Viewing data from:

FIASP

BLA

INSULIN ASPART | B208751 | NOVO

3 products0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

September 29, 2029(1184 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 29, 2029	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 70/100

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

Discovered Patents

View all 68 patents →

Top 50 of 68 AI-discovered patents by relevance.

Composition

(16)

88/10011498951Grant: 2022-11-15 | Exp: 2042-11-10

88/10010040839Grant: 2018-08-07 | Exp: 2038-08-02

85/10012122818Grant: 2024-10-22 | Exp: 2044-10-17

85/1007087408Grant: 2006-08-08 | Exp: 2026-08-03

85/10010919949Grant: 2021-02-16 | Exp: 2041-02-11

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

80/10011352406Grant: 2022-06-07 | Exp: 2042-06-02

78/1009260501Grant: 2016-02-16 | Exp: 2036-02-11

75/1008003605Grant: 2011-08-23 | Exp: 2031-08-18

75/1008158583Grant: 2012-04-17 | Exp: 2032-04-12

75/1008883449Grant: 2014-11-11 | Exp: 2034-11-06

75/10012227528Grant: 2025-02-18 | Exp: 2045-02-13

72/1009242011Grant: 2016-01-26 | Exp: 2036-01-21

70/1006521738Grant: 2003-02-18 | Exp: 2023-02-13

65/10011274280Grant: 2022-03-15 | Exp: 2042-03-10

65/10011208452Grant: 2021-12-28 | Exp: 2041-12-23

Formulation

(7)

92/10012152063Grant: 2024-11-26 | Exp: 2044-11-21

88/1008097584Grant: 2012-01-17 | Exp: 2032-01-12

88/1008324157Grant: 2012-12-04 | Exp: 2032-11-29

75/1007387996Grant: 2008-06-17 | Exp: 2028-06-12

72/1009034818Grant: 2015-05-19 | Exp: 2035-05-14

68/1009387176Grant: 2016-07-12 | Exp: 2036-07-07

65/1008399078Grant: 2013-03-19 | Exp: 2033-03-14

Method of Use

(4)

88/10010137172Grant: 2018-11-27 | Exp: 2038-11-22

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

75/10012226458Grant: 2025-02-18 | Exp: 2045-02-13

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

Manufacturing

(11)

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

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

82/1007396903Grant: 2008-07-08 | Exp: 2028-07-03

82/1009056921Grant: 2015-06-16 | Exp: 2035-06-11

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

75/1008129146Grant: 2012-03-06 | Exp: 2032-03-01

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

72/1006183989Grant: 2001-02-06 | Exp: 2021-02-01

72/1008518668Grant: 2013-08-27 | Exp: 2033-08-22

65/1006180757Grant: 2001-01-30 | Exp: 2021-01-25

65/1008153395Grant: 2012-04-10 | Exp: 2032-04-05

Device

(11)

72/10011373759Grant: 2022-06-28 | Exp: 2042-06-23

70/10012249425Grant: 2025-03-11 | Exp: 2045-03-06

68/1009750886Grant: 2017-09-05 | Exp: 2037-08-31

65/10011273261Grant: 2022-03-15 | Exp: 2042-03-10

65/10011462313Grant: 2022-10-04 | Exp: 2042-09-29

65/1006461334Grant: 2002-10-08 | Exp: 2022-10-03

65/10010357616Grant: 2019-07-23 | Exp: 2039-07-18

60/10011944791Grant: 2024-04-02 | Exp: 2044-03-28

60/10011672912Grant: 2023-06-13 | Exp: 2043-06-08

60/10010245383Grant: 2019-04-02 | Exp: 2039-03-28

58/1008062253Grant: 2011-11-22 | Exp: 2031-11-17

Diagnostic

(1)

60/10010914728Grant: 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 208751 | 4 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

insulin aspart

Applicant

Novo Nordisk Inc.

Approval Date

29-Sep-17

Presentations

1000UNITS/10ML (100UNITS/ML) — Multi-Dose Vial (Intravenous, Subcutaneous)

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

300UNITS/3ML (100UNITS/ML) — Multi-Dose Cartridge (Subcutaneous)

160UNITS/1.6ML (100UNITS/ML) — Multi-Dose Cartridge (Subcutaneous)

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jun 22, 2023	SUPPL -20	View Letter (PDF)
Mar 23, 2020	SUPPL -8	View Letter (PDF)
Mar 23, 2020	SUPPL -13	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -10	View Letter (PDF)
Mar 23, 2020	SUPPL -11	View Letter (PDF)
Mar 23, 2020	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1000 UNITS/10ML (100 UNITS/ML)

▴

SOLUTION;INTRAVENOUS, SUBCUTANEOUS | Approved: 2017-09-29 00:00:00

No patent or exclusivity listings for this strength.

#002 — 300 UNITS/3ML (100 UNITS/ML)

▾

SOLUTION;SUBCUTANEOUS | Approved: 2017-09-29 00:00:00

#003 — 300 UNITS/3ML (100 UNITS/ML)

▾

SOLUTION;SUBCUTANEOUS | Approved: 2017-09-29 00:00:00