Viewing data from:

BAQSIMI

NDA

GLUCAGON | N210134 | AMPHASTAR PHARMACEUTICALS INC

1 strength3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivity

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Today

10213487

Feb. 16, 2036

10765602

Sep. 23, 2039

12370241

Feb. 16, 2036

NPP

Mar. 17, 2028

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

89 trials from ClinicalTrials.gov, 4 active, 68 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
GLP-1 and Hypoglycemia NCT01858896	Early Phase 1	Active	University of Maryland, Baltimore	28	2013-07 → 2026-12
Liver Glycogen and Hypoglycemia in Humans NCT03241706	Phase 1	Active	Jason Winnick	40	2018-08-02 → 2028-05-31
Effect of Prolonged (72 Hour) Glucagon Administration on Energy Expenditure in Healthy Obese Subjects NCT03139305	Phase 1	Active	AdventHealth Translational Research Institute	30	2017-10-24 → 2027-02
To Determine Tolerability to Glucagon Infusion in Obese Subjects NCT02817659	Phase 1	Active	AdventHealth Translational Research Institute	20	2016-11-01 → 2026-12
A Study of MK-0893 on Glucagon-Induced Glycemic Excursion in Healthy Male Participants Following Intravenous Administration of Glucagon, Sandostatine® and Insulin (MK-0893-002)NCT02012166	Phase 1	Completed	Merck Sharp & Dohme LLC	18	2005-07 → 2005-12
Bioequivalence of Fresenius Kabi USA, LLC Glucagon for SC Injection Compared to Glucagon for Injection (Bedford Laboratories)NCT02086227	Phase 1	Completed	Fresenius Kabi USA, LLC	32	2013-05 → 2013-06
GIP and GLP-1 on Gastric Emptying, Appetite and Insulin-glucose NCT01079624	Phase 1	Completed	Uppsala University	15	2006-08 → 2009-11
Characterization of Metabolic and Brain Effects of Rising Glucagon During an Oral Glucose Challenge NCT03061227	N/A	Completed	University Hospital Tuebingen	32	2017-02-10 → 2020-04-30
Effects of Exenatide on Motor Function and the Brain NCT03456687	Phase 1	Completed	University of Florida	5	2018-06-05 → 2021-08-25
The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men During Hypoglycemia NCT00418288	N/A	Completed	University of Aarhus	10	2007-01 → 2008-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$293.83

per ea

Lowest NADAC/Unit

$293.39

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00548835202BAQSIMI 3 MG SPRAY TWO PACK	$293.83	EA	Brand	—	2026-05-01
00548835101BAQSIMI 3 MG SPRAY ONE PACK	$293.39	EA	Brand	—	2026-05-01

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$209.97

Highest Price

$421.96

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00548-8351-01BAQSIMI 3MG INHL,NASAL,1 PK	$209.97	FSS	Amphastar Pharmaceuticals, Inc.	01/14/2027
00548-8352-02BAQSIMI 3MG INHL,NASAL,2 PK	$421.96	FSS	Amphastar Pharmaceuticals, Inc.	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Baqsimi (2024)

Total Spending

$21.5M

Total Claims

43,157

Beneficiaries

31,463

Avg Cost/Unit

$282.93

Spending Trend

$1.2M(2019)→$9.0M(2020)→$14.3M(2021)→$19.1M(2022)→$25.5M(2023)→$21.5M(2024)

YoY Change:-4.3%

5yr CAGR:-0.4%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs4 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

BACHEM AGGLUCAGON

DMF 182772005

AMBIOPHARM INCGLUCAGON (SYNTHETIC)

DMF 263262012

BACHEM AGGLUCAGON PHARMA GRADE

DMF 327032018

FRESENIUS KABI IPSUM SRLGLUCAGON

DMF 360172022

NOVO NORDISK ASInactiveGLUCAGON (BULK)

DMF 29611977

DIOSYNTH BVInactiveGLUCAGON

DMF 55461984

BACHEM FINE CHEMICALS INCInactiveGLUCAGON (1-29), HUMAN HCl SALT - TORRANCE AND SAN DIEGO, CA.

DMF 82531989

BACHEM CALIFORNIAInactiveGLUCAGON (1-29), HUMAN

DMF 122971996

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 18, 2025	SUPPL -4	View Letter (PDF)
Nov 2, 2020	SUPPL -2	View Letter (PDF)
Jul 25, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3MG

RLD

3 patents1 exclusivity▴

POWDER;NASAL | Approved: Jul 24, 2019

Patents (3) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10213487	Feb 16, 2036	—	—	Yes		—
10765602	Sep 23, 2039	—	—	Yes	—	—
12370241	Feb 16, 2036	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
NPP	Mar 17, 2028	Active