Viewing data from:

LEUKINE

BLA

SARGRAMOSTIM | B103362 | BERLEX LABS

2 products0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

March 29, 2025(461 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
7-Year Orphan	Mar. 29, 2025	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Aug. 7, 20456975 days remaining

Based on latest discovered patent 12384839(method of use) · relevance 88/100

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

Discovered Patents

View all 79 patents →

Top 50 of 79 AI-discovered patents by relevance.

Composition

(24)

95/1008268311Grant: 2012-09-18 | Exp: 2032-09-13

95/10010105415Grant: 2018-10-23 | Exp: 2038-10-18

92/1008263075Grant: 2012-09-11 | Exp: 2032-09-06

92/10011332525Grant: 2022-05-17 | Exp: 2042-05-12

92/1009085628Grant: 2015-07-21 | Exp: 2035-07-16

90/1006809191Grant: 2004-10-26 | Exp: 2024-10-21

90/10012187803Grant: 2025-01-07 | Exp: 2045-01-02

90/10011267859Grant: 2022-03-08 | Exp: 2042-03-03

88/10010889641Grant: 2021-01-12 | Exp: 2041-01-07

88/10010647767Grant: 2020-05-12 | Exp: 2040-05-07

85/1008506960Grant: 2013-08-13 | Exp: 2033-08-08

85/1008481704Grant: 2013-07-09 | Exp: 2033-07-04

85/1009132146Grant: 2015-09-15 | Exp: 2035-09-10

85/10011926662Grant: 2024-03-12 | Exp: 2044-03-07

85/10011993638Grant: 2024-05-28 | Exp: 2044-05-23

84/10012043844Grant: 2024-07-23 | Exp: 2044-07-18

82/1007223593Grant: 2007-05-29 | Exp: 2027-05-24

78/1009862927Grant: 2018-01-09 | Exp: 2038-01-04

78/10010253331Grant: 2019-04-09 | Exp: 2039-04-04

75/1009968664Grant: 2018-05-15 | Exp: 2038-05-10

75/1006764675Grant: 2004-07-20 | Exp: 2024-07-15

72/1009322010Grant: 2016-04-26 | Exp: 2036-04-21

72/10010023841Grant: 2018-07-17 | Exp: 2038-07-12

68/1008277818Grant: 2012-10-02 | Exp: 2032-09-27

Formulation

(2)

92/1006274175Grant: 2001-08-14 | Exp: 2021-08-09

88/1007858582Grant: 2010-12-28 | Exp: 2030-12-23

Method of Use

(19)

92/1009522172Grant: 2016-12-20 | Exp: 2036-12-15

92/10011655293Grant: 2023-05-23 | Exp: 2043-05-18

92/10011000521Grant: 2021-05-11 | Exp: 2041-05-06

88/10012384839Grant: 2025-08-12 | Exp: 2045-08-07

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

86/1006309632Grant: 2001-10-30 | Exp: 2021-10-25

85/10011020455Grant: 2021-06-01 | Exp: 2041-05-27

85/1009161969Grant: 2015-10-20 | Exp: 2035-10-15

85/10011938169Grant: 2024-03-26 | Exp: 2044-03-21

85/1007732407Grant: 2010-06-08 | Exp: 2030-06-03

85/10012173326Grant: 2024-12-24 | Exp: 2044-12-19

85/10011452768Grant: 2022-09-27 | Exp: 2042-09-22

82/1008273712Grant: 2012-09-25 | Exp: 2032-09-20

80/10010086067Grant: 2018-10-02 | Exp: 2038-09-27

78/1007361330Grant: 2008-04-22 | Exp: 2028-04-17

75/10011229645Grant: 2022-01-25 | Exp: 2042-01-20

72/10011229683Grant: 2022-01-25 | Exp: 2042-01-20

70/10010682400Grant: 2020-06-16 | Exp: 2040-06-11

68/10012016900Grant: 2024-06-25 | Exp: 2044-06-20

Manufacturing

(2)

82/1007150992Grant: 2006-12-19 | Exp: 2026-12-14

78/10012146161Grant: 2024-11-19 | Exp: 2044-11-14

Device

(1)

70/10010328133Grant: 2019-06-25 | Exp: 2039-06-20

Diagnostic

(2)

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

72/10011977075Grant: 2024-05-07 | Exp: 2044-05-02

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 103362 | 2 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

sargramostim

Applicant

Partner Therapeutics, Inc.

Approval Date

5-Mar-91

Orphan Exclusivity

29-Mar-25

Expired

Presentations

250MCG — Single-Dose Vial (Intravenous, Subcutaneous)

500MCG/ML — Multi-Dose Vial (Intravenous, Subcutaneous)

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 6, 2022	SUPPL -5249	View Letter (PDF)
Apr 1, 2018	SUPPL -5240	View Letter (PDF)
Feb 10, 2017	SUPPL -5237	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250UG/ML

▴

VIAL | Approved: 1991-03-05 00:00:00

No patent or exclusivity listings for this strength.

#002 — 500UG/ML

▾

VIAL | Approved: 1991-03-05 00:00:00