BLA number
103737
FDA Purple Book product · 351(a) biologic
Rituxan
rituximab
Rituxan, BLA 103737, is listed in the FDA Purple Book as a 351(a) biologic. This page consolidates 2 exact FDA presentation rows, and no exact reference-product relationship is asserted. It separates the BLA applicant from any unverified manufacturer and does not infer clinical labeling, pharmacy substitution, commercial availability, or patent conclusions.
351(a)BLA 103737 2 presentationsDiscVoluntarily Revoked IDEC Pharmaceuticals Corp.
Approved
Feb 19, 2002
License type
351(a)
Marketing
Disc
Listed patents
15
Rituxan (rituximab) is IDEC Pharmaceuticals Corp.'s FDA-licensed 351(a) biologic under BLA 103737, approved in 2002. The FDA Purple Book lists 15 published patents for it, the last expiring 2035. 3 351(k) products in the loaded data name-link to Rituxan, but the available fields do not unambiguously assign that relationship to this exact BLA; the page therefore does not call it a proven reference BLA.
Sourced from the FDA Purple Book · verified Aug 11, 2026
What this Purple Book record establishes
Regulatory interpretation
Regulatory role
351(a) biologic
Applicant
IDEC Pharmaceuticals Corp.
Applicant is not automatically the physical manufacturer.
Presentations
2
Exact FDA presentation rows under this BLA.
Approval
Feb 19, 2002
Reference product
Not stated
Rituxan is an FDA-licensed 351(a) biologic.
FDA rows name-link 3 351(k) products to Rituxan, but the loaded data does not unambiguously assign that relationship to BLA 103737.
Substitution boundary
The absence of a linked 351(k) record is a bounded database result, not proof that the product can never serve as a reference product.
Key dates
Licensure & exclusivity
Approval
Approval date of this BLA submission.
Feb 19, 2002
24 yr 11 mo ago
Today
Strengths & presentations
2 FDA presentation rows · BLA 103737
Strength
100MG/10ML (10MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1235
Product number
001
Submission type
Not listed
Supplement number
Not listed
Change type
Not listed
Strength
500MG/50ML (10MG/ML)
Dosage form
Injection
Route
Intravenous
Presentation
Single-Dose Vial
Center
CDER
License number
1235
Product number
002
Submission type
Not listed
Supplement number
Not listed
Change type
Not listed
Exact presentation matrix
One row per FDA presentation under this exact BLA. Missing cells remain unavailable rather than being borrowed from another product.
| Product | Strength | Dosage form | Route | Presentation | Licensure | Marketing |
|---|---|---|---|---|---|---|
| 001 | 100MG/10ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Voluntarily Revoked | Disc |
| 002 | 500MG/50ML (10MG/ML) | Injection | Intravenous | Single-Dose Vial | Voluntarily Revoked | Disc |
Exact-source evidence coverage
Labeling & approval review
Current product label
Exact-source research required
No exact-BLA label candidate is stored for this record. Approved uses, dosing, and warnings are intentionally unavailable and queued for exact-source research.
FDA approval evidence
Not applicable to 351(a)
A biosimilar totality-of-evidence summary is not applicable to this 351(a) record. Product-specific clinical content still requires an exact-BLA label or review source.
Human review pending
Automated BLA-level interpretation has not been marked human-reviewed. The research queue contains 1 exact-source task. Labeling and approval-review claims stay unavailable until their own match gate passes.
Reference product family
Biosimilars & interchangeables
3 follow-on products are linked to the same FDA-stated reference name, but this exact BLA's reference-product role remains unresolved.
No reference product is stated in this exact Purple Book row. This is a bounded snapshot result, not proof of real-world absence.
- 2018TruximaBiosimilar 351(k)
rituximab-abbs · CELLTRION, Inc.
- 2019RuxienceBiosimilar 351(k)
rituximab-pvvr · Pfizer Ireland Pharmaceuticals Unlimited Company
- 2020RiabniBiosimilar 351(k)
rituximab-arrx · Amgen Inc.
Reference-family comparison
| Product | Designation | BLA | Approved | Presentation | Marketing |
|---|---|---|---|---|---|
| Rituxanrituximab | 351(a) biologic | 103737 | Feb 19, 2002 | 100MG/10ML (10MG/ML) · Intravenous | Disc |
| Truximarituximab-abbs | 351(k) biosimilar | 761088 | Nov 28, 2018 | 100MG/10ML (10MG/ML) · Intravenous | Rx |
| Ruxiencerituximab-pvvr | 351(k) biosimilar | 761103 | Jul 23, 2019 | 100MG/10ML (10MG/ML) · Intravenous | Rx |
| Riabnirituximab-arrx | 351(k) biosimilar | 761140 | Dec 17, 2020 | 100MG/10ML (10MG/ML) · Intravenous | Rx |
This brand is also licensed under 1 other BLA:
Published patents
BPCIA patent list
| Patent | Expires | In | Source |
|---|---|---|---|
| 7,485,704 | Mar 08, 2025 | 1 yr 6 mo ago | FDA |
| 7,976,838 | Jun 30, 2025 | 1 yr 3 mo ago | FDA |
| 10,450,379 | Nov 14, 2026 | in 2 mo | FDA |
| 10,654,940 | Nov 14, 2026 | in 2 mo | FDA |
| 10,759,866 | Jul 08, 2028 | in 1 yr 10 mo | FDA |
| 8,574,869 | Jul 08, 2028 | in 1 yr 10 mo | FDA |
| 8,460,895 | Aug 08, 2029 | in 2 yr 11 mo | FDA |
| 10,982,003 | Aug 06, 2030 | in 4 yr | FDA |
| 9,714,293 | Aug 06, 2030 | in 4 yr | FDA |
| 8,512,983 | Jan 04, 2031 | in 4 yr 5 mo | FDA |
| 10,662,237 | Aug 07, 2031 | in 5 yr | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 7 mo | FDA |
| 10,676,710 | Mar 14, 2034 | in 7 yr 7 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 7 mo | FDA |
| 10,336,983 | Jul 31, 2035 | in 9 yr | FDA |
Practical characteristics and limits
Source-bounded interpretation
Presentation coverage
2 exact FDA presentation rows are consolidated under this BLA rather than split across duplicate pages.
Administration fields
The loaded rows list Intravenous and Injection; these are regulatory presentation fields, not dosing instructions.
Applicant boundary
IDEC Pharmaceuticals Corp. is the listed BLA applicant. The page does not relabel the applicant as manufacturer, labeler, distributor, or commercial supplier without an exact product-specific source.
Regulatory comparison
Rituxan is an FDA-licensed 351(a) biologic. Family comparisons preserve each BLA's own designation and do not use Orange Book therapeutic-equivalence terminology.
Source provenance
FDA Purple Book data
Source kind · Monthly download
Checked Aug 11, 2026FDA release · June 2026
- advanced-searchAdvanced Search · Jul 02, 2026
- monthly-downloadMonthly download · Jul 02, 2026
What this record does not establish
- Purple Book marketing status is a regulatory field, not real-time commercial inventory or launch status.
- The listed applicant or BLA holder is not automatically the product’s physical manufacturer, labeler, or distributor.
- Biosimilar status and interchangeability are distinct FDA designations; neither is a therapeutic-equivalence code from the Orange Book.
- A missing patent or exclusivity row is not proof that no relevant rights exist, and listed patent information is not a freedom-to-operate opinion.
- Approved uses, dosing, warnings, and clinical evidence require the exact current product label or approval package and are not inferred from the reference product.
Change history
Record versions
- v5Aug 11, 2026
- v4Jul 02, 2026
- v3Jul 02, 2026
- v2Jul 02, 2026
Rituxan: frequently asked questions
Licensure, biosimilar status, exclusivity, and patents for this biologic, from the FDA Purple Book.
Built directly from the FDA Purple Book database of licensed biological products. License types, approval and exclusivity dates, and the patent list match the official FDA record. The Purple Book patent list reflects the statutory BPCIA patent exchange and is not exhaustive.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
