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BLA

INSULIN GLARGINE RECOMBINANT | B021081 | SANOFI AVENTIS US

2 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Sanofi-Aventis U.S. LLC et al v. Merck Sharp & Dohme Corp. 1:2016cv00812 10 patentsinsulin glargine [rDNA origin]	D. Del.	2016-09-16	Terminated 2018-10-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 21081 | 4 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

insulin glargine

Applicant

Sanofi-Aventis U.S. LLC

Approval Date

20-Apr-00

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

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

500UNITS/5ML (100UNITS/ML) — Multi-Dose Vial (Subcutaneous)

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

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

Approval Letters

18 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100 UNITS/ML

▴

INJECTABLE;INJECTION | Approved: 2000-04-20 00:00:00

No patent or exclusivity listings for this strength.

#002 — 300 UNITS/3ML (100 UNITS/ML)

▾

INJECTABLE;INJECTION | Approved: 2000-04-20 00:00:00