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APIDRA

BLA

INSULIN GLULISINE RECOMBINANT | B021629 | SANOFI AVENTIS US

3 products0 Purple Book patents

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

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 21629 | 3 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

insulin glulisine

Applicant

Sanofi-Aventis U.S. LLC

Approval Date

16-Apr-04

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

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

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

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

Approval Letters

11 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1000 UNITS/10ML (100 UNITS/ML)

▴

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: 2004-04-16 00:00:00

No patent or exclusivity listings for this strength.

#002 — 300 UNITS/3ML (100 UNITS/ML)

▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: 2004-04-16 00:00:00

#003 — 300 UNITS/3ML

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INJECTABLE;SUBCUTANEOUS | Approved: 2004-04-16 00:00:00