Viewing data from:

NUFYMCO

Interchangeable Biosimilar

RANIBIZUMAB-LEYK | B761473 | FORMYCON AG

2 products0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

December 18, 2037(4186 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 18, 2037	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Sep. 18, 20457017 days remaining

Based on latest discovered patent 12421299(manufacturing) · relevance 85/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Approved Biosimilars

NufymcoBLA 761473ICNufymcoBLA 761473IC

Discovered Patents

View all 1,016 patents →

Top 50 of 1,016 AI-discovered patents by relevance.

Composition

(35)

95/1009273113Grant: 2016-03-01 | Exp: 2036-02-25

95/1008226960Grant: 2012-07-24 | Exp: 2032-07-19

92/1008114960Grant: 2012-02-14 | Exp: 2032-02-09

92/10011407794Grant: 2022-08-09 | Exp: 2042-08-04

92/1009815869Grant: 2017-11-14 | Exp: 2037-11-09

90/1008252287Grant: 2012-08-28 | Exp: 2032-08-23

88/1007862827Grant: 2011-01-04 | Exp: 2030-12-30

88/1008163522Grant: 2012-04-24 | Exp: 2032-04-19

88/10011639378Grant: 2023-05-02 | Exp: 2043-04-27

88/10011530275Grant: 2022-12-20 | Exp: 2042-12-15

88/1006686455Grant: 2004-02-03 | Exp: 2024-01-29

85/10012023378Grant: 2024-07-02 | Exp: 2044-06-27

85/1006911321Grant: 2005-06-28 | Exp: 2025-06-23

85/1006639055Grant: 2003-10-28 | Exp: 2023-10-23

85/10011285207Grant: 2022-03-29 | Exp: 2042-03-24

85/10011999802Grant: 2024-06-04 | Exp: 2044-05-30

85/1009926379Grant: 2018-03-27 | Exp: 2038-03-22

85/1007291708Grant: 2007-11-06 | Exp: 2027-11-01

85/1008563683Grant: 2013-10-22 | Exp: 2033-10-17

85/10010808028Grant: 2020-10-20 | Exp: 2040-10-15

85/10010696721Grant: 2020-06-30 | Exp: 2040-06-25

85/10010450381Grant: 2019-10-22 | Exp: 2039-10-17

85/10010358465Grant: 2019-07-23 | Exp: 2039-07-18

85/10011827717Grant: 2023-11-28 | Exp: 2043-11-23

85/1007618636Grant: 2009-11-17 | Exp: 2029-11-12

85/1007427596Grant: 2008-09-23 | Exp: 2028-09-18

85/1007201897Grant: 2007-04-10 | Exp: 2027-04-05

85/1007318918Grant: 2008-01-15 | Exp: 2028-01-10

85/1006583272Grant: 2003-06-24 | Exp: 2023-06-19

85/1008722859Grant: 2014-05-13 | Exp: 2034-05-08

85/1007427404Grant: 2008-09-23 | Exp: 2028-09-18

85/1006407213Grant: 2002-06-18 | Exp: 2022-06-13

85/10011111311Grant: 2021-09-07 | Exp: 2041-09-02

85/10011466087Grant: 2022-10-11 | Exp: 2042-10-06

85/1008119145Grant: 2012-02-21 | Exp: 2032-02-16

Method of Use

(3)

92/10012240884Grant: 2025-03-04 | Exp: 2045-02-27

92/10012146187Grant: 2024-11-19 | Exp: 2044-11-14

85/1008802092Grant: 2014-08-12 | Exp: 2034-08-07

Manufacturing

(9)

88/1009631007Grant: 2017-04-25 | Exp: 2037-04-20

88/1007662934Grant: 2010-02-16 | Exp: 2030-02-11

85/10012421299Grant: 2025-09-23 | Exp: 2045-09-18

85/1008884096Grant: 2014-11-11 | Exp: 2034-11-06

85/10011976127Grant: 2024-05-07 | Exp: 2044-05-02

85/10011370838Grant: 2022-06-28 | Exp: 2042-06-23

85/10010975168Grant: 2021-04-13 | Exp: 2041-04-08

85/1006555373Grant: 2003-04-29 | Exp: 2023-04-24

85/10010723762Grant: 2020-07-28 | Exp: 2040-07-23

Device

(1)

85/1008118782Grant: 2012-02-21 | Exp: 2032-02-16

Diagnostic

(2)

85/10011221324Grant: 2022-01-11 | Exp: 2042-01-06

85/10012174184Grant: 2024-12-24 | Exp: 2044-12-19

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 761473 | 2 presentations

InterchangeableLicensedCDERInjection

Proper Name

ranibizumab-leyk

Applicant

Formycon AG

Approval Date

18-Dec-25

Reference Product: Lucentis — ranibizumab

Presentations

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

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

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 19, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 6MG/ML

▴

INJECTION | Approved: 2025-12-18 00:00:00

No patent or exclusivity listings for this strength.

#002 — 10MG/ML

▾

INJECTION | Approved: 2025-12-18 00:00:00