Viewing data from:

EQUETRO

NDA

CARBAMAZEPINE | N021710 | VALIDUS PHARMACEUTICALS LLC

3 strengths0 unique patents0 unique exclusivities

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

No clinical trials found on ClinicalTrials.gov for this drug

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 3 NDCs

Highest NADAC/Unit

$4.70

per ea

Lowest NADAC/Unit

$3.64

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
30698042312EQUETRO 300 MG CAPSULE	$4.70	EA	Brand	—	2026-10-21
30698042112EQUETRO 200 MG CAPSULE	$4.17	EA	Brand	—	2026-10-21
30698041912EQUETRO 100 MG CAPSULE	$3.64	EA	Brand	—	2026-10-21

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

VA Federal Supply Schedule

Government-negotiated contract prices | 3 NDCs (3 FSS)

Lowest Price

$344.55

Highest Price

$436.14

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
30698-0419-12EQUETRO 100MG CAP XR	$344.55	FSS	Validus Pharmaceuticals LLC	03/31/2028
30698-0421-12EQUETRO 200MG CAP XR	$387.62	FSS	Validus Pharmaceuticals LLC	03/31/2028
30698-0423-12EQUETRO 300MG CAP XR	$436.14	FSS	Validus Pharmaceuticals LLC	03/31/2028

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

Medicare Part D Spending

CMS annual spending data for Equetro (2024)

Total Spending

$1.0M

Total Claims

2,532

Beneficiaries

397

Avg Cost/Unit

$4.39

Spending Trend

$2.1M(2019)→$2.0M(2020)→$1.5M(2021)→$1.4M(2022)→$1.2M(2023)→$1.0M(2024)

YoY Change:-5.7%

5yr CAGR:-0.9%

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

API Supply Chain10 active DMFs16 inactive

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

SIEGFRIED EVIONNAZ SACARBAMAZEPINE

DMF 43411981

TAPI NL BVCARBAMAZEPINE USP

DMF 47191982

TARO PHARMACEUTICAL INDUSTRIES LTDCARBAMAZEPINE USP

DMF 49291983

FIS FABBRICA ITALIANA SINTETICI SPACARBAMAZEPINE

DMF 66411986

JUBILANT BIOSYS LTDCARBAMAZEPINE USP

DMF 144101999

SIEGFRIED EVIONNAZ SACARBAMAZEPINE (CARBATOL)

DMF 151952000

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)CARBAMAZEPINE USP

DMF 231702009

CTX LIFE SCIENCES PVT LTDCARBAMAZEPINE USP

DMF 241952010

ZAKLADY FARMACEUTYCZNE POLPHARMA SACARBAMAZEPINE

DMF 262662012

DASAMI LAB PRIVATE LTDCARBAMAZEPINE USP

DMF 361642021

ORION CORP LTDInactiveCARBAMAZEPINE USP XX

DMF 56651984

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveCARBAMAZEPINE

DMF 67421986

HEXAGON LABORATORIES INCInactiveCARBAMAZEPINE USP

DMF 67481986

SHANGHAI NO 2 PHARMACEUTICAL FACTORYInactiveCARBAMAZEPINE

DMF 71631987

AMERICAN CHEMICAL INDUSTRIAL CORPInactiveCARBAMAZEPINE

DMF 72881988

FREEDOM CHEMICAL DIAMALT GMBHInactiveCARBAMAZEPINE

DMF 77441988

CL PHARMA AGInactiveCARBAMAZEPINE

DMF 78151988

VIS FARMACEUTICI INSTITUTO SCIENTIFICO VINEZIE SPAInactiveCARBAMAZEPINE

DMF 78271988

CHEMWERTH INCInactiveCARBAMAZEPINE

DMF 79041989

FARCHEMIA SRLInactiveCARBAMAZEPINE

DMF 99671992

ARZNEIMITTELWERK DRESDEN GMBHInactiveCARBAMAZEPINE

DMF 119011996

MAX INDIA LTDInactiveCARBAMAZEPINE BULK DRUG SUBSTANCE

DMF 125121997

TEVA GROUPInactiveCARBAMAZEPINE USP

DMF 131251998

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDInactiveCARBAMAZEPINE USP

DMF 148932000

PHARMAZELL GMBHInactiveCARBAMAZEPINE

DMF 203762007

PHARMAZELL GMBHInactiveCARBAMAZEPINE (PROCESS II)

DMF 233282009

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Oct 17, 2022	SUPPL -18	View Letter (PDF)
Sep 26, 2016	SUPPL -12	View Letter (PDF)
Sep 26, 2016	SUPPL -11	View Letter (PDF)
Nov 14, 2012	SUPPL -9	View Letter (PDF)
Jan 31, 2012	SUPPL -13	View Letter (PDF)
Oct 27, 2010	SUPPL -8	View Letter (PDF)
May 4, 2009	SUPPL -6	View Letter (PDF)
Jan 9, 2008	SUPPL -5	View Letter (PDF)
Dec 28, 2006	SUPPL -3	View Letter (PDF)
Dec 10, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MG

RLD

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Dec 10, 2004

No patent or exclusivity listings for this strength.

#002 — 200MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Dec 10, 2004

#003 — 300MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Dec 10, 2004