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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

3 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	—
UCB, Inc. et al v. Cipla Limited et al 1:2021cv01229	D. Del.	2021-08-26	Terminated 2021-11-18	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

450 trials from ClinicalTrials.gov — 5 recruiting, 6 active, 333 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer NCT02365597	Phase 2	Active	Janssen Research & Development, LLC	239	2015-04-22 → 2027-03-31
Understanding How Ketamine Brings About Rapid Improvement in OCD NCT02624596	Phase 2	Active	Stanford University	120	2016-06 → 2026-06
Optimization of Procedural Sedation Protocol Used for Dental Care Delivery in People With Mental Disability NCT02078336	Phase 4	Active	Universitaire Ziekenhuizen KU Leuven	40	2013-12 → 2025-07
First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia NCT04067336	Phase 1/2	Active	Kura Oncology, Inc.	263	2019-09-12 → 2028-10-16
Safety of Driving After Minor Surgery With Monitored Anesthesia Care NCT00577200	Phase 4	Active	Rush University Medical Center	625	2008-01 → 2026-12
Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer NCT03436485	Phase 1/2	Active	Orion Corporation, Orion Pharma	204	2018-03-19 → 2026-07-31
Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients NCT03401593	N/A	Not Yet Recruiting	Yonsei University	135	2019-10 → 2028-06
Quelling of Excitotoxicity in Acute Stroke With Ketamine NCT03223220	Phase 2/3	Not Yet Recruiting	Lower Merion Neurology Research Foundation	120	2024-07-01 → 2027-12-31
The Effects of Different Anesthetics on Functional Connectivity NCT03343873	N/A	Recruiting	Beijing Tiantan Hospital	240	2017-04-01 → 2025-12-31
Sedation Versus Protective Stabilization for Pediatric Dental Treatment NCT04119180	Phase 4	Recruiting	Universidade Federal de Goias	152	2020-01-30 → 2026-02-28

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$327.11

per ea

Lowest NADAC/Unit

$327.11

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50474050015NAYZILAM 5 MG NASAL SPRAY	$327.11	EA	Brand	—	2026-06-17

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 (1 FSS, 1 Big4)

Lowest Price

$492.17

Highest Price

$598.56

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
50474-0500-15NAYZILAM 5MG/SPRAY	$598.56	FSS	UCB, Inc.	09/14/2030
50474-0500-15NAYZILAM 5MG/SPRAY	$492.17	Big4	UCB, Inc.	09/14/2030

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

Medicare Part D Spending

CMS annual spending data for Nayzilam (2024)

Total Spending

$36.9M

Total Claims

39,175

Beneficiaries

18,184

Avg Cost/Unit

$327.23

Spending Trend

$169K(2019)→$6.5M(2020)→$12.0M(2021)→$18.8M(2022)→$27.5M(2023)→$36.9M(2024)

YoY Change:-1.2%

5yr CAGR:+3.6%

Source: CMS Medicare Part D Spending by Drug (2024). 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) · 3 use codes

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