14, 2026 | in 5 mo | FDA |
| 10,654,940 | Nov 14, 2026 | in 5 mo | FDA |
| 10,759,866 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 8,574,869 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 8,460,895 | Aug 08, 2029 | in 3 yr 3 mo | FDA |
| 10,982,003 | Aug 06, 2030 | in 4 yr 3 mo | FDA |
| 9,714,293 | Aug 06, 2030 | in 4 yr 3 mo | FDA |
| 8,512,983 | Jan 04, 2031 | in 4 yr 8 mo | FDA |
| 10,662,237 | Aug 07, 2031 | in 5 yr 3 mo | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,676,710 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,336,983 | Jul 31, 2035 | in 9 yr 3 mo | FDA |
Taxonomy and ontology
12 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(k) Biosimilar
blaType · 351(k) Biosimilar
application pathway
Section 351(k) Biosimilar or Interchangeable
blaType · 351(k)
product role
Biosimilar
blaType · Biosimilar
marketing status
Prescription
marketingStatus · Rx
licensure status
Licensed
licensure · Licensed
route
Intravenous
routeOfAdministration · Intravenous
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
- Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
- Food and Drug Administrationsource forMonthly Download
- Biologics License Applicationparent ofSection 351(a) Biologic
- Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Biosimilar
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Interchangeable
Source provenance
