Viewing data from:

LUCENTIS

BLA

RANIBIZUMAB | B125156 | GENENTECH

2 products11 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

November 5, 2035(3412 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Aug. 10, 2024	Expired	Computed

Purple Book Patents (11)

Patent	Expiration	Status
6716602	Nov. 1, 2021	Expired
10829732	Mar. 14, 2034	Active
6828121	Jul. 8, 2022	Expired
6921659	Oct. 17, 2023	Expired
8383773	Dec. 13, 2023	Expired
8574869	Jul. 8, 2028	Active
9688775	Dec. 31, 2022	Expired
9765379	Mar. 10, 2034	Active
10017732	Mar. 14, 2034	Active
10112994	Nov. 5, 2035	Active
10421984	Sep. 19, 2033	Active

Discovered Patents

View all 279 patents →

Top 50 of 279 AI-discovered patents by relevance.

Composition

(34)

95/10011820816Grant: 2023-11-21 | Exp: 2043-11-16

92/1007365166Grant: 2008-04-29 | Exp: 2028-04-24

92/1006884879Grant: 2005-04-26 | Exp: 2025-04-21

92/1007297334Grant: 2007-11-20 | Exp: 2027-11-15

90/10010683345Grant: 2020-06-16 | Exp: 2040-06-11

90/1007060269Grant: 2006-06-13 | Exp: 2026-06-08

88/10011524998Grant: 2022-12-13 | Exp: 2042-12-08

88/10010428125Grant: 2019-10-01 | Exp: 2039-09-26

88/10011111291Grant: 2021-09-07 | Exp: 2041-09-02

88/1007169901Grant: 2007-01-30 | Exp: 2027-01-25

88/1007375193Grant: 2008-05-20 | Exp: 2028-05-15

85/10011891437Grant: 2024-02-06 | Exp: 2044-02-01

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

85/10011254738Grant: 2022-02-22 | Exp: 2042-02-17

85/1008268313Grant: 2012-09-18 | Exp: 2032-09-13

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

82/1007342104Grant: 2008-03-11 | Exp: 2028-03-06

82/1008268314Grant: 2012-09-18 | Exp: 2032-09-13

82/1008604185Grant: 2013-12-10 | Exp: 2033-12-05

80/1008945552Grant: 2015-02-03 | Exp: 2035-01-29

80/10011866490Grant: 2024-01-09 | Exp: 2044-01-04

80/10012209121Grant: 2025-01-28 | Exp: 2045-01-23

78/1009708396Grant: 2017-07-18 | Exp: 2037-07-13

75/1008211429Grant: 2012-07-03 | Exp: 2032-06-28

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

75/10010696721Grant: 2020-06-30 | Exp: 2040-06-25

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

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

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

75/1007629145Grant: 2009-12-08 | Exp: 2029-12-03

75/1006407213Grant: 2002-06-18 | Exp: 2022-06-13

75/1006936695Grant: 2005-08-30 | Exp: 2025-08-25

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

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

Method of Use

(9)

92/1007622115Grant: 2009-11-24 | Exp: 2029-11-19

88/10010035850Grant: 2018-07-31 | Exp: 2038-07-26

87/10012371481Grant: 2025-07-29 | Exp: 2045-07-24

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

85/10011725246Grant: 2023-08-15 | Exp: 2043-08-10

77/1007740846Grant: 2010-06-22 | Exp: 2030-06-17

75/10011033621Grant: 2021-06-15 | Exp: 2041-06-10

75/10011098110Grant: 2021-08-24 | Exp: 2041-08-19

75/1009186336Grant: 2015-11-17 | Exp: 2035-11-12

Manufacturing

(4)

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

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

75/1007018809Grant: 2006-03-28 | Exp: 2026-03-23

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

Device

(1)

82/1009220631Grant: 2015-12-29 | Exp: 2035-12-24

Diagnostic

(2)

88/10010031141Grant: 2018-07-24 | Exp: 2038-07-19

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

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2016-01608	6716602	IPR	bioeq IP AG et al.	Terminated	2016-08-16	—

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 125156 | 4 presentations | 11 patents

351(a) ReferenceLicensedCDERInjection

Proper Name

ranibizumab

Applicant

Genentech, Inc.

Approval Date

30-Jun-06

Listed Patents

Patent Number	Expiration
6716602	November 1, 2021
10829732	March 14, 2034
6828121	July 8, 2022
6921659	October 17, 2023
8383773	December 13, 2023
8574869	July 8, 2028
9688775	December 31, 2022
9765379	March 10, 2034
10017732	March 14, 2034
10112994	November 5, 2035
10421984	September 19, 2033

Presentations

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

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

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

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

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2024	SUPPL -128	View Letter (PDF)
Mar 28, 2018	SUPPL -117	View Letter (PDF)
Apr 18, 2017	SUPPL -114	View Letter (PDF)
Jan 13, 2017	SUPPL -111	View Letter (PDF)
Nov 25, 2016	SUPPL -112	View Letter (PDF)
Oct 17, 2016	SUPPL -110	View Letter (PDF)
Feb 10, 2015	SUPPL -106	View Letter (PDF)
Nov 28, 2014	SUPPL -105	View Letter (PDF)
Mar 4, 2014	SUPPL -94	View Letter (PDF)
Mar 12, 2013	SUPPL -87	View Letter (PDF)
Feb 8, 2013	SUPPL -81	View Letter (PDF)
Aug 13, 2012	SUPPL -76	View Letter (PDF)
Aug 13, 2012	SUPPL -69	View Letter (PDF)
Jul 2, 2010	SUPPL -53	View Letter (PDF)
Jul 13, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG/ML

▴

INJECTABLE; INJECTION | Approved: 2006-06-30 00:00:00

No patent or exclusivity listings for this strength.

#002 — 6MG/ML

▾

Injectable; Injection | Approved: 2006-06-30 00:00:00