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BLA

EFLAPEGRASTIM-XNST | B761148 | SPECTRUM PHARMS

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

September 9, 2034(2990 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 9, 2034	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 65/100

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

Discovered Patents

View all 43 patents →

43 AI-discovered patents, sorted by relevance.

Composition

(14)

70/1006552170Grant: 2003-04-22 | Exp: 2023-04-17

70/1007169905Grant: 2007-01-30 | Exp: 2027-01-25

70/1008357367Grant: 2013-01-22 | Exp: 2033-01-17

65/1007112659Grant: 2006-09-26 | Exp: 2026-09-21

65/10011427627Grant: 2022-08-30 | Exp: 2042-08-25

65/1008518403Grant: 2013-08-27 | Exp: 2033-08-22

60/1007189827Grant: 2007-03-13 | Exp: 2027-03-08

55/1008143380Grant: 2012-03-27 | Exp: 2032-03-22

55/1009273106Grant: 2016-03-01 | Exp: 2036-02-25

55/1007166707Grant: 2007-01-23 | Exp: 2027-01-18

55/1007842784Grant: 2010-11-30 | Exp: 2030-11-25

55/1007186810Grant: 2007-03-06 | Exp: 2027-03-01

55/1009279013Grant: 2016-03-08 | Exp: 2036-03-03

50/10010829551Grant: 2020-11-10 | Exp: 2040-11-05

Formulation

(5)

70/1009352043Grant: 2016-05-31 | Exp: 2036-05-26

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

60/10011813328Grant: 2023-11-14 | Exp: 2043-11-09

55/1009320797Grant: 2016-04-26 | Exp: 2036-04-21

50/10010166189Grant: 2019-01-01 | Exp: 2038-12-27

Manufacturing

(24)

75/10010822630Grant: 2020-11-03 | Exp: 2040-10-29

72/10010513723Grant: 2019-12-24 | Exp: 2039-12-19

70/10010167492Grant: 2019-01-01 | Exp: 2038-12-27

70/1009359435Grant: 2016-06-07 | Exp: 2036-06-02

65/10012325737Grant: 2025-06-10 | Exp: 2045-06-05

65/10011130980Grant: 2021-09-28 | Exp: 2041-09-23

65/10010106829Grant: 2018-10-23 | Exp: 2038-10-18

60/10011384140Grant: 2022-07-12 | Exp: 2042-07-07

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

55/1006268212Grant: 2001-07-31 | Exp: 2021-07-26

55/10012195779Grant: 2025-01-14 | Exp: 2045-01-09

55/1008952138Grant: 2015-02-10 | Exp: 2035-02-05

55/1007381545Grant: 2008-06-03 | Exp: 2028-05-29

52/10011384378Grant: 2022-07-12 | Exp: 2042-07-07

50/10011077404Grant: 2021-08-03 | Exp: 2041-07-29

50/1008354105Grant: 2013-01-15 | Exp: 2033-01-10

50/1007662930Grant: 2010-02-16 | Exp: 2030-02-11

50/1006210924Grant: 2001-04-03 | Exp: 2021-03-29

50/10011854779Grant: 2023-12-26 | Exp: 2043-12-21

50/1008217153Grant: 2012-07-10 | Exp: 2032-07-05

50/10010481164Grant: 2019-11-19 | Exp: 2039-11-14

50/10011486883Grant: 2022-11-01 | Exp: 2042-10-27

50/1008053236Grant: 2011-11-08 | Exp: 2031-11-03

50/10010227627Grant: 2019-03-12 | Exp: 2039-03-07

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 761148

351(a) ReferenceLicensedCDERInjection

Proper Name

eflapegrastim-xnst

Applicant

Spectrum Pharmaceuticals, Inc.

Approval Date

9-Sep-22

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 18, 2025	SUPPL -11	View Letter (PDF)
Jun 20, 2023	SUPPL -2	View Letter (PDF)
Sep 13, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 13.2MG/0.6ML

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2022-09-09 00:00:00

No patent or exclusivity listings for this strength.