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YUFLYMA

Interchangeable Biosimilar

ADALIMUMAB-AATY | B761219 | CELLTRION

1 product0 Purple Book patents5 biosimilars

Biologic LOEBiosimilar competition

5 approved biosimilars

May 23, 2035(3246 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 23, 2035	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Oct. 5, 20436303 days remaining

Based on latest discovered patent 11779643(diagnostic) · relevance 75/100

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

Approved Biosimilars

YuflymaBLA 761219ICYuflymaBLA 761219ICYuflymaBLA 761219ICYuflymaBLA 761219ICYuflymaBLA 761219IC

Discovered Patents

View all 12 patents →

12 AI-discovered patents, sorted by relevance.

Composition

(2)

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

92/1009803009Grant: 2017-10-31 | Exp: 2037-10-26

Formulation

(1)

55/10010603388Grant: 2020-03-31 | Exp: 2040-03-26

Method of Use

(1)

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

Manufacturing

(3)

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

55/1009266950Grant: 2016-02-23 | Exp: 2036-02-18

50/1009975948Grant: 2018-05-22 | Exp: 2038-05-17

Device

(4)

60/1008708968Grant: 2014-04-29 | Exp: 2034-04-24

55/1009764090Grant: 2017-09-19 | Exp: 2037-09-14

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

50/10010183117Grant: 2019-01-22 | Exp: 2039-01-17

Diagnostic

(1)

75/10011779643Grant: 2023-10-10 | Exp: 2043-10-05

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 761219 | 5 presentations

InterchangeableLicensedCDERInjection

Proper Name

adalimumab-aaty

Applicant

CELLTRION, Inc.

Approval Date

23-May-23

Reference Product: Humira — adalimumab

Presentations

40MG/0.4ML — Autoinjector (Subcutaneous)

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

80MG/0.8ML — Autoinjector (Subcutaneous)

80MG/0.8ML — Pre-Filled Syringe (Subcutaneous)

20MG/0.2ML — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Oct 20, 2025	SUPPL -18	View Letter (PDF)
May 23, 2025	SUPPL -16	View Letter (PDF)
May 21, 2025	SUPPL -9	View Letter (PDF)
Apr 9, 2025	SUPPL -17	View Letter (PDF)
Dec 27, 2024	SUPPL -13	View Letter (PDF)
Aug 19, 2024	SUPPL -11	View Letter (PDF)
Dec 27, 2023	SUPPL -8	View Letter (PDF)
Dec 27, 2023	SUPPL -6	View Letter (PDF)
Dec 27, 2023	SUPPL -7	View Letter (PDF)
Dec 1, 2023	SUPPL -2	View Letter (PDF)
Oct 3, 2023	ORIG -1	View Letter (PDF)
Sep 25, 2023	SUPPL -4	View Letter (PDF)
Sep 7, 2023	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/0.4ML

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INJECTABLE;INJECTION | Approved: 2023-05-23 00:00:00

No patent or exclusivity listings for this strength.