Viewing data from:

ABRILADA

Interchangeable Biosimilar

ADALIMUMAB-AFZB | B761118 | PFIZER INC

3 products0 Purple Book patents5 biosimilars

Biologic LOEBiosimilar competition

5 approved biosimilars

November 15, 2031(1961 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 15, 2031	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Nov. 9, 20436338 days remaining

Based on latest discovered patent 11814435 · relevance 62/100

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

Approved Biosimilars

AbriladaBLA 761118ICAbriladaBLA 761118ICAbriladaBLA 761118ICAbriladaBLA 761118ICAbriladaBLA 761118IC

Discovered Patents

View all 83 patents →

Top 50 of 83 AI-discovered patents by relevance.

Composition

(18)

85/1009803009Grant: 2017-10-31 | Exp: 2037-10-26

85/1008877194Grant: 2014-11-04 | Exp: 2034-10-30

75/10010912842Grant: 2021-02-09 | Exp: 2041-02-04

75/1009592293Grant: 2017-03-14 | Exp: 2037-03-09

72/1009051372Grant: 2015-06-09 | Exp: 2035-06-04

72/1009526798Grant: 2016-12-27 | Exp: 2036-12-22

70/10011180552Grant: 2021-11-23 | Exp: 2041-11-18

70/1009132182Grant: 2015-09-15 | Exp: 2035-09-10

65/10011230610Grant: 2022-01-25 | Exp: 2042-01-20

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

65/1007700751Grant: 2010-04-20 | Exp: 2030-04-15

65/1008017116Grant: 2011-09-13 | Exp: 2031-09-08

62/10011135308Grant: 2021-10-05 | Exp: 2041-09-30

60/1009447181Grant: 2016-09-20 | Exp: 2036-09-15

60/1009127060Grant: 2015-09-08 | Exp: 2035-09-03

55/10011319526Grant: 2022-05-03 | Exp: 2042-04-28

55/10010208109Grant: 2019-02-19 | Exp: 2039-02-14

55/10011674240Grant: 2023-06-13 | Exp: 2043-06-08

Formulation

(5)

75/1007635473Grant: 2009-12-22 | Exp: 2029-12-17

72/10010188600Grant: 2019-01-29 | Exp: 2039-01-24

72/1007758860Grant: 2010-07-20 | Exp: 2030-07-15

68/1007744890Grant: 2010-06-29 | Exp: 2030-06-24

55/1008318164Grant: 2012-11-27 | Exp: 2032-11-22

Method of Use

(2)

65/1007379820Grant: 2008-05-27 | Exp: 2028-05-22

65/1009550986Grant: 2017-01-24 | Exp: 2037-01-19

Manufacturing

(18)

75/1007294484Grant: 2007-11-13 | Exp: 2027-11-08

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

70/1007795494Grant: 2010-09-14 | Exp: 2030-09-09

70/1008993326Grant: 2015-03-31 | Exp: 2035-03-26

70/1007714111Grant: 2010-05-11 | Exp: 2030-05-06

68/10010494348Grant: 2019-12-03 | Exp: 2039-11-28

65/1009279000Grant: 2016-03-08 | Exp: 2036-03-03

65/1008067182Grant: 2011-11-29 | Exp: 2031-11-24

65/1008350013Grant: 2013-01-08 | Exp: 2033-01-03

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

65/1009822143Grant: 2017-11-21 | Exp: 2037-11-16

60/1009816069Grant: 2017-11-14 | Exp: 2037-11-09

58/1008129145Grant: 2012-03-06 | Exp: 2032-03-01

55/1007820799Grant: 2010-10-26 | Exp: 2030-10-21

55/1007247475Grant: 2007-07-24 | Exp: 2027-07-19

55/1006942802Grant: 2005-09-13 | Exp: 2025-09-08

55/1009469672Grant: 2016-10-18 | Exp: 2036-10-13

55/1007947495Grant: 2011-05-24 | Exp: 2031-05-19

Device

(2)

60/10010183117Grant: 2019-01-22 | Exp: 2039-01-17

55/1009821117Grant: 2017-11-21 | Exp: 2037-11-16

Diagnostic

(1)

55/1009170262Grant: 2015-10-27 | Exp: 2035-10-22

other

(4)

75/10010647756Grant: 2020-05-12 | Exp: 2040-05-07

62/10011814435Grant: 2023-11-14 | Exp: 2043-11-09

55/10011718864Grant: 2023-08-08 | Exp: 2043-08-03

55/10011746154Grant: 2023-09-05 | Exp: 2043-08-31

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 761118 | 5 presentations

InterchangeableLicensedCDERInjection

Proper Name

adalimumab-afzb

Applicant

Pfizer Inc.

Approval Date

15-Nov-19

Reference Product: Humira — adalimumab

Presentations

40MG/0.8ML — Autoinjector (Subcutaneous)

40MG/0.8ML — Pre-Filled Syringe (Subcutaneous)

20MG/0.4ML — Pre-Filled Syringe (Subcutaneous)

10MG/0.2ML — Pre-Filled Syringe (Subcutaneous)

40MG/0.8ML — Single-Dose Vial (Subcutaneous)

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Dec 19, 2025	SUPPL -20	View Letter (PDF)
Mar 15, 2024	SUPPL -12	View Letter (PDF)
Oct 5, 2023	SUPPL -7	View Letter (PDF)
Aug 17, 2023	SUPPL -11	View Letter (PDF)
Jun 15, 2023	SUPPL -9	View Letter (PDF)
Aug 1, 2022	SUPPL -6	View Letter (PDF)
Nov 19, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 40MG/0.8ML

▴

INJECTABLE;INJECTION | Approved: 2019-11-15 00:00:00

No patent or exclusivity listings for this strength.

#002 — 20MG/0.4ML

▾

INJECTABLE;INJECTION | Approved: 2019-11-15 00:00:00

#003 — 10MG/0.2ML

▾

INJECTABLE;INJECTION | Approved: 2019-11-15 00:00:00