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ZIMRIXBY

Biosimilar

RITUXIMAB-CDXX | B761376 | DR REDDYS LABS SA

2 products0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

July 31, 2038(4287 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jul. 31, 2038	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Approved Biosimilars

ZimrixbyBLA 761376ZimrixbyBLA 761376

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761376 | 2 presentations

BiosimilarLicensedCDERInjection

Proper Name

rituximab-cdxx

Applicant

Dr. Reddy's Laboratories SA

Approval Date

July 31, 2026

Reference Product: Rituxan — rituximab

Presentations

100MG/10ML (10MG/ML) — Single-Dose Vial (Intravenous)

500MG/50ML (10MG/ML) — Single-Dose Vial (Intravenous)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 4, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG/10ML

▴

INJECTION | Approved: 2026-07-31 00:00:00

No patent or exclusivity listings for this strength.

#002 — 500MG/50ML

▾

INJECTION | Approved: 2026-07-31 00:00:00