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BLA

TBO-FILGRASTIM | B125294 | SICOR BIOTECH

2 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

February 29, 2024(855 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Feb. 29, 2024	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jun. 5, 20456912 days remaining

Based on latest discovered patent 12325737(manufacturing) · relevance 58/100

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

Discovered Patents

View all 68 patents →

Top 50 of 68 AI-discovered patents by relevance.

Composition

(23)

95/1007550565Grant: 2009-06-23 | Exp: 2029-06-18

92/1007232668Grant: 2007-06-19 | Exp: 2027-06-14

92/1006646110Grant: 2003-11-11 | Exp: 2023-11-06

90/10011813310Grant: 2023-11-14 | Exp: 2043-11-09

90/10011684655Grant: 2023-06-27 | Exp: 2043-06-22

90/1007696153Grant: 2010-04-13 | Exp: 2030-04-08

89/1006797493Grant: 2004-09-28 | Exp: 2024-09-23

88/1007226759Grant: 2007-06-05 | Exp: 2027-05-31

88/1007550566Grant: 2009-06-23 | Exp: 2029-06-18

88/1006555660Grant: 2003-04-29 | Exp: 2023-04-24

87/1008268311Grant: 2012-09-18 | Exp: 2032-09-13

86/1006716606Grant: 2004-04-06 | Exp: 2024-04-01

86/1009273108Grant: 2016-03-01 | Exp: 2036-02-25

85/1006831158Grant: 2004-12-14 | Exp: 2024-12-09

85/10010813913Grant: 2020-10-27 | Exp: 2040-10-22

85/1007371370Grant: 2008-05-13 | Exp: 2028-05-08

85/1007402304Grant: 2008-07-22 | Exp: 2028-07-17

82/1008557546Grant: 2013-10-15 | Exp: 2033-10-10

72/1007169905Grant: 2007-01-30 | Exp: 2027-01-25

65/10010376495Grant: 2019-08-13 | Exp: 2039-08-08

65/1006552170Grant: 2003-04-22 | Exp: 2023-04-17

60/10010640542Grant: 2020-05-05 | Exp: 2040-04-30

55/1006841147Grant: 2005-01-11 | Exp: 2025-01-06

Formulation

(7)

94/1007449444Grant: 2008-11-11 | Exp: 2028-11-06

75/1006245740Grant: 2001-06-12 | Exp: 2021-06-07

75/1006451346Grant: 2002-09-17 | Exp: 2022-09-12

72/1007160924Grant: 2007-01-09 | Exp: 2027-01-04

65/10010653781Grant: 2020-05-19 | Exp: 2040-05-14

58/1007323169Grant: 2008-01-29 | Exp: 2028-01-24

55/10011040102Grant: 2021-06-22 | Exp: 2041-06-17

Method of Use

(6)

88/10011229683Grant: 2022-01-25 | Exp: 2042-01-20

88/10012274736Grant: 2025-04-15 | Exp: 2045-04-10

85/10010286039Grant: 2019-05-14 | Exp: 2039-05-09

82/1009642917Grant: 2017-05-09 | Exp: 2037-05-04

78/1006967029Grant: 2005-11-22 | Exp: 2025-11-17

55/1006207454Grant: 2001-03-27 | Exp: 2021-03-22

Manufacturing

(14)

65/10012195779Grant: 2025-01-14 | Exp: 2045-01-09

65/1006770746Grant: 2004-08-03 | Exp: 2024-07-29

62/10011407784Grant: 2022-08-09 | Exp: 2042-08-04

62/10012269843Grant: 2025-04-08 | Exp: 2045-04-03

60/10011426706Grant: 2022-08-30 | Exp: 2042-08-25

58/10012325737Grant: 2025-06-10 | Exp: 2045-06-05

55/10010513723Grant: 2019-12-24 | Exp: 2039-12-19

55/10010106829Grant: 2018-10-23 | Exp: 2038-10-18

55/10010167492Grant: 2019-01-01 | Exp: 2038-12-27

55/10011384140Grant: 2022-07-12 | Exp: 2042-07-07

55/10011254963Grant: 2022-02-22 | Exp: 2042-02-17

55/1009388447Grant: 2016-07-12 | Exp: 2036-07-07

55/10010822630Grant: 2020-11-03 | Exp: 2040-10-29

54/1009012178Grant: 2015-04-21 | Exp: 2035-04-16

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 125294 | 4 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

tbo-filgrastim

Applicant

UAB Teva Baltics

Approval Date

29-Aug-12

First Licensure

29-Aug-12

Presentations

300MCG/0.5ML — Pre-Filled Syringe (Subcutaneous)

480MCG/0.8ML — Pre-Filled Syringe (Subcutaneous)

300MCG/1ML — Single-Dose Vial (Subcutaneous)

480MCG/1.6ML — Single-Dose Vial (Subcutaneous)

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Nov 24, 2023	SUPPL -58	View Letter (PDF)
Oct 10, 2019	SUPPL -48	View Letter (PDF)
Mar 29, 2019	SUPPL -46	View Letter (PDF)
Aug 3, 2018	SUPPL -45	View Letter (PDF)
Jun 22, 2017	SUPPL -42	View Letter (PDF)
Feb 3, 2017	SUPPL -40	View Letter (PDF)
Jul 22, 2013	SUPPL -7	View Letter (PDF)
Sep 4, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 300MCG/0.5ML

▴

INJECTABLE; INJECTION | Approved: 2012-08-29 00:00:00

No patent or exclusivity listings for this strength.

#002 — 480MCG/0.8ML

▾

INJECTABLE; INJECTION | Approved: 2012-08-29 00:00:00