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NAYZILAM

NDA

MIDAZOLAM | N211321 | UCB INC

1 strength4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2027

2028

Today

Jan. 18, 2028

Jan. 18, 2028

Jan. 18, 2028

Jan. 18, 2028

ODE-243

May. 17, 2026

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

2 cases on OB patents (2 active) from PACER

Case	Court	Filed	Status	Judge
UCB, Inc. et al v. Rubicon Research Limited 1:2026cv00427 4 patentsANDA 221285midazolam	D. Del.	2026-04-14	Active	—
UCB, Inc. et al v. Hikma Pharmaceuticals USA Inc. 1:2025cv00382 4 patentsANDA 219736midazolam	D. Del.	2025-03-28	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 Nayzilam (2023)

Total Spending

$27.5M

Total Claims

28,951

Beneficiaries

13,209

Avg Cost/Unit

$331.31

Spending Trend

$169K(2019)→$6.5M(2020)→$12.0M(2021)→$18.8M(2022)→$27.5M(2023)

YoY Change:+6.6%

5yr CAGR:+4.1%

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

API Supply Chain8 active DMFs4 inactive

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

WAVELENGTH ENTERPRISES LTDMIDAZOLAM

DMF 125531997

CAMBREX PROFARMACO MILANO SRLMIDAZOLAM

DMF 126861997

FIS FABBRICA ITALIANA SINTETICI SPAMIDAZOLAM HCI

DMF 252042011

COHANCE LIFESCIENCES LTDMIDAZOLAM USP

DMF 268712013

SOLARA ACTIVE PHARMA SCIENCES LTDMIDAZOLAM

DMF 298812015

CAMBREX PROFARMACO MILANO SRLMIDAZOLAM MALEATE

DMF 371022022

GLOBAL CALCIUM PRIVATE LTDMIDAZOLAM USP

DMF 393652024

SUPRIYA LIFESCIENCE LTDMIDAZOLAM USP

DMF 432712025

ABBOTT LABORATORIES HOSP PRODUCTS DIVInactiveMIDAZOLAM

DMF 127451997

DIOSYNTH BVInactiveMIDAZOLAM

DMF 129101998

PCASInactiveMIDAZOLAM BASE

DMF 129291998

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveMIDAZOLAM (NON-STERILE BULK) USP

DMF 151702000

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jan 17, 2023	SUPPL -8	View Letter (PDF)
Feb 9, 2021	SUPPL -5	View Letter (PDF)
Jun 20, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG/SPRAY

RLD

4 patents1 exclusivity▴

SPRAY;NASAL | Approved: May 17, 2019

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8217033	Jan 18, 2028	—	—	Yes		—
8809322	Jan 18, 2028	—	—	Yes	—	—
9289432	Jan 18, 2028	—	—	Yes		—
9687495	Jan 18, 2028	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
ODE-243	May 17, 2026	Expired