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GLUCAGEN

NDA

GLUCAGON HYDROCHLORIDE | N020918 | NOVO NORDISK PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

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

Medicare Part D Spending

CMS annual spending data for Glucagen (2023)

Total Spending

$4.9M

Total Claims

14,171

Beneficiaries

9,515

Avg Cost/Unit

$294.73

Spending Trend

$20.6M(2019)→$18.2M(2020)→$8.6M(2021)→$5.9M(2022)→$4.9M(2023)

YoY Change:+5.3%

5yr CAGR:-0.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Glucagen (2023)

Total Spending

$5.8M

Total Claims

28,595

Beneficiaries

26,881

ASP Price

—

HCPCS: J1610 — Injection, glucagon hydrochloride, per 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Jul 22, 2021	SUPPL -56	View Letter (PDF)
Mar 12, 2021	SUPPL -54	View Letter (PDF)
Sep 17, 2020	SUPPL -53	View Letter (PDF)
Apr 20, 2018	SUPPL -49	View Letter (PDF)
Dec 15, 2015	SUPPL -43	View Letter (PDF)
Mar 19, 2014	SUPPL -42	View Letter (PDF)
Apr 30, 2013	SUPPL -40	View Letter (PDF)
Jan 17, 2012	SUPPL -34	View Letter (PDF)
Dec 21, 2010	SUPPL -30	View Letter (PDF)
Nov 18, 2005	SUPPL -17	View Letter (PDF)
Dec 29, 2004	SUPPL -12	View Letter (PDF)
Mar 2, 2004	SUPPL -8	View Letter (PDF)
Jul 11, 2002	SUPPL -3	View Letter (PDF)
Jun 22, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

POWDER;INTRAMUSCULAR, INTRAVENOUS | Approved: Jun 22, 1998

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Approved: Jun 22, 1998