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LEVEMIR

BLA

INSULIN DETEMIR RECOMBINANT | B021536 | 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 21536 | 5 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

insulin detemir

Applicant

Novo Nordisk Inc.

Approval Date

16-Jun-05

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

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

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

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

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

Approval Letters

23 letters from Drugs@FDA

Source: Drugs@FDA application documents.