Testing version — LOERadar is in active testing. Features and data may change.

NOVOLOG (INSULIN ASPART RECOMBINANT) | LOERadar

Viewing data from:

NOVOLOG

BLA

INSULIN ASPART RECOMBINANT | B020986 | NOVO NORDISK INC

5 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

October 31, 2025(245 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Oct. 31, 2025	Expired	Computed

Purple Book Patents

No listed patents in Purple Book.

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 20986 | 5 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

insulin aspart

Applicant

Novo Nordisk Inc.

Approval Date

7-Jun-00

Presentations

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

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

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

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

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

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

Approval Letters

38 letters from Drugs@FDA

Date	Submission	Document
Mar 1, 2023	SUPPL -96	View Letter (PDF)
Nov 2, 2022	SUPPL -95	View Letter (PDF)
Mar 24, 2021	SUPPL -93	View Letter (PDF)
Mar 23, 2020	SUPPL -58	View Letter (PDF)
Mar 23, 2020	SUPPL -37	View Letter (PDF)
Mar 23, 2020	SUPPL -40	View Letter (PDF)
Mar 23, 2020	SUPPL -45	View Letter (PDF)
Mar 23, 2020	SUPPL -59	View Letter (PDF)
Mar 23, 2020	SUPPL -64	View Letter (PDF)
Mar 23, 2020	SUPPL -67	View Letter (PDF)
Mar 23, 2020	SUPPL -82	View Letter (PDF)
Mar 23, 2020	SUPPL -49	View Letter (PDF)
Mar 23, 2020	SUPPL -53	View Letter (PDF)
Mar 23, 2020	SUPPL -60	View Letter (PDF)
Mar 23, 2020	SUPPL -61	View Letter (PDF)
Mar 23, 2020	SUPPL -62	View Letter (PDF)
Mar 23, 2020	SUPPL -75	View Letter (PDF)
Mar 23, 2020	SUPPL -4	View Letter (PDF)
Mar 23, 2020	SUPPL -11	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -20	View Letter (PDF)
Mar 23, 2020	SUPPL -23	View Letter (PDF)
Mar 23, 2020	SUPPL -24	View Letter (PDF)
Mar 23, 2020	SUPPL -33	View Letter (PDF)
Mar 23, 2020	SUPPL -47	View Letter (PDF)
Mar 23, 2020	SUPPL -57	View Letter (PDF)
Mar 23, 2020	SUPPL -78	View Letter (PDF)
Mar 23, 2020	SUPPL -80	View Letter (PDF)
Mar 23, 2020	SUPPL -81	View Letter (PDF)
Mar 23, 2020	SUPPL -84	View Letter (PDF)
Mar 23, 2020	SUPPL -79	View Letter (PDF)
Mar 23, 2020	SUPPL -87	View Letter (PDF)
Mar 23, 2020	SUPPL -2	View Letter (PDF)
Mar 23, 2020	SUPPL -90	View Letter (PDF)
Mar 23, 2020	SUPPL -91	View Letter (PDF)
Mar 23, 2020	SUPPL -19	View Letter (PDF)
Mar 23, 2020	SUPPL -50	View Letter (PDF)
Mar 23, 2020	SUPPL -54	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 1000 UNITS/10ML (100 UNITS/ML)

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2000-06-07 00:00:00

No patent or exclusivity listings for this strength.

#003 — 300 UNITS/3ML (100 UNITS/ML)

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2000-06-07 00:00:00

#005 — 300 UNITS/3ML (100 UNITS/ML)

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2000-06-07 00:00:00

#004 — 300 UNITS/3ML (100 UNITS/ML)

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2000-06-07 00:00:00

#002 — 300 UNITS/3ML (100 UNITS/ML)

▾

INJECTABLE;SUBCUTANEOUS | Approved: 2000-06-07 00:00:00