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

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Baqsimi (2023)

Total Spending

$25.5M

Total Claims

48,621

Beneficiaries

32,681

Avg Cost/Unit

$295.57

Spending Trend

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

YoY Change:+0.4%

5yr CAGR:+1.0%

Source: CMS Medicare Part D Spending by Drug (2023). 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)

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