Viewing data from:

HADLIMA

Interchangeable Biosimilar

ADALIMUMAB-BWWD | B761059 | SAMSUNG BIOEPIS CO LTD

1 product0 Purple Book patents5 biosimilars

Biologic LOEBiosimilar competition

5 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

Nov. 30, 20436359 days remaining

Based on latest discovered patent 11833214(manufacturing) · relevance 50/100

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

Approved Biosimilars

HadlimaBLA 761059ICHadlimaBLA 761059ICHadlimaBLA 761059ICHadlimaBLA 761059ICHadlimaBLA 761059IC

Discovered Patents

View all 20 patents →

20 AI-discovered patents, sorted by relevance.

Composition

(9)

92/1008877194Grant: 2014-11-04 | Exp: 2034-10-30

92/1009409986Grant: 2016-08-09 | Exp: 2036-08-04

88/1009447183Grant: 2016-09-20 | Exp: 2036-09-15

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

75/1009447184Grant: 2016-09-20 | Exp: 2036-09-15

55/10011753669Grant: 2023-09-12 | Exp: 2043-09-07

50/10011129904Grant: 2021-09-28 | Exp: 2041-09-23

50/1008012485Grant: 2011-09-06 | Exp: 2031-09-01

50/10010273310Grant: 2019-04-30 | Exp: 2039-04-25

Method of Use

(1)

50/1009915665Grant: 2018-03-13 | Exp: 2038-03-08

Manufacturing

(5)

55/10010053720Grant: 2018-08-21 | Exp: 2038-08-16

55/1009598667Grant: 2017-03-21 | Exp: 2037-03-16

50/1008491904Grant: 2013-07-23 | Exp: 2033-07-18

50/1009266950Grant: 2016-02-23 | Exp: 2036-02-18

50/10011833214Grant: 2023-12-05 | Exp: 2043-11-30

Device

(5)

65/1008708968Grant: 2014-04-29 | Exp: 2034-04-24

60/1009764090Grant: 2017-09-19 | Exp: 2037-09-14

55/10010022503Grant: 2018-07-17 | Exp: 2038-07-12

50/1009821117Grant: 2017-11-21 | Exp: 2037-11-16

50/100D832424Grant: 2018-10-30 | Exp: 2038-10-25

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 761059 | 5 presentations

InterchangeableLicensedCDERInjection

Proper Name

adalimumab-bwwd

Applicant

Samsung Bioepis Co., Ltd.

Approval Date

23-Jul-19

Reference Product: Humira — adalimumab

Presentations

40MG/0.8ML — Autoinjector (Subcutaneous)

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

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

40MG/0.4ML — Autoinjector (Subcutaneous)

40MG/0.4ML — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Oct 21, 2025	SUPPL -32	View Letter (PDF)
Jun 24, 2025	SUPPL -30	View Letter (PDF)
May 21, 2025	SUPPL -26	View Letter (PDF)
May 21, 2025	SUPPL -25	View Letter (PDF)
Oct 11, 2024	SUPPL -18	View Letter (PDF)
Jul 12, 2023	SUPPL -8	View Letter (PDF)
Jun 27, 2023	SUPPL -6	View Letter (PDF)
Apr 27, 2023	SUPPL -13	View Letter (PDF)
Dec 27, 2022	SUPPL -7	View Letter (PDF)
Aug 16, 2022	SUPPL -5	View Letter (PDF)
Jun 21, 2022	SUPPL -4	View Letter (PDF)
Sep 5, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/0.8ML

▴

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

No patent or exclusivity listings for this strength.