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IXIFI

Biosimilar

INFLIXIMAB-QBTX | B761072 | PFIZER INC

1 product0 Purple Book patents1 biosimilar

Biologic LOEBiosimilar competition

1 approved biosimilar

December 13, 2029(1259 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 13, 2029	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

May. 15, 20456891 days remaining

Based on latest discovered patent 12303483(formulation) · relevance 75/100

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

Approved Biosimilars

IxifiBLA 761072

Discovered Patents

View all 74 patents →

Top 50 of 74 AI-discovered patents by relevance.

Composition

(23)

95/1007160543Grant: 2007-01-09 | Exp: 2027-01-04

92/1006835823Grant: 2004-12-28 | Exp: 2024-12-23

92/1007160995Grant: 2007-01-09 | Exp: 2027-01-04

92/1006790444Grant: 2004-09-14 | Exp: 2024-09-09

92/1007179893Grant: 2007-02-20 | Exp: 2027-02-15

90/1007101674Grant: 2006-09-05 | Exp: 2026-08-31

88/1007744885Grant: 2010-06-29 | Exp: 2030-06-24

85/1007070775Grant: 2006-07-04 | Exp: 2026-06-29

75/10010053513Grant: 2018-08-21 | Exp: 2038-08-16

75/1008415291Grant: 2013-04-09 | Exp: 2033-04-04

65/10010328084Grant: 2019-06-25 | Exp: 2039-06-20

65/1008975040Grant: 2015-03-10 | Exp: 2035-03-05

65/10010669344Grant: 2020-06-02 | Exp: 2040-05-28

65/10012065488Grant: 2024-08-20 | Exp: 2044-08-15

58/10011319526Grant: 2022-05-03 | Exp: 2042-04-28

55/1007279157Grant: 2007-10-09 | Exp: 2027-10-04

55/10012134636Grant: 2024-11-05 | Exp: 2044-10-31

55/10011078263Grant: 2021-08-03 | Exp: 2041-07-29

55/10011220531Grant: 2022-01-11 | Exp: 2042-01-06

55/1007491390Grant: 2009-02-17 | Exp: 2029-02-12

55/1008455622Grant: 2013-06-04 | Exp: 2033-05-30

55/1007037496Grant: 2006-05-02 | Exp: 2026-04-27

55/10010179812Grant: 2019-01-15 | Exp: 2039-01-10

Formulation

(6)

75/1008871201Grant: 2014-10-28 | Exp: 2034-10-23

75/10012303483Grant: 2025-05-20 | Exp: 2045-05-15

72/1007635473Grant: 2009-12-22 | Exp: 2029-12-17

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

65/1007744890Grant: 2010-06-29 | Exp: 2030-06-24

55/10010391181Grant: 2019-08-27 | Exp: 2039-08-22

Method of Use

(6)

95/1007166284Grant: 2007-01-23 | Exp: 2027-01-18

92/1007179466Grant: 2007-02-20 | Exp: 2027-02-15

92/1007416729Grant: 2008-08-26 | Exp: 2028-08-21

85/1007214376Grant: 2007-05-08 | Exp: 2027-05-03

85/1007160542Grant: 2007-01-09 | Exp: 2027-01-04

70/1008277809Grant: 2012-10-02 | Exp: 2032-09-27

Manufacturing

(10)

70/10012084475Grant: 2024-09-10 | Exp: 2044-09-05

65/1008574907Grant: 2013-11-05 | Exp: 2033-10-31

65/1009469672Grant: 2016-10-18 | Exp: 2036-10-13

65/1007820799Grant: 2010-10-26 | Exp: 2030-10-21

62/1009816069Grant: 2017-11-14 | Exp: 2037-11-09

62/1008853371Grant: 2014-10-07 | Exp: 2034-10-02

55/1008163551Grant: 2012-04-24 | Exp: 2032-04-19

55/10010443035Grant: 2019-10-15 | Exp: 2039-10-10

55/1007714111Grant: 2010-05-11 | Exp: 2030-05-06

50/1008450086Grant: 2013-05-28 | Exp: 2033-05-23

other

(5)

60/10010647756Grant: 2020-05-12 | Exp: 2040-05-07

55/10011578428Grant: 2023-02-14 | Exp: 2043-02-09

55/10010941216Grant: 2021-03-09 | Exp: 2041-03-04

55/10011780935Grant: 2023-10-10 | Exp: 2043-10-05

50/10011326185Grant: 2022-05-10 | Exp: 2042-05-05

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 761072

BiosimilarLicensedCDERFor Injection

Proper Name

infliximab-qbtx

Applicant

Pfizer Ireland Pharmaceuticals

Approval Date

13-Dec-17

Reference Product: Remicade — infliximab

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Oct 10, 2025	SUPPL -14	View Letter (PDF)
Dec 28, 2023	SUPPL -9	View Letter (PDF)
Jan 15, 2020	SUPPL -6	View Letter (PDF)
Dec 18, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/VIAL

▴

INJECTABLE;INJECTION | Approved: 2017-12-13 00:00:00

No patent or exclusivity listings for this strength.