Basaglar® (insulin glargine)

NDA 205692 [505(b)(2)]

Basaglar® (insulin glargine)

NDA 205692 [505(b)(2)]

U.S. License Holder:

Eli Lilly and Co.

Date of License:

December-16-2015

Last Update:

December-09-2018

approved_indications FDA-Approved Indications


BASAGLAR (insulin glargine) is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

U.S. Patent Nos.
7,476,652 (Acidic Insulin Preparations having Improved Stability) 7,713,930 (Acidic Insulin Preparations having Improved Stability) 8,556,864 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 8,603,044 (Pen-Type Injector) 8,679,069 (Pen-Type Injector)

Plaintiffs
Sanofi-Aventis Deutschland GmbH; Sanofi-Aventis US LLC

Defendants
Eli Lilly and Co.

Status
Settled

BPCIA
N

U.S. Patent Nos.
7,476,652 (Acidic Insulin Preparations having Improved Stability) 7,713,930 (Acidic Insulin Preparations having Improved Stability) 7,918,833 (Pen-Type Injector) 8,512,297 (Pen-Type Injector) 8,556,864 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 8,603,044 (Pen-Type Injector) 8,679,069 (Pen-Type Injector)

Plaintiffs
Sanofi-Aventis Deutschland GmbH; Sanofi-Aventis US LLC

Defendants
Eli Lilly and Co.

Status
Settled

BPCIA
N

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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