Viewing data from:

RANLUSPEC

Interchangeable Biosimilar

RANIBIZUMAB-HKDZ | B761480 | LUPIN LIMITED

2 products0 Purple Book patents4 biosimilars

Biologic LOEBiosimilar competition

4 approved biosimilars

June 2, 2038(4228 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 2, 2038	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Approved Biosimilars

RanluspecBLA 761480ICRanluspecBLA 761480ICRanluspecBLA 761480ICRanluspecBLA 761480IC

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 761480 | 4 presentations

InterchangeableLicensedCDERInjection

Proper Name

ranibizumab-hkdz

Applicant

Lupin Limited (Biotech Division)

Approval Date

June 2, 2026

Reference Product: Lucentis — ranibizumab

Presentations

6MG/ML (0.3MG/0.05ML) — Single-Dose Vial (Intravitreal)

10MG/ML (0.5MG/0.05ML) — Single-Dose Vial (Intravitreal)

6MG/ML (0.3MG/0.05ML) — Pre-Filled Syringe (Intravitreal)

10MG/ML (0.5MG/0.05ML) — Pre-Filled Syringe (Intravitreal)

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 3, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG/ML

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INJECTION | Approved: 2026-06-02 00:00:00

No patent or exclusivity listings for this strength.

#002 — 6MG/ML

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INJECTION | Approved: 2026-06-02 00:00:00