Viewing data from:

HULIO

Interchangeable Biosimilar

ADALIMUMAB-FKJP | B761154 | MYLAN PHARMS INC

1 product0 Purple Book patents3 biosimilars

Biologic LOEBiosimilar competition

3 approved biosimilars

July 6, 2032(2195 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jul. 6, 2032	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Oct. 1, 20405204 days remaining

Based on latest discovered patent 10792372(composition) · relevance 50/100

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

Approved Biosimilars

HulioBLA 761154ICHulioBLA 761154ICHulioBLA 761154IC

Discovered Patents

View all 54 patents →

Top 50 of 54 AI-discovered patents by relevance.

Composition

(15)

92/1009315573Grant: 2016-04-19 | Exp: 2036-04-14

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

85/1008436149Grant: 2013-05-07 | Exp: 2033-05-02

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

65/1008163546Grant: 2012-04-24 | Exp: 2032-04-19

60/1007897148Grant: 2011-03-01 | Exp: 2031-02-24

60/1009775916Grant: 2017-10-03 | Exp: 2037-09-28

55/1008012485Grant: 2011-09-06 | Exp: 2031-09-01

55/1008889669Grant: 2014-11-18 | Exp: 2034-11-13

50/1009458244Grant: 2016-10-04 | Exp: 2036-09-29

50/10010040852Grant: 2018-08-07 | Exp: 2038-08-02

50/1008404445Grant: 2013-03-26 | Exp: 2033-03-21

50/1006913748Grant: 2005-07-05 | Exp: 2025-06-30

50/1008236319Grant: 2012-08-07 | Exp: 2032-08-02

50/10010792372Grant: 2020-10-06 | Exp: 2040-10-01

Formulation

(21)

98/1008802101Grant: 2014-08-12 | Exp: 2034-08-07

95/1008932591Grant: 2015-01-13 | Exp: 2035-01-08

95/1009289497Grant: 2016-03-22 | Exp: 2036-03-17

95/1008916158Grant: 2014-12-23 | Exp: 2034-12-18

95/1008916157Grant: 2014-12-23 | Exp: 2034-12-18

95/1009295725Grant: 2016-03-29 | Exp: 2036-03-24

95/1009220781Grant: 2015-12-29 | Exp: 2035-12-24

95/1009738714Grant: 2017-08-22 | Exp: 2037-08-17

95/1009950066Grant: 2018-04-24 | Exp: 2038-04-19

95/1008802102Grant: 2014-08-12 | Exp: 2034-08-07

94/1009114166Grant: 2015-08-25 | Exp: 2035-08-20

92/1008216583Grant: 2012-07-10 | Exp: 2032-07-05

92/1008802100Grant: 2014-08-12 | Exp: 2034-08-07

92/1009272042Grant: 2016-03-01 | Exp: 2036-02-25

90/1008940305Grant: 2015-01-27 | Exp: 2035-01-22

90/1009327032Grant: 2016-05-03 | Exp: 2036-04-28

90/1008911741Grant: 2014-12-16 | Exp: 2034-12-11

90/1009750808Grant: 2017-09-05 | Exp: 2037-08-31

89/1009732152Grant: 2017-08-15 | Exp: 2037-08-10

88/1009272041Grant: 2016-03-01 | Exp: 2036-02-25

88/1008795670Grant: 2014-08-05 | Exp: 2034-07-31

Method of Use

(3)

82/1008846046Grant: 2014-09-30 | Exp: 2034-09-25

55/1009550986Grant: 2017-01-24 | Exp: 2037-01-19

55/1009915665Grant: 2018-03-13 | Exp: 2038-03-08

Manufacturing

(9)

75/1007795494Grant: 2010-09-14 | Exp: 2030-09-09

65/1008633139Grant: 2014-01-21 | Exp: 2034-01-16

65/1009975948Grant: 2018-05-22 | Exp: 2038-05-17

65/1009598667Grant: 2017-03-21 | Exp: 2037-03-16

60/1007947495Grant: 2011-05-24 | Exp: 2031-05-19

52/10010494431Grant: 2019-12-03 | Exp: 2039-11-28

50/10010053720Grant: 2018-08-21 | Exp: 2038-08-16

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

50/1008283170Grant: 2012-10-09 | Exp: 2032-10-04

Device

(1)

55/10010183117Grant: 2019-01-22 | Exp: 2039-01-17

Diagnostic

(1)

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

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 761154 | 3 presentations

InterchangeableLicensedCDERInjection

Proper Name

adalimumab-fkjp

Applicant

Biocon Biologics Inc.

Approval Date

6-Jul-20

Reference Product: Humira — adalimumab

Presentations

40MG/0.8ML — Autoinjector (Subcutaneous)

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

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

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Dec 19, 2023	SUPPL -8	View Letter (PDF)
Aug 28, 2023	SUPPL -5	View Letter (PDF)
Apr 3, 2023	SUPPL -3	View Letter (PDF)
Jul 15, 2022	SUPPL -2	View Letter (PDF)
Jul 7, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG;0.4ML

▴

INJECTABLE;INJECTION | Approved: 2020-07-06 00:00:00

No patent or exclusivity listings for this strength.