U.S. License Holder:
Sanofi Aventis US
Date of License:
April-20-2000
Last Update:
May-23-2023
FDA-Approved Indications
LANTUS (insulin glargine recombinant) is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.
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) Semglee® (Mylan / Biocon) (June-2020; July-2021 Interchangeable) Rezvoglar: Eli Lilly Co. (December-2021; November-2022 Interchangeable)
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Basaglar (Eli Lilly) (August-2015)
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)
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
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
19-1368 (Lead appeal, consolidated with 19-1369)
Supreme Court Appeal(s)
19A886; 19-1451
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed, Petitions for Panel Rehearing and Rehearing En Banc Denied; Supreme Court Denied Stay of Federal Circuit Mandate; Writ of Certiorari Denied
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
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
19-1369 (Consolidated with lead appeal 19-1368)
Supreme Court Appeal(s)
19A886; 19-1451
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Affirmed, Petitions for Panel Rehearing and Rehearing En Banc Denied; Supreme Court Denied Stay of Federal Circuit Mandate; Writ of Certiorari Denied
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
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-1871 (Lead appeal, consolidated with 20-2029, 20-2032, 20-2033, 20-2034, 20-2159)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed
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
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2029 (Consolidated with lead appeal 20-1871)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Dismissed as Moot
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
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2032 (Consolidated with lead appeal 20-1871)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed
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
Terminated Prior to Institution Decision
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Terminated Prior to Institution Decision
Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Terminated Prior to Institution Decision - Petitioner Requested Dismissal Due to Clerical Error i
IPR Status
Dismissed at Petitioner's Request Prior to Institution Decision. Refiled as IPR2019-00122.
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
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2033 (Consolidated with lead appeal 20-1871)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed
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
Y
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2066 (Lead appeal, consolidated with 20-2068, 20-2069)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Affirmed
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
Y
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2068 (Consolidated with lead appeal 20-2066)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Affirmed
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
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2069 (Consolidated with lead appeal 20-2066)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Dismissed as Moot
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
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2071; 20-2139 and 20-2144 (Cross appeals) (Cross appeals consolidated with lead appeal 20-2071)
IPR Status
Final Written Decision (Some Instituted Claims Found Unpatentable); Federal Circuit Appeals 20-2139 and 20-2144 Withdrawn; Federal Circuit Appeal 20-2071 Affirmed
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
N
IPR Status
IPR Not Instituted
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
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2034 (Consolidated with lead appeal 20-1871)
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Dismissed as Moot
U.S. Patent No.
8,603,044 (Pen-Type Injector)
Patent Owner
Sanofi-Aventis Deutschland GmbH
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y; Joined with IPR2018-01675
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2029 (Consolidated with lead appeal 20-1871)
IPR Status
Joined with IPR2018-01675, Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Dismissed as Moot
U.S. Patent No.
8,603,044 (Pen-Type Injector)
Patent Owner
Sanofi-Aventis Deutschland GmbH
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y; Joined with IPR2018-01676
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2032 (Consolidated with lead appeal 20-1871)
IPR Status
Joined with IPR2018-01676, Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed
U.S. Patent No.
8,679,069 (Pen-Type Injector)
Patent Owner
Sanofi-Aventis Deutschland GmbH
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2159 (Consolidated with lead appeal 20-1871)
IPR Status
Joinder with IPR2018-01670 Denied; Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed
U.S. Patent No.
8,992,486 (Pen-Type Injector)
Patent Owner
Sanofi-Aventis Deutschland GmbH
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y; Joined with IPR2018-01678
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2033 (Consolidated with lead appeal 20-1871)
IPR Status
Joined with IPR2018-01678; Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Affirmed
U.S. Patent No.
8,992,486 (Pen-Type Injector)
Patent Owner
Sanofi-Aventis Deutschland GmbH
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
Y
Claim Types Challenged Under § 102
Other (Drug Delivery Device)
§ 102 Challenge Instituted
Y; Joined with IPR2018-01679
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y; Joined with IPR2018-01679
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2066 (Lead appeal, consolidated with 20-2068, 20-2069)
IPR Status
Joined with IPR2018-01679; Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Affirmed
U.S. Patent No.
8,992,486 (Pen-Type Injector)
Patent Owner
Sanofi-Aventis Deutschland GmbH
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y; Joined with IPR2019-00122
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2034 (Consolidated with lead appeal 20-1871)
IPR Status
Joined with IPR2019-00122; Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Appeal Dismissed as Moot
U.S. Patent No.
9,604,008 (Drive Mechanisms Suitable for Use in Drug Delivery Devices)
Patent Owner
Sanofi-Aventis Deutschland GmbH
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y; Joined with IPR2018-01684
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2071; 20-2139 and 20-2144 (Cross appeals) (Cross appeals consolidated with lead appeal 20-2071)
IPR Status
Joined with IPR2018-01684, Final Written Decision (Some Instituted Claims Found Unpatentable); Federal Circuit Appeals 20-2139 and 20-2144 Withdrawn; Federal Circuit Appeal 20-2071 Affirmed
U.S. Patent No.
9,526,844 (Pen-type Injector)
Patent Owner
Sanofi-Aventis Deutschland GmbH
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
Y
Claim Types Challenged Under § 102
Other (Drug Delivery Device)
§ 102 Challenge Instituted
Y; Joined with IPR2018-01680
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y; Joined with IPR2018-01680
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2068 (Consolidated with lead appeal 20-2066)
IPR Status
Joined with IPR2018-01680, Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Affirmed
U.S. Patent No.
9,526,844 (Pen-type Injector)
Patent Owner
Sanofi-Aventis Deutschland GmbH
Petitioner(s)
Hospira, Inc.; Pfizer Inc.
§ 102 Challenge
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y; Joined with IPR2018-01682
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
20-2069 (Consolidated with lead appeal 20-2066)
IPR Status
Joined with IPR2018-01682, Final Written Decision (All Instituted Claims Found Unpatentable), Motion to Amend Denied; Federal Circuit Appeal Dismissed as Moot
U.S. Patent No.
RE47,614 (Drug Delivery Device and Method of Manufacturing a Drug Delivery Device)
Patent Owner
Sanofi-Aventis Deutschland GmbH
Petitioner(s)
Mylan Pharmaceuticals Inc.
§ 102 Challenge
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
Y
Final Written Decision Issued
Y
Federal Circuit Appeal(s)
21-1981
IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable); Federal Circuit Reversed
U.S. Patent No.
RE47,614 (Drug Delivery Device and Method of Manufacturing a Drug Delivery Device)
Patent Owner
Sanofi-Aventis Deutschland GmbH
Petitioner(s)
Mylan Pharmaceuticals Inc.
§ 102 Challenge
N
§ 103 challenge
Y
Claim Types Challenged Under § 103
Other (Drug Delivery Device)
§ 103 Challenge Instituted
N
IPR Status
IPR Not Instituted
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
Stipulated Dismissal
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
Stipulated Dismissal
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
Federal Circuit Appeal(s)
21-1262
Status
652 and '930 Patents: PTAB Found All Claims Unpatentable in IPRs; Federal Circuit Affirmed; Supreme Court Denied Certiorari;
'044 and '069 Patents: District Court Decision Finding Patents Not Infringed;
'486 and '008 Patents: Parties Dismissed Challenges;
'844 Patent: District Court Decision Finding Claims 21, 22, 25 and 30 Not Infringed and Invalid; Federal Circuit Appeal Dismissed as Moot
BPCIA
N