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Biosimilar

EPOETIN ALFA-EPBX | B125545 | HOSPIRA INC

5 products0 Purple Book patents7 biosimilars

Biologic LOEBiosimilar competition

7 approved biosimilars

May 15, 2030(1412 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 15, 2030	Active	Computed

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 55/100

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

Approved Biosimilars

RetacritBLA 125545RetacritBLA 125545RetacritBLA 125545RetacritBLA 125545RetacritBLA 125545RetacritBLA 125545RetacritBLA 125545

Discovered Patents

View all 57 patents →

Top 50 of 57 AI-discovered patents by relevance.

Composition

(6)

85/1007166707Grant: 2007-01-23 | Exp: 2027-01-18

72/10011427627Grant: 2022-08-30 | Exp: 2042-08-25

55/10010829551Grant: 2020-11-10 | Exp: 2040-11-05

52/1006552170Grant: 2003-04-22 | Exp: 2023-04-17

50/10011319526Grant: 2022-05-03 | Exp: 2042-04-28

50/1009132182Grant: 2015-09-15 | Exp: 2035-09-10

Formulation

(5)

65/1009320797Grant: 2016-04-26 | Exp: 2036-04-21

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

55/1008318164Grant: 2012-11-27 | Exp: 2032-11-22

50/10011813328Grant: 2023-11-14 | Exp: 2043-11-09

50/10012178873Grant: 2024-12-31 | Exp: 2044-12-26

Manufacturing

(37)

75/1006210924Grant: 2001-04-03 | Exp: 2021-03-29

75/1008632995Grant: 2014-01-21 | Exp: 2034-01-16

75/1009012178Grant: 2015-04-21 | Exp: 2035-04-16

72/1009388447Grant: 2016-07-12 | Exp: 2036-07-07

72/10010106829Grant: 2018-10-23 | Exp: 2038-10-18

72/1008173394Grant: 2012-05-08 | Exp: 2032-05-03

70/1009371554Grant: 2016-06-21 | Exp: 2036-06-16

70/1007514237Grant: 2009-04-07 | Exp: 2029-04-02

70/1009803166Grant: 2017-10-31 | Exp: 2037-10-26

68/1009133493Grant: 2015-09-15 | Exp: 2035-09-10

65/10010822630Grant: 2020-11-03 | Exp: 2040-10-29

65/1007427659Grant: 2008-09-23 | Exp: 2028-09-18

65/10011254963Grant: 2022-02-22 | Exp: 2042-02-17

65/10011486883Grant: 2022-11-01 | Exp: 2042-10-27

65/1007842187Grant: 2010-11-30 | Exp: 2030-11-25

65/10011384378Grant: 2022-07-12 | Exp: 2042-07-07

65/10010227627Grant: 2019-03-12 | Exp: 2039-03-07

65/10010513723Grant: 2019-12-24 | Exp: 2039-12-19

65/10010167492Grant: 2019-01-01 | Exp: 2038-12-27

65/1007781395Grant: 2010-08-24 | Exp: 2030-08-19

58/1009359435Grant: 2016-06-07 | Exp: 2036-06-02

55/10010583397Grant: 2020-03-10 | Exp: 2040-03-05

55/1008354105Grant: 2013-01-15 | Exp: 2033-01-10

55/1008940878Grant: 2015-01-27 | Exp: 2035-01-22

55/10012325737Grant: 2025-06-10 | Exp: 2045-06-05

55/10010301663Grant: 2019-05-28 | Exp: 2039-05-23

55/1009279000Grant: 2016-03-08 | Exp: 2036-03-03

52/1008129145Grant: 2012-03-06 | Exp: 2032-03-01

52/1008058407Grant: 2011-11-15 | Exp: 2031-11-10

52/10012312381Grant: 2025-05-27 | Exp: 2045-05-22

52/10011130980Grant: 2021-09-28 | Exp: 2041-09-23

50/1007855280Grant: 2010-12-21 | Exp: 2030-12-16

50/1008263750Grant: 2012-09-11 | Exp: 2032-09-06

50/1007906024Grant: 2011-03-15 | Exp: 2031-03-10

50/1009643997Grant: 2017-05-09 | Exp: 2037-05-04

50/10011407784Grant: 2022-08-09 | Exp: 2042-08-04

50/10012269843Grant: 2025-04-08 | Exp: 2045-04-03

Device

(1)

50/10012053618Grant: 2024-08-06 | Exp: 2044-08-01

other

(1)

50/10010738334Grant: 2020-08-11 | Exp: 2040-08-06

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 125545 | 7 presentations

BiosimilarLicensedCDERInjection

Proper Name

epoetin alfa-epbx

Applicant

Hospira Inc., a Pfizer Company

Approval Date

15-May-18

Reference Product: Procrit — epoetin alfa

Presentations

2,000UNITS/ML — Single-Dose Vial (Intravenous, Subcutaneous)

3,000UNITS/ML — Single-Dose Vial (Intravenous, Subcutaneous)

4,000UNITS/ML — Single-Dose Vial (Intravenous, Subcutaneous)

10,000UNITS/ML — Single-Dose Vial (Intravenous, Subcutaneous)

40,000UNITS/ML — Single-Dose Vial (Intravenous, Subcutaneous)

20,000UNITS/2ML (10,000UNITS/ML) — Multi-Dose Vial (Intravenous, Subcutaneous)

20,000UNITS/ML — Multi-Dose Vial (Intravenous, Subcutaneous)

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jun 5, 2024	SUPPL -32	View Letter (PDF)
Apr 20, 2023	SUPPL -22	View Letter (PDF)
Jul 1, 2020	SUPPL -5	View Letter (PDF)
Jan 22, 2019	SUPPL -3	View Letter (PDF)
May 15, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.