Viewing data from:

RUXIENCE

Biosimilar

RITUXIMAB-PVVR | B761103 | PFIZER INC

2 products0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

July 23, 2031(1846 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jul. 23, 2031	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 68/100

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

Approved Biosimilars

RuxienceBLA 761103RuxienceBLA 761103

Discovered Patents

View all 234 patents →

Top 50 of 234 AI-discovered patents by relevance.

Composition

(17)

94/1009321843Grant: 2016-04-26 | Exp: 2036-04-21

89/1008999324Grant: 2015-04-07 | Exp: 2035-04-02

75/1006538124Grant: 2003-03-25 | Exp: 2023-03-20

75/10010407505Grant: 2019-09-10 | Exp: 2039-09-05

75/1007297775Grant: 2007-11-20 | Exp: 2027-11-15

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

72/1006528624Grant: 2003-03-04 | Exp: 2023-02-27

72/10010933112Grant: 2021-03-02 | Exp: 2041-02-25

72/1008722859Grant: 2014-05-13 | Exp: 2034-05-08

72/10011440971Grant: 2022-09-13 | Exp: 2042-09-08

70/1006194551Grant: 2001-02-27 | Exp: 2021-02-22

70/1006242195Grant: 2001-06-05 | Exp: 2021-05-31

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

70/10011931414Grant: 2024-03-19 | Exp: 2044-03-14

70/10010618965Grant: 2020-04-14 | Exp: 2040-04-09

68/1007741072Grant: 2010-06-22 | Exp: 2030-06-17

65/1009242013Grant: 2016-01-26 | Exp: 2036-01-21

Formulation

(7)

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

70/1007758860Grant: 2010-07-20 | Exp: 2030-07-15

70/1008945543Grant: 2015-02-03 | Exp: 2035-01-29

68/1008318161Grant: 2012-11-27 | Exp: 2032-11-22

68/10010188600Grant: 2019-01-29 | Exp: 2039-01-24

65/10010933141Grant: 2021-03-02 | Exp: 2041-02-25

65/1009254321Grant: 2016-02-09 | Exp: 2036-02-04

Method of Use

(1)

70/1009733245Grant: 2017-08-15 | Exp: 2037-08-10

Manufacturing

(22)

75/1008574907Grant: 2013-11-05 | Exp: 2033-10-31

75/10010370456Grant: 2019-08-06 | Exp: 2039-08-01

75/10010377793Grant: 2019-08-13 | Exp: 2039-08-08

75/1007820799Grant: 2010-10-26 | Exp: 2030-10-21

75/1008163551Grant: 2012-04-24 | Exp: 2032-04-19

75/1009816069Grant: 2017-11-14 | Exp: 2037-11-09

72/10011634836Grant: 2023-04-25 | Exp: 2043-04-20

72/10011028149Grant: 2021-06-08 | Exp: 2041-06-03

72/1009493548Grant: 2016-11-15 | Exp: 2036-11-10

72/1007294484Grant: 2007-11-13 | Exp: 2027-11-08

72/10011802165Grant: 2023-10-31 | Exp: 2043-10-26

70/10011661579Grant: 2023-05-30 | Exp: 2043-05-25

70/10010501491Grant: 2019-12-10 | Exp: 2039-12-05

70/1009809835Grant: 2017-11-07 | Exp: 2037-11-02

70/1009365881Grant: 2016-06-14 | Exp: 2036-06-09

70/10010975168Grant: 2021-04-13 | Exp: 2041-04-08

70/10011299539Grant: 2022-04-12 | Exp: 2042-04-07

70/10010377794Grant: 2019-08-13 | Exp: 2039-08-08

70/10011649262Grant: 2023-05-16 | Exp: 2043-05-11

68/10010435694Grant: 2019-10-08 | Exp: 2039-10-03

65/1009631007Grant: 2017-04-25 | Exp: 2037-04-20

65/10010889802Grant: 2021-01-12 | Exp: 2041-01-07

Diagnostic

(2)

70/10010352943Grant: 2019-07-16 | Exp: 2039-07-11

68/10012174184Grant: 2024-12-24 | Exp: 2044-12-19

other

(1)

70/10011578428Grant: 2023-02-14 | Exp: 2043-02-09

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 761103 | 2 presentations

BiosimilarLicensedCDERInjection

Proper Name

rituximab-pvvr

Applicant

Pfizer Ireland Pharmaceuticals

Approval Date

23-Jul-19

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

4 letters from Drugs@FDA

Date	Submission	Document
Oct 17, 2023	SUPPL -11	View Letter (PDF)
Nov 17, 2021	SUPPL -5	View Letter (PDF)
May 29, 2020	SUPPL -3	View Letter (PDF)
Aug 20, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG/10ML(10MG/ML)

▴

INJECTABLE;INJECTION | Approved: 2019-07-23 00:00:00

No patent or exclusivity listings for this strength.

#002 — 500MG/50ML(10MG/ML)

▾

INJECTABLE;INJECTION | Approved: 2019-07-23 00:00:00