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NOVOLIN R

BLA

INSULIN RECOMBINANT HUMAN | B019938 | NOVO NORDISK INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

June 1, 2030(1429 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 1, 2030	Active	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 19938 | 2 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

insulin human

Applicant

Novo Nordisk Inc.

Approval Date

25-Jun-91

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

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

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

Approval Letters

16 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 100 UNITS/ML

▴

INJECTABLE;INJECTION | Approved: 1991-06-25 00:00:00

No patent or exclusivity listings for this strength.