Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant)

NDA 021081

Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant)

NDA 021081

U.S. License Holder:

Sanofi Aventis US

Date of License:

April-20-2000

Last Update:

November-30-2018

approved_indications FDA-Approved Indications


LANTUS (insulin glargine recombinant) 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 aBLA / 505(b)(2) Activity


aBLA / 505(b)(2) Approved by FDA

Basaglar®: Eli Lilly and Co. (December-2015) Lusduna Nexvue: Merck (Tentative Approval July-2017)

aBLA / 505(b)(2) Accepted by FDA

Unknown (Mylan/Biocon) (Complete Response Letter June-2018)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars


Biosimilars Approved In The E.U.

Abasaglar (Eli Lilly / Boehringer Ingelheim) (September-2014);
Lusduna (Merck) (January-2017)
Semglee (Mylan / Biocon) (March-2018)

Biosimilars Approved In Australia

Basaglar (Eli Lilly Australia) (November-2014)
Semglee (Mylan / Biocon) (March-2018)

Biosimilars Approved In Japan

Insulin glargine BS (Biocon / Fujifilm Pharma) (March-2016)
Insulin glargine BS (Eli Lilly / Boehringer Ingelheim) (December-2014)

Biosimilars Approved In South Korea

Glarzia (GC Pharma) (March-2018)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

U.S. Patent No.
7,476,652 (Acidic Insulin Preparations having Improved Stability)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan NV; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y

IPR Status
IPR Trial Ongoing

U.S. Patent No.
7,713,930 (Acidic Insulin Preparations having Improved Stability)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan NV; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Formulation

§ 103 Challenge Instituted
Y

IPR Status
IPR Trial Ongoing

U.S. Patent No.
8,679,069 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

U.S. Patent No.
8,603,044 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

U.S. Patent No.
8,603,044 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Petitioner's Motion to Dismiss Pending

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Petitioner's Motion to Dismiss Pending

IPR Status
Institution Decision Pending; Petitioner's Motion to Dismiss Pending

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Awaiting Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

U.S. Patent No.
9,526,844 (Pen-type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
Y

Claim Types Challenged Under § 102
Other (Drug Delivery Device)

§ 102 Challenge Instituted
Awaiting Institution Decision

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

U.S. Patent No.
9,526,844 (Pen-type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

U.S. Patent No.
9,604,008 (Drive Mechanisms Suitable for Use in Drug Delivery Devices)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

U.S. Patent No.
9,526,844 (Pen-type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

U.S. Patent No.
8,992,486 (Pen-Type Injector)

Patent Owner
Sanofi-Aventis Deutschland GmbH

Petitioner(s)
Biocon Limited; Biocon Research Ltd.; Mylan GmbH; Mylan Inc.; Mylan NV; Mylan Pharmaceuticals Inc.; Becton, Dickinson and Company

§ 102 Challenge
N

§ 103 challenge
Y

Claim Types Challenged Under § 103
Other (Drug Delivery Device)

§ 103 Challenge Instituted
Awaiting Institution Decision

IPR Status
Institution Decision Pending

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

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
Dismissed

BPCIA
N

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
Case Ongoing

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) 8,992,486 (Pen-Type Injector) 9,011,391 (Pen-Type Injector) 9,233,211 (Relating to a Pen-Type Injector) 9,408,979 (Pen-Type Injector) 9,526,844 (Pen-type Injector) 9,533,105 (Drive Mechanisms Suitable For Use In Drug Delivery Devices) 9,561,331 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,604,008 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,604,009 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,610,409 (Drive Mechanisms Suitable for Use in Drug Delivery Devices) 9,623,189 (Relating to Drive Mechanisms Suitable for Use in Drug Delivery Devices)

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

Defendants
Mylan Pharmaceuticals, Inc.; Mylan GmbH; Mylan Inc.; Mylan NV

Status
Case Ongoing

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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