Viewing data from:

EPRONTIA

NDA

TOPIRAMATE | N214679 | AZURITY PHARMACEUTICALS INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2026

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Today

Aug. 21, 2040

Aug. 21, 2040

Aug. 21, 2040

Aug. 21, 2040

Aug. 21, 2040

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

215 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 169 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Topiramate and Schizophrenia: Effects on Weight and Psychopathology NCT02808533	N/A	Active	Centre for Addiction and Mental Health	50	2016-05 → 2026-08
Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD NCT03667846	Phase 2	Recruiting	NYU Langone Health	150	2019-10-10 → 2025-08-31
A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to Control Epilepsy NCT00236730	Phase 2	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	178	1988-06 → 1990-12
Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity NCT04298203	Phase 2	Completed	University of Minnesota	100	2021-08-04 → 2026-05-22
Qsymia as an Adjunct to Surgical Therapy in the Superobese NCT02301416	Phase 2	Completed	Wake Forest University Health Sciences	25	2014-12 → 2018-06-27
A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder NCT00037674	Phase 3	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	434	2001-01 → 2003-05
Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individuals NCT00300742	Phase 2	Completed	University of Virginia	5	2006-03 → 2008-07
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With Epilepsy NCT00236743	Phase 3	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	90	1994-06 → 2000-10
A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy NCT00266604	Phase 4	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	409	2005-12 → 2007-06
Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults NCT00518466	Phase 1	Completed	VIVUS LLC	64	2007-07 → 2007-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$2.70

per ml

Lowest NADAC/Unit

$1.58

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52652900103EPRONTIA 25 MG/ML SOLUTION	$2.70	ML	Brand	$2.07	2026-06-17
52652900102EPRONTIA 25 MG/ML SOLUTION	$2.55	ML	Brand	—	2026-01-01
52652900101EPRONTIA 25 MG/ML SOLUTION	$1.58	ML	Brand	$1.09	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 | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$228.32

Highest Price

$670.95

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52652-9001-01EPRONTIA 25MG/ML SOLN,ORAL	$670.95	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
52652-9001-01EPRONTIA 25MG/ML SOLN,ORAL	$585.31	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026
52652-9001-02EPRONTIA 25MG/ML SOLN,ORAL	$504.45	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
52652-9001-02EPRONTIA 25MG/ML SOLN,ORAL	$424.89	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026
52652-9001-03EPRONTIA 25MG/ML SOLN,ORAL	$270.25	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
52652-9001-03EPRONTIA 25MG/ML SOLN,ORAL	$228.32	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026

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

Medicare Part D Spending

CMS annual spending data for Eprontia (2024)

Total Spending

$896K

Total Claims

1,364

Beneficiaries

235

Avg Cost/Unit

$1.89

Spending Trend

$175K(2022)→$522K(2023)→$896K(2024)

YoY Change:+11.0%

5yr CAGR:+12.3%

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

API Supply Chain19 active DMFs11 inactive

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

JANSSEN PHARMACEUTICA NVTOPIRAMATE DRUG SUBSTANCE

DMF 109191994

CIPLA LTDTOPIRAMATE USP

DMF 156932001

DR REDDYS LABORATORIES LTDTOPIRAMATE USP

DMF 165332003

SCINOPHARM TAIWAN LTDTOPIRAMATE USP

DMF 170352003

ALIVUS LIFE SCIENCES LTDTOPIRAMATE USP

DMF 177292004

SUN PHARMACEUTICAL INDUSTRIES LTDTOPIRAMATE USP

DMF 181722005

HETERO DRUGS LTDTOPIRAMATE

DMF 183462005

ZYDUS LIFESCIENCES LTDTOPIRAMATE USP

DMF 187002005

APITORIA PHARMA PRIVATE LTDTOPIRAMATE USP

DMF 192472006

TORRENT PHARMACEUTICALS LTDTOPIRAMATE

DMF 203862007

ZAKLADY FARMACEUTYCZNE POLPHARMA SATOPIRAMATE

DMF 205812007

UNIMARK REMEDIES LTDTOPIRAMATE USP

DMF 209322007

UNIMARK REMEDIES LTDTOPIRAMATE USP (PROCESS A)

DMF 233492009

MSN ORGANICS PRIVATE LTDTOPIRAMATE USP [ROUTE CODE - "TI"]

DMF 257132012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDTOPIRAMATE

DMF 283712014

UNICHEM LABORATORIES LTDTOPIRAMATE USP

DMF 351912020

GLOBAL CALCIUM PRIVATE LTDTOPIRAMATE USP

DMF 396362024

HUADONG MEDICINE (XI'AN) BODYGUARD PHARMACEUTICAL CO LTDTOPIRAMATE

DMF 408292024

SNJ LIFECARE PVT LTDTOPIRAMATE USP

DMF 420322025

CILAG AGInactiveTOPIRAMATE

DMF 109781994

FERRO PFANSTIEHL LABORATORIES INCInactiveTOPIRAMATE

DMF 156582001

ALKALOIDA CHEMICAL CO ZRTInactiveTOPIRAMATE

DMF 164052003

CF PHARMA LTDInactiveTOPIRAMATE

DMF 182692005

LUPIN LTDInactiveTOPIRAMATE USP

DMF 193252006

DIVIS LABORATORIES LTDInactiveTOPIRAMATE

DMF 210682007

SIGNA SA DE CVInactiveTOPIRAMATE USP

DMF 216572008

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactiveTOPIRAMATE

DMF 227452009

ALEMBIC PHARMACEUTICALS LTDInactiveTOPIRAMATE USP

DMF 248332011

DISHMAN PHARMACEUTICALS AND CHEMICALS LTDInactiveTOPIRAMATE USP

DMF 269192013

ALEMBIC PHARMACEUTICALS LTDInactiveTOPIRAMATE

DMF 274392013

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Mar 9, 2026	SUPPL -12	View Letter (PDF)
Mar 14, 2025	SUPPL -9	View Letter (PDF)
May 20, 2024	SUPPL -7	View Letter (PDF)
Oct 28, 2022	SUPPL -2	View Letter (PDF)
Nov 8, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG/ML

RLDAB

5 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Nov 5, 2021

Patents (5) · 9 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11433046	Aug 21, 2040	—	—	—		—
11633374	Aug 21, 2040	—	—	Yes	—	—
11826343	Aug 21, 2040	—	—	Yes	—	—
11911362	Aug 21, 2040	—	—	Yes		—
12290503	Aug 21, 2040	—	—	Yes		—