Viewing data from:

KIRSTY

Interchangeable Biosimilar

INSULIN ASPART-XJHZ | B761188 | BIOCON BIOLOGICS INC

1 product0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

July 15, 2037(4030 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jul. 15, 2037	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Mar. 6, 20456821 days remaining

Based on latest discovered patent 12249425(device) · relevance 65/100

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

Approved Biosimilars

KirstyBLA 761188ICKirstyBLA 761188IC

Discovered Patents

View all 82 patents →

Top 50 of 82 AI-discovered patents by relevance.

Composition

(16)

88/1008710000Grant: 2014-04-29 | Exp: 2034-04-24

88/1008859493Grant: 2014-10-14 | Exp: 2034-10-09

85/1008476228Grant: 2013-07-02 | Exp: 2033-06-27

85/1008575096Grant: 2013-11-05 | Exp: 2033-10-31

85/1008067362Grant: 2011-11-29 | Exp: 2031-11-24

82/1007087408Grant: 2006-08-08 | Exp: 2026-08-03

75/10010919949Grant: 2021-02-16 | Exp: 2041-02-11

75/1008722620Grant: 2014-05-13 | Exp: 2034-05-08

75/10010259856Grant: 2019-04-16 | Exp: 2039-04-11

75/10011208452Grant: 2021-12-28 | Exp: 2041-12-23

75/1006521738Grant: 2003-02-18 | Exp: 2023-02-13

70/10012227528Grant: 2025-02-18 | Exp: 2045-02-13

70/1008987197Grant: 2015-03-24 | Exp: 2035-03-19

68/1009242011Grant: 2016-01-26 | Exp: 2036-01-21

65/1008710001Grant: 2014-04-29 | Exp: 2034-04-24

65/1008883449Grant: 2014-11-11 | Exp: 2034-11-06

Formulation

(8)

80/1006489292Grant: 2002-12-03 | Exp: 2022-11-28

78/1006635617Grant: 2003-10-21 | Exp: 2023-10-16

75/1009034818Grant: 2015-05-19 | Exp: 2035-05-14

72/1009387176Grant: 2016-07-12 | Exp: 2036-07-07

72/1008399078Grant: 2013-03-19 | Exp: 2033-03-14

72/1008324157Grant: 2012-12-04 | Exp: 2032-11-29

70/1006211144Grant: 2001-04-03 | Exp: 2021-03-29

65/100OB8114833Grant: 2012-02-14 | Exp: 2032-02-09

Method of Use

(3)

85/1007446091Grant: 2008-11-04 | Exp: 2028-10-30

75/10010596229Grant: 2020-03-24 | Exp: 2040-03-19

65/10011373746Grant: 2022-06-28 | Exp: 2042-06-23

Manufacturing

(10)

85/1006777207Grant: 2004-08-17 | Exp: 2024-08-12

85/1009056921Grant: 2015-06-16 | Exp: 2035-06-11

85/1007378390Grant: 2008-05-27 | Exp: 2028-05-22

80/1008129146Grant: 2012-03-06 | Exp: 2032-03-01

75/1006183989Grant: 2001-02-06 | Exp: 2021-02-01

75/10011472835Grant: 2022-10-18 | Exp: 2042-10-13

75/1007402565Grant: 2008-07-22 | Exp: 2028-07-17

75/1008518668Grant: 2013-08-27 | Exp: 2033-08-22

75/1007105314Grant: 2006-09-12 | Exp: 2026-09-07

70/1008153395Grant: 2012-04-10 | Exp: 2032-04-05

Device

(12)

80/10010406291Grant: 2019-09-10 | Exp: 2039-09-05

78/10011164668Grant: 2021-11-02 | Exp: 2041-10-28

75/10011311679Grant: 2022-04-26 | Exp: 2042-04-21

72/1009095660Grant: 2015-08-04 | Exp: 2035-07-30

72/1006514230Grant: 2003-02-04 | Exp: 2023-01-30

70/1006755810Grant: 2004-06-29 | Exp: 2024-06-24

70/1009533106Grant: 2017-01-03 | Exp: 2036-12-29

68/10011462313Grant: 2022-10-04 | Exp: 2042-09-29

68/10011400225Grant: 2022-08-02 | Exp: 2042-07-28

68/1009833579Grant: 2017-12-05 | Exp: 2037-11-30

68/10011628256Grant: 2023-04-18 | Exp: 2043-04-13

65/10012249425Grant: 2025-03-11 | Exp: 2045-03-06

Diagnostic

(1)

70/10010914728Grant: 2021-02-09 | Exp: 2041-02-04

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 761188 | 2 presentations

InterchangeableLicensedCDERInjection

Proper Name

insulin aspart-xjhz

Applicant

Biocon Biologics Inc.

Approval Date

15-Jul-25

Reference Product: Novolog — insulin aspart

Presentations

300UNITS/3ML (100UNITS/ML) — Autoinjector (Subcutaneous)

1,000UNITS/10ML (100UNITS/ML) — Multi-Dose Vial (Intravenous, Subcutaneous)

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 15, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100 UNITS/ML

▴

INJECTION;SOLUTION | Approved: 2025-07-15 00:00:00

No patent or exclusivity listings for this strength.