Viewing data from:

NYVEPRIA

Biosimilar

PEGFILGRASTIM-APGF | B761111 | HOSPIRA INC

1 product0 Purple Book patents1 biosimilar

Biologic LOEBiosimilar competition

1 approved biosimilar

June 10, 2032(2169 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 10, 2032	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Oct. 2, 20457031 days remaining

Based on latest discovered patent 12434015(device) · relevance 55/100

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

Approved Biosimilars

NyvepriaBLA 761111

Discovered Patents

View all 58 patents →

Top 50 of 58 AI-discovered patents by relevance.

Composition

(9)

75/1006552170Grant: 2003-04-22 | Exp: 2023-04-17

65/1007667008Grant: 2010-02-23 | Exp: 2030-02-18

65/1007166707Grant: 2007-01-23 | Exp: 2027-01-18

65/1008143380Grant: 2012-03-27 | Exp: 2032-03-22

65/1009279013Grant: 2016-03-08 | Exp: 2036-03-03

55/1009708375Grant: 2017-07-18 | Exp: 2037-07-13

55/1008518403Grant: 2013-08-27 | Exp: 2033-08-22

52/10010941182Grant: 2021-03-09 | Exp: 2041-03-04

50/1007189827Grant: 2007-03-13 | Exp: 2027-03-08

Formulation

(6)

55/1007956160Grant: 2011-06-07 | Exp: 2031-06-02

52/1009556240Grant: 2017-01-31 | Exp: 2037-01-26

52/1009320797Grant: 2016-04-26 | Exp: 2036-04-21

50/1007744890Grant: 2010-06-29 | Exp: 2030-06-24

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

50/10010653781Grant: 2020-05-19 | Exp: 2040-05-14

Manufacturing

(25)

68/10010106829Grant: 2018-10-23 | Exp: 2038-10-18

68/1008632995Grant: 2014-01-21 | Exp: 2034-01-16

68/1009012178Grant: 2015-04-21 | Exp: 2035-04-16

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

65/1009388447Grant: 2016-07-12 | Exp: 2036-07-07

62/1007427659Grant: 2008-09-23 | Exp: 2028-09-18

62/1009371554Grant: 2016-06-21 | Exp: 2036-06-16

62/1009133493Grant: 2015-09-15 | Exp: 2035-09-10

60/1007514237Grant: 2009-04-07 | Exp: 2029-04-02

58/1008940878Grant: 2015-01-27 | Exp: 2035-01-22

55/1009359435Grant: 2016-06-07 | Exp: 2036-06-02

55/10011486883Grant: 2022-11-01 | Exp: 2042-10-27

55/1009803166Grant: 2017-10-31 | Exp: 2037-10-26

55/1007842187Grant: 2010-11-30 | Exp: 2030-11-25

55/1007781395Grant: 2010-08-24 | Exp: 2030-08-19

55/1006210924Grant: 2001-04-03 | Exp: 2021-03-29

52/10011786866Grant: 2023-10-17 | Exp: 2043-10-12

50/1006942802Grant: 2005-09-13 | Exp: 2025-09-08

50/10011384140Grant: 2022-07-12 | Exp: 2042-07-07

50/1008952138Grant: 2015-02-10 | Exp: 2035-02-05

50/10011130980Grant: 2021-09-28 | Exp: 2041-09-23

50/1007294484Grant: 2007-11-13 | Exp: 2027-11-08

50/1007820799Grant: 2010-10-26 | Exp: 2030-10-21

50/1007335491Grant: 2008-02-26 | Exp: 2028-02-21

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

Device

(8)

72/1006270479Grant: 2001-08-07 | Exp: 2021-08-02

68/10012290666Grant: 2025-05-06 | Exp: 2045-05-01

65/10010646664Grant: 2020-05-12 | Exp: 2040-05-07

60/10010398854Grant: 2019-09-03 | Exp: 2039-08-29

55/10012434015Grant: 2025-10-07 | Exp: 2045-10-02

55/10011167082Grant: 2021-11-09 | Exp: 2041-11-04

50/10011033684Grant: 2021-06-15 | Exp: 2041-06-10

50/10010646652Grant: 2020-05-12 | Exp: 2040-05-07

other

(2)

65/10010570189Grant: 2020-02-25 | Exp: 2040-02-20

60/10010738334Grant: 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 761111

BiosimilarLicensedCDERInjection

Proper Name

pegfilgrastim-apgf

Applicant

Hospira Inc., a Pfizer Company

Approval Date

10-Jun-20

Reference Product: Neulasta — pegfilgrastim

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 26, 2026	SUPPL -10	View Letter (PDF)
Apr 19, 2021	SUPPL -4	View Letter (PDF)
Jun 12, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 6MG/0.6ML

▴

INJECTABLE;INJECTION | Approved: 2020-06-10 00:00:00

No patent or exclusivity listings for this strength.