Viewing data from:

TANZEUM

BLA

ALBIGLUTIDE | B125431 | GLAXOSMITHKLINE LLC

1 product0 Purple Book patents

Biologic LOELOE has passed

Estimated date when biosimilar competition may begin

April 15, 2026(79 days ago)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Apr. 15, 2026	Expired	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jul. 10, 20456947 days remaining

Based on latest discovered patent 12358945(manufacturing) · relevance 50/100

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

Discovered Patents

View all 16 patents →

16 AI-discovered patents, sorted by relevance.

Composition

(4)

95/1007238660Grant: 2007-07-03 | Exp: 2027-06-28

95/1007977306Grant: 2011-07-12 | Exp: 2031-07-07

85/10012257287Grant: 2025-03-25 | Exp: 2045-03-20

78/1009040668Grant: 2015-05-26 | Exp: 2035-05-21

Formulation

(3)

85/1008748377Grant: 2014-06-10 | Exp: 2034-06-05

75/1009938243Grant: 2018-04-10 | Exp: 2038-04-05

55/10010286037Grant: 2019-05-14 | Exp: 2039-05-09

Method of Use

(3)

95/1008691763Grant: 2014-04-08 | Exp: 2034-04-03

85/1008202837Grant: 2012-06-19 | Exp: 2032-06-14

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

Manufacturing

(6)

72/1009926570Grant: 2018-03-27 | Exp: 2038-03-22

50/1006194168Grant: 2001-02-27 | Exp: 2021-02-22

50/10012358945Grant: 2025-07-15 | Exp: 2045-07-10

50/1006949372Grant: 2005-09-27 | Exp: 2025-09-22

50/1006632425Grant: 2003-10-14 | Exp: 2023-10-09

50/10011667887Grant: 2023-06-06 | Exp: 2043-06-01

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 125431 | 2 presentations

351(a) ReferenceVoluntarily RevokedCDERFor Injection

Proper Name

albiglutide

Applicant

GlaxoSmithKline LLC

Approval Date

15-Apr-14

Presentations

30MG — Autoinjector (Subcutaneous)

50MG — Autoinjector (Subcutaneous)

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2017	SUPPL -20	View Letter (PDF)
Dec 18, 2017	SUPPL -21	View Letter (PDF)
Aug 2, 2017	SUPPL -19	View Letter (PDF)
Sep 15, 2016	SUPPL -18	View Letter (PDF)
Jul 28, 2015	SUPPL -14	View Letter (PDF)
May 11, 2015	SUPPL -9	View Letter (PDF)
Mar 11, 2015	SUPPL -8	View Letter (PDF)
Apr 16, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 30MG

▴

INJECTABLE;INJECTION | Approved: 2014-04-15 00:00:00

No patent or exclusivity listings for this strength.