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BLA

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA | B125164 | HOFFMAN-LA ROCHE

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

April 28, 2028(665 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Apr. 28, 2028	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Aug. 28, 20456996 days remaining

Based on latest discovered patent 12403181(method of use) · relevance 72/100

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

Discovered Patents

View all 69 patents →

Top 50 of 69 AI-discovered patents by relevance.

Composition

(15)

92/1006583272Grant: 2003-06-24 | Exp: 2023-06-19

92/1007128913Grant: 2006-10-31 | Exp: 2026-10-26

85/10011939369Grant: 2024-03-26 | Exp: 2044-03-21

75/1009981037Grant: 2018-05-29 | Exp: 2038-05-24

75/1007201897Grant: 2007-04-10 | Exp: 2027-04-05

72/1007193031Grant: 2007-03-20 | Exp: 2027-03-15

72/1009833520Grant: 2017-12-05 | Exp: 2037-11-30

70/1007479544Grant: 2009-01-20 | Exp: 2029-01-15

68/1007304034Grant: 2007-12-04 | Exp: 2027-11-29

65/1008476232Grant: 2013-07-02 | Exp: 2033-06-27

65/1006870033Grant: 2005-03-22 | Exp: 2025-03-17

65/1007635749Grant: 2009-12-22 | Exp: 2029-12-17

65/1007005504Grant: 2006-02-28 | Exp: 2026-02-23

62/1008293236Grant: 2012-10-23 | Exp: 2032-10-18

60/10010717776Grant: 2020-07-21 | Exp: 2040-07-16

Formulation

(11)

88/1007169754Grant: 2007-01-30 | Exp: 2027-01-25

85/1006277367Grant: 2001-08-21 | Exp: 2021-08-16

85/1007202208Grant: 2007-04-10 | Exp: 2027-04-05

82/10011998643Grant: 2024-06-04 | Exp: 2044-05-30

75/1006627187Grant: 2003-09-30 | Exp: 2023-09-25

75/1007504477Grant: 2009-03-17 | Exp: 2029-03-12

72/1007749520Grant: 2010-07-06 | Exp: 2030-07-01

60/10010933141Grant: 2021-03-02 | Exp: 2041-02-25

55/10011938189Grant: 2024-03-26 | Exp: 2044-03-21

55/10010525137Grant: 2020-01-07 | Exp: 2040-01-02

55/10010188735Grant: 2019-01-29 | Exp: 2039-01-24

Method of Use

(5)

75/1009168288Grant: 2015-10-27 | Exp: 2035-10-22

75/10010822415Grant: 2020-11-03 | Exp: 2040-10-29

72/10011090367Grant: 2021-08-17 | Exp: 2041-08-12

72/1008173129Grant: 2012-05-08 | Exp: 2032-05-03

72/10012403181Grant: 2025-09-02 | Exp: 2045-08-28

Manufacturing

(14)

85/1007214532Grant: 2007-05-08 | Exp: 2027-05-03

85/1006555373Grant: 2003-04-29 | Exp: 2023-04-24

85/10011518781Grant: 2022-12-06 | Exp: 2042-12-01

85/10012208142Grant: 2025-01-28 | Exp: 2045-01-23

85/1006548296Grant: 2003-04-15 | Exp: 2023-04-10

80/1006544748Grant: 2003-04-08 | Exp: 2023-04-03

75/1007214514Grant: 2007-05-08 | Exp: 2027-05-03

72/1007241442Grant: 2007-07-10 | Exp: 2027-07-05

72/1007897404Grant: 2011-03-01 | Exp: 2031-02-24

70/1006399333Grant: 2002-06-04 | Exp: 2022-05-30

65/1006391633Grant: 2002-05-21 | Exp: 2022-05-16

55/10011028149Grant: 2021-06-08 | Exp: 2041-06-03

55/10010745731Grant: 2020-08-18 | Exp: 2040-08-13

55/10011987637Grant: 2024-05-21 | Exp: 2044-05-16

Diagnostic

(5)

90/1009879325Grant: 2018-01-30 | Exp: 2038-01-25

88/10012379368Grant: 2025-08-05 | Exp: 2045-07-31

75/10011779643Grant: 2023-10-10 | Exp: 2043-10-05

72/1009541560Grant: 2017-01-10 | Exp: 2037-01-05

72/10012018086Grant: 2024-06-25 | Exp: 2044-06-20

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 125164 | 19 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

methoxy polyethylene glycol-epoetin beta

Applicant

Vifor (International) Inc.

Approval Date

28-Apr-16

Presentations

30MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

50MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

100MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

200MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

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

400MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

600MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

1,000MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

400MCG/0.6ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

600MCG/0.6ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

800MCG/0.6ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

50MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

75MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

100MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

120MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

150MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

200MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

250MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

360MCG/0.6ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jun 5, 2024	SUPPL -91	View Letter (PDF)
May 2, 2024	SUPPL -89	View Letter (PDF)
Apr 7, 2023	SUPPL -87	View Letter (PDF)
Aug 31, 2022	SUPPL -86	View Letter (PDF)
Jun 14, 2018	SUPPL -78	View Letter (PDF)
May 2, 2016	SUPPL -73	View Letter (PDF)
May 2, 2016	SUPPL -71	View Letter (PDF)
May 2, 2016	SUPPL -72	View Letter (PDF)
Aug 24, 2015	SUPPL -70	View Letter (PDF)
Oct 3, 2014	SUPPL -62	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.6MG/KG

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SOLUTION; INJECTION | Approved: 2007-11-14 00:00:00

No patent or exclusivity listings for this strength.