Viewing data from:

TOUJEO SOLOSTAR

BLA

INSULIN GLARGINE RECOMBINANT | B206538 | SANOFI US SERVICES

2 products0 Purple Book patents

Biologic LOELOE within 1 year

Estimated date when biosimilar competition may begin

February 25, 2027(237 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Feb. 25, 2027	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Oct. 2, 20457031 days remaining

Based on latest discovered patent 12434003(device) · relevance 76/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Discovered Patents

View all 240 patents →

Top 50 of 240 AI-discovered patents by relevance.

Composition

(8)

92/1009644017Grant: 2017-05-09 | Exp: 2037-05-04

85/1006534288Grant: 2003-03-18 | Exp: 2023-03-13

85/1008048854Grant: 2011-11-01 | Exp: 2031-10-27

85/10011396534Grant: 2022-07-26 | Exp: 2042-07-21

85/1006875589Grant: 2005-04-05 | Exp: 2025-03-31

85/1008633156Grant: 2014-01-21 | Exp: 2034-01-16

78/1006686177Grant: 2004-02-03 | Exp: 2024-01-29

75/10010117909Grant: 2018-11-06 | Exp: 2038-11-01

Formulation

(14)

95/1009895424Grant: 2018-02-20 | Exp: 2038-02-15

95/10011026999Grant: 2021-06-08 | Exp: 2041-06-03

92/10011191722Grant: 2021-12-07 | Exp: 2041-12-02

92/1009821032Grant: 2017-11-21 | Exp: 2037-11-16

90/10012186374Grant: 2025-01-07 | Exp: 2045-01-02

90/1007476652Grant: 2009-01-13 | Exp: 2029-01-08

90/1009345750Grant: 2016-05-24 | Exp: 2036-05-19

90/10010092513Grant: 2018-10-09 | Exp: 2038-10-04

88/1009950039Grant: 2018-04-24 | Exp: 2038-04-19

85/10010610595Grant: 2020-04-07 | Exp: 2040-04-02

85/10010029011Grant: 2018-07-24 | Exp: 2038-07-19

82/1007713930Grant: 2010-05-11 | Exp: 2030-05-06

82/1009839692Grant: 2017-12-12 | Exp: 2037-12-07

78/1007452860Grant: 2008-11-18 | Exp: 2028-11-13

Method of Use

(4)

95/1007977310Grant: 2011-07-12 | Exp: 2031-07-07

92/1007405196Grant: 2008-07-29 | Exp: 2028-07-24

90/10010434147Grant: 2019-10-08 | Exp: 2039-10-03

88/1008809270Grant: 2014-08-19 | Exp: 2034-08-14

Manufacturing

(5)

95/1007659363Grant: 2010-02-09 | Exp: 2030-02-04

85/1006710167Grant: 2004-03-23 | Exp: 2024-03-18

85/1008410048Grant: 2013-04-02 | Exp: 2033-03-28

78/10011952602Grant: 2024-04-09 | Exp: 2044-04-04

75/1006727346Grant: 2004-04-27 | Exp: 2024-04-22

Device

(19)

80/10011160928Grant: 2021-11-02 | Exp: 2041-10-28

78/1009717852Grant: 2017-08-01 | Exp: 2037-07-27

77/1009750890Grant: 2017-09-05 | Exp: 2037-08-31

76/1009526844Grant: 2016-12-27 | Exp: 2036-12-22

76/10012329935Grant: 2025-06-17 | Exp: 2045-06-12

76/10012434003Grant: 2025-10-07 | Exp: 2045-10-02

75/1008187233Grant: 2012-05-29 | Exp: 2032-05-24

75/1009724472Grant: 2017-08-08 | Exp: 2037-08-03

75/1009125993Grant: 2015-09-08 | Exp: 2035-09-03

75/10011376365Grant: 2022-07-05 | Exp: 2042-06-30

75/1009775954Grant: 2017-10-03 | Exp: 2037-09-28

75/1009861749Grant: 2018-01-09 | Exp: 2038-01-04

75/10010232125Grant: 2019-03-19 | Exp: 2039-03-14

75/1009125994Grant: 2015-09-08 | Exp: 2035-09-03

75/1008317757Grant: 2012-11-27 | Exp: 2032-11-22

75/1008475414Grant: 2013-07-02 | Exp: 2033-06-27

75/1009242048Grant: 2016-01-26 | Exp: 2036-01-21

75/10012214169Grant: 2025-02-04 | Exp: 2045-01-30

75/10011759575Grant: 2023-09-19 | Exp: 2043-09-14

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 206538 | 2 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

insulin glargine

Applicant

Sanofi-Aventis U.S. LLC

Approval Date

25-Feb-15

Presentations

450UNITS/1.5ML (300UNITS/ML) — Autoinjector (Subcutaneous)

900UNITS/3ML (300UNITS/ML) — Autoinjector (Subcutaneous)

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 30, 2024	SUPPL -17	View Letter (PDF)
Aug 17, 2022	SUPPL -16	View Letter (PDF)
Mar 23, 2020	SUPPL -6	View Letter (PDF)
Mar 23, 2020	ORIG -1	View Letter (PDF)
Mar 23, 2020	SUPPL -13	View Letter (PDF)
Mar 23, 2020	SUPPL -14	View Letter (PDF)
Mar 23, 2020	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 900 UNITS/3ML (300 UNITS/ML)

▾

SOLUTION;SUBCUTANEOUS | Approved: 2015-02-25 00:00:00

#001 — 450 UNITS/1.5ML (300 UNITS/ML)

▴

SOLUTION;SUBCUTANEOUS | Approved: 2015-02-25 00:00:00

No patent or exclusivity listings for this strength.