Lusduna Nexvue (insulin glargine)

Lusduna Nexvue Tentatively Approved

Lusduna Nexvue (insulin glargine)

Lusduna Nexvue Tentatively Approved

U.S. License Holder:

Merck

Date of License:

505(b)(2) application accepted by FDA August-2016

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

Lusduna Nexvue (insulin glargine) has been tentatively approved by the FDA.

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In The E.U.

Lusduna (insulin glargine recombinant) (Merck) (January-2017)

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:16-cv-00812 (D. Del.)

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) 8,992,486 (Pen-Type Injector) 9,011,391 (Pen-Type Injector) 9,233,211 (Relating to a Pen-Type Injector) 9,457,152 (Drive Mechanism For A Medication Delivery Device And Medication Delivery Device) 9,486,587 (Assembly For A Drug Delivery Device And Drug Delivery Device) 9,526,844 (Pen-type Injector) 9,533,105 (Drive Mechanisms Suitable For Use In Drug Delivery Devices) 9,592,348 (Assembly For A Drug Delivery Device And Drug Delivery Device) 9,604,008 (Drive Mechanisms Suitable for Use in Drug Delivery Devices)

Plaintiffs
Sanofi-Aventis U.S. LLC; Sanofi-Aventis Deutschland GmbH; Sanofi Winthrop Industrie

Defendants
Merck Sharp and Dohme Corp.

Status
Stipulated Dismissal

BPCIA
N

2:17-cv-05914 (D.N.J.)

U.S. Patent Nos.
7,476,652 (Acidic Insulin Preparations having Improved Stability) 7,713,930 (Acidic Insulin Preparations having Improved Stability)

Plaintiffs
Sanofi-Aventis U.S. LLC; Sanofi-Aventis Deutschland GmbH; Sanofi Winthrop Industrie

Defendants
Merck Sharp and Dohme Corp.

Status
Stipulated Dismissal

BPCIA
N

Methodology

Information contained in the Venable 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 BiologicsHQ database.

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