Viewing data from:

BYOOVIZ

Interchangeable Biosimilar

RANIBIZUMAB-NUNA | B761202 | SAMSUNG BIOEPIS CO LTD

1 product0 Purple Book patents1 biosimilar

Biologic LOEBiosimilar competition

1 approved biosimilar

September 17, 2033(2633 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 17, 2033	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Dec. 19, 20446744 days remaining

Based on latest discovered patent 12174184(diagnostic) · relevance 75/100

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

Approved Biosimilars

ByoovizBLA 761202IC

Discovered Patents

View all 221 patents →

Top 50 of 221 AI-discovered patents by relevance.

Composition

(23)

85/1007090834Grant: 2006-08-15 | Exp: 2026-08-10

75/1006395707Grant: 2002-05-28 | Exp: 2022-05-23

75/10011407794Grant: 2022-08-09 | Exp: 2042-08-04

75/10010428125Grant: 2019-10-01 | Exp: 2039-09-26

75/1007449551Grant: 2008-11-11 | Exp: 2028-11-06

75/1006350450Grant: 2002-02-26 | Exp: 2022-02-21

75/1007364731Grant: 2008-04-29 | Exp: 2028-04-24

75/1007378507Grant: 2008-05-27 | Exp: 2028-05-22

75/1009273113Grant: 2016-03-01 | Exp: 2036-02-25

75/1009409979Grant: 2016-08-09 | Exp: 2036-08-04

75/10011078243Grant: 2021-08-03 | Exp: 2041-07-29

75/1008268313Grant: 2012-09-18 | Exp: 2032-09-13

72/1009284376Grant: 2016-03-15 | Exp: 2036-03-10

72/10010047162Grant: 2018-08-14 | Exp: 2038-08-09

72/1007005504Grant: 2006-02-28 | Exp: 2026-02-23

72/10010696721Grant: 2020-06-30 | Exp: 2040-06-25

72/1007264801Grant: 2007-09-04 | Exp: 2027-08-30

70/1006639055Grant: 2003-10-28 | Exp: 2023-10-23

70/1006407213Grant: 2002-06-18 | Exp: 2022-06-13

70/10011634497Grant: 2023-04-25 | Exp: 2043-04-20

70/10011440971Grant: 2022-09-13 | Exp: 2042-09-08

70/1009803191Grant: 2017-10-31 | Exp: 2037-10-26

65/10012098213Grant: 2024-09-24 | Exp: 2044-09-19

Formulation

(8)

72/1009254321Grant: 2016-02-09 | Exp: 2036-02-04

72/1008758747Grant: 2014-06-24 | Exp: 2034-06-19

70/1009458240Grant: 2016-10-04 | Exp: 2036-09-29

70/1009216219Grant: 2015-12-22 | Exp: 2035-12-17

70/10010188735Grant: 2019-01-29 | Exp: 2039-01-24

70/10010525137Grant: 2020-01-07 | Exp: 2040-01-02

70/10011865177Grant: 2024-01-09 | Exp: 2044-01-04

68/1009662395Grant: 2017-05-30 | Exp: 2037-05-25

Method of Use

(1)

85/1007078382Grant: 2006-07-18 | Exp: 2026-07-13

Manufacturing

(16)

75/1007863042Grant: 2011-01-04 | Exp: 2030-12-30

75/10011680110Grant: 2023-06-20 | Exp: 2043-06-15

75/1009200030Grant: 2015-12-01 | Exp: 2035-11-26

72/1009150641Grant: 2015-10-06 | Exp: 2035-10-01

72/10011976127Grant: 2024-05-07 | Exp: 2044-05-02

72/1009422329Grant: 2016-08-23 | Exp: 2036-08-18

72/1007018809Grant: 2006-03-28 | Exp: 2026-03-23

70/1009994612Grant: 2018-06-12 | Exp: 2038-06-07

70/10010377793Grant: 2019-08-13 | Exp: 2039-08-08

70/10011807855Grant: 2023-11-07 | Exp: 2043-11-02

70/1006489447Grant: 2002-12-03 | Exp: 2022-11-28

70/1008574869Grant: 2013-11-05 | Exp: 2033-10-31

68/10010745731Grant: 2020-08-18 | Exp: 2040-08-13

68/1008710196Grant: 2014-04-29 | Exp: 2034-04-24

68/10010590186Grant: 2020-03-17 | Exp: 2040-03-12

68/10012173080Grant: 2024-12-24 | Exp: 2044-12-19

Diagnostic

(2)

75/1008227195Grant: 2012-07-24 | Exp: 2032-07-19

75/10012174184Grant: 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 761202

InterchangeableLicensedCDERInjection

Proper Name

ranibizumab-nuna

Applicant

Samsung Bioepis Co., Ltd.

Approval Date

17-Sep-21

Reference Product: Lucentis — ranibizumab

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Mar 31, 2026	SUPPL -19	View Letter (PDF)
Nov 13, 2025	SUPPL -17	View Letter (PDF)
Aug 18, 2025	SUPPL -16	View Letter (PDF)
Oct 5, 2023	SUPPL -6	View Letter (PDF)
Jun 21, 2023	SUPPL -7	View Letter (PDF)
Aug 16, 2022	SUPPL -3	View Letter (PDF)
Jun 10, 2022	SUPPL -4	View Letter (PDF)
Sep 21, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5MG(10MG/ML)

▴

INJECTABLE;INJECTION | Approved: 2021-09-17 00:00:00

No patent or exclusivity listings for this strength.